Ropinirole
- Product NDC
- 0054-0122
- 11-digit product format
- 000540122
- Labeler code
- 0054
- Product ID
- 0054-0122_89b0f8ed-b89f-461b-a0d7-6a52a82aa57d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rOPINIRole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- West-Ward Pharmaceuticals Corp.
- Application
- ANDA077852
- Marketing category
- ANDA
- Marketing start
- 2008-05-05
- Marketing end
- 2021-04-09
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 5 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 |
|---|
| 0054-0122-25 | 00054012225 | 100 TABLET in 1 BOTTLE (0054-0122-25) | 100 tablet | 2008-05-21 | 2021-04-09 | No | No | Current |