Ropinirole
- Product NDC
- 72189-416
- 11-digit product format
- 721890416
- Labeler code
- 72189
- Product ID
- 72189-416_2c4cfec2-fee0-e007-e063-6294a90a3cf9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ropinirole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA090135
- Marketing category
- ANDA
- Marketing start
- 2023-02-01
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- .25 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| D7ZD41RZI9 | ROPINIROLE HYDROCHLORIDE | 91374-20-8 | ROPINIROLE HYDROCHLORIDE |
| 030PYR8953 | ROPINIROLE | 91374-21-9 | Ropinirole |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-416-30 | 72189041630 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-416-30) | 2023-02-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ropinirole | Direct_Rx | 2025-01-22 | HUMAN PRESCRIPTION DRUG LABEL | 2 |