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 |