{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "safetyreportversion": "7", "safetyreportid": "18285788", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20250716", "reporttype": "2", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20200918", "receiptdateformat": "102", "receiptdate": "20250509", "fulfillexpeditecriteria": "1", "companynumb": "US-SHIRE-US202030205", "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "6", "senderorganization": "TAKEDA" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientweight": "67", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Diverticulitis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Skin cancer", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "COVID-19", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Pleurisy", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Bronchitis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Throat irritation", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Multiple allergies", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Product dose omission issue", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Seasonal allergy", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Sinusitis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Upper respiratory tract infection", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Asthma", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Feeling abnormal", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Cough", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "HUMAN IMMUNOGLOBULIN G", "drugauthorizationnumb": "125596", "drugstructuredosagenumb": "2", "drugstructuredosageunit": "002", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "2 GRAM, QD", "drugdosageform": "Solution for infusion", "drugindication": "Immunodeficiency common variable", "drugstartdateformat": "102", 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"manufacturer_name": [ "ADMA Biologics, Inc.", "Kedrion S.p.A." ], "product_ndc": [ "69800-0250", "76179-010" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "HUMAN IMMUNOGLOBULIN G" ], "rxcui": [ "2123037", "2123042", "2726016", "2726023", "2726025", "2726026" ], "spl_id": [ "4ecc6123-99fa-fa43-e063-6294a90a548f", "59a061e8-a6b0-4036-800e-1344e2d4ce97" ], "spl_set_id": [ "d74f4360-3b51-496c-96fb-84c3976958d2", "6f1933e0-240f-48f4-b246-8a30e63a4160" ], "package_ndc": [ "69800-0250-2", "69800-0250-1", "76179-010-01", "76179-010-02", "76179-010-03", "76179-010-04" ], "nui": [ "N0000184165", "N0000183365", "N0000184008", "M0011122" ], "pharm_class_epc": [ "Human Immunoglobulin G [EPC]" ], "pharm_class_pe": [ "Passively Acquired Immunity [PE]" ], "pharm_class_moa": [ "Antigen Neutralization [MoA]" ], "pharm_class_cs": [ "Immunoglobulins [CS]" ], "unii": [ "66Y330CJHS" ] } }, { "drugcharacterization": "1", "medicinalproduct": "HUMAN IMMUNOGLOBULIN G", "drugauthorizationnumb": "125596", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "002", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "2 GRAM, 5/WEEK", "drugdosageform": "Solution for infusion", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "HUMAN IMMUNOGLOBULIN G" }, "openfda": { "application_number": [ "BLA125590", "BLA125822" ], "brand_name": [ "ASCENIV", "QIVIGY KTHM" ], "generic_name": [ "HUMAN IMMUNOGLOBULIN G" ], "manufacturer_name": [ "ADMA Biologics, Inc.", "Kedrion S.p.A." ], "product_ndc": [ "69800-0250", "76179-010" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "HUMAN IMMUNOGLOBULIN G" ], "rxcui": [ "2123037", "2123042", "2726016", "2726023", "2726025", "2726026" ], "spl_id": [ "4ecc6123-99fa-fa43-e063-6294a90a548f", 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"ANDA219215", "ANDA219096", "ANDA204052", "ANDA214331", "NDA204957", "NDA018337", "M", "ANDA215403", "ANDA202605", "NDA204767", "ANDA216592", "ANDA076200", "NDA206968", "ANDA210969" ], "brand_name": [ "AMAZON BASIC CARE ACETAMINOPHEN", "PAIN RELIEF", "MAXIMUM STRENGTH NON-ASPIRIN 100", "MAXIMUM STRENGTH NON-ASPIRIN 250", "INFANTS PAIN FEVER", "TOPCARE PAIN RELIEF", "ACETAMINOPHEN", "PEDIACARE CHILDRENS ACETAMINOPHEN GRAPE", "PAIN RELIEVER EXTRA STRENGTH", "8 HOUR ARTHRITIS PAIN", "PAIN RELIEVER", "CHILDRENS PAIN AND FEVER", "TOPCARE CHILDRENS PAIN AND FEVER", "TOPCARE 8 HR ARTHRITIS PAIN RELIEF", "APAP", "FOSTER AND THRIVE PAIN RELIEVER", "DYE FREE INFANTS PAIN AND FEVER", "CHILDRENS TYLENOL", "GENEXA ACETAMINOPHEN EXTRA STRENGTH", "ARTHRITIS PAIN RELIEVER", "ARTHRITIS PAIN RELIEF", "TYLENOL EXTRA STRENGTH", "DR SIMI PAIN RELIEF 100", "EXTRA STRENGTH ACETAMINOPHEN", "EXTRA STRENGTH PAIN RELIEF", "HEB", "ACETAMINOPHEN EXTRA STRENGTH", "CAREALL ACETAMINOPHEN", "PAIN AND FEVER", "PAIN RELIEF EXTRA STRENGTH", "LEADER INFANTS PAIN AND FEVER", "CHILDRENS ACETAMINOPHEN", "TYLENOL 8 HR MUSCLE ACHES AND PAIN", "CHILDRENS CHEWABLE ACETAMINOPHEN", "PAIN RELIEF CHILDRENS", "TYLENOL 8 HR ARTHRITIS PAIN", "TYLENOL FOR CHILDREN PLUS ADULTS", "ACETAMINOPHEN FOR CHILDREN", "INFANTS PAIN AND FEVER", "UP AND UP ACETAMINOPHEN INFANTS", "TYLENOL REGULAR STRENGTH", "CHILDRENS PAIN RELIEF", "DG HEALTH CHILDRENS PAIN AND FEVER", "RAPIDOL 500 EXTRA STRENGTH", "CVS CHILDRENS PAIN PLUS FEVER RELIEF", "CHILDRENS PAIN AND FEVER RELIEF", "PENTREXCILINA", "INFANTS FEVER REDUCER AND PAIN RELIEVER", "GOOD NEIGHBOR PHARMACY INFANTS PAIN AND FEVER", "CHILDREN ACETAMINOPHEN ORAL SOLUTION", "ACETAMINOPHEN REGULAR STRENGTH", "PEDIACARE CHILDRENS GRAPE", "NEO-LUBRINA", "ACETAMINOPHEN EASY TABS EXTRA STRENGTH", "GENCARE- PAIN RELIEF ACETAMINOPHEN", "GOOD NEIGHBOR PHARMACY PAIN RELIEF", "CHILDRENS PAIN RELIEVER", "EQUATE PAIN RELIEVER", "NIGHTTIME COLD AND FLU RELIEF", "CLEAR CHOICE REGULAR STRENGTH PAIN RELIEVER", "AMAZON BASICS ACETAMINOPHEN", "FOSTER AND THRIVE INFANTS PAIN AND FEVER", "TOPCARE INFANTS PAIN AND FEVER", "SIGNATURE CARE CHILDRENS PAIN RELIEF", "CABINET PAIN RELIEVER AND FEVER REDUCER REFILL ACETAMINOPHEN", "CVS ACETAMINOPHEN", "PAIN RELIEF REGULAR STRENGTH", "PANADOL EXTRA STRENGTH", "BASIC CARE CHILDRENS PAIN AND FEVER", "8HR MUSCLE ACHES AND PAIN", "MEDIQUE EXTRA STRENGTH APAP", "MEDI-FIRST EXTRA STRENGTH NON-ASPIRIN", "MEDI-FIRST PLUS EXTRA STRENGTH NON-ASPIRIN", "EXTRA STRENGTH PAIN RELIEVER", "BASIC CARE INFANTS PAIN AND FEVER", "GOOD SENSE PAIN RELIEF", "PAIN RELIEF ACETAMINOPHEN 325 MG", "REVASOL ACETAMINOPHEN SUSPENSION", "MEDIQUE APAP EXTRA STRENGTH", "MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH", "MEDI FIRST PLUS NON-ASPIRIN EXTRA STRENGTH", "ACETAMINOPHEN 500 MG", "EQUATE PAIN AND FEVER INFANTS", "REGULAR STRENGTH PAIN RELIEVER", "DYE FREE CHILDRENS ACETAMINOPHEN", "EQUATE 8HR ARTHRITIS PAIN RELIEF", "8 HOUR PAIN RELIEF", "EQUATE PAIN RELIEVER ACETAMINOPHEN FOR ADULTS 250 MG", "M-PAP", "INFANTS PAIN RELIEF", "ACETAMINOPHEN 325MG", "REVASOL ACETAMINOPHEN SUSPENSION DYE FREE", "DURALGINA EXTRA