NDC 0071-0369

Dilantin

Extended Phenytoin Sodium

Dilantin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Parke-davis Div Of Pfizer Inc. The primary component is Phenytoin Sodium.

Product ID0071-0369_06311c9f-47af-4aae-a7a4-a0a40182ee7c
NDC0071-0369
Product TypeHuman Prescription Drug
Proprietary NameDilantin
Generic NameExtended Phenytoin Sodium
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1976-08-27
Marketing CategoryANDA / ANDA
Application NumberANDA084349
Labeler NameParke-Davis Div of Pfizer 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 0071-0369-24

100 CAPSULE in 1 BOTTLE (0071-0369-24)
Marketing Start Date1976-08-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0071-0369-24 [00071036924]

Dilantin CAPSULE
Marketing CategoryANDA
Application NumberANDA084349
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1976-08-27

NDC 0071-0369-40 [00071036940]

Dilantin CAPSULE
Marketing CategoryANDA
Application NumberANDA084349
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1976-08-27

NDC 0071-0369-32 [00071036932]

Dilantin CAPSULE
Marketing CategoryANDA
Application NumberANDA084349
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1976-08-27

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM100 mg/1

OpenFDA Data

SPL SET ID:8848de76-8d74-4620-bcc7-a86a596e5dd9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855673
  • 855871
  • 855671
  • 855869
    • UPC Code
  • 0300710369245

    • 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 "Dilantin" or generic name "Extended Phenytoin Sodium"

    NDCBrand NameGeneric Name
    0071-0369DilantinExtended Phenytoin Sodium
    0071-3740DilantinExtended Phenytoin Sodium
    43353-131DilantinPhenytoin Sodium
    50090-0029DilantinPhenytoin Sodium
    68151-1019DilantinPhenytoin Sodium
    69189-3742DilantinPhenytoin Sodium
    70518-0980DilantinPhenytoin 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
    0378-2670Phenytekextended phenytoin sodium

    Trademark Results [Dilantin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DILANTIN
    DILANTIN
    71404865 0359292 Live/Registered
    PARKE, DAVIS & COMPANY
    1938-04-04
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