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NDC 53746-0734-30 Felbamate 400 mg/1 Details
Felbamate 400 mg/1
Felbamate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals of New York LLC. 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: 53746-0734-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Felbamate
Product Information
| NDC | 53746-0734 |
|---|---|
| Product ID | 53746-734_a979682b-bb8c-4ba1-8373-3170967a2125 |
| Associated GPIs | |
| GCN Sequence Number | 020041 |
| GCN Sequence Number Description | felbamate TABLET 400 MG ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 38021 |
| HICL Sequence Number | 008186 |
| HICL Sequence Number Description | FELBAMATE |
| Brand/Generic | Generic |
| Proprietary Name | Felbamate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Felbamate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 400 |
| Active Ingredient Units | mg/1 |
| Substance Name | FELBAMATE |
| Labeler Name | Amneal Pharmaceuticals of New York LLC |
| Pharmaceutical Class | Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA201680 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53746-0734-30 (53746073430)
| NDC Package Code | 53746-734-30 |
|---|---|
| Billing NDC | 53746073430 |
| Package | 30 TABLET in 1 BOTTLE (53746-734-30) |
| Marketing Start Date | 2022-08-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |