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NDC 68462-0713-05 rufinamide 200 mg/1 Details
rufinamide 200 mg/1
rufinamide is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., USA. The primary component is RUFINAMIDE.
MedlinePlus Drug Summary
Rufinamide is used with other medication(s) to control seizures in people who have Lennox-Gastaut syndrome (a severe form of epilepsy that begins during childhood and causes several types of seizures, behavioral disturbances, and developmental delays). Rufinamide is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
Related Packages: 68462-0713-05Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Rufinamide
Product Information
| NDC | 68462-0713 |
|---|---|
| Product ID | 68462-713_087abf2a-9b50-469c-ac8b-5d3eb98c3b62 |
| Associated GPIs | 72600065000320 |
| GCN Sequence Number | 063076 |
| GCN Sequence Number Description | rufinamide TABLET 200 MG ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 98836 |
| HICL Sequence Number | 034982 |
| HICL Sequence Number Description | RUFINAMIDE |
| Brand/Generic | Generic |
| Proprietary Name | rufinamide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | rufinamide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | RUFINAMIDE |
| Labeler Name | Glenmark Pharmaceuticals Inc., USA |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205075 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 68462-0713-05 (68462071305)
| NDC Package Code | 68462-713-05 |
|---|---|
| Billing NDC | 68462071305 |
| Package | 500 TABLET, FILM COATED in 1 BOTTLE (68462-713-05) |
| Marketing Start Date | 2016-05-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |