NDC 59762-0531

Phenytoin

Phenytoin

Phenytoin is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Greenstone Llc. The primary component is Phenytoin.

Product ID59762-0531_100487df-82b5-4522-8550-12626c5dcc36
NDC59762-0531
Product TypeHuman Prescription Drug
Proprietary NamePhenytoin
Generic NamePhenytoin
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2012-10-09
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA008762
Labeler NameGreenstone LLC
Substance NamePHENYTOIN
Active Ingredient Strength125 mg/5mL
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 Through2022-12-31

Packaging

NDC 59762-0531-2

1 BOTTLE, PLASTIC in 1 CARTON (59762-0531-2) > 237 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2020-04-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59762-0531-1 [59762053101]

Phenytoin SUSPENSION
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA008762
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-10-09

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN125 mg/5mL

OpenFDA Data

SPL SET ID:37943ec1-a8d2-42df-967e-6f96f84c017b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1313112
  • 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]

    Medicade Reported Pricing

    59762053101 PHENYTOIN 125 MG/5 ML SUSP

    Pricing Unit: ML | Drug Type:

    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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