NDC 71335-0913

Phenytoin Sodium

Phenytoin Sodium

Phenytoin Sodium is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Phenytoin Sodium.

Product ID71335-0913_1106f6a6-0343-48d3-b1d8-f18f71ae0843
NDC71335-0913
Product TypeHuman Prescription Drug
Proprietary NamePhenytoin Sodium
Generic NamePhenytoin Sodium
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-07-24
Marketing CategoryANDA / ANDA
Application NumberANDA040684
Labeler NameBryant Ranch Prepack
Substance NamePHENYTOIN SODIUM
Active Ingredient Strength100 mg/1
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
Listing Certified Through2023-12-31

Packaging

NDC 71335-0913-1

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0913-1)
Marketing Start Date2022-02-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0913-4 [71335091304]

Phenytoin Sodium CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040684
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-24

NDC 71335-0913-3 [71335091303]

Phenytoin Sodium CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040684
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-24

NDC 71335-0913-6 [71335091306]

Phenytoin Sodium CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040684
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-24

NDC 71335-0913-5 [71335091305]

Phenytoin Sodium CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040684
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-24

NDC 71335-0913-1 [71335091301]

Phenytoin Sodium CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040684
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-24

NDC 71335-0913-2 [71335091302]

Phenytoin Sodium CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040684
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-24

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM100 mg/1

OpenFDA Data

SPL SET ID:1106f6a6-0343-48d3-b1d8-f18f71ae0843
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855671

    • 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.