Baclofen is a Intrathecal Injection in the Human Prescription Drug category. It is labeled and distributed by Mala Pharmaceuticals, Inc.. The primary component is Baclofen.
| Product ID | 70511-123_caff7943-0b7c-47d1-983c-fbbda2d9a70d |
| NDC | 70511-123 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Baclofen |
| Generic Name | Baclofen |
| Dosage Form | Injection |
| Route of Administration | INTRATHECAL |
| Marketing Start Date | 2020-12-23 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA210315 |
| Labeler Name | MAlA Pharmaceuticals, Inc. |
| Substance Name | BACLOFEN |
| Active Ingredient Strength | 1000 ug/mL |
| Pharm Classes | GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-12-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA210315 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-08-13 |
| Ingredient | Strength |
|---|---|
| BACLOFEN | 1000 ug/mL |
| SPL SET ID: | dfa6148c-693c-45f1-89be-0e77d39f313e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0115-1010 | Baclofen | Baclofen |
| 0115-1011 | Baclofen | Baclofen |
| 0115-1012 | Baclofen | Baclofen |
| 0172-4096 | Baclofen | Baclofen |
| 0172-4097 | Baclofen | Baclofen |
| 0527-1330 | Baclofen | baclofen |
| 0527-1333 | Baclofen | baclofen |
| 0527-1337 | Baclofen | baclofen |
| 0603-2406 | Baclofen | Baclofen |
| 0603-2407 | Baclofen | Baclofen |
| 0615-3541 | Baclofen | Baclofen |
| 0615-3542 | Baclofen | Baclofen |
| 0615-8411 | Baclofen | Baclofen |
| 0615-8412 | Baclofen | Baclofen |
| 68071-3075 | Baclofen | Baclofen |
| 68071-3001 | Baclofen | Baclofen |
| 68084-855 | Baclofen | Baclofen |
| 68084-868 | Baclofen | Baclofen |
| 68788-0522 | Baclofen | Baclofen |
| 68788-6903 | Baclofen | Baclofen |
| 68788-9246 | Baclofen | Baclofen |
| 68788-6384 | Baclofen | Baclofen |
| 68788-9735 | Baclofen | Baclofen |
| 68788-9796 | Baclofen | Baclofen |
| 68788-9846 | Baclofen | Baclofen |
| 70518-0215 | Baclofen | Baclofen |
| 70518-0362 | Baclofen | Baclofen |
| 70518-0411 | Baclofen | Baclofen |
| 70518-0547 | Baclofen | Baclofen |
| 70518-1515 | Baclofen | Baclofen |
| 70710-1285 | Baclofen | Baclofen |
| 70771-1449 | Baclofen | Baclofen |
| 70771-1448 | Baclofen | Baclofen |
| 70710-1286 | Baclofen | Baclofen |
| 71335-0206 | Baclofen | Baclofen |
| 71335-0344 | Baclofen | Baclofen |
| 71335-0103 | Baclofen | Baclofen |
| 71335-0949 | BACLOFEN | BACLOFEN |
| 0832-1025 | Baclofen | Baclofen |
| 0832-1055 | Baclofen | Baclofen |
| 0832-1024 | Baclofen | Baclofen |
| 0832-1054 | Baclofen | Baclofen |
| 0904-5222 | Baclofen | Baclofen |
| 0904-3365 | Baclofen | Baclofen |
| 0904-6476 | Baclofen | Baclofen |
| 0904-6475 | Baclofen | Baclofen |
| 10135-533 | Baclofen | Baclofen |
| 10135-532 | Baclofen | Baclofen |
| 10544-172 | Baclofen | Baclofen |
| 16714-072 | Baclofen | Baclofen |