NDC 17856-4069

Phenytoin

Phenytoin

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

Product ID17856-4069_72a45cbd-e2e7-4804-b314-813fe1b64d58
NDC17856-4069
Product TypeHuman Prescription Drug
Proprietary NamePhenytoin
Generic NamePhenytoin
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2004-04-08
Marketing CategoryANDA / ANDA
Application NumberANDA040521
Labeler NameATLANTIC BIOLOGICALS CORP.
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 17856-4069-4

4.8 mL in 1 CUP (17856-4069-4)
Marketing Start Date2021-01-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-4069-4 [17856406904]

Phenytoin SUSPENSION
Marketing CategoryANDA
Application NumberANDA040521
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-09-25

NDC 17856-4069-1 [17856406901]

Phenytoin SUSPENSION
Marketing CategoryANDA
Application NumberANDA040521
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-25
Marketing End Date2019-09-25

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN125 mg/5mL

OpenFDA Data

SPL SET ID:4d746e08-0212-45e0-b4d0-ad5211718b97
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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