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Ropinirole
Ropinirole - 13811-643-01 - (Ropinirole)
Drug Information of Ropinirole
| Product NDC: | 13811-643 |
| Proprietary Name: | Ropinirole |
| Non Proprietary Name: | Ropinirole |
| Active Ingredient(s): | 12 mg/1 & nbsp; Ropinirole |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Ropinirole
| Product NDC: | 13811-643 |
| Labeler Name: | Trigen Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA202786 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130615 |
Package Information of Ropinirole
| Package NDC: | 13811-643-01 |
| Package Description: | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13811-643-01) |
NDC Information of Ropinirole
| NDC Code | 13811-643-01 |
| Proprietary Name | Ropinirole |
| Package Description | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13811-643-01) |
| Product NDC | 13811-643 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Ropinirole |
| Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20130615 |
| Marketing Category Name | ANDA |
| Labeler Name | Trigen Laboratories, Inc. |
| Substance Name | ROPINIROLE HYDROCHLORIDE |
| Strength Number | 12 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |
