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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ROPINIROLE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROPINIROLE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D7ZD41RZI9 |
| Rxcui | 312847 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-1489-3 | ROPINIROLE | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67046-1489 | ROPINIROLE TABLET, FILM COATED [COUPLER LLC] | 1 | Current NDC, 1 package rows | 20250130_2cdae415-479b-c14c-e063-6394a90adb6c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |