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NDC 53002-1501-03 PHENYTOIN SODIUM 100 mg/1 Details

PHENYTOIN SODIUM 100 mg/1

PHENYTOIN SODIUM is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK 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: 53002-1501-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenytoin

Product Information

NDC	53002-1501
Product ID	53002-1501_a01d0d87-d355-4028-bcb5-fd8892248388
Associated GPIs	72200030200110
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PHENYTOIN SODIUM
Proprietary Name Suffix	n/a
Non-Proprietary Name	PHENYTOIN SODIUM
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	PHENYTOIN SODIUM
Labeler Name	RPK 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	ANDA040621
Listing Certified Through	2024-12-31

Package

NDC 53002-1501-03 (53002150103)

Pricing Information	N/A
NDC Package Code	53002-1501-3
Billing NDC	53002150103
Package	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-1501-3)
Marketing Start Date	2017-09-01
NDC Exclude Flag	N