METAXALONE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Metaxalone.
| Product ID | 50742-277_401b0712-b041-489a-addb-a34515ef9026 |
| NDC | 50742-277 |
| Product Type | Human Prescription Drug |
| Proprietary Name | METAXALONE |
| Generic Name | Metaxalone |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-10-21 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA213836 |
| Labeler Name | Ingenus Pharmaceuticals, LLC |
| Substance Name | METAXALONE |
| Active Ingredient Strength | 800 mg/1 |
| Pharm Classes | Centrally-mediated Muscle Relaxation [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-10-21 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0115-1745 | Metaxalone | Metaxalone |
| 0115-1748 | Metaxalone | Metaxalone |
| 0185-0448 | Metaxalone | Metaxalone |
| 0276-0508 | Metaxalone | Metaxalone |
| 0527-1435 | Metaxalone | Metaxalone |
| 0591-2341 | Metaxalone | Metaxalone |
| 0904-6831 | Metaxalone | Metaxalone |
| 10544-002 | Metaxalone | Metaxalone |
| 10544-144 | Metaxalone | Metaxalone |
| 21695-585 | Metaxalone | Metaxalone |
| 33261-724 | Metaxalone | Metaxalone |
| 35356-570 | Metaxalone | Metaxalone |
| 42254-040 | Metaxalone | Metaxalone |
| 42291-587 | Metaxalone | Metaxalone |
| 43063-239 | Metaxalone | Metaxalone |
| 43063-581 | Metaxalone | Metaxalone |
| 45865-942 | Metaxalone | Metaxalone |
| 45865-985 | Metaxalone | Metaxalone |
| 50090-1182 | Metaxalone | Metaxalone |
| 50090-3174 | Metaxalone | Metaxalone |
| 50090-3297 | Metaxalone | Metaxalone |
| 50090-3650 | Metaxalone | Metaxalone |
| 50090-3670 | Metaxalone | Metaxalone |
| 68001-004 | Metaxalone | Metaxalone |
| 68084-135 | Metaxalone | Metaxalone |
| 68151-4668 | Metaxalone | Metaxalone |
| 68258-7100 | Metaxalone | Metaxalone |
| 68387-108 | Metaxalone | Metaxalone |
| 68788-7073 | Metaxalone | Metaxalone |
| 68788-7018 | Metaxalone | Metaxalone |
| 68788-6466 | Metaxalone | Metaxalone |
| 68788-9896 | Metaxalone | Metaxalone |
| 68788-9277 | Metaxalone | Metaxalone |
| 70332-330 | Metaxalone | Metaxalone |
| 70518-0818 | Metaxalone | Metaxalone |
| 70518-0771 | Metaxalone | Metaxalone |
| 70518-1161 | Metaxalone | Metaxalone |
| 70934-160 | Metaxalone | Metaxalone |
| 71335-0099 | Metaxalone | Metaxalone |
| 71335-0186 | Metaxalone | Metaxalone |
| 71205-016 | Metaxalone | Metaxalone |
| 71335-0375 | Metaxalone | Metaxalone |
| 71335-0958 | Metaxalone | Metaxalone |
| 50228-323 | Metaxalone | Metaxalone |
| 50436-0448 | Metaxalone | Metaxalone |
| 50268-530 | Metaxalone | Metaxalone |
| 50436-3024 | Metaxalone | Metaxalone |
| 51655-162 | Metaxalone | Metaxalone |
| 51655-167 | Metaxalone | Metaxalone |
| 51655-163 | Metaxalone | Metaxalone |