Baclofen (Intrathecal) 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 | 70511-124_c1aad0b3-4d62-4bf4-8d31-06a1aab94943 |
| NDC | 70511-124 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Baclofen (Intrathecal) |
| Generic Name | Baclofen |
| Dosage Form | Injection |
| Route of Administration | INTRATHECAL |
| Marketing Start Date | 2019-09-25 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA210048 |
| Labeler Name | MAlA Pharmaceuticals, Inc. |
| Substance Name | BACLOFEN |
| Active Ingredient Strength | 2000 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 | 2020-12-31 |
| Marketing Start Date | 2019-09-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA210048 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-09-25 |
| Ingredient | Strength |
|---|---|
| BACLOFEN | 2000 ug/mL |
| SPL SET ID: | 11ba5575-a856-414a-89f8-17f3a01de55b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 71525-040 | Baclofen (intrathecal) | Baclofen (intrathecal) |
| 71525-010 | Baclofen (intrathecal) | Baclofen (intrathecal) |
| 71525-005 | Baclofen (intrathecal) | Baclofen (intrathecal) |
| 70511-124 | Baclofen (Intrathecal) | Baclofen (Intrathecal) |
| 70511-122 | Baclofen (Intrathecal) | Baclofen (Intrathecal) |
| 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 |