NDC 0378-2670

Phenytek

Extended Phenytoin Sodium

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

Product ID0378-2670_1d5e0f86-680d-4351-9606-da6573e8c500
NDC0378-2670
Product TypeHuman Prescription Drug
Proprietary NamePhenytek
Generic NameExtended Phenytoin Sodium
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2001-12-10
Marketing CategoryANDA / ANDA
Application NumberANDA040298
Labeler NameMylan Pharmaceuticals Inc.
Substance NamePHENYTOIN SODIUM
Active Ingredient Strength200 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 Through2020-12-31

Packaging

NDC 0378-2670-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-2670-01)
Marketing Start Date2001-12-10
Marketing End Date2030-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-2670-93 [00378267093]

Phenytek CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040298
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-12-10

NDC 0378-2670-01 [00378267001]

Phenytek CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040298
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-12-10

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM200 mg/1

OpenFDA Data

SPL SET ID:0f94c791-8b07-4b41-927e-c9f28bec5f60
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855863
  • 855873
  • 855861
  • 855875

    • 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]
    • 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 "Phenytek" or generic name "Extended Phenytoin Sodium"

    NDCBrand NameGeneric Name
    0378-2670Phenytekextended phenytoin sodium
    0378-3750Phenytekphenytoin sodium
    0071-0369DilantinExtended Phenytoin Sodium
    0071-3740DilantinExtended Phenytoin 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
    68180-561Extended Phenytoin SodiumExtended Phenytoin Sodium

    Trademark Results [Phenytek]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PHENYTEK
    PHENYTEK
    76080693 2767226 Live/Registered
    MYLAN BERTEK PHARMACEUTICALS, INC.
    2000-06-30
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