NDC 51079-905

Phenytoin Sodium

Phenytoin Sodium

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

Product ID51079-905_7ceecc60-3725-51df-e053-2991aa0af0bf
NDC51079-905
Product TypeHuman Prescription Drug
Proprietary NamePhenytoin Sodium
Generic NamePhenytoin Sodium
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date1999-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA040298
Labeler NameMylan Institutional Inc.
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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51079-905-20

100 BLISTER PACK in 1 CARTON (51079-905-20) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (51079-905-01)
Marketing Start Date1999-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51079-905-19 [51079090519]

Phenytoin Sodium CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040298
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-12-15
Marketing End Date2016-09-30

NDC 51079-905-20 [51079090520]

Phenytoin Sodium CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040298
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-05-01

NDC 51079-905-01 [51079090501]

Phenytoin Sodium CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040298
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-05-01

NDC 51079-905-30 [51079090530]

Phenytoin Sodium CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040298
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-05-01
Marketing End Date2018-12-13

NDC 51079-905-17 [51079090517]

Phenytoin Sodium CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040298
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-05-01
Marketing End Date2018-12-13

NDC 51079-905-56 [51079090556]

Phenytoin Sodium CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040298
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-08-01
Marketing End Date2018-08-31

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM100 mg/1

OpenFDA Data

SPL SET ID:2b686efb-8c2f-4690-8839-78cb843e8c2c
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]

    Medicade Reported Pricing

    51079090556 PHENYTOIN SOD EXT 100 MG CAP

    Pricing Unit: EA | Drug Type:

    51079090530 PHENYTOIN SOD EXT 100 MG CAP

    Pricing Unit: EA | Drug Type:

    51079090520 PHENYTOIN SOD EXT 100 MG CAP

    Pricing Unit: EA | Drug Type:

    51079090519 PHENYTOIN SOD EXT 100 MG CAP

    Pricing Unit: EA | Drug Type:

    51079090517 PHENYTOIN SOD EXT 100 MG CAP

    Pricing Unit: EA | Drug Type:

    51079090501 PHENYTOIN SOD EXT 100 MG CAP

    Pricing Unit: EA | Drug Type:

    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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