ropinirole
- Product NDC
- 71335-0631
- 11-digit product format
- 713350631
- Labeler code
- 71335
- Product ID
- 71335-0631_ae5d1a22-5d4f-4279-b24e-00a1a54ca7ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090135
- Marketing category
- ANDA
- Marketing start
- 2010-02-25
- 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
- 2027-12-31
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 |
|---|
| 71335-0631-1 | ropinirole | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 100 |
| 71335-0631-2 | ropinirole | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 100 |
| 71335-0631-3 | ropinirole | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 100 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0631 | ROPINIROLE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 100 | Current NDC, Legacy NDC, 3 package rows | 20240526_c89f68e5-d2ad-4aad-a63c-c32eff5e82c9.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 |
|---|
| 71335-0631-1 | 71335063101 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0631-1) | 2024-05-24 | 0000-00-00 | No | No | Current |
| 71335-0631-2 | 71335063102 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0631-2) | 2024-05-24 | 0000-00-00 | No | No | Current |
| 71335-0631-3 | 71335063103 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0631-3) | 2024-05-24 | 0000-00-00 | No | No | Current |