NDC 0615-8260

Phenytoin Infatabs

Phenytoin

Phenytoin Infatabs is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. The primary component is Phenytoin.

Product ID0615-8260_38d6f9ab-c76b-4d2c-94f9-c76cafa98fbb
NDC0615-8260
Product TypeHuman Prescription Drug
Proprietary NamePhenytoin Infatabs
Generic NamePhenytoin
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2012-12-27
Marketing End Date2023-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA084427
Labeler NameNCS HealthCare of KY, LLC dba Vangard Labs
Substance NamePHENYTOIN
Active Ingredient Strength50 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

Packaging

NDC 0615-8260-39

30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8260-39)
Marketing Start Date2019-01-08
Marketing End Date2023-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-8260-39 [00615826039]

Phenytoin Infatabs TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA084427
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-08

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN50 mg/1

OpenFDA Data

SPL SET ID:89e9a6f9-f200-4071-9993-48182efa24cb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1313885
  • 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]
    • 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 "Phenytoin Infatabs" or generic name "Phenytoin"

    NDCBrand NameGeneric Name
    0615-8260Phenytoin InfatabsPhenytoin
    0615-8424Phenytoin InfatabsPhenytoin
    59762-5210Phenytoin InfatabsPhenytoin Infatabs
    0071-0007Dilantin InfatabsPhenytoin
    0071-2214Dilantin-125Phenytoin
    0121-0892PhenytoinPhenytoin
    0378-3850PhenytoinPhenytoin
    0615-7764PhenytoinPhenytoin
    0904-7079PhenytoinPhenytoin
    0904-7199PhenytoinPhenytoin
    17856-0067PhenytoinPhenytoin
    17856-4069PhenytoinPhenytoin
    17856-4070PhenytoinPhenytoin
    51079-129PhenytoinPhenytoin
    51672-4069PhenytoinPhenytoin
    51672-4146PhenytoinPhenytoin
    59762-0531PhenytoinPhenytoin

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