ROPINIROLE HYDROCHLORIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Ropinirole Hydrochloride.
| Product ID | 46708-035_091670a3-3f00-4f03-9127-3792f22efddb |
| NDC | 46708-035 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ROPINIROLE HYDROCHLORIDE |
| Generic Name | Ropinirole Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-09-12 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA090429 |
| Labeler Name | Alembic Pharmaceuticals Limited |
| Substance Name | ROPINIROLE HYDROCHLORIDE |
| Active Ingredient Strength | 4 mg/1 |
| Pharm Classes | Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2024-12-31 |
| Marketing Start Date | 2013-09-12 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA090429 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-09-12 |
| Marketing Category | ANDA |
| Application Number | ANDA090429 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-09-12 |
| Ingredient | Strength |
|---|---|
| ROPINIROLE HYDROCHLORIDE | 4 mg/1 |
| SPL SET ID: | 9a25f575-09ab-4d32-b73e-5426f08c00c4 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-5501 | Ropinirole Hydrochloride | ropinirole |
| 0378-5502 | Ropinirole Hydrochloride | ropinirole |
| 0378-5503 | Ropinirole Hydrochloride | ropinirole |
| 0378-5504 | Ropinirole Hydrochloride | ropinirole |
| 0378-5505 | Ropinirole Hydrochloride | ropinirole |
| 0378-5525 | Ropinirole Hydrochloride | ropinirole |
| 0378-5550 | Ropinirole Hydrochloride | ropinirole |
| 0615-7536 | Ropinirole Hydrochloride | Ropinirole Hydrochloride |
| 0615-7537 | Ropinirole Hydrochloride | Ropinirole Hydrochloride |
| 0615-7538 | Ropinirole Hydrochloride | Ropinirole Hydrochloride |
| 0615-7539 | Ropinirole Hydrochloride | Ropinirole Hydrochloride |
| 0615-7567 | Ropinirole Hydrochloride | Ropinirole Hydrochloride |
| 0615-8188 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE |
| 0615-8189 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE |
| 0615-8190 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE |
| 0615-8191 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE |
| 0904-6373 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE |
| 0904-6374 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE |
| 21695-792 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE |
| 21695-793 | ropinirole hydrochloride | ropinirole hydrochloride |
| 21695-794 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE |
| 21695-798 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE |
| 43353-194 | ropinirole hydrochloride | ropinirole hydrochloride |
| 43353-195 | ropinirole hydrochloride | ropinirole hydrochloride |
| 68258-7162 | Ropinirole Hydrochloride | Ropinirole Hydrochloride |
| 68382-340 | ropinirole hydrochloride | ropinirole hydrochloride |
| 68382-342 | ropinirole hydrochloride | ropinirole hydrochloride |
| 68382-338 | ropinirole hydrochloride | ropinirole hydrochloride |
| 68382-343 | ropinirole hydrochloride | ropinirole hydrochloride |
| 68382-344 | ropinirole hydrochloride | ropinirole hydrochloride |
| 68382-339 | ropinirole hydrochloride | ropinirole hydrochloride |
| 68382-341 | ropinirole hydrochloride | ropinirole hydrochloride |
| 71335-0728 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE |
| 71335-0829 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE |
| 71335-0727 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE |
| 43353-265 | Ropinirole Hydrochloride | Ropinirole Hydrochloride |
| 43547-273 | ropinirole hydrochloride | ropinirole hydrochloride |
| 43353-267 | Ropinirole Hydrochloride | Ropinirole Hydrochloride |
| 43353-196 | ropinirole hydrochloride | ropinirole hydrochloride |
| 43353-198 | ropinirole hydrochloride | ropinirole hydrochloride |
| 43353-258 | Ropinirole Hydrochloride | Ropinirole Hydrochloride |
| 43353-266 | Ropinirole Hydrochloride | Ropinirole Hydrochloride |
| 43547-270 | ropinirole hydrochloride | ropinirole hydrochloride |
| 43547-271 | ropinirole hydrochloride | ropinirole hydrochloride |
| 43547-268 | ropinirole hydrochloride | ropinirole hydrochloride |
| 43547-269 | ropinirole hydrochloride | ropinirole hydrochloride |
| 43547-274 | ropinirole hydrochloride | ropinirole hydrochloride |
| 43547-272 | ropinirole hydrochloride | ropinirole hydrochloride |
| 46708-032 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE |
| 46708-030 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE |