NDC 70121-1381

Fosphenytoin Sodium

Fosphenytoin

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 ID70121-1381_3af8a2a9-c91a-4e34-bdb3-7f92bddc11c8
NDC70121-1381
Product TypeHuman Prescription Drug
Proprietary NameFosphenytoin Sodium
Generic NameFosphenytoin
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2016-08-11
Marketing CategoryANDA / ANDA
Application NumberANDA078476
Labeler NameAmneal Pharmaceuticals LLC
Substance NameFOSPHENYTOIN SODIUM
Active Ingredient Strength50 mg/mL
Pharm ClassesAnti-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 Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70121-1381-5

25 VIAL in 1 CARTON (70121-1381-5) > 2 mL in 1 VIAL (70121-1381-1)
Marketing Start Date2016-08-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70121-1381-1 [70121138101]

Fosphenytoin Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA078476
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-11

NDC 70121-1381-5 [70121138105]

Fosphenytoin Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA078476
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-11

Drug Details

Active Ingredients

IngredientStrength
FOSPHENYTOIN SODIUM50 mg/mL

OpenFDA Data

SPL SET ID:39b58213-b9e2-4847-9010-99e187c1b778
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1670195
  • 1670200
    • UPC Code
  • 0370121139010
  • 0370121138112

    • 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"

    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
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