NDC 46129-200

Antizol

Fomepizole

Antizol is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Paladin Laboratories (usa) Inc. The primary component is Fomepizole.

• Product ID: 46129-200_c045b5a8-b220-4f0a-a831-155b29c19454
• NDC: 46129-200
• Product Type: Human Prescription Drug
• Proprietary Name: Antizol
• Generic Name: Fomepizole
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2009-07-31
• Marketing Category: NDA / NDA
• Application Number: NDA020696
• Labeler Name: PALADIN LABORATORIES (USA) INC
• Substance Name: FOMEPIZOLE
• Active Ingredient Strength: 1 g/mL
• Pharm Classes: Antidote [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 46129-200-02

4 VIAL in 1 PACKAGE (46129-200-02) > 1.5 mL in 1 VIAL

• Marketing Start Date: 2009-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46129-200-01 [46129020001]

Antizol INJECTION

• Marketing Category: NDA
• Application Number: NDA020696
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-31
• Inactivation Date: 2019-10-21

NDC 46129-200-02 [46129020002]

Antizol INJECTION

• Marketing Category: NDA
• Application Number: NDA020696
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-31
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
FOMEPIZOLE	1 g/mL

OpenFDA Data

• SPL SET ID: c045b5a8-b220-4f0a-a831-155b29c19454
• Manufacturer:
  • PALADIN LABORATORIES (USA) INC
• UNII:
  • 83LCM6L2BY
• RxNorm Concept Unique ID - RxCUI:
  • 213184
  • 310414

Pharmacological Class

• Antidote [EPC]

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

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