fomepizole

Generic: fomepizole

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fomepizole
Generic Name fomepizole
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fomepizole 1 g/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-510
Product ID 68083-510_69c8a021-8f8d-4989-b5b5-976c1ec5b7b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216791
Listing Expiration 2026-12-31
Marketing Start 2023-07-06

Pharmacologic Class

Established (EPC)
antidote [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083510
Hyphenated Format 68083-510

Supplemental Identifiers

RxCUI
310414
UNII
83LCM6L2BY
NUI
N0000175429

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fomepizole (source: ndc)
Generic Name fomepizole (source: ndc)
Application Number ANDA216791 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-510-01) / 1.5 mL in 1 VIAL
source: ndc

Packages (1)

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

Ingredients (1)

fomepizole (1 g/mL)

Linked Drug Pages (1)

Fomepizole ndc-match (0.9)

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"}