Ropinirole
- Product NDC
- 46708-262
- 11-digit product format
- 467080262
- Labeler code
- 46708
- Product ID
- 46708-262_a1e5da4e-74fc-4482-8e15-599c665f2c2f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ropinirole
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA202786
- Marketing category
- ANDA
- Marketing start
- 2013-03-14
- 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 | 799054, 799055, 799056, 824959, 848582 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-262-10 | Ropinirole | 100 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 100 | | 4 |
| 46708-262-30 | Ropinirole | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 4 |
| 46708-262-31 | Ropinirole | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 4 |
| 46708-262-71 | Ropinirole | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 4 |
| 46708-262-90 | Ropinirole | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 4 |
| 46708-262-91 | Ropinirole | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-262 | ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 4 | Current NDC, Legacy NDC, 6 package rows | 20230129_2e01dbdd-f439-45d7-9085-2d92a1a1fee2.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 |
|---|
| 46708-262-10 | 46708026210 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (46708-262-10) | 2013-03-14 | 0000-00-00 | No | No | Current |
| 46708-262-30 | 46708026230 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-262-30) | 2013-03-14 | 0000-00-00 | No | No | Current |
| 46708-262-31 | 46708026231 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-262-31) | 2013-03-14 | 0000-00-00 | No | No | Current |
| 46708-262-71 | 46708026271 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-262-71) | 2013-03-14 | 0000-00-00 | No | No | Current |
| 46708-262-90 | 46708026290 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-262-90) | 2013-03-14 | 0000-00-00 | No | No | Current |
| 46708-262-91 | 46708026291 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-262-91) | 2013-03-14 | 0000-00-00 | No | No | Current |