NDC 67457-517

Fosphenytoin Sodium

Fosphenytoin Sodium

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

Product ID67457-517_6c9313b1-9247-4c40-b6aa-1ba1554b6c7d
NDC67457-517
Product TypeHuman Prescription Drug
Proprietary NameFosphenytoin Sodium
Generic NameFosphenytoin Sodium
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2016-12-06
Marketing End Date2023-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA078736
Labeler NameMylan Institutional 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

Packaging

NDC 67457-517-01

10 VIAL, SINGLE-DOSE in 1 CARTON (67457-517-01) > 10 mL in 1 VIAL, SINGLE-DOSE (67457-517-00)
Marketing Start Date2016-12-06
Marketing End Date2023-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-517-01 [67457051701]

Fosphenytoin Sodium INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078736
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-12-06

NDC 67457-517-00 [67457051700]

Fosphenytoin Sodium INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078736
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-12-06

Drug Details

Active Ingredients

IngredientStrength
FOSPHENYTOIN SODIUM50 mg/mL

OpenFDA Data

SPL SET ID:564feac7-eb0d-42a0-a0f1-9613deeb0cec
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.