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Ropinirole Hydrochloride
Ropinirole Hydrochloride - 0378-4093-05 - (ropinirole hydrochloride)
Drug Information of Ropinirole Hydrochloride
| Product NDC: | 0378-4093 |
| Proprietary Name: | Ropinirole Hydrochloride |
| Non Proprietary Name: | ropinirole hydrochloride |
| Active Ingredient(s): | 8 mg/1 & nbsp; ropinirole hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Ropinirole Hydrochloride
| Product NDC: | 0378-4093 |
| Labeler Name: | Mylan Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA200462 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20121016 |
Package Information of Ropinirole Hydrochloride
| Package NDC: | 0378-4093-05 |
| Package Description: | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4093-05) |
NDC Information of Ropinirole Hydrochloride
| NDC Code | 0378-4093-05 |
| Proprietary Name | Ropinirole Hydrochloride |
| Package Description | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4093-05) |
| Product NDC | 0378-4093 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ropinirole hydrochloride |
| Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20121016 |
| Marketing Category Name | ANDA |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | ROPINIROLE HYDROCHLORIDE |
| Strength Number | 8 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |
