Ropinirole
- Product NDC
- 0378-5504
- 11-digit product format
- 003785504
- Labeler code
- 0378
- Product ID
- 0378-5504_626decf2-0627-4789-9b7c-600d8d75b2a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA078881
- Marketing category
- ANDA
- Marketing start
- 2008-05-05
- Marketing end
- 2023-04-30
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-5504-01 | 00378550401 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-5504-01) | 100 tablet | 2008-05-05 | 0000-00-00 | No | No | Current |