NDC 55154-5117

Phenytoin Sodium

Phenytoin Sodium

Phenytoin Sodium is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Cardinal Health. The primary component is Phenytoin Sodium.

Product ID55154-5117_c0abc09e-16d0-4330-8421-bac7283d4f1c
NDC55154-5117
Product TypeHuman Prescription Drug
Proprietary NamePhenytoin Sodium
Generic NamePhenytoin Sodium
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date1975-07-16
Marketing End Date2019-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA084307
Labeler NameCardinal Health
Substance NamePHENYTOIN 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

Packaging

NDC 55154-5117-5

5 VIAL in 1 BAG (55154-5117-5) > 2 mL in 1 VIAL
Marketing Start Date1975-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55154-5117-5 [55154511705]

Phenytoin Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA084307
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1975-07-16
Marketing End Date2015-10-31

NDC 55154-5117-8 [55154511708]

Phenytoin Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA084307
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1975-07-16
Marketing End Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM50 mg/mL

OpenFDA Data

SPL SET ID:354fb830-05eb-4e2c-bb41-e7d0e481b992
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1670351
  • UPC Code
  • 0055154511759
  • 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 "Phenytoin Sodium" or generic name "Phenytoin Sodium"

    NDCBrand NameGeneric Name
    0378-1560Phenytoin Sodiumphenytoin sodium
    0404-9932Phenytoin SodiumPhenytoin Sodium
    0404-9933Phenytoin SodiumPhenytoin Sodium
    0615-1343Phenytoin Sodiumphenytoin sodium
    0615-8020Phenytoin SodiumPhenytoin Sodium
    0641-0493Phenytoin SodiumPhenytoin Sodium
    0641-2555Phenytoin SodiumPhenytoin Sodium
    0641-6138Phenytoin SodiumPhenytoin Sodium
    0641-6139Phenytoin SodiumPhenytoin Sodium
    21695-167Phenytoin SodiumPhenytoin Sodium
    29300-379Phenytoin SodiumPhenytoin Sodium
    39822-4050PHENYTOIN SODIUMPHENYTOIN SODIUM
    42192-614PHENYTOIN SODIUMPHENYTOIN SODIUM
    70518-0107Phenytoin SodiumPhenytoin Sodium
    70518-0981PHENYTOIN SODIUMPHENYTOIN SODIUM
    70518-1776Phenytoin SodiumPhenytoin Sodium
    71335-0913Phenytoin SodiumPhenytoin Sodium
    71335-0232PHENYTOIN SODIUMPHENYTOIN SODIUM
    50090-3499Phenytoin SodiumPhenytoin Sodium
    50090-2903PHENYTOIN SODIUMPHENYTOIN SODIUM
    50090-3539Phenytoin SodiumPhenytoin Sodium
    51079-905Phenytoin SodiumPhenytoin Sodium
    51662-1251PHENYTOIN SODIUMPHENYTOIN SODIUM
    51662-1250PHENYTOIN SODIUMPHENYTOIN SODIUM
    51672-4111Phenytoin SodiumPhenytoin Sodium
    52584-555Phenytoin SodiumPhenytoin Sodium
    52584-493Phenytoin SodiumPhenytoin Sodium
    53002-1501PHENYTOIN SODIUMPHENYTOIN SODIUM
    53808-0652Phenytoin SodiumPhenytoin Sodium
    55154-5496Phenytoin SodiumPhenytoin Sodium
    55154-5117Phenytoin SodiumPhenytoin Sodium
    57664-808Phenytoin SodiumPhenytoin Sodium
    58118-1402PHENYTOIN SODIUMPHENYTOIN SODIUM
    58118-4111Phenytoin SodiumPhenytoin Sodium
    61919-815PHENYTOIN SODIUMPHENYTOIN SODIUM
    62756-299phenytoin sodiumphenytoin sodium
    62756-402PHENYTOIN SODIUMPHENYTOIN SODIUM
    62756-432phenytoin sodiumphenytoin sodium
    63187-891PHENYTOIN SODIUMPHENYTOIN SODIUM
    63629-6382PHENYTOIN SODIUMPHENYTOIN SODIUM
    63629-6364PHENYTOIN SODIUMPHENYTOIN SODIUM
    63629-2552Phenytoin SodiumPhenytoin Sodium
    64725-4111Phenytoin SodiumPhenytoin Sodium
    67046-585Phenytoin SodiumPhenytoin Sodium
    67296-1251PHENYTOIN SODIUMPHENYTOIN SODIUM
    67544-517Phenytoin SodiumPhenytoin Sodium
    0071-0369DilantinPhenytoin Sodium
    0071-3740DilantinPhenytoin Sodium
    43353-131DilantinPhenytoin Sodium
    0904-6187Extended Phenytoin SodiumPhenytoin Sodium

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.