fomepizole

Generic: fomepizole

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fomepizole
Generic Name fomepizole
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fomepizole 1 g/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-0710
Product ID 0517-0710_fe5cc52b-7f4b-405a-a8d7-d52fd63289db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078368
Listing Expiration 2026-12-31
Marketing Start 2018-07-16

Pharmacologic Class

Established (EPC)
antidote [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05170710
Hyphenated Format 0517-0710

Supplemental Identifiers

RxCUI
310414
UPC
0300000000001
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 ANDA078368 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0517-0710-01) / 1.5 mL in 1 VIAL
source: ndc

Packages (1)

0517-0710-01 1 VIAL in 1 CARTON (0517-0710-01) / 1.5 mL in 1 VIAL

Ingredients (1)

fomepizole (1 g/mL)

Linked Drug Pages (2)

fomepizole ndc-match (0.9) fomepizole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fe5cc52b-7f4b-405a-a8d7-d52fd63289db", "openfda": {"nui": ["N0000175429"], "upc": ["0300000000001"], "unii": ["83LCM6L2BY"], "rxcui": ["310414"], "spl_set_id": ["82dc2920-af7f-4e43-9f6d-8877a71884cd"], "pharm_class_epc": ["Antidote [EPC]"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0517-0710-01)  / 1.5 mL in 1 VIAL", "package_ndc": "0517-0710-01", "marketing_start_date": "20180716"}], "brand_name": "fomepizole", "product_id": "0517-0710_fe5cc52b-7f4b-405a-a8d7-d52fd63289db", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antidote [EPC]"], "product_ndc": "0517-0710", "generic_name": "fomepizole", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fomepizole", "active_ingredients": [{"name": "FOMEPIZOLE", "strength": "1 g/mL"}], "application_number": "ANDA078368", "marketing_category": "ANDA", "marketing_start_date": "20180716", "listing_expiration_date": "20261231"}