ROPINIROLE
- Product NDC
- 0904-6373
- 11-digit product format
- 009046373
- Labeler code
- 0904
- Product ID
- 0904-6373_5ebf9666-159a-4aee-a889-dc1ab6f104b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROPINIROLE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA090429
- Marketing category
- ANDA
- Marketing start
- 2014-10-01
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- .25 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 | .25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D7ZD41RZI9 |
| Rxcui | 312845, 314208 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6373-61 | ROPINIROLE | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 10 |
| 0904-6373-61 | ROPINIROLE | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ROPINIROLE HYDROCHLORIDE | ACTIVE INGREDIENT | D7ZD41RZI9 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| ROPINIROLE | ACTIVE MOIETY | 030PYR8953 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6373 | ROPINIROLE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250130_e7ef58c0-73ba-4af2-b82b-a33954ec44df.zip |
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 |
|---|
| 0904-6373-61 | 00904637361 | 100 BLISTER PACK in 1 CARTON (0904-6373-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2014-10-01 | 0000-00-00 | No | No | Current |