STRENGTH", "KINDERFARMS INFANTS PAIN AND FEVER", "DYE FREE PAIN RELIEVER CHILDRENS", "ULINE ACETAMINOPHEN EXTRA STRENGTH", "PAIN RELIEF FEVER REDUCER CHILDREN", "BACTIMICINA CHILDRENS PAIN AND FEVER", "DOLO- NEUROBION ACETAMINOPHEN 500MG", "MEMBERS MARK ARTHRITIS PAIN", "MEJORALITO CHILDREN", "LIL DRUG STORE CHILDRENS PAIN AND FEVER", "KIDS PAIN AND FEVER", "BASIC CARE ACETAMINOPHEN", "ACETAMINOPHEN PAIN RELIEVER FEVER REDUCER", "PAIN AND FEVER CHILDRENS", "REGULAR STRENGTH ACETAMINOPHEN", "EQUALINE ACETAMINOPHEN", "PANADOL", "CHILDRENS PAIN RELIEVER AND FEVER REDUCER GRAPE", "LLORENS CARE CHILDREN ACETAMINOPHEN", "LEADER CHILDRENS PAIN AND FEVER", "INFANTS TYLENOL", "VICKS PAINQUIL LIQUICAPS PAIN RELIEVER", "GERICARE LIQUID PAIN RELIEF", "NITE-TIME COLD/FLU MEDICINE CHERRY", "AUROPHEN REGULAR STRENGTH", "FAMILY WELLNESS CHILDRENS PAIN RELIEVER 574", "REXALL PAIN RELIEF", "MEIJER CHILDRENS PAIN AND FEVER REDUCER", "EIGHT HOUR PAIN RELIEF", "DOLO-NEUROBION", "CHILDRENS PAIN AND FEVER DISSOLVE PACKS", "MOMMYS BLISS INFANTS PAIN AND FEVER", "8HR ARTHRITIS PAIN", "GOOD NEIGHBOR PHARMACY CHILDRENS PAIN AND FEVER", "REGULAR STRENGTH PAIN RELIEF", "MIDOL LONG LASTING RELIEF", "PAIN RELIEVER CHILDRENS", "8 HR ARTHRITIS PAIN", "KIRKLAND SIGNATURE ACETAMINOPHEN ADULT EXTRA STRENGTH", "ACETAMINOPHEN GELCAPS", "WALGREENCHILDRENS PAIN FEVER", "COUNTERACT PAIN", "KROGER CHILDREN PAIN PLUS FEVER CHEWABLES", "FEVERALL", "DRX CHOICE REGULAR STRENGTH", "ACETAMINOPHEN EXTENDED-RELEASE", "GOOD SENSE CHILDRENS PAIN AND FEVER", "NOTTS - EXTRA STRENGTH 500 MG", "MEDLINE", "ROBITUSSIN DIRECT SORE THROAT PAIN", "TOPCARE 8 HOUR PAIN RELIEF", "ARTHRITIS PAIN", "CHEWABLE ACETAMINOPHEN CHILDRENS", "ACETAMINOPHEN CAPLETS", "DESENFRIOL-ITO PLUS", "TEMP X", "MEJORALITO", "FEVERALL CHILDRENS", "FEVER REDUCING CHILDRENS", "JUNIOR ACETAMINOPHEN AGES 6-11", "GENEXA ACETAMINOPHEN PM EXTRA STRENGTH", "CAREALL ACETAMINOPHEN EXTRA STRENGTH", "CHILDREN PAIN AND FEVER RELIVER", "GREEN GUARD MAXIMUM NON-ASPIRIN", "CETAFEN EXTRA", "CHILDRENS ACETAMINOPHEN ORAL LIQUID GRAPE FLAVOR", "PAIN RELIEF CHILDRENS DYE FREE", "MEJORALITO CHILDREN CHILDREN", "DR. SANA PAIN AND FEVER FOR CHILDREN", "CAREONE INFANTS ACETAMINOPHEN", "MEDIQUE APAP", "MEDI-FIRST NON-ASPIRIN", "MEDI-FIRST PLUS NON-ASPIRIN", "DOVER AMINOFEN", "DOVER AMINOPHEN", "MEDI FIRST PLUS NON-ASPIRIN", "EQUALINE CHILDRENS ACETAMINOPHEN", "GOOD SENSE PAIN RELIEF ARTHRITIS PAIN", "UP AND UP CHILDRENS ACETAMINOPHEN", "MAJOR EXTRA STRENGTH ACETAMINOPHEN LIQUID", "UP AND UP INFANTS ACETAMINOPHEN", "ACETAMINOPHEN GELCAPS EXTRA STRENGTH", "CAREONE CHILDRENS ACETAMINOPHEN", "GENEXA KIDS PAIN AND FEVER", "FOSTER AND THRIVE CHILDRENS PAIN AND FEVER", "ACETAMINOPHEN 325 MG", "CHILDREN ACETAMINOPHEN", "365 WHOLE FOODS MARKET ACETAMINOPHEN", "CAREONE 8 HOUR PAIN RELIEF", "PAIN AND FEVER CHEWABLES CHILDRENS", "NOTTS - MUSCLE ACHES AND PAIN", "CIRCLE K PAIN RELIEVER EXTRA STRENGTH", "EXTRA STRENGTH PAIN RELEIF", "ACETAMINOPHEN SOLUTION", "NEO-LUBRINA CHILDREN", "LITTLE REMEDIES INFANT FEVER/PAIN RELIEVER", "PHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH", "EQUATE PAIN AND FEVER CHILDRENS", "PAIN RELIEVER FEVER REDUCER CHILDRENS", "ACETAMINOPHEN (RED)", "CHILDRENS PAIN AND FEVER, GRAPE FLAVOR", "TYLENOL 8HR", "CHILDRENS ACETAMINOPHEN ORAL SUSPENSION", "DURALGINA", "MAJOR ACETAMINOPHEN", "MOMMYS BLISS CHILDRENS PAIN AND FEVER", "DG HEALTH PAIN RELIEF", "CHILDRENS FEVER REDUCER AND