NDC 0615-1343

Phenytoin Sodium

Phenytoin Sodium

Phenytoin Sodium is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Phenytoin Sodium.

Product ID0615-1343_963929bb-80d0-4b86-a6e1-555f6985af57
NDC0615-1343
Product TypeHuman Prescription Drug
Proprietary NamePhenytoin Sodium
Generic NamePhenytoin Sodium
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-11-20
Marketing CategoryANDA / ANDA
Application NumberANDA040298
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NamePHENYTOIN SODIUM
Active Ingredient Strength100 mg/1
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 0615-1343-39

30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-1343-39)
Marketing Start Date2009-11-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-1343-39 [00615134339]

Phenytoin Sodium CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040298
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-20
Inactivation Date2019-10-29

NDC 0615-1343-31 [00615134331]

Phenytoin Sodium CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040298
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-20
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM100 mg/1

OpenFDA Data

SPL SET ID:836cd001-99e8-4591-860a-07094ea0de74
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.