NDC 65162-998

Fosphenytoin Sodium

Fosphenytoin Sodium

Fosphenytoin Sodium is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Fosphenytoin Sodium.

Product ID65162-998_94c5c824-7e95-404b-b1d9-5cc28eb510c8
NDC65162-998
Product TypeHuman Prescription Drug
Proprietary NameFosphenytoin Sodium
Generic NameFosphenytoin Sodium
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2013-05-17
Marketing CategoryANDA / ANDA
Application NumberANDA078476
Labeler NameAmneal Pharmaceuticals LLC
Substance NameFOSPHENYTOIN SODIUM
Active Ingredient Strength50 mg/mL
Pharm ClassesAnti-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]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65162-998-25

25 VIAL in 1 CARTON (65162-998-25) > 2 mL in 1 VIAL (65162-998-01)
Marketing Start Date2013-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-998-01 [65162099801]

Fosphenytoin Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA078476
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-17

NDC 65162-998-25 [65162099825]

Fosphenytoin Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA078476
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FOSPHENYTOIN SODIUM50 mg/mL

OpenFDA Data

SPL SET ID:87ff8a91-5b37-401c-b75c-dc6efd348761
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1670195
  • 1670200
    • UPC Code
  • 0365162999105
  • 0365162999013

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Fosphenytoin Sodium" or generic name "Fosphenytoin Sodium"

    NDCBrand NameGeneric Name
    0143-9782Fosphenytoin SodiumFosphenytoin Sodium
    0143-9788Fosphenytoin SodiumFosphenytoin Sodium
    0641-6136Fosphenytoin SodiumFosphenytoin Sodium
    0641-6137Fosphenytoin SodiumFosphenytoin Sodium
    64679-729FOSPHENYTOIN SODIUMfosphenytoin sodium
    64679-730FOSPHENYTOIN SODIUMfosphenytoin sodium
    65162-998Fosphenytoin SodiumFosphenytoin Sodium
    70121-1381Fosphenytoin SodiumFosphenytoin Sodium
    70121-1390Fosphenytoin SodiumFosphenytoin Sodium
    65162-999Fosphenytoin SodiumFosphenytoin Sodium
    67457-517Fosphenytoin SodiumFosphenytoin Sodium
    67457-516Fosphenytoin SodiumFosphenytoin Sodium
    0069-5471CEREBYXFosphenytoin Sodium
    0069-5474CEREBYXFosphenytoin Sodium
    0069-6001CEREBYXFosphenytoin Sodium
    63323-403FosphenytoinFOSPHENYTOIN SODIUM
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.