ropinirole hydrochloride
- Product NDC
- 71335-1626
- 11-digit product format
- 713351626
- Labeler code
- 71335
- Product ID
- 71335-1626_d88b1f49-8ea3-43fa-ae34-0cb10ca3a562
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078110
- Marketing category
- ANDA
- Marketing start
- 2011-09-20
- 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
openFDA Listing Details
- Product ID
- 71335-1626_d88b1f49-8ea3-43fa-ae34-0cb10ca3a562
- SPL ID
- d88b1f49-8ea3-43fa-ae34-0cb10ca3a562
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- ropinirole hydrochloride
- Generic name
- ropinirole hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2011-09-20
- Marketing category
- ANDA
- Application number
- ANDA078110
- Pharmacologic classes
- Dopamine Agonists [MoA]; Nonergot Dopamine Agonist [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| ROPINIROLE HYDROCHLORIDE | 2 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | D7ZD41RZI9 |
| Rxcui | 312845, 312847, 314208 |
| Spl Set Id | 6c10444a-48da-469d-bf8f-1e6e0b7e15f8 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-1626-1 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1626-1) | 2020-06-08 | No |
| 71335-1626-2 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1626-2) | 2020-06-08 | No |
| 71335-1626-3 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1626-3) | 2020-06-08 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| D7ZD41RZI9 | ROPINIROLE HYDROCHLORIDE | 91374-20-8 | ROPINIROLE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1626-1 | 71335162601 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1626-1) | 2020-06-08 | No | No | Historical |
| 71335-1626-2 | 71335162602 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1626-2) | 2020-06-08 | No | No | Historical |
| 71335-1626-3 | 71335162603 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1626-3) | 2020-06-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ropinirole hydrochloride | Bryant Ranch Prepack | 2023-10-30 | HUMAN PRESCRIPTION DRUG LABEL | 10 |