NDC 0904-7079

Phenytoin

Phenytoin

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

Product ID0904-7079_070e56f4-db77-4ead-aad9-054a1dad8507
NDC0904-7079
Product TypeHuman Prescription Drug
Proprietary NamePhenytoin
Generic NamePhenytoin
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2004-04-08
Marketing CategoryANDA /
Application NumberANDA040521
Labeler NameMajor Pharmaceuticals
Substance NamePHENYTOIN
Active Ingredient Strength100 mg/4mL
Pharm ClassesAnti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0904-7079-57

50 CUP, UNIT-DOSE in 1 CASE (0904-7079-57) > 4 mL in 1 CUP, UNIT-DOSE (0904-7079-24)
Marketing Start Date2004-04-08
NDC Exclude FlagN
Sample Package?N

Drug Details

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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.