NDC 65162-212

Extended Phenytoin Sodium

Phenytoin Sodium

Extended Phenytoin Sodium is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Phenytoin Sodium.

Product ID65162-212_0f6017c3-7a87-4efc-b18e-d91a7c109487
NDC65162-212
Product TypeHuman Prescription Drug
Proprietary NameExtended Phenytoin Sodium
Generic NamePhenytoin Sodium
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2009-12-16
Marketing CategoryANDA / ANDA
Application NumberANDA040765
Labeler NameAmneal Pharmaceuticals LLC
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 Through2024-12-31

Packaging

NDC 65162-212-03

30 CAPSULE in 1 BOTTLE (65162-212-03)
Marketing Start Date2009-12-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-212-10 [65162021210]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA040765
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-12-16

NDC 65162-212-50 [65162021250]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA040765
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-12-16

NDC 65162-212-11 [65162021211]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA040765
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-12-16

NDC 65162-212-03 [65162021203]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA040765
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-16

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM100 mg/1

OpenFDA Data

SPL SET ID:7e467c02-49a0-4b62-b537-430fdfa4f10e
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

    65162021250 PHENYTOIN SOD EXT 100 MG CAP

    Pricing Unit: EA | Drug Type:

    65162021211 PHENYTOIN SOD EXT 100 MG CAP

    Pricing Unit: EA | Drug Type:

    65162021210 PHENYTOIN SOD EXT 100 MG CAP

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Extended Phenytoin Sodium" or generic name "Phenytoin Sodium"

    NDCBrand NameGeneric Name
    68084-376Extended Phenytoin SodiumExtended Phenytoin Sodium
    68788-6968Extended Phenytoin SodiumExtended Phenytoin Sodium
    70518-0231Extended Phenytoin SodiumExtended Phenytoin Sodium
    0904-6187Extended Phenytoin SodiumExtended Phenytoin Sodium
    10135-603Extended Phenytoin SodiumExtended Phenytoin Sodium
    43063-492Extended Phenytoin SodiumExtended Phenytoin Sodium
    50090-2089Extended Phenytoin SodiumExtended Phenytoin Sodium
    50090-3165Extended Phenytoin SodiumExtended Phenytoin Sodium
    50090-3142Extended Phenytoin SodiumExtended Phenytoin Sodium
    53808-1040Extended Phenytoin SodiumExtended 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
    65162-212Extended Phenytoin SodiumExtended Phenytoin Sodium
    65862-692Extended Phenytoin SodiumExtended Phenytoin Sodium
    55154-7979Extended 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
    42291-772Extended Phenytoin SodiumExtended Phenytoin Sodium
    0071-0369DilantinExtended Phenytoin Sodium
    0071-3740DilantinExtended Phenytoin Sodium
    0378-2670Phenytekextended phenytoin sodium
    0378-3750Phenytekphenytoin sodium
    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.