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NDC 00904-7079-57 Phenytoin 100 mg/4mL Details

Phenytoin 100 mg/4mL

Phenytoin is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is PHENYTOIN.

MedlinePlus Drug Summary

Phenytoin is used to control certain type of seizures, and to treat and prevent seizures that may begin during or after surgery to the brain or nervous system. Phenytoin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

Related Packages: 00904-7079-57
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenytoin

Product Information

NDC	00904-7079
Product ID	0904-7079_070e56f4-db77-4ead-aad9-054a1dad8507
Associated GPIs	72200030001810
GCN Sequence Number	063845
GCN Sequence Number Description	phenytoin ORAL SUSP 100 MG/4ML ORAL
HIC3	H4B
HIC3 Description	ANTICONVULSANTS
GCN	99557
HICL Sequence Number	001879
HICL Sequence Number Description	PHENYTOIN
Brand/Generic	Generic
Proprietary Name	Phenytoin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Phenytoin
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/4mL
Substance Name	PHENYTOIN
Labeler Name	Major Pharmaceuticals
Pharmaceutical Class	Anti-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
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA040521
Listing Certified Through	2024-12-31

Package

NDC 00904-7079-57 (00904707957)

Pricing Information	N/A
NDC Package Code	0904-7079-57
Billing NDC	00904707957
Package	50 CUP, UNIT-DOSE in 1 CASE (0904-7079-57) / 4 mL in 1 CUP, UNIT-DOSE (0904-7079-24)
Marketing Start Date	2004-04-08
NDC Exclude Flag	N