Ropinirole
- Product NDC
- 0054-0119
- 11-digit product format
- 000540119
- Labeler code
- 0054
- Product ID
- 0054-0119_89b0f8ed-b89f-461b-a0d7-6a52a82aa57d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rOPINIRole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- West-Ward Pharmaceuticals Corp.
- Application
- ANDA077852
- Marketing category
- ANDA
- Marketing start
- 2008-05-05
- Marketing end
- 2021-04-09
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ROPINIROLE HYDROCHLORIDE | ACTIVE INGREDIENT | D7ZD41RZI9 | ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| ROPINIROLE | ACTIVE MOIETY | 030PYR8953 | ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0119-25 | 00054011925 | 100 TABLET in 1 BOTTLE (0054-0119-25) | 100 tablet | 2008-05-05 | 2021-04-09 | No | No | Current |