Package 68083-613-10
Brand: tranexamic acid in sodium chloride
Generic: tranexamic acidPackage Facts
Identity
Package NDC
68083-613-10
Digits Only
6808361310
Product NDC
68083-613
Description
10 POUCH in 1 CARTON (68083-613-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
Marketing
Marketing Status
Brand
tranexamic acid in sodium chloride
Generic
tranexamic acid
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "71e0764f-b584-49fb-ba62-11f3fb32d3fc", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "rxcui": ["2170286"], "spl_set_id": ["f06f07de-bedf-4b37-b15e-0959e0a154e6"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (68083-613-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG", "package_ndc": "68083-613-10", "marketing_start_date": "20240416"}], "brand_name": "TRANEXAMIC ACID IN SODIUM CHLORIDE", "product_id": "68083-613_71e0764f-b584-49fb-ba62-11f3fb32d3fc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "68083-613", "generic_name": "TRANEXAMIC ACID", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRANEXAMIC ACID IN SODIUM CHLORIDE", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "10 mg/mL"}], "application_number": "ANDA218599", "marketing_category": "ANDA", "marketing_start_date": "20240416", "listing_expiration_date": "20261231"}