NDC 0615-8424

Phenytoin Infatabs

Phenytoin

Phenytoin Infatabs is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. The primary component is Phenytoin.

Product ID0615-8424_f85591e3-60f7-46b4-b12d-f0c53e726d3f
NDC0615-8424
Product TypeHuman Prescription Drug
Proprietary NamePhenytoin Infatabs
Generic NamePhenytoin
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2021-11-23
Marketing CategoryANDA /
Application NumberANDA084427
Labeler NameNCS HealthCare of KY, LLC dba Vangard Labs
Substance NamePHENYTOIN
Active Ingredient Strength50 mg/1
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 0615-8424-39

30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8424-39)
Marketing Start Date2022-02-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Phenytoin Infatabs" or generic name "Phenytoin"

NDCBrand NameGeneric Name
0615-8260Phenytoin InfatabsPhenytoin
0615-8424Phenytoin InfatabsPhenytoin
59762-5210Phenytoin InfatabsPhenytoin Infatabs
0071-0007Dilantin InfatabsPhenytoin
0071-2214Dilantin-125Phenytoin
0121-0892PhenytoinPhenytoin
0378-3850PhenytoinPhenytoin
0615-7764PhenytoinPhenytoin
0904-7079PhenytoinPhenytoin
0904-7199PhenytoinPhenytoin
17856-0067PhenytoinPhenytoin
17856-4069PhenytoinPhenytoin
17856-4070PhenytoinPhenytoin
51079-129PhenytoinPhenytoin
51672-4069PhenytoinPhenytoin
51672-4146PhenytoinPhenytoin
59762-0531PhenytoinPhenytoin

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