NDC 0517-0710

fomepizole

Fomepizole

fomepizole is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Fomepizole.

• Product ID: 0517-0710_004af6c3-20cf-4bbf-aac7-41102ee3252c
• NDC: 0517-0710
• Product Type: Human Prescription Drug
• Proprietary Name: fomepizole
• Generic Name: Fomepizole
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-07-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078368
• Labeler Name: American Regent, Inc.
• Substance Name: FOMEPIZOLE
• Active Ingredient Strength: 1 g/mL
• Pharm Classes: Antidote [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0517-0710-88

1 VIAL in 1 CARTON (0517-0710-88) > 1.5 mL in 1 VIAL

• Marketing Start Date: 2020-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0517-0710-01 [00517071001]

fomepizole INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078368
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-07-16

Drug Details

Active Ingredients

Ingredient	Strength
FOMEPIZOLE	1 g/mL

OpenFDA Data

• SPL SET ID: 82dc2920-af7f-4e43-9f6d-8877a71884cd
• Manufacturer:
  • American Regent, Inc.
• UNII:
  • 83LCM6L2BY
• RxNorm Concept Unique ID - RxCUI:
  • 310414

Pharmacological Class

• 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