Package 68083-510-01

Brand: fomepizole

Generic: fomepizole
NDC Package

Package Facts

Identity

Package NDC 68083-510-01
Digits Only 6808351001
Product NDC 68083-510
Description

1 VIAL in 1 CARTON (68083-510-01) / 1.5 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2023-07-06
Brand fomepizole
Generic fomepizole
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "69c8a021-8f8d-4989-b5b5-976c1ec5b7b2", "openfda": {"nui": ["N0000175429"], "unii": ["83LCM6L2BY"], "rxcui": ["310414"], "spl_set_id": ["7e133194-dacb-446a-a657-2d2430a02373"], "pharm_class_epc": ["Antidote [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-510-01)  / 1.5 mL in 1 VIAL", "package_ndc": "68083-510-01", "marketing_start_date": "20230706"}], "brand_name": "Fomepizole", "product_id": "68083-510_69c8a021-8f8d-4989-b5b5-976c1ec5b7b2", "dosage_form": "INJECTION", "pharm_class": ["Antidote [EPC]"], "product_ndc": "68083-510", "generic_name": "Fomepizole", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fomepizole", "active_ingredients": [{"name": "FOMEPIZOLE", "strength": "1 g/mL"}], "application_number": "ANDA216791", "marketing_category": "ANDA", "marketing_start_date": "20230706", "listing_expiration_date": "20261231"}