PAIN RELIEVER", "LIQUID ACETAMINOPHEN", "GENEXA INFANTS PAIN AND FEVER", "TYLENOL EXTRA STRENGTH, TRAVEL BASIX", "TYLENOL EXTRA STRENGTH, CVP HEALTH", "PHARBETOL", "8HR ARTHRITIS PAIN RELIEF", "SIGNATURE CARE PAIN RELIEF", "PARRY-500MG ACETAMINOPHEN", "ACETAMINOPHEN 650MG", "PAIN RELIEF EXTRA STRENGTH, NON-ASPIRIN", "CHILDRENS PAIN AND FEVER CHERRY FLAVOR", "GOOD SENSE PAIN AND FEVER INFANTS", "RUGBY INFANTS ACETAMINOPHEN", "PAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH", "8HR PAIN RELIEF", "DOLO - NEUROBION ACETAMINOPHEN MAX EXTENDED-RELEASE 650 MG", "PARENTS CHOICE INFANTS PAIN AND FEVER", "VICKS PAINQUIL PAIN RELIEVER", "FEVERALL JR. STRENGTH", "DR KIDS PAIN AND FEVER", "DG HEALTH 8 HOUR PAIN RELIEF", "AUROPHEN EXTRA STRENGTH FOR ADULTS", "CAREALL NON ASPIRIN EXTRA STRENGTH", "EXTRA STRENGTH MINI SOFTGELS PAIN RELIEVER", "MEDI-FIRST EXTRA STRENGTH NON ASPIRIN", "MEDI-FIRST PLUS EXTRA STRENGTH NON ASPIRIN", "MEMBERS MARK ACETAMINOPHEN", "ONESSIP ACETAMINOPHEN", "GOOD SENSE PAIN AND FEVER", "SAFETYNADOL", "CHILDRENS TUKOL ACETAMINOPHEN FEVER REDUCER PAIN REDUCER", "MAX RELIEF JUNIOR", "EQUATE PAIN RELIEF", "LEADER ACETAMINOPHEN", "RAPIDOL", "FEVERALL INFANTS", "ATAMEL FORTE", "KOSHER MEDS CHILDRENS PAIN AND FEVER", "EXTRA STRENGTH NO-PAIN", "MUSCLE ACHES AND PAINS ACETAMINOPHEN EXTENDED RELEASE", "GREEN GUARD MAXIMUM STRENGTH NON-ASPIRIN", "TEMPERAL-ITO", "EXCEDRIN RAPID RELIEF", "PUREGEN LABS ACETAMINOPHEN", "HENRY SCHEIN ACETAMINOPHEN", "8 HR PAIN RELIEF", "ED APAP", "INFANTS PAIN AND FEVER CHERRY FLAVOR", "PAIN RELIEVER FEVER REDUCER EXTRA STRENGTH", "WELBY ACETAMINOPHEN", "MEDIQUE AT HOME APAP", "PAIN RELIEF 8 HR", "THOMPSON EXTRA STRENGTH NON-ASPIRIN", "CROCIN MAX", "ADWE CHILDRENS PAIN FEVER", "TOPCARE PAIN AND FEVER", "GOOD NEIGHBOR PHARMACY MENSTRUAL PAIN RELIEF", "CHILDRENS CHEWABLES", "MCKESSON ACETAMINOPHEN 325", "CHILDRENS PAIN PLUS FEVER RELIEF", "RUGBY CHILDRENS ACETAMINOPHEN", "EQUATE INFANTS PAIN AND FEVER", "EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY", "FAST ACTING PEDIA CRAE", "DOLEX CHILDREN PAIN AND FEVER", "DIRECT SAFETY ASPIRIN FREE", "SIGNATURE CARE INFANTS PAIN RELIEF", "RUGBY REGULAR STRENGTH ACETAMINOPHEN", "WALGREEN CHILDRENS PAIN PLUS FEVER", "CHILDRENS ACETAMINOPHEN DYE FREE GRAPE", "CHILDRENS PAIN RELIEF AND FEVER REDUCER ORAL SUSPENSION CHERRY", "UNISHIELD EXTRA STRENGTH NON-ASPIRIN", "UNISHIELD EXTRA STRENGTH NON ASPIRIN", "GENEXA CHILDRENS ACETAMINOPHEN", "RIGHT REMEDIES PAIN RELIEF EXTRA STRENGTH CAPLET", "DG HEALTH 8 HR ARTHRITIS PAIN RELIEF", "VITAPIRENA", "PAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH", "GOODNOW PAIN RELIEF", "GOOD SENSE INFANTS PAIN AND FEVER", "GOOD NEIGHBOR PHARMACY PAIN AND FEVER CHILDRENS", "EQUATE MENSTRUAL PAIN RELIEF", "LEADER 8HR ARTHRITIS PAIN RELIEF", "MAPAP EXTRA STRENGTH", "MANTRA PAIN GEL RASPBERRY", "RINGL", "BETTER LIVING BRANDS CHILDRENS FEVER AND PAIN RELIVER", "DYE FREE PAIN AND FEVER CHILDRENS", "RAPID RELEASE PAIN RELIEF", "NON-ASPIRIN CHILDRENS", "APHEN", "CHILDREN PAIN AND FEVER RELIEVER", "CHILDRENS PAIN RELIEVER AND FEVER REDUCER CHERRY", "DR. COCOA FOR CHILDREN PAIN AND FEVER", "KINDERFARMS CHILDRENS PAIN AND FEVER", "GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN", "CETAFEN", "ARTHRITIS PAIN ACETAMINOPHEN", "BERKLEY AND JENSEN PAIN RELIEF", "PHARBETOL REGULAR STRENGTH", "BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN", "XPECT ACETAMINOPHEN", "TYLENOL