ropinirole
- Product NDC
- 68462-257
- 11-digit product format
- 684620257
- Labeler code
- 68462
- Product ID
- 68462-257_eaf797e1-337e-4fc1-bb49-29227b544fdb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA090135
- Marketing category
- ANDA
- Marketing start
- 2010-02-25
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 3 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 | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D7ZD41RZI9 |
| Rxcui | 283858, 312845, 312846, 312847, 312849, 314208, 562704 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-257-01 | ropinirole | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 16 |
| 68462-257-10 | ropinirole | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ROPINIROLE HYDROCHLORIDE | ACTIVE INGREDIENT | D7ZD41RZI9 | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| ROPINIROLE | ACTIVE MOIETY | 030PYR8953 | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-257 | ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 15 | Current NDC, Legacy NDC, 2 package rows | 20240104_85971b31-6f7d-421c-bf3c-5b33f3c1e781.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 |
|---|
| 68462-257-01 | 68462025701 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-257-01) | 2010-02-25 | 0000-00-00 | No | No | Current |
| 68462-257-10 | 68462025710 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-257-10) | 2010-02-25 | 0000-00-00 | No | No | Current |