Ropinirole
- Product NDC
- 71335-2515
- 11-digit product format
- 713352515
- Labeler code
- 71335
- Product ID
- 71335-2515_59b4ff27-308c-4a28-810f-946f584d06d5
- 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
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Ropinirole
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| ROPINIROLE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | D7ZD41RZI9 |
| Rxcui | 312847 |
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 |
|---|
| 71335-2515-1 | 71335251501 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2515-1) | 2024-10-24 | No | No | Current |
| 71335-2515-2 | 71335251502 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2515-2) | 2024-10-24 | No | No | Current |
| 71335-2515-3 | 71335251503 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2515-3) | 2024-10-24 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ropinirole | Bryant Ranch Prepack | 2024-10-24 | HUMAN PRESCRIPTION DRUG LABEL | 1 |