Ropinirole
- Product NDC
- 71335-9653
- 11-digit product format
- 713359653
- Labeler code
- 71335
- Product ID
- 71335-9653_ed933cbc-f57f-420f-ba50-591150d6d084
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ropinirole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA079229
- Marketing category
- ANDA
- Marketing start
- 2022-09-15
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- .5 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 |
|---|
| 71335-9653-1 | 71335965301 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9653-1) | 2023-03-13 | No | No | Historical |
| 71335-9653-2 | 71335965302 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9653-2) | 2023-02-14 | No | No | Historical |
| 71335-9653-3 | 71335965303 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9653-3) | 2023-11-28 | No | No | Historical |
| 71335-9653-4 | 71335965304 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9653-4) | 2024-04-03 | No | No | Historical |
| 71335-9653-5 | 71335965305 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9653-5) | 2023-06-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ropinirole | Bryant Ranch Prepack | 2024-04-03 | HUMAN PRESCRIPTION DRUG LABEL | 102 |