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NDC 68462-0381-10 riluzole 50 mg/1 Details
riluzole 50 mg/1
riluzole 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 RILUZOLE.
MedlinePlus Drug Summary
Riluzole is used to treat amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease). Riluzole is in a class of medications called benzothiazoles. It works by changing the activity of certain natural substances in the body that affect nerves and muscles.
Related Packages: 68462-0381-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Riluzole
Product Information
| NDC | 68462-0381 |
|---|---|
| Product ID | 68462-381_e8a81e60-47b6-4097-9e49-48eb88e694f6 |
| Associated GPIs | 74503070000320 |
| GCN Sequence Number | 024508 |
| GCN Sequence Number Description | riluzole TABLET 50 MG ORAL |
| HIC3 | H6I |
| HIC3 Description | AMYOTROPHIC LATERAL SCLEROSIS AGENTS |
| GCN | 12120 |
| HICL Sequence Number | 010247 |
| HICL Sequence Number Description | RILUZOLE |
| Brand/Generic | Generic |
| Proprietary Name | riluzole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | riluzole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | RILUZOLE |
| Labeler Name | Glenmark Pharmaceuticals Inc., USA |
| Pharmaceutical Class | Benzothiazole [EPC], Benzothiazoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091394 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 68462-0381-10 (68462038110)
| NDC Package Code | 68462-381-10 |
|---|---|
| Billing NDC | 68462038110 |
| Package | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-381-10) |
| Marketing Start Date | 2013-06-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |