NDC 64679-729

FOSPHENYTOIN SODIUM

Fosphenytoin Sodium

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

Product ID64679-729_0e34d972-005a-4fc1-9be5-e394db5b7059
NDC64679-729
Product TypeHuman Prescription Drug
Proprietary NameFOSPHENYTOIN SODIUM
Generic NameFosphenytoin Sodium
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2007-08-06
Marketing CategoryANDA / ANDA
Application NumberANDA078137
Labeler NameWockhardt USA 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 Through2019-12-31

Packaging

NDC 64679-729-01

25 VIAL in 1 CARTON (64679-729-01) > 2 mL in 1 VIAL (64679-729-02)
Marketing Start Date2007-08-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64679-729-01 [64679072901]

FOSPHENYTOIN SODIUM INJECTION
Marketing CategoryANDA
Application NumberANDA078137
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-08-06

NDC 64679-729-02 [64679072902]

FOSPHENYTOIN SODIUM INJECTION
Marketing CategoryANDA
Application NumberANDA078137
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-08-06

Drug Details

Active Ingredients

IngredientStrength
FOSPHENYTOIN SODIUM50 mg/mL

OpenFDA Data

SPL SET ID:94278264-e417-4b53-acef-9f48f2ca3022
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1670195
  • 1670200

    • 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
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