NDC 70518-0980

Dilantin

Phenytoin Sodium

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

Product ID70518-0980_675f81f5-1b9f-fd0f-e053-2a91aa0a12a9
NDC70518-0980
Product TypeHuman Prescription Drug
Proprietary NameDilantin
Generic NamePhenytoin Sodium
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-01-22
Marketing CategoryANDA / ANDA
Application NumberANDA084349
Labeler NameREMEDYREPACK INC.
Substance NamePHENYTOIN SODIUM
Active Ingredient Strength30 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 70518-0980-0

30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-0980-0)
Marketing Start Date2018-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0980-1 [70518098001]

Dilantin CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA084349
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-06

NDC 70518-0980-2 [70518098002]

Dilantin CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA084349
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-26

NDC 70518-0980-0 [70518098000]

Dilantin CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA084349
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-22

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM30 mg/1

OpenFDA Data

SPL SET ID:f1d41925-3be0-42a8-86f8-181569399c5b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855871
  • 855869

    • 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 "Phenytoin Sodium"

    NDCBrand NameGeneric Name
    0071-0369DilantinExtended Phenytoin Sodium
    0071-3740DilantinExtended Phenytoin Sodium
    68151-1019DilantinDilantin
    69189-3742DilantinDilantin
    70518-0980DilantinDilantin
    43353-131DilantinDilantin
    50090-0029DilantinDilantin
    0904-6187Extended Phenytoin SodiumPhenytoin Sodium
    10135-603Extended Phenytoin SodiumPhenytoin 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
    21695-167Phenytoin SodiumPhenytoin 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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