NDC 70518-2554

Phenytoin

Phenytoin

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

Product ID70518-2554_9ddf7b40-441f-dc0d-e053-2995a90a5267
NDC70518-2554
Product TypeHuman Prescription Drug
Proprietary NamePhenytoin
Generic NamePhenytoin
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2020-01-23
Marketing CategoryANDA / ANDA
Application NumberANDA040610
Labeler NameREMEDYREPACK 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 Through2021-12-31

Packaging

NDC 70518-2554-0

10 CUP in 1 BOX (70518-2554-0) > 10 mL in 1 CUP (70518-2554-1)
Marketing Start Date2020-01-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2554-0 [70518255400]

Phenytoin SUSPENSION
Marketing CategoryANDA
Application NumberANDA040610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-23

NDC 70518-2554-1 [70518255401]

Phenytoin SUSPENSION
Marketing CategoryANDA
Application NumberANDA040610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-23

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN125 mg/5mL

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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