NDC 39822-4050

PHENYTOIN SODIUM

Phenytoin Sodium

PHENYTOIN SODIUM is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by X-gen Pharmaceuticals, Inc.. The primary component is Phenytoin Sodium.

Product ID39822-4050_492a8728-d60f-41ea-bedd-ead7375f3ad5
NDC39822-4050
Product TypeHuman Prescription Drug
Proprietary NamePHENYTOIN SODIUM
Generic NamePhenytoin Sodium
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2011-05-02
Marketing CategoryANDA / ANDA
Application NumberANDA040573
Labeler NameX-GEN Pharmaceuticals, Inc.
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 39822-4050-6

25 VIAL, SINGLE-DOSE in 1 CARTON (39822-4050-6) > 10 mL in 1 VIAL, SINGLE-DOSE (39822-4050-5)
Marketing Start Date2011-05-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 39822-4050-6 [39822405006]

PHENYTOIN SODIUM INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040573
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-05-02
Marketing End Date2016-04-30
Inactivation Date2020-01-31
Reactivation Date2020-02-03

NDC 39822-4050-2 [39822405002]

PHENYTOIN SODIUM INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040573
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-05-02
Marketing End Date2016-04-30

NDC 39822-4050-3 [39822405003]

PHENYTOIN SODIUM INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040573
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-05-02
Marketing End Date2016-04-30
Inactivation Date2020-01-31
Reactivation Date2020-02-03

NDC 39822-4050-5 [39822405005]

PHENYTOIN SODIUM INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040573
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-05-02
Marketing End Date2016-04-30

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM50 mg/mL

OpenFDA Data

SPL SET ID:ab923d09-747d-4527-9bdf-2c807a5775d2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1670353
  • 1670351

    • 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
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