NDC 70710-1478

Fomepizole

Fomepizole

Fomepizole is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals Usa Inc.. The primary component is Fomepizole.

• Product ID: 70710-1478_3f024d25-7f96-4a69-b413-535b53b1e0d6
• NDC: 70710-1478
• Product Type: Human Prescription Drug
• Proprietary Name: Fomepizole
• Generic Name: Fomepizole
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-10-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078537
• Labeler Name: Zydus Pharmaceuticals USA Inc.
• Substance Name: FOMEPIZOLE
• Active Ingredient Strength: 1 g/mL
• Pharm Classes: Antidote [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70710-1478-1

1 VIAL in 1 CARTON (70710-1478-1) > 1.5 mL in 1 VIAL

• Marketing Start Date: 2021-03-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70710-1478-1 [70710147801]

Fomepizole INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078537
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-09-10

Drug Details

Active Ingredients

Ingredient	Strength
FOMEPIZOLE	1 g/mL

OpenFDA Data

• SPL SET ID: 256910fe-91f2-48f6-b0b4-55edc52dacd4
• Manufacturer:
  • Zydus Pharmaceuticals USA Inc.
• UNII:
  • 83LCM6L2BY
• RxNorm Concept Unique ID - RxCUI:
  • 310414
• UPC Code:
  • 0370710147815

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