{ "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": "2026-07-14", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "5", "submission_status": "AP", "submission_status_date": "20151211", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "6", "submission_status": "AP", "submission_status_date": "20170309", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "47547", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021855Orig1s006ltr.pdf", "date": "20170314", "type": "Letter" }, { "id": "47567", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021855Orig1s006lbl.pdf", "date": "20170316", "type": "Label" } ] }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20050804", "review_priority": "STANDARD", "submission_class_code": "TYPE 3", "submission_class_code_description": "Type 3 - New Dosage Form", "application_docs": [ { "id": "6309", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021855ltr.pdf", "date": "20050808", "type": "Letter" }, { "id": "21843", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021855s000TOC.html", "date": "20070604", "type": "Review" }, { "id": "37765", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021855lbl.pdf", "date": "20050808", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "14", "submission_status": "AP", "submission_status_date": "20200622", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "63686", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021855Orig1s014ltr.pdf", "date": "20200624", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "9", "submission_status": "AP", "submission_status_date": "20190131", "review_priority": "N/A", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "59326", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021855Orig1s009ltr.pdf", "date": "20190715", "type": "Letter" }, { "id": "59327", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021855Orig1s009lbl.pdf", "date": "20190715", "type": "Label" } ] } ], "application_number": "NDA021855", "sponsor_name": "BIONPHARMA", "openfda": { "application_number": [ "NDA021855" ], "brand_name": [ "ANTI-DIARRHEAL", "WELMATE ANTI DIARRHEAL LOPERAMIDE HCL SOFTGELS", "IMODIUM A-D" ], "generic_name": [ "LOPERAMIDE HYDROCHLORIDE" ], "manufacturer_name": [ "CHAIN DRUG MARKETING ASSOCIATION INC.", "PUBLIX SUPER MARKETS INC", "DISCOUNT DRUG MART, INC.", "AMERISOURCE BERGEN", "Rite Aid Corporation", "Northeast Pharma", "HEB", "WALGREENS", "VALU MERCHANDISERS COMPANY", "YYBA CORP", "CARDINAL HEALTH", "Albertsons Companies", "TOP CARE (Topco Associates LLC)", "KROGER COMPANY", "Kenvue Brands LLC", "TARGET Corporation", "MEIJER DISTRIBUTION INC", "Strategic Sourcing Services LLC", "Bionpharma Inc.", "Wal-Mart Stores, Inc.", "Premier Value Alliance LLC", "CVS Pharmacy, Inc.", "STRATEGIC SOURCING SERVICES", "DOLGENCORP, LLC", "Amazon.com Services LLC" ], "product_ndc": [ "83324-208", "56062-680", "53943-176", "83324-209", "63868-876", "46122-581", "11822-7834", "80136-851", "37808-988", "0363-1176", "63941-684", "73581-102", "70000-0461", "21130-835", "36800-208", "30142-159", "50580-367", "11673-177", "41250-210", "62011-0390", "69452-266", "49035-483", "68016-058", "69452-176", "69842-061", "70677-1062", "55910-176", "72288-313" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LOPERAMIDE HYDROCHLORIDE" ], "rxcui": [ "978006", "978009" ], "spl_id": [ "35a92deb-282b-5262-e063-6294a90a72f3", "239a6963-45b0-760f-e063-6394a90a9d39", "29f7ad31-3aec-834f-e063-6294a90a170d", "35aa2a71-e0a8-4dfd-e063-6294a90a3861", "f05dd9d9-e5a3-61ab-e053-2a95a90acbe0", "da57d294-64fd-f68f-e053-2a95a90ad396", "dfc3cd50-392a-4d97-e053-2a95a90a4d71", "f1172e57-0b18-d64f-e053-2a95a90a44db", "df62ad54-5aa3-4d05-e053-2a95a90aa48d", "460acf07-59c8-5b07-e063-6294a90a6021", "06fe77f7-a20c-f066-e063-6294a90a7653", "ec6b87f1-e600-21c2-e053-2a95a90ab76d", "19c647b6-61c7-68ed-e063-6294a90a02ff", "323643aa-2d51-0968-e063-6394a90aba7a", "f10fa51b-9cb9-502a-e053-2995a90a11d1", "29f7c72a-0e47-839c-e063-6294a90aed09", "460d0a84-5c0c-b974-e063-6294a90ab761", "45c5d51b-0158-8112-e063-6394a90a0640", "45b3f80b-d3f9-9ed7-e063-6394a90a41fa", "dfc6d50d-e754-c868-e053-2a95a90aafa8", "0d650c1b-bb45-6131-e063-6294a90a369e", "f0feada3-d253-2da9-e053-2a95a90a178e", "f0fe4551-a400-5bec-e053-2a95a90a55df", "a3d76812-4130-4578-a272-e165f67d9238", "4bcfb428-8f47-d298-e063-6394a90a58dd", "f9e03d2b-2ec1-322b-e053-6394a90a1599", "e08f6085-d26e-518a-e053-2995a90a0495", "4fe731b6-0352-f925-e063-6394a90a4171" ], "spl_set_id": [ "35a938af-decf-5b5d-e063-6294a90a9ab0", "17035ff7-8ba8-131c-e063-6394a90af5ea", "ed28814d-9733-46ff-930f-b148e31f2f51", "35aa2daf-3486-7ee2-e063-6394a90ad473", "edae1ea7-7a6a-4971-8a21-c2b508e96f4e", "1a8f6a42-e74f-4725-b12e-b85c2d015191", "9cee17ca-bd11-3d40-e053-2995a90ac8fe", "c2db4155-68d4-71be-e053-2a95a90a7f35", "3ea49be2-1744-4d14-bc43-09d35fd4b3c7", "50814751-8bee-4768-bf6c-e9da3400090b", "fed347ad-cfbb-9ee8-e053-6394a90ad275", "ae2e15e9-1707-296d-e053-2995a90a1b95", "bd58d6e9-628c-4c6b-b44c-da95e0417ba7", "1d4ec76d-ff0d-a55d-e063-6294a90ae22c", "c62bc8d4-0857-16fc-e053-2a95a90a0c41", "ff5dcb48-318c-4f2a-8df2-73ff6dd2a49e", "31bfcbb4-c58c-4edc-ac68-356a448b7507", "ee8a6bdf-847e-4b88-8aea-6d3daa669994", "440fb3ce-4106-4169-b187-cfbfdd2f42c1", "1537febf-2816-438b-979a-8c8f16f06de5", "a14bd404-cc79-06e0-e053-2a95a90a6841", "507acd63-b2b4-465e-bb94-2d66724de20a", "0dd97bfb-67ce-472f-9b23-15f613bb3135", "8f1ee652-a4f7-4e5b-874f-46aa641cd43f", "60bc8f05-f35e-45e0-ba3b-c82a87d60f5b", "f9e03d2b-2ec0-322b-e053-6394a90a1599", "d1fd9a92-9d96-4921-b789-c1f710ee2351", "04a35525-ae8e-b41e-e063-6294a90ab10e" ], "package_ndc": [ "83324-208-12", "56062-680-12", "53943-176-12", "83324-209-24", "63868-876-12", "63868-876-24", "46122-581-62", "11822-7834-2", "11822-7834-9", "80136-851-42", "37808-988-12", "0363-1176-12", "0363-1176-08", "63941-684-12", "73581-102-24", "70000-0461-1", "21130-835-12", "36800-208-12", "30142-159-08", "30142-159-12", "50580-367-01", "50580-367-02", "11673-177-12", "41250-210-12", "41250-210-08", "62011-0390-1", "69452-266-12", "49035-483-12", "68016-058-12", "69452-176-12", "69842-061-12", "69842-061-08", "70677-1062-1", "55910-176-12", "55910-176-08", "72288-313-12" ], "unii": [ "77TI35393C" ] }, "products": [ { "product_number": "002", "reference_drug": "Yes", "brand_name": "LOPERAMIDE HYDROCHLORIDE", "active_ingredients": [ { "name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2MG" } ], "reference_standard": "Yes", "dosage_form": "CAPSULE", "route": "ORAL", "marketing_status": "Over-the-counter" }, { "product_number": "001", "reference_drug": "Yes", "brand_name": "LOPERAMIDE HYDROCHLORIDE", "active_ingredients": [ { "name": "LOPERAMIDE HYDROCHLORIDE", "strength": "1MG" } ], "reference_standard": "No", "dosage_form": "CAPSULE", "route": "ORAL", "marketing_status": "Over-the-counter" } ] } ] }