ROPINIROLE HYDROCHLORIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Inc.. The primary component is Ropinirole Hydrochloride.
Product ID | 62332-034_852de55f-da70-42b7-a2be-1875623c4fee |
NDC | 62332-034 |
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 | 2016-01-29 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA090429 |
Labeler Name | Alembic Pharmaceuticals Inc. |
Substance Name | ROPINIROLE HYDROCHLORIDE |
Active Ingredient Strength | 3 mg/1 |
Pharm Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2016-01-29 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA090429 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2016-01-29 |
Marketing End Date | 2019-01-30 |
Marketing Category | ANDA |
Application Number | ANDA090429 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2016-01-29 |
Marketing Category | ANDA |
Application Number | ANDA090429 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2016-01-29 |
Marketing End Date | 2019-01-30 |
Marketing Category | ANDA |
Application Number | ANDA090429 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2016-01-29 |
Ingredient | Strength |
---|---|
ROPINIROLE HYDROCHLORIDE | 3 mg/1 |
SPL SET ID: | 6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c |
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 |