ropinirole
- Product NDC
- 68462-254
- 11-digit product format
- 684620254
- Labeler code
- 68462
- Product ID
- 68462-254_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
- .5 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 |
|---|---|
| ROPINIROLE HYDROCHLORIDE | .5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | D7ZD41RZI9 |
| Rxcui | 283858, 312845, 312846, 312847, 312849, 314208, 562704 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| dc920868-8845-b908-7ca8-0dee3e345af5 | Product name | 2 | 20230123 |
| e24bc1b4-1e16-908e-3d09-29da3ca2fb1f | Product name | 2 | 20170517 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68462-254-01 | ropinirole | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 16 | |
| 68462-254-10 | ropinirole | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 16 | |
| 68462-254-11 | ropinirole | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 16 | |
| 68462-254-11 | ropinirole | 10 in 1 CARTON | TABLET, FILM COATED | 10 | 16 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312845 | rOPINIRole HCl 0.25 MG Oral Tablet | PSN | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 312846 | rOPINIRole HCl 0.5 MG Oral Tablet | PSN | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 314208 | rOPINIRole HCl 1 MG Oral Tablet | PSN | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 312847 | rOPINIRole HCl 2 MG Oral Tablet | PSN | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 283858 | rOPINIRole HCl 3 MG Oral Tablet | PSN | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 562704 | rOPINIRole HCl 4 MG Oral Tablet | PSN | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 312849 | rOPINIRole HCl 5 MG Oral Tablet | PSN | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 312845 | ropinirole 0.25 MG Oral Tablet | SCD | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 312846 | ropinirole 0.5 MG Oral Tablet | SCD | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 314208 | ropinirole 1 MG Oral Tablet | SCD | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 312847 | ropinirole 2 MG Oral Tablet | SCD | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 283858 | ropinirole 3 MG Oral Tablet | SCD | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 562704 | ropinirole 4 MG Oral Tablet | SCD | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 312849 | ropinirole 5 MG Oral Tablet | SCD | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 312845 | ropinirole 0.25 MG (as ropinirole hydrochloride) Oral Tablet | SY | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 312846 | ropinirole 0.5 MG (as ropinirole hydrochloride) Oral Tablet | SY | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 314208 | ropinirole 1 MG (as ropinirole hydrochloride) Oral Tablet | SY | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 312847 | ropinirole 2 MG (as ropinirole hydrochloride) Oral Tablet | SY | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 283858 | ropinirole 3 MG (as ropinirole hydrochloride) Oral Tablet | SY | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 562704 | ropinirole 4 MG (as ropinirole hydrochloride) Oral Tablet | SY | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 312849 | ropinirole 5 MG (as ropinirole hydrochloride) Oral Tablet | SY | 85971b31-6f7d-421c-bf3c-5b33f3c1e781 | 16 |
| 312846 | rOPINIRole HCl 0.5 MG Oral Tablet | PSN | 16752e1b-10eb-4c31-92d4-ff6c6e8466f4 | 5 |
| 312846 | ropinirole 0.5 MG Oral Tablet | SCD | 16752e1b-10eb-4c31-92d4-ff6c6e8466f4 | 5 |
| 312846 | ropinirole 0.5 MG (as ropinirole hydrochloride) Oral Tablet | SY | 16752e1b-10eb-4c31-92d4-ff6c6e8466f4 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68462-254-01 | 68462025401 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-254-01) | 2010-02-25 | 0000-00-00 | No | No | Current | |
| 68462-254-10 | 68462025410 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-254-10) | 2010-02-25 | 0000-00-00 | No | No | Current | |
| 68462-254-11 | 68462025411 | 10 BLISTER PACK in 1 CARTON (68462-254-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2010-02-25 | 0000-00-00 | No | No | Current |