EXTRA STRENGTH CAPLET", "DYE FREEINFANTS PAIN AND FEVER", "EQUATE CHILDRENS PAIN AND FEVER", "CAREONE ACETAMINOPHEN", "ADWE FEVERX ACETAMINOPHEN CAPLETS, 500 MG EXTRA STRENGTH", "CHILDRENS MAPAP", "DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE", "8 HR ARTHRITIS PAIN RELIEF", "PAIN RELIEVER DYE FREE", "RESFRIOL-ITO CHILDREN", "FOSTER AND THRIVE RAPID RELEASE PAIN RELIEF", "ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 MG", "BERKLEY AND JENSEN ACETAMINOPHEN", "CHILDRENS PAIN AND FEVER DYE FREE", "8 HR MUSCLE ACHES AND PAIN", "8HR MUSCLE ACHES AND PAIN RELIEF", "NITE-TIME COLD/FLU MEDICINE", "DR SIMI PAIN RELIEF", "GESTEIRA", "CARE ONE ARTHRITIS PAIN RELIEF", "LITTLE REMEDIES CHILDRENS FEVER PAIN RELIEVER" ], "generic_name": [ "ACETAMINOPHEN", "ACETAMINOPHEN 500MG", "ACETAMINOPHEN TABLET EXTENDED RELEASE", "PAIN RELIEVER" ], "manufacturer_name": [ "Amazon.com Services LLC", "Meijer, Inc.", "JHK Inc dba American Safety & First Aid", "H E B", "Sixarp, LLC", "PAI Holdings, LLC dba PAI Pharma", "HYVEE INC", "RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH", "L.N.K. International, Inc.", "AMERISOURCE BERGEN", "WALMART INC. (see also Equate)", "Walgreen Company", "Kroger Company", "AptaPharma Inc.", "Topco Associates LLC", "Granules USA, Inc", "Advance Pharmaceutical Inc.", "Meijer Distribution Inc", "Strategic Sourcing Services LLC", "FAMILY DOLLAR SERVICES INC", "Kenvue Brands LLC", "Genexa Inc.", "WALGREENS", "LIDL US LLC", "PUBLIX SUPERMARKETS, INC", "KROGER COMPANY", "Farmacias De Similares TX LLC", "Pinnacle RX LLC", "VALU MERCHANDISERS COMPANY", "HEB", "Magno-Humphries, Inc.", "Hi-Tech Nutraceuticals, LLC", "CVS PHARMACY", "New World Imports, Inc", "Chain Drug Marketing Association", "Cardinal Health 110, LLC. dba Leader", "Aurohealth LLC", "DISCOUNT DRUG MART", "United Natural Foods, Inc. dba UNFI", "American Health Packaging", "P & L Development, LLC", "GERI-CARE PHARMACEUTICAL CORP", "Major Pharmaceuticals", "TIME CAP LABORATORIES, INC", "Rite Aid Corporation", "Padagis Israel Pharmaceuticals Ltd", "LEADER/ Cardinal Health 110, Inc.", "Target Corporation", "Acetris Pharma Holdings, LLC", "Better Living Brands, LLC", "Valu Merchandisers Company", "Dolgencorp Inc", "Pharmadel LLC", "Softgel Healthcare Pvt Ltd", "Chain Drug Marketing Association, Inc.", "OPMX LLC", "Dolgencorp, LLC", "Wal-Mart Stores Inc", "KinderFarms, LLC", "HyVee Inc", "HARRIS TEETER", "Amerisource Bergen", "MAJOR PHARMACEUTICALS", "GoodSense", "TOPCO ASSOCIATES LLC", "BLESSINGS INTERNATIONAL", "OPMX Chula Vista", "WinCo Foods, LLC", "Pioneer Life Sciences, LLC", "COSTCO WHOLESALE CORPORATION", "Grocery Outlet, Inc.", "CVS Pharmacy", "BJWC (Berkley & Jensen / BJ's)", "Wildman Business Group", "WALMART INC.", "Dr. Reddy's Laboratories Inc.", "Bi-Mart", "Walgreens", "Allegiant Health", "TIME CAP LABORATORIES, INC.", "Athlete's Needs, Inc.", "Safeway", "Meijer", "ARMY AND AIR FORCE EXCHANGE SERVICE", "PUBLIX SUPER MARKETS INC", "MEIJER, INC.", "Cabinet Health P.B.C.", "Family Dollar, Inc.", "STRATEGIC SOURCING SERVICES LLC", "WAL-MART STORES INC", "Haleon US Holdings LLC", "WALGREEN CO.", "CVS HEALTH CORP", "CVS PHARMACY INC", "FSA STORE INC.", "Unifirst First Aid Corporation", "AAA Pharmaceutical, Inc.", "INGLES MARKETS, INC.", "L. Perrigo Company", "NUVICARE LLC", "Rnv LLC", "Shield Pharmaceuticals Corp", "CVS Pharmacy, Inc.", "Geri-Care Pharmaceutical Corp", "Strategic