NDC 55648-720

EXTENDED PHENYTOIN SODIUM

Extended Phenytoin Sodium

EXTENDED PHENYTOIN SODIUM is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Limited. The primary component is Phenytoin Sodium.

Product ID55648-720_21c147fd-c3a2-4c0d-b8a0-4370bebc33f0
NDC55648-720
Product TypeHuman Prescription Drug
Proprietary NameEXTENDED PHENYTOIN SODIUM
Generic NameExtended Phenytoin Sodium
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2008-01-30
Marketing CategoryANDA / ANDA
Application NumberANDA040732
Labeler NameWockhardt Limited
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 55648-720-02

1000 CAPSULE in 1 BOTTLE (55648-720-02)
Marketing Start Date2008-01-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-720-01 [55648072001]

EXTENDED PHENYTOIN SODIUM CAPSULE
Marketing CategoryANDA
Application NumberANDA040732
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-01-30
Inactivation Date2020-01-31

NDC 55648-720-02 [55648072002]

EXTENDED PHENYTOIN SODIUM CAPSULE
Marketing CategoryANDA
Application NumberANDA040732
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-01-30
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM100 mg/1

OpenFDA Data

SPL SET ID:e54861d7-a4e4-4e47-8229-6e9c2ace21f8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855671
  • UPC Code
  • 0364679720028
  • 0364679720011
  • 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 "EXTENDED PHENYTOIN SODIUM" or generic name "Extended Phenytoin Sodium"

    NDCBrand NameGeneric Name
    0904-6187Extended Phenytoin SodiumPhenytoin Sodium
    10135-603Extended Phenytoin SodiumPhenytoin Sodium
    42291-772Extended Phenytoin SodiumPhenytoin Sodium
    43063-492Extended Phenytoin SodiumPhenytoin Sodium
    50090-2089Extended Phenytoin SodiumPhenytoin Sodium
    50090-3142Extended Phenytoin SodiumPhenytoin Sodium
    50090-3165Extended Phenytoin SodiumPhenytoin Sodium
    53808-1040Extended Phenytoin SodiumPhenytoin Sodium
    55154-7979Extended Phenytoin SodiumPhenytoin Sodium
    55289-906EXTENDED PHENYTOIN SODIUMEXTENDED PHENYTOIN SODIUM
    55648-720EXTENDED PHENYTOIN SODIUMEXTENDED PHENYTOIN SODIUM
    64679-720EXTENDED PHENYTOIN SODIUMEXTENDED PHENYTOIN SODIUM
    64725-0720EXTENDED PHENYTOIN SODIUMEXTENDED PHENYTOIN SODIUM
    65162-212Extended Phenytoin SodiumPhenytoin Sodium
    65862-692Extended Phenytoin SodiumPhenytoin Sodium
    68084-376Extended Phenytoin SodiumExtended Phenytoin Sodium
    68788-6968Extended Phenytoin SodiumExtended Phenytoin Sodium
    70518-0231Extended Phenytoin SodiumExtended Phenytoin Sodium
    70518-2227Extended Phenytoin SodiumExtended Phenytoin Sodium
    71335-1349Extended Phenytoin SodiumExtended Phenytoin Sodium
    68180-561Extended Phenytoin SodiumExtended Phenytoin Sodium
    71610-479Extended Phenytoin SodiumExtended Phenytoin Sodium
    0071-0369DilantinExtended Phenytoin Sodium
    0071-3740DilantinExtended Phenytoin Sodium
    0378-2670Phenytekextended phenytoin sodium

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