ropinirole
- Product NDC
- 50090-4803
- 11-digit product format
- 500904803
- Labeler code
- 50090
- Product ID
- 50090-4803_964359dc-018a-469d-a2e6-cf5191a4b2ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA204022
- Marketing category
- ANDA
- Marketing start
- 2018-10-17
- 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 |
|---|
| 50090-4803-0 | 50090480300 | 100 TABLET, FILM COATED in 1 BOTTLE (50090-4803-0) | 2019-12-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ropinirole | A-S Medication Solutions | 2024-01-08 | HUMAN PRESCRIPTION DRUG LABEL | 7 |