ropinirole
- Product NDC
- 70518-3482
- 11-digit product format
- 705183482
- Labeler code
- 70518
- Product ID
- 70518-3482_4f1c972f-67a2-e8c3-e063-6294a90af4c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090135
- Marketing category
- ANDA
- Marketing start
- 2022-08-17
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ropinirole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROPINIROLE HYDROCHLORIDE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D7ZD41RZI9 |
| Rxcui | 314208 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3482-0 | ropinirole | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3482 | ROPINIROLE TABLET, FILM COATED [REMEDYREPACK INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240113_864b38b0-1d4b-4da8-9645-c1760a2080ce.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3482-0 | 70518348200 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3482-0) | 2022-08-17 | 0000-00-00 | No | No | Current |