68083-460 : Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection, Solution


NDC: 68083-460
Labeler: Gland Pharma Limited
Product Type: Human Prescription Drug
Drug Name:  Fosphenytoin Sodium
Dosage Form: Intramuscular; Intravenous Injection, Solution
Application #: ANDA214926
Rev. Date: 


NDC Package Codes:

  • 68083-460-25: 25 VIAL, SINGLE‑DOSE IN 1 CARTON (68083‑460‑25) / 2 ML IN 1 VIAL, SINGLE‑DOSE (68083‑460‑01)

Active Ingredients:

  • Fosphenytoin Sodium

Dosage Strength:

  • 50 mg/mL

Pharmaceutical Classes:

  • Anti-epileptic Agent [EPC]
  • Cytochrome P450 1A2 Inducers [MoA]
  • Cytochrome P450 2B6 Inducers [MoA]
  • Cytochrome P450 2C19 Inducers [MoA]
  • Cytochrome P450 2C8 Inducers [MoA]
  • Cytochrome P450 2C9 Inducers [MoA]
  • Cytochrome P450 2D6 Inducers [MoA]
  • Cytochrome P450 3A Inducers [MoA]
  • Decreased Central Nervous System Disorganized Electrical Activity [PE]

Related Products:

Based on records with the same trade name.
  • 68083-461 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection, Solution by Gland Pharma Limited
  • 0143-9782 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection, Solution by West-ward Pharmaceutical Corp
  • 0143-9788 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravascular Injection, Solution by West-ward Pharmaceutical Corp
  • 0409-4857 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection, Solution by Hospira, Inc.
  • 0517-6902 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection, Solution by American Regent, Inc.
  • 0641-6136 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection by West-ward Pharmaceutical Corp.
  • 0641-6137 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection by West-ward Pharmaceutical Corp.
  • 10139-025 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection, Solution by Generamedix Inc.
  • 47335-833 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection, Solution by Sun Pharma Global Fze
  • 47335-834 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection, Solution by Sun Pharma Global Fze
  • 55390-175 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection, Solution by Bedford Laboratories
  • 55390-176 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection, Solution by Bedford Laboratories
  • 64679-729 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection by Wockhardt USA LLC.
  • 64679-730 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection by Wockhardt USA LLC.
  • 65162-998 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection by Amneal Pharmaceuticals of New York, LLC
  • 65162-999 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection by Amneal Pharmaceuticals of New York, LLC
  • 67457-516 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection, Solution by Mylan Institutional LLC
  • 67457-517 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection, Solution by Mylan Institutional LLC
  • 68462-621 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection, Solution by Glenmark Pharmaceuticals Inc., USA
  • 68462-622 Fosphenytoin Sodium 50 mg/ml Intramuscular; Intravenous Injection, Solution by Glenmark Pharmaceuticals Inc., USA
  • More related products ...

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.