NDC 60687-275

Phenytoin

Phenytoin

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

Product ID60687-275_7ee193fd-d595-9efc-e053-2991aa0a7054
NDC60687-275
Product TypeHuman Prescription Drug
Proprietary NamePhenytoin
Generic NamePhenytoin
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2019-01-10
Marketing CategoryANDA / ANDA
Application NumberANDA040521
Labeler NameAmerican Health Packaging
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 60687-275-66

5 TRAY in 1 CASE (60687-275-66) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-275-63) > 4 mL in 1 CUP, UNIT-DOSE (60687-275-62)
Marketing Start Date2019-01-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60687-275-62 [60687027562]

Phenytoin SUSPENSION
Marketing CategoryANDA
Application NumberANDA040521
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-01-10

NDC 60687-275-63 [60687027563]

Phenytoin SUSPENSION
Marketing CategoryANDA
Application NumberANDA040521
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-01-10

NDC 60687-275-66 [60687027566]

Phenytoin SUSPENSION
Marketing CategoryANDA
Application NumberANDA040521
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-01-10

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN125 mg/5mL

OpenFDA Data

SPL SET ID:f9fe4c92-2761-4cb4-9cf3-7066e240e014
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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