NDC 63323-403

Fosphenytoin

Fosphenytoin Sodium

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

Product ID63323-403_3f1207bc-bacb-431f-b41d-86f1d328ade7
NDC63323-403
Product TypeHuman Prescription Drug
Proprietary NameFosphenytoin
Generic NameFosphenytoin Sodium
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2009-12-14
Marketing CategoryANDA / ANDA
Application NumberANDA078052
Labeler NameFresenius Kabi 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 Through2021-12-31

Packaging

NDC 63323-403-02

25 VIAL in 1 TRAY (63323-403-02) > 2 mL in 1 VIAL (63323-403-01)
Marketing Start Date2009-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-403-02 [63323040302]

Fosphenytoin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078052
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-12-14

NDC 63323-403-10 [63323040310]

Fosphenytoin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078052
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-12-14

NDC 63323-403-09 [63323040309]

Fosphenytoin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078052
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-14
Marketing End Date2014-04-21

NDC 63323-403-01 [63323040301]

Fosphenytoin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078052
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-05-08

NDC 63323-403-04 [63323040304]

Fosphenytoin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078052
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-05-08

Drug Details

Active Ingredients

IngredientStrength
FOSPHENYTOIN SODIUM50 mg/mL

OpenFDA Data

SPL SET ID:b60c9c82-e5c7-4e05-98c7-5bbba4af04b2
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" or generic name "Fosphenytoin Sodium"

    NDCBrand NameGeneric Name
    63323-403FosphenytoinFOSPHENYTOIN SODIUM
    0069-5471CEREBYXFosphenytoin Sodium
    0069-5474CEREBYXFosphenytoin Sodium
    0069-6001CEREBYXFosphenytoin Sodium
    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
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