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NDC 00037-0442-67 Felbatol 600 mg/5mL Details

Felbatol 600 mg/5mL

Felbatol is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Meda Pharmaceuticals Inc.. The primary component is FELBAMATE.

MedlinePlus Drug Summary

Felbamate is used to treat certain seizures in adults and children with epilepsy whose seizures have not improved with other treatments. It is used alone or in combination with other medications to treat partial seizures in adults. It is used in combination with other medications to treat partial and generalized seizures in children with Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays). Felbamate is in a class of medications called anticonvulsants. It works by decreasing abnormal activity in the brain.

Related Packages: 00037-0442-67
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Felbamate

Product Information

NDC	00037-0442
Product ID	0037-0442_7bbea585-978a-44c8-be8f-48a7dfabaced
Associated GPIs	72120020001810
GCN Sequence Number	020040
GCN Sequence Number Description	felbamate ORAL SUSP 600 MG/5ML ORAL
HIC3	H4B
HIC3 Description	ANTICONVULSANTS
GCN	38020
HICL Sequence Number	008186
HICL Sequence Number Description	FELBAMATE
Brand/Generic	Brand
Proprietary Name	Felbatol
Proprietary Name Suffix	n/a
Non-Proprietary Name	felbamate
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	600
Active Ingredient Units	mg/5mL
Substance Name	FELBAMATE
Labeler Name	Meda Pharmaceuticals Inc.
Pharmaceutical Class	Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA020189
Listing Certified Through	n/a

Package

NDC 00037-0442-67 (00037044267)

Pricing Information	N/A
NDC Package Code	0037-0442-67
Billing NDC	00037044267
Package	237 mL in 1 BOTTLE, PLASTIC (0037-0442-67)
Marketing Start Date	1993-07-29
NDC Exclude Flag	N