Riluzole is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Riluzole.
| Product ID | 0378-4145_75a73f3c-36f0-482c-87fc-c5bab212d4e5 |
| NDC | 0378-4145 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Riluzole |
| Generic Name | Riluzole |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-07-22 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203042 |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | RILUZOLE |
| Active Ingredient Strength | 50 mg/1 |
| Pharm Classes | Benzothiazole [EPC],Benzothiazoles [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2013-07-22 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA203042 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-07-22 |
| Marketing Category | ANDA |
| Application Number | ANDA203042 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-07-22 |
| Marketing End Date | 2016-06-20 |
| Ingredient | Strength |
|---|---|
| RILUZOLE | 50 mg/1 |
| SPL SET ID: | 97457622-5727-4b07-9e72-edd784b2d76d |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-4145 | Riluzole | riluzole |
| 42291-775 | Riluzole | riluzole |
| 60505-3285 | RILUZOLE | RILUZOLE |
| 62756-538 | Riluzole | Riluzole |
| 64980-191 | Riluzole | riluzole |
| 67877-286 | Riluzole | Riluzole |
| 68084-908 | RILUZOLE | RILUZOLE |
| 68462-381 | riluzole | riluzole |
| 69076-200 | Riluzole | riluzole |
| 69076-611 | Riluzole | Riluzole |
| 10094-350 | EXSERVAN | riluzole |
| 70510-2201 | Exservan | riluzole |
| 70510-2202 | Exservan | riluzole |
| 70515-700 | Rilutek | riluzole |
| 70726-0303 | TIGLUTIK | Riluzole |