NDC 68180-561

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 Lupin Pharmaceuticals, Inc.. The primary component is Phenytoin Sodium.

Product ID68180-561_2af18311-3d00-4d79-94ba-eb36ff78e916
NDC68180-561
Product TypeHuman Prescription Drug
Proprietary NameExtended Phenytoin Sodium
Generic NameExtended Phenytoin Sodium
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA211633
Labeler NameLupin Pharmaceuticals, Inc.
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 68180-561-01

100 CAPSULE in 1 BOTTLE (68180-561-01)
Marketing Start Date2020-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68180-561-01 [68180056101]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA211633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-01

NDC 68180-561-03 [68180056103]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA211633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-01

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM100 mg/1

OpenFDA Data

SPL SET ID:5b17816d-5b7f-4e4b-9471-30c93822afe8
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 "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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