{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Anticoagulant Citrate Dextrose A Anhydrous Citric Acid, Dextrose Monohydrate, and Trisodium Citrate Dihydrate DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE ANHYDROUS CITRIC ACID ANHYDROUS CITRIC ACID TRISODIUM CITRATE DIHYDRATE ANHYDROUS CITRIC ACID" ], "description": [ "Description Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., (ACD-A), is a sterile, non-pyrogenic solution of citric acid, sodium citrate, and dextrose, in water for injection. Each 10 mL of solution contains: Citric Acid, anhydrous, USP 0.073 g Sodium Citrate, dihydrate, USP 0.220 g Dextrose, monohydrate, USP 0.245 g Water for Injection, USP q.s. pH: 4.5 – 5.5 Single patient use only, on a single occasion. single use" ], "description_table": [ "
Citric Acid, anhydrous, USP0.073 g
Sodium Citrate, dihydrate, USP0.220 g
Dextrose, monohydrate, USP0.245 g
Water for Injection, USPq.s.
pH: 4.5 – 5.5
" ], "clinical_pharmacology": [ "Clinical Pharmacology ACD-A acts as an anticoagulant by the action of the citrate ion chelating free ionized calcium, thus making calcium unavailable to the coagulation system." ], "indications_and_usage": [ "Indications and Usage Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P. (ACD-A), is intended for use as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use." ], "contraindications": [ "Contraindications NOT FOR DIRECT INTRAVENOUS INFUSION" ], "warnings": [ "Warnings NOT FOR DIRECT INTRAVENOUS INFUSION" ], "precautions": [ "Precautions General Aseptic technique must be maintained at all times. ACD-A solution is a clear and colorless solution. If the product shows any cloudiness or turbidity, the product should be discarded. The closure system provides a biological barrier and should be intact – discard product if system is compromised. Information for Patients None. Carcinogenesis, mutagenesis, impairment of fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of ACD-A. Pregnancy Long-term studies in animals have not been performed to evaluate the effects of ACD- A on pregnant women. Pediatric Use The safety and effectiveness of ACD-A in children have not been established." ], "general_precautions": [ "General Aseptic technique must be maintained at all times. ACD-A solution is a clear and colorless solution. If the product shows any cloudiness or turbidity, the product should be discarded. The closure system provides a biological barrier and should be intact – discard product if system is compromised." ], "information_for_patients": [ "Information for Patients None." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, mutagenesis, impairment of fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of ACD-A." ], "pregnancy": [ "Pregnancy Long-term studies in animals have not been performed to evaluate the effects of ACD- A on pregnant women." ], "pediatric_use": [ "Pediatric Use The safety and effectiveness of ACD-A in children have not been established." ], "adverse_reactions": [ "Adverse Reactions Not applicable. This product is used as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP)." ], "overdosage": [ "Overdosage Not applicable. This product is used as an anticoagulant in the extracorporeal blood processing with Autologous PRP systems in production of platelet rich plasma (PRP)." ], "dosage_and_administration": [ "Dosage and Administration Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use." ], "spl_unclassified_section": [ "Rx Only Caution: Federal Law (US) restricts this devise to sale by or on the order of a Physician.", "Manufactured & Distributed by: Citra Labs™ 55 Messina Drive, Braintree, MA 02184 Phone Number: 1-800-299-3411 Authorized Representative: Biomet Global Supply Chain Center B.V. Hazeldonk 6530 4836 LD Breda The Netherlands Principal Display Panel" ], "how_supplied": [ "How Supplied Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., (ACD-A) REF SIZE CASE PN 9350-10 30 mL 10 Vials/Case PN 9350-25 30 mL 25 Vials/Case It is recommended that the product be stored at ambient room temperature, 24 °C (75 °F); however, the product can be stored between 15 °C (59 °F) and 30 °C (86 °F). Protect from freezing and exposure to excessive heat should be minimized." ], "how_supplied_table": [ "