Sourcing Services, LLC", "Granules USA, Inc.", "Richmond Pharmaceuticals, Inc.", "Granules Pharmaceuticals Inc.", "MARC GLASSMAN, INC.", "Walmart Inc", "Method Pharmaceuticals, LLC", "Publix Super Markets Inc", "CVS PHARMACY, INC.", "Marlex Pharmaceuticals Inc", "Harris Teeter", "Menper Distributors, Inc.", "Safeway, Inc.", "Uline", "Ellywell, LLC", "DLC Laboratories, Inc.", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "BENARD INDUSTRIES INC", "Camber Pharmaceuticals, Inc.", "WALMART INC", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Sam's West Inc", "Lil' Drug Store Products, Inc.", "CARDINAL HEALTH", "DOLGENCORP, LLC", "SAFEWAY", "Rising Pharma Holdings, Inc.", "DeMoulas Market Basket", "Salado Sales, Inc.", "Llorens Pharmaceutical International Division, Inc.", "Topco Associates, LLC", "The Procter & Gamble Manufacturing Company", "CVS PHARMACY, INC", "Geri-Care Pharmaceuticals, Corp", "Family Dollar Services, Inc.", "MEIJER DISTRIBUTION INC", "TIME CAP LABS INC", "WALGREENS CO.", "Mom Enterprises, LLC.", "Mylan Institutional LLC", "Reliable 1 Laboratories LLC", "Belmora LLC", "Bayer HealthCare LLC.", "Sagent Pharmaceuticals", "Costco Wholesale Company", "Caplin Steriles Limited", "WALGREEN COMPANY", "Family Dollar (FAMILY WELLNESS)", "Civica, Inc.", "AMERICAN SALES COMPANY", "TARGET CORPORATION", "Demoulas Super Markets, Inc", "Oncor Pharmaceuticals", "Melaleuca, Inc.", "Sun Pharmaceutical Industries, Inc.", "Raritan Pharmaceuticals Inc.", "FOODHOLD U.S.A., LLC", "VIVUNT PHARMA LLC", "Medline Industries, LP", "Baxter Healthcare Corporation", "SAM'S WEST INC", "Sandoz Inc", "Cardinal Health 110, LLC. DBA Leader", "Breeden Brothers, LLC", "B. Braun Medical Inc.", "Family Dollar Services Inc", "MEIJER", "QUALITY CHOICE (Chain Drug Marketing Association)", "Chain Drug Consortium", "AARNA USA INC.", "HART Health", "GADAL Laboratories, Inc", "CVS PHARMACY iNC", "CHAIN DRUG MARKETING ASSOCIATION INC", "Rugby Laboratories", "Retail Business Services, LLC", "Discount Drug Mart", "Kroger", "AMERIFOODS TRADING COMPANY", "WG Critical Care, LLC", "American Sales Company", "Genexa, Inc.", "Whole Foods Market, INC.", "Shield Pharmaceuticals Corp.", "Solupharm Pharmazeutische Erzeugnisse GmbH", "Walmart", "Marc Glassman, Inc.", "Orelli Inc.", "Patrin Pharma, Inc.", "CHAIN DRUG CONSORTIUM", "BETTER LIVING BRANDS LLC.", "Medtech Products Inc.", "Acme United Corporation", "PuraCap Pharmaceutical LLC", "Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.", "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "Menper Distributors Inc.", "RITE AID", "Granules India Limited", "RETAIL BUSINESS SERVICES , LLC.", "Walmart Inc.", "Prostat First Aid", "Hikma Pharmaceuticals USA Inc.", "LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION", "BluePoint Laboratories", "LEADER/ Cardinal Health 110, Inc", "Family Dollar Stores, LLC", "Pharbest Pharmaceuticals, Inc.", "CHAIN DRUG MARKETING ASSOCIATION INC.", "Velocity Pharma LLC", "Better Living Brands LLC", "MDC PHARMACEUTICALS LIMITED", "Forreal Pharmaceuticals, LLC", "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd", "CalmCo LLC", "Best Choice (Valu Merchandisers Company)", "Meijer Distribution, Inc.", "TopCo Associates LLC", "BETTER LIVING BRANDS, LLC", "MEDWISE LIFESCIENCES INC.", "Westminster Pharmaceuticals, LLC", "Sinew Pharma Inc.", "FSA Store Inc.", "Genomma Lab USA, Inc.", "Akron Pharma Inc.", "Mollec Inc", "Safrel