67457-211 : Fomepizole 1 g/ml Intravenous Injection, Solution


NDC: 67457-211
Labeler: Mylan Institutional LLC
Product Type: Human Prescription Drug
Drug Name:  Fomepizole
Dosage Form: Intravenous Injection, Solution
Application #: ANDA078639
Rev. Date: 
CSA Schedule: CIII (US) [1]


[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 67457-211-02: 1 VIAL, GLASS IN 1 CARTON (67457‑211‑02) > 1.5 ML IN 1 VIAL, GLASS

Active Ingredients:

  • Fomepizole

Dosage Strength:

  • 1 g/mL

Pharmaceutical Classes:

  • Antidote [EPC]

Related Products:

Based on records with the same trade name.
  • 0517-0710 Fomepizole 1 g/ml Intravenous Injection, Solution by American Regent, Inc.
  • 0781-3182 Fomepizole 1 g/ml Intravenous Injection, Solution by Sandoz Inc.
  • 25021-829 Fomepizole 1 g/1.5ml Intravenous Injection by Sagent Pharmaceuticals
  • 39822-0710 Fomepizole 1 g/ml Intravenous Injection, Solution by X-gen Pharmaceuticals, Inc.
  • 68083-510 Fomepizole 1 g/ml Intravenous Injection by Gland Pharma Limited
  • 68475-510 Fomepizole 1 g/ml Intravenous Injection, Solution by Navinta LLC
  • 70710-1478 Fomepizole 1 g/ml Intravenous Injection, Solution by Zydus Pharmaceuticals USA Inc.

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