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NDC 70518-1967-00 Phenytoin 125 mg/5mL Details

Phenytoin 125 mg/5mL

Phenytoin is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by REMEDYREPACK INC.. 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: 70518-1967-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenytoin

Product Information

NDC	70518-1967
Product ID	70518-1967_fe2f644f-cda0-b373-e053-6294a90aa20d
Associated GPIs
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	Phenytoin
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	125
Active Ingredient Units	mg/5mL
Substance Name	PHENYTOIN
Labeler Name	REMEDYREPACK 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	ANDA040521
Listing Certified Through	2024-12-31

Package

NDC 70518-1967-00 (70518196700)

Pricing Information	N/A
NDC Package Code	70518-1967-0
Billing NDC	70518196700
Package	10 CUP, UNIT-DOSE in 1 BOX (70518-1967-0) / 10 mL in 1 CUP, UNIT-DOSE (70518-1967-1)
Marketing Start Date	2019-06-20
NDC Exclude Flag	N