NDC 55289-906

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 Pd-rx Pharmaceuticals, Inc.. The primary component is Phenytoin Sodium.

Product ID55289-906_7c3433f5-f826-6e4b-e053-2a91aa0a5056
NDC55289-906
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 NamePD-Rx Pharmaceuticals, 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 55289-906-30

30 CAPSULE in 1 BOTTLE, PLASTIC (55289-906-30)
Marketing Start Date2012-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-906-60 [55289090660]

EXTENDED PHENYTOIN SODIUM CAPSULE
Marketing CategoryANDA
Application NumberANDA040732
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-12-28
Marketing End Date2019-09-09

NDC 55289-906-30 [55289090630]

EXTENDED PHENYTOIN SODIUM CAPSULE
Marketing CategoryANDA
Application NumberANDA040732
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-28
Marketing End Date2019-09-09

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM100 mg/1

OpenFDA Data

SPL SET ID:904939e7-5f4c-4906-99ae-f45db41f46b3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855671
  • UPC Code
  • 0355289913375
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.