RILUZOLE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Riluzole.
| Product ID | 68084-908_5cc44dca-00d9-b589-e053-2a91aa0a0521 |
| NDC | 68084-908 |
| Product Type | Human Prescription Drug |
| Proprietary Name | RILUZOLE |
| Generic Name | Riluzole |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-03-31 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA091300 |
| Labeler Name | American Health Packaging |
| Substance Name | RILUZOLE |
| Active Ingredient Strength | 50 mg/1 |
| Pharm Classes | Benzothiazole [EPC],Benzothiazoles [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2015-11-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA091300 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-03-31 |
| Marketing End Date | 2020-10-31 |
| Marketing Category | ANDA |
| Application Number | ANDA091300 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-03-31 |
| Marketing End Date | 2016-08-09 |
| Marketing Category | ANDA |
| Application Number | ANDA091300 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-09-23 |
| Marketing End Date | 2020-10-31 |
| Marketing Category | ANDA |
| Application Number | ANDA091300 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-11-16 |
| Marketing End Date | 2020-10-31 |
| Ingredient | Strength |
|---|---|
| RILUZOLE | 50 mg/1 |
| SPL SET ID: | 62719a26-880c-48ce-81dc-a9228e9cc0d7 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| 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 |