NDC 67457-211

Fomepizole

Fomepizole

Fomepizole is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Fomepizole.

• Product ID: 67457-211_ac92fef1-664f-4cfd-aa72-b6507934b28f
• NDC: 67457-211
• Product Type: Human Prescription Drug
• Proprietary Name: Fomepizole
• Generic Name: Fomepizole
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-10-09
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078639
• Labeler Name: Mylan Institutional LLC
• Substance Name: FOMEPIZOLE
• Active Ingredient Strength: 1 g/mL
• Pharm Classes: Antidote [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 67457-211-02

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

• Marketing Start Date: 2012-10-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-211-02 [67457021102]

Fomepizole INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078639
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-10-09

Drug Details

Active Ingredients

Ingredient	Strength
FOMEPIZOLE	1 g/mL

OpenFDA Data

• SPL SET ID: 911312e2-3a7c-4c97-88a8-b8d92cd12923
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • 83LCM6L2BY
• RxNorm Concept Unique ID - RxCUI:
  • 310414

Pharmacological Class

• Antidote [EPC]
• Antidote [EPC]

NDC Crossover Matching brand name "Fomepizole" or generic name "Fomepizole"

NDC	Brand Name	Generic Name
0517-0710	fomepizole	fomepizole
0781-3182	fomepizole	fomepizole
67457-211	Fomepizole	Fomepizole
68475-510	Fomepizole	Fomepizole
70710-1478	Fomepizole	Fomepizole
46129-200	Antizol	fomepizole