fomepizole

Generic: fomepizole

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fomepizole
Generic Name fomepizole
Labeler sagent pharmaceuticals
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fomepizole 1.5 g/1.5mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-829
Product ID 25021-829_2a2d60c6-d777-411f-9ccb-d742fe777dda
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216791
Listing Expiration 2026-12-31
Marketing Start 2023-11-15

Pharmacologic Class

Established (EPC)
antidote [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021829
Hyphenated Format 25021-829

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
  • 1.5 g/1.5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-829-02) / 1.5 mL in 1 VIAL
source: ndc

Packages (1)

25021-829-02 1 VIAL in 1 CARTON (25021-829-02) / 1.5 mL in 1 VIAL

Ingredients (1)

fomepizole (1.5 g/1.5mL)

Linked Drug Pages (1)

Fomepizole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2a2d60c6-d777-411f-9ccb-d742fe777dda", "openfda": {"nui": ["N0000175429"], "unii": ["83LCM6L2BY"], "rxcui": ["310414"], "spl_set_id": ["1dea37fd-ec17-416e-b28e-980a87d49e1a"], "pharm_class_epc": ["Antidote [EPC]"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-829-02)  / 1.5 mL in 1 VIAL", "package_ndc": "25021-829-02", "marketing_start_date": "20231115"}], "brand_name": "Fomepizole", "product_id": "25021-829_2a2d60c6-d777-411f-9ccb-d742fe777dda", "dosage_form": "INJECTION", "pharm_class": ["Antidote [EPC]"], "product_ndc": "25021-829", "generic_name": "Fomepizole", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fomepizole", "active_ingredients": [{"name": "FOMEPIZOLE", "strength": "1.5 g/1.5mL"}], "application_number": "ANDA216791", "marketing_category": "ANDA", "marketing_start_date": "20231115", "listing_expiration_date": "20261231"}