fomepizole

Generic: fomepizole

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fomepizole
Generic Name fomepizole
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fomepizole 1 g/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-211
Product ID 67457-211_ac92fef1-664f-4cfd-aa72-b6507934b28f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078639
Listing Expiration 2026-12-31
Marketing Start 2012-10-09

Pharmacologic Class

Established (EPC)
antidote [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457211
Hyphenated Format 67457-211

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 ANDA078639 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (67457-211-02) / 1.5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

67457-211-02 1 VIAL, GLASS in 1 CARTON (67457-211-02) / 1.5 mL in 1 VIAL, GLASS

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": "ac92fef1-664f-4cfd-aa72-b6507934b28f", "openfda": {"nui": ["N0000175429"], "unii": ["83LCM6L2BY"], "rxcui": ["310414"], "spl_set_id": ["911312e2-3a7c-4c97-88a8-b8d92cd12923"], "pharm_class_epc": ["Antidote [EPC]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (67457-211-02)  / 1.5 mL in 1 VIAL, GLASS", "package_ndc": "67457-211-02", "marketing_start_date": "20121009"}], "brand_name": "Fomepizole", "product_id": "67457-211_ac92fef1-664f-4cfd-aa72-b6507934b28f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antidote [EPC]"], "product_ndc": "67457-211", "generic_name": "Fomepizole", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fomepizole", "active_ingredients": [{"name": "FOMEPIZOLE", "strength": "1 g/mL"}], "application_number": "ANDA078639", "marketing_category": "ANDA", "marketing_start_date": "20121009", "listing_expiration_date": "20261231"}