REFSIZECASE
PN 9350-1030 mL10 Vials/Case
PN 9350-2530 mL25 Vials/Case
" ], "storage_and_handling": [ "It is recommended that the product be stored at ambient room temperature, 24 °C (75 °F); however, the product can be stored between 15 °C (59 °F) and 30 °C (86 °F). Protect from freezing and exposure to excessive heat should be minimized." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 10 Vial Case Label C E 0044 ACD-A Anticoagulant Citrate Dextrose Solution, 10 Vials / Case Solution A, U.S.P., ACD-A, 30 mL REF PN 9350-10 WARNING: NOT FOR DIRECT INTRAVENOUS INFUSION Used as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to PRP Systems manufacturer's Directions for Use. Manufactured & Distributed by: Citra Labs A Biomet Inc. Company. Citra Labs, LLC. 55 Messina Drive, Braintree, MA 02184 1-800-299-3411 EC REP Authorized Representative: Biomet Global Supply Chain Center B.V. Hazeldonk 6530 4836 LD Breda The Netherlands STERILE • NON-PYROGENIC Composition per 10 mL of Solution: Citric Acid, (Anhydrous), U.S.P. 0.073 g. Sodium Citrate, (Dihydrate), U.S.P. 0.220 g. Dextrose, (Monohydrate), U.S.P. 0.245 g. CAUTION: Single Procedure Use-Discard Unused Portion Do Not Use Unless Solution is Clear and Seal is Intact. Store Between 15 °C - 30 °C (59 °F - 86 °F). RX Only: EXP DATE LOT LA9350-10B 01/20 symbols label", "PRINCIPAL DISPLAY PANEL - 25 Vial Case Label C E 0044 ACD-A Anticoagulant Citrate Dextrose Solution, 25 Vials / Case Solution A, U.S.P., ACD-A, 30 mL REF PN 9350-25 WARNING: NOT FOR DIRECT INTRAVENOUS INFUSION Used as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to PRP Systems manufacturer's Directions for Use. Manufactured & Distributed by: Citra Labs A Biomet Inc. Company. Citra Labs, LLC. 55 Messina Drive, Braintree, MA 02184 1-800-299-3411 EC REP Authorized Representative: Biomet Global Supply Chain Center B.V. Hazeldonk 6530 4836 LD Breda The Netherlands STERILE • NON-PYROGENIC Composition per 10 mL of Solution: Citric Acid, (Anhydrous), U.S.P. 0.073 g. Sodium Citrate, (Dihydrate), U.S.P. 0.220 g. Dextrose, (Monohydrate), U.S.P. 0.245 g. CAUTION: Single Procedure Use-Discard Unused Portion Do Not Use Unless Solution is Clear and Seal is Intact. Store Between 15 °C - 30 °C (59 °F - 86 °F). RX Only: EXP DATE LOT LA9350-25 01/20 label" ], "set_id": "5bcd261e-ebba-4ecb-af22-e5aaeb04499b", "id": "9a133b17-0377-431f-b839-3e090fdabd78", "effective_time": "20230214", "version": "5", "openfda": { "application_number": [ "BN020037" ], "brand_name": [ "Anticoagulant Citrate Dextrose A" ], "generic_name": [ "ANHYDROUS CITRIC ACID, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE" ], "manufacturer_name": [ "Citra Labs LLC" ], "product_ndc": [ "23731-6051" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "EXTRACORPOREAL" ], "substance_name": [ "ANHYDROUS CITRIC ACID", "DEXTROSE MONOHYDRATE", "TRISODIUM CITRATE DIHYDRATE" ], "spl_id": [ "9a133b17-0377-431f-b839-3e090fdabd78" ], "spl_set_id": [ "5bcd261e-ebba-4ecb-af22-e5aaeb04499b" ], "package_ndc": [ "23731-6051-3", "23731-6051-1", "23731-6051-2" ], "is_original_packager": [ true ], "nui": [ "N0000175833", "N0000175835", "N0000175980", "N0000008556", "N0000175089" ], "pharm_class_moa": [ "Acidifying Activity [MoA]", "Calcium Chelating Activity [MoA]" ], "pharm_class_epc": [ "Calculi Dissolution Agent [EPC]", "Anti-coagulant [EPC]" ], "pharm_class_pe": [ "Decreased Coagulation Factor Activity [PE]" ], "unii": [ "XF417D3PSL", "LX22YL083G", "B22547B95K" ] } } ] }