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NDC 00378-2670-01 Phenytek 200 mg/1 Details

Phenytek 200 mg/1

Phenytek is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is PHENYTOIN SODIUM.

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: 00378-2670-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenytoin

Product Information

NDC	00378-2670
Product ID	0378-2670_ef0ae0b6-fe8b-4aa7-bd37-5414db9069cf
Associated GPIs	72200030200120
GCN Sequence Number	049445
GCN Sequence Number Description	phenytoin sodium extended CAPSULE 200 MG ORAL
HIC3	H4B
HIC3 Description	ANTICONVULSANTS
GCN	15038
HICL Sequence Number	001877
HICL Sequence Number Description	PHENYTOIN SODIUM EXTENDED
Brand/Generic	Brand
Proprietary Name	Phenytek
Proprietary Name Suffix	n/a
Non-Proprietary Name	extended phenytoin sodium
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	PHENYTOIN SODIUM
Labeler Name	Mylan Pharmaceuticals Inc.
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	ANDA040298
Listing Certified Through	2024-12-31

Package

NDC 00378-2670-01 (00378267001)

Pricing Information	N/A
NDC Package Code	0378-2670-01
Billing NDC	00378267001
Package	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-2670-01)
Marketing Start Date	2001-12-10
NDC Exclude Flag	N