ROPINIROLE
- Product NDC
- 67046-1489
- 11-digit product format
- 670461489
- Labeler code
- 67046
- Product ID
- 67046-1489_2cdaf99a-56b8-4d61-e063-6294a90a3bc3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROPINIROLE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA090429
- Marketing category
- ANDA
- Marketing start
- 2025-01-29
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 2 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 |
|---|
| 67046-1489-3 | 67046148903 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1489-3) | 2025-01-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ROPINIROLE | Coupler LLC | 2025-01-29 | HUMAN PRESCRIPTION DRUG LABEL | 1 |