Pharmaceuticals, LLC.", "Advanced Rx LLC", "Henry Schein, Inc.", "Health Pharma USA LLC", "DOLGENCORP, INC.", "EDWARDS PHARMACEUTICALS, INC.", "FAMILY DOLLAR", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "Aldi, Inc", "Fresenius Kabi USA, LLC", "Thompson", "CVS Pharmacy,Inc.", "RARITAN PHARMACEUTICALS INC", "McKesson Medical-Surgical, Inc.", "CVS Pharmacy, Inc", "Randob Labs., Ltd.", "Conney Safety Products, LLC", "RUGBY LABORATORIES", "FSA Store Inc. (Caring Mills)", "Puro Pharma Inc.", "THE KROGER CO", "Unishield", "Strive Pharmaceuticals Inc.", "RAONBIO CORP", "Trifecta Pharmaceuticals USA LLC", "Gobrands, Inc", "CVS", "OPMX", "MOREMED INC.", "RETAIL BUSINESS SERVICES,LLC.", "Sato Pharmaceutical Co., Ltd.", "BETTER LIVING BRANDS LLC", "WINCO FOODS, LLC", "Asclemed USA, Inc.", "Infirst Healthcare Inc.", "McKesson", "BJWC", "AmeriSource Bergen", "Cintas Corporation", "Jones Healthcare Group - Packaging Services, Inc", "Aurex Laboratories Limited Liability Company", "HHH Pharmaceuticals", "Advagen Pharma Limited", "MARKSANS PHARMA LIMITED", "UNFI", "Gland Pharma Limited", "Eugia US LLC" ], "product_ndc": [ "72288-405", "79481-0302", "73598-1122", "73598-1124", "59640-766", "59368-210", "0121-2094", "42507-404", "52412-906", "50844-519", "46122-629", "79903-172", "0363-1502", "30142-561", "76281-526", "36800-202", "69848-008", "36800-455", "17714-013", "41250-148", "70677-1138", "55319-206", "50580-579", "69676-0059", "0363-9781", 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"362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "TC2D6JAD40", "WK2XYI10QM" ], "nui": [ "N0000000160", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "OMEPRAZOLE", "drugseparatedosagenumb": "1", "drugindication": "Product used for unknown indication", "activesubstance": { "activesubstancename": "OMEPRAZOLE" }, "openfda": { "application_number": [ "NDA022032", "ANDA079182", "ANDA210593", "ANDA207891", "ANDA075410", "ANDA206877", "ANDA075757", "ANDA206582", "ANDA075576", "NDA209400", "ANDA216096", "ANDA091352", "ANDA203481", "ANDA207740", "ANDA076515", "ANDA076048", "ANDA211732", "ANDA204012", "ANDA218829", "ANDA091672", "ANDA213201", "ANDA078490", "ANDA212977", "ANDA203270" ], "brand_name": [ "GOOD NEIGHBOR PHARMACY OMEPRAZOLE", "OMEPRAZOLE/SODIUM BICARBONATE", "KIRKLAND SIGNATURE OMEPRAZOLE", "OMEPRAZOLE", "FOSTER AND THRIVE OMEPRAZOLE", "ACID REDUCER", "GOOD NOW OMEPRAZOLE", "GOOD SENSE OMEPRAZOLE", "BASIC CARE OMEPRAZOLE", "OMEPRAZOLE DELAYED RELEASE", "BERKLEY AND JENSEN OMEPRAZOLE", "UP AND UP OMEPRAZOLE", "EQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER", "DG HEALTH OMEPRAZOLE", "TOPCARE OMEPRAZOLE", "CAREONE OMEPRAZOLE", "EQUALINE OMEPRAZOLE", "LEADER OMEPRAZOLE", "EQUATE OMEPRAZOLE", "DG HEALTH OMPERAZOLE", "OMEPRAZOLE DELAYED-RELEASE", "SIGNATURE CARE OMEPRAZOLE", "MEMBERS MARK OMEPRAZOLE", "AMAZON BASIC CARE OMEPRAZOLE", "RUGBY OMEPRAZOLE", "TOPCARE OMEPRAZOLE DELAYED RELEASE", "24 HR OMEPRAZOLE", "CARE ONE OMEPRAZOLE", "EXCHANGE SELECT OMEPRAZOLE", "GOOD SENSE OMEPRAZOLE DELAYED RELEASE" ], "generic_name": [ "OMEPRAZOLE", "OMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "Amerisource Bergen", "Strides Pharma Science Limited", "Costco Wholesale Company", "INNOVUS PHARMACEUTICALS, INC.", "OHM LABORATORIES INC.", "Strategic Sourcing Services LLC", "STRATEGIC SOURCING SERVICES LLC", "GERI-CARE PHARMACEUTICALS, CORP", "Lannett Company, Inc.", "WALGREEN