NDC 0615-7764

Phenytoin

Phenytoin

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

Product ID0615-7764_72ca248c-2b35-4319-b081-855f3ce1b5d3
NDC0615-7764
Product TypeHuman Prescription Drug
Proprietary NamePhenytoin
Generic NamePhenytoin
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2012-12-26
Marketing CategoryANDA / ANDA
Application NumberANDA200691
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NamePHENYTOIN
Active Ingredient Strength50 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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0615-7764-39

30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-7764-39)
Marketing Start Date2012-12-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-7764-39 [00615776439]

Phenytoin TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA200691
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-12-26
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN50 mg/1

OpenFDA Data

SPL SET ID:708599c8-6d55-4765-94b6-0c8229dd1379
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]

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

    NDCBrand NameGeneric Name
    0121-0892PhenytoinPhenytoin
    0378-3850PhenytoinPhenytoin
    0615-7764PhenytoinPhenytoin
    0904-7079PhenytoinPhenytoin
    0904-7199PhenytoinPhenytoin
    17856-0067PhenytoinPhenytoin
    17856-4069PhenytoinPhenytoin
    17856-4070PhenytoinPhenytoin
    51079-129PhenytoinPhenytoin
    51672-4069PhenytoinPhenytoin
    51672-4146PhenytoinPhenytoin
    59762-0531PhenytoinPhenytoin
    70518-0841PhenytoinPhenytoin
    70518-1967PhenytoinPhenytoin
    60432-131PhenytoinPhenytoin
    60687-156PhenytoinPhenytoin
    60687-275PhenytoinPhenytoin
    64950-231PhenytoinPhenytoin
    66689-775PhenytoinPhenytoin
    66689-036PhenytoinPhenytoin
    70518-2554PhenytoinPhenytoin
    0071-0007Dilantin InfatabsPhenytoin
    0071-2214Dilantin-125Phenytoin
    0615-8260Phenytoin InfatabsPhenytoin
    0615-8424Phenytoin InfatabsPhenytoin

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