Package 68083-568-01

Brand: argatroban

Generic: argatroban
NDC Package

Package Facts

Identity

Package NDC 68083-568-01
Digits Only 6808356801
Product NDC 68083-568
Description

1 VIAL in 1 CARTON (68083-568-01) / 50 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2023-07-31
Brand argatroban
Generic argatroban
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "0f487fff-cf82-44ce-bc1b-c32fa7bdf1c7", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "unii": ["IY90U61Z3S"], "rxcui": ["1804735"], "spl_set_id": ["270dbb59-e080-4a64-91d9-a68bed4bd2e5"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-568-01)  / 50 mL in 1 VIAL", "package_ndc": "68083-568-01", "marketing_start_date": "20230731"}], "brand_name": "Argatroban", "product_id": "68083-568_0f487fff-cf82-44ce-bc1b-c32fa7bdf1c7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "68083-568", "generic_name": "Argatroban", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Argatroban", "active_ingredients": [{"name": "ARGATROBAN", "strength": "50 mg/50mL"}], "application_number": "ANDA217848", "marketing_category": "ANDA", "marketing_start_date": "20230731", "listing_expiration_date": "20261231"}