ROPINIROLE
- Product NDC
- 43547-554
- 11-digit product format
- 435470554
- Labeler code
- 43547
- Product ID
- 43547-554_9bbec058-00a5-4353-bd58-426ddb0b2020
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA204413
- Marketing category
- ANDA
- Marketing start
- 2022-03-22
- Substance
- ROPINIROLE
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ROPINIROLE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ROPINIROLE | 2 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 030PYR8953 |
| Rxcui | 799054, 799055, 799056, 824959, 848582 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| dc920868-8845-b908-7ca8-0dee3e345af5 | Product name | 2 | 20230123 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| e24bc1b4-1e16-908e-3d09-29da3ca2fb1f | Product name | 2 | 20170517 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43547-554-03 | ROPINIROLE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 824959 | rOPINIRole 12 MG 24HR Extended Release Oral Tablet | PSN | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 799055 | rOPINIRole 2 MG 24HR Extended Release Oral Tablet | PSN | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 799056 | rOPINIRole 4 MG 24HR Extended Release Oral Tablet | PSN | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 848582 | rOPINIRole 6 MG 24HR Extended Release Oral Tablet | PSN | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 799054 | rOPINIRole 8 MG 24HR Extended Release Oral Tablet | PSN | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 824959 | 24 HR ropinirole 12 MG Extended Release Oral Tablet | SCD | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 799055 | 24 HR ropinirole 2 MG Extended Release Oral Tablet | SCD | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 799056 | 24 HR ropinirole 4 MG Extended Release Oral Tablet | SCD | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 848582 | 24 HR ropinirole 6 MG Extended Release Oral Tablet | SCD | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 799054 | 24 HR ropinirole 8 MG Extended Release Oral Tablet | SCD | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 824959 | ropinirole 12 MG (as ropinirole hydrochloride 13.68 MG) 24 HR Extended Release Oral Tablet | SY | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 824959 | ropinirole 12 MG 24 HR Extended Release Oral Tablet | SY | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 799055 | ropinirole 2 MG (as ropinirole hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet | SY | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 799055 | ropinirole 2 MG 24 HR Extended Release Oral Tablet | SY | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 799056 | ropinirole 4 MG (as ropinirole hydrochloride 4.56 MG) 24 HR Extended Release Oral Tablet | SY | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 799056 | ropinirole 4 MG 24 HR Extended Release Oral Tablet | SY | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 848582 | ropinirole 6 MG (ropinirole hydrochloride 6.84 MG) 24 HR Extended Release Oral Tablet | SY | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 848582 | ropinirole 6 MG 24 HR Extended Release Oral Tablet | SY | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 799054 | ropinirole 8 MG (as ropinirole hydrochloride 9.12 MG) 24 HR Extended Release Oral Tablet | SY | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
| 799054 | ropinirole 8 MG 24 HR Extended Release Oