NDC 0641-6136

Fosphenytoin Sodium

Fosphenytoin Sodium

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

Product ID0641-6136_1f2504bd-e9a2-4fc5-b743-b2bddcea580d
NDC0641-6136
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 NumberANDA077989
Labeler NameWest-Ward Pharmaceuticals Corp.
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 0641-6136-25

25 VIAL in 1 CARTON (0641-6136-25) > 2 mL in 1 VIAL (0641-6136-01)
Marketing Start Date2007-08-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0641-6136-25 [00641613625]

Fosphenytoin Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA077989
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-08-06

NDC 0641-6136-01 [00641613601]

Fosphenytoin Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA077989
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:519a44e3-8a93-456c-b71c-894513810d45
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]
    • 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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