CO.", "Sandoz Inc", "Cardinal Health", "Chartwell RX, LLC", "CVS Pharmacy, Inc.", "HARRIS TEETER", "PLD Acquisitions LLC DBA Avma Pharma Solutions", "RELIABLE 1 LABORATORIES LLC", "DISCOUNT DRUG MART", "Gobrands, Inc", "L. Perrigo Company", "WinCo Foods, LLC", "Aurohealth LLC", "Amazon.com Services LLC", "Meijer Distribution Inc.", "Meijer Distribution Inc", "H2-Pharma, LLC", "BJWC", "CVS Pharmacy", "H E B", "Quallent Pharmaceuticals Health LLC", "Target Corporation", "Fred's, Inc.", "Wal-Mart Stores Inc", "THE KROGER COMPANY", "HyVee Inc", "Meijer, Inc.", "Dolgencorp, LLC", "Topco Associates LLC", "Dolgencorp Inc", "Zydus Lifesciences Limited", "NORTHEAST PHARMA", "P & L Development, LLC", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Retail Business Services, LLC", "Walgreen Company", "United Natural Foods, Inc. dba UNFI", "Little Pharma, Inc.", "American Sales Company", "Golden State Medical Supply, Inc.", "Padagis Israel Pharmaceuticals Ltd", "BluePoint Laboratories", "Cardinal Health 110, LLC. dba Leader", "Twin Med LLC", "Sun Pharmaceutical Industries, Inc.", "Zydus Pharmaceuticals USA Inc.", "Walmart Inc.", "Apotex Corp", "Strategic Sourcing Services", "Rite Aid", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Rite Aid Corporation", "Rugby Laboratories", "VALU MERCHANDISERS COMPANY", "WALMART INC. (see also Equate)", "Camber Pharmaceuticals, Inc.", "H-E-B", "KROGER COMPANY", "Living Better Brands LLC", "Safeway", "Publix Super Markets Inc", "Sam's West Inc", "Camber Consumer Care Inc", "Glenmark Pharmaceuticals Inc., USA", "Family Dollar (FAMILY WELLNESS)", "Allegiant Health", "Dr. Reddy's Laboratories Limited", "Kroger Company", "NorthStar Rx LLC", "BI-MART", "Family Dollar Stores, LLC", "Chain Drug Marketing Association INC", "AMERISOURCEBERGEN DRUG CORPORATION", "CVS Pharamacy, Inc", "Bi-Mart", "Dr. Reddys Laboratories Inc", "YYBA CORP", "Aurobindo Pharma Limited", "UP & UP", "Winco Foods, LLC.", "Xiromed, LLC", "WALMART INC.", "7-Eleven", "Army & Air Force Exchange Service", "Best Choice", "Rising Pharma Holdings, Inc.", "Walgreens", "Wal-Mart Stores, Inc.", "Discount Drug Mart, Inc" ], "product_ndc": [ "46122-281", "64380-182", "64380-183", "63981-915", "57483-740", "51660-029", "70677-1275", "70677-1098", "57896-659", "62175-114", "62175-118", "62175-136", "0363-1008", 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"1667880", "1667882", "1667885", "1667886", "2166203", "2166204" ], "spl_id": [ "e44a3eea-f679-45fc-994a-0e960975b36b" ], "spl_set_id": [ "7b656b14-fcaa-2741-f6f0-e0be48971c02" ], "package_ndc": [ "0597-0160-61", "0597-0160-28", "0597-0100-61", "0597-0100-28", "0597-0100-51" ], "unii": [ "XX112XZP0J" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ADVAIR HFA", "drugseparatedosagenumb": "1", "activesubstance": { "activesubstancename": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE" }, "openfda": { "application_number": [ "NDA021254" ], "brand_name": [ "ADVAIR HFA" ], "generic_name": [ "FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE" ], "manufacturer_name": [ "GlaxoSmithKline LLC" ], "product_ndc": [ "0173-0715", "0173-0716", "0173-0717" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "RESPIRATORY (INHALATION)" ], "substance_name": [ "FLUTICASONE PROPIONATE", "SALMETEROL XINAFOATE" ], "rxcui": [ "896231", "896235", "896236", "896237", "896239", "896243", "896244", 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