ropinirole is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Ropinirole Hydrochloride.
| Product ID | 71335-0064_cbc3905f-e2bc-4eaa-8166-2774d6d11390 |
| NDC | 71335-0064 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ropinirole |
| Generic Name | Ropinirole |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2010-02-25 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA090135 |
| Labeler Name | Bryant Ranch Prepack |
| Substance Name | ROPINIROLE HYDROCHLORIDE |
| Active Ingredient Strength | 1 mg/1 |
| Pharm Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2021-12-27 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA090135 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-07-19 |
| Marketing End Date | 2019-05-31 |
| Marketing Category | ANDA |
| Application Number | ANDA090135 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-07-19 |
| Marketing End Date | 2019-05-31 |
| Marketing Category | ANDA |
| Application Number | ANDA090135 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-07-19 |
| Marketing End Date | 2019-05-31 |
| Marketing Category | ANDA |
| Application Number | ANDA090135 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-07-19 |
| Marketing End Date | 2019-05-31 |
| Marketing Category | ANDA |
| Application Number | ANDA090135 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-07-19 |
| Marketing End Date | 2019-05-31 |
| Ingredient | Strength |
|---|---|
| ROPINIROLE HYDROCHLORIDE | .5 mg/1 |
| SPL SET ID: | cc80be71-8856-42f6-ab76-6090049342a5 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0116 | Ropinirole | rOPINIRole |
| 0054-0117 | Ropinirole | rOPINIRole |
| 0054-0118 | Ropinirole | rOPINIRole |
| 0054-0119 | Ropinirole | rOPINIRole |
| 0054-0120 | Ropinirole | rOPINIRole |
| 0054-0121 | Ropinirole | rOPINIRole |
| 0054-0122 | Ropinirole | rOPINIRole |
| 0228-3640 | Ropinirole | Ropinirole |
| 0228-3658 | Ropinirole | Ropinirole |
| 0228-3659 | Ropinirole | Ropinirole |
| 0228-3660 | Ropinirole | Ropinirole |
| 0228-3661 | Ropinirole | Ropinirole |
| 0378-5501 | Ropinirole | ropinirole |
| 0378-5502 | Ropinirole | ropinirole |
| 68151-4073 | Ropinirole | Ropinirole |
| 68151-4071 | Ropinirole | Ropinirole |
| 68151-4072 | Ropinirole | Ropinirole |
| 68258-7163 | ropinirole | ropinirole |
| 68462-259 | ropinirole | ropinirole |
| 68462-253 | ropinirole | ropinirole |
| 68462-255 | ropinirole | ropinirole |
| 68462-256 | ropinirole | ropinirole |
| 68462-258 | ropinirole | ropinirole |
| 68462-254 | ropinirole | ropinirole |
| 68462-257 | ropinirole | ropinirole |
| 71335-0064 | ropinirole | ropinirole |
| 71335-0560 | ropinirole | ropinirole |
| 71335-0447 | ropinirole | ropinirole |
| 71335-0631 | ropinirole | ropinirole |
| 0781-5786 | ropinirole | ropinirole |
| 0781-5782 | ropinirole | ropinirole |
| 0781-5784 | ropinirole | ropinirole |
| 0781-5780 | ropinirole | ropinirole |
| 0781-5788 | ropinirole | ropinirole |
| 10135-673 | Ropinirole | Ropinirole |
| 10135-674 | Ropinirole | Ropinirole |
| 10135-675 | Ropinirole | Ropinirole |
| 10135-679 | Ropinirole | Ropinirole |
| 10135-678 | Ropinirole | Ropinirole |
| 10135-677 | Ropinirole | Ropinirole |
| 10135-676 | Ropinirole | Ropinirole |
| 13811-639 | Ropinirole | Ropinirole |
| 13811-643 | Ropinirole | Ropinirole |
| 13811-641 | Ropinirole | Ropinirole |
| 13811-640 | Ropinirole | Ropinirole |
| 13811-642 | Ropinirole | Ropinirole |
| 16729-235 | ropinirole | ropinirole |
| 16729-234 | ropinirole | ropinirole |
| 16729-233 | ropinirole | ropinirole |
| 16729-237 | ropinirole | ropinirole |