Baclofen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by New Horizon Rx Group, Llc. The primary component is Baclofen.
| Product ID | 58517-440_165688ef-8ccc-47c2-ae3e-4c6bf2dcb048 |
| NDC | 58517-440 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Baclofen |
| Generic Name | Baclofen |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-08-25 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA077068 |
| Labeler Name | New Horizon Rx Group, LLC |
| Substance Name | BACLOFEN |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 2013-08-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA077068 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-08-25 |
| Inactivation Date | 2019-11-27 |
| Ingredient | Strength |
|---|---|
| BACLOFEN | 10 mg/1 |
| SPL SET ID: | d6045fb8-9204-46cd-ab10-de8e9b1a41fe |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| 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 |