NDC 66689-775

Phenytoin

Phenytoin

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

Product ID66689-775_3d419c6a-4d57-4834-bd1d-36f97c1e469d
NDC66689-775
Product TypeHuman Prescription Drug
Proprietary NamePhenytoin
Generic NamePhenytoin
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2017-03-29
Marketing CategoryANDA / ANDA
Application NumberANDA040610
Labeler NameVistaPharm, Inc.
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 Through2020-12-31

Packaging

NDC 66689-775-08

237 mL in 1 BOTTLE (66689-775-08)
Marketing Start Date2017-03-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66689-775-50 [66689077550]

Phenytoin SUSPENSION
Marketing CategoryANDA
Application NumberANDA040610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-29
Marketing End Date2018-11-19

NDC 66689-775-01 [66689077501]

Phenytoin SUSPENSION
Marketing CategoryANDA
Application NumberANDA040610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-29
Marketing End Date2018-11-19

NDC 66689-775-08 [66689077508]

Phenytoin SUSPENSION
Marketing CategoryANDA
Application NumberANDA040610
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-03-29

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN125 mg/5mL

OpenFDA Data

SPL SET ID:8c683979-9ea5-4917-9256-ab5fde590269
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]

    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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