Package 83634-401-10

Brand: tranexamic acid

Generic: tranexamic acid
NDC Package

Package Facts

Identity

Package NDC 83634-401-10
Digits Only 8363440110
Product NDC 83634-401
Product ID 83634-401_5dece4b5-d95e-4fe7-b0ed-89bd573f2fad
Description

10 VIAL, SINGLE-DOSE in 1 CARTON (83634-401-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-401-41)

Marketing

Marketing Status
Marketed Since 2024-06-01
Brand tranexamic acid
Generic tranexamic acid
Sample Package No

Linked Drug Pages (1)

tranexamic acid ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5dece4b5-d95e-4fe7-b0ed-89bd573f2fad", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "rxcui": ["238720"], "spl_set_id": ["00630e54-0e84-465d-96a5-63486c87dcd9"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Avenacy, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-401-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (83634-401-41)", "package_ndc": "83634-401-10", "marketing_start_date": "20240601"}], "brand_name": "tranexamic acid", "product_id": "83634-401_5dece4b5-d95e-4fe7-b0ed-89bd573f2fad", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "83634-401", "generic_name": "tranexamic acid", "labeler_name": "Avenacy, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tranexamic acid", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "100 mg/mL"}], "application_number": "ANDA203521", "marketing_category": "ANDA", "marketing_start_date": "20240601", "listing_expiration_date": "20261231"}