ropinirole is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare Inc.. The primary component is Ropinirole Hydrochloride.
| Product ID | 16729-238_7890ff3c-e5a7-a0fa-e053-2991aa0af0b8 |
| NDC | 16729-238 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ropinirole |
| Generic Name | Ropinirole |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-10-17 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA204022 |
| Labeler Name | Accord Healthcare Inc. |
| Substance Name | ROPINIROLE HYDROCHLORIDE |
| Active Ingredient Strength | 5 mg/1 |
| Pharm Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2018-10-17 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA204022 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-10-17 |
| Ingredient | Strength |
|---|---|
| ROPINIROLE HYDROCHLORIDE | 5 mg/1 |
| SPL SET ID: | 4a2a5b63-5b14-6975-e054-00144ff8d46c |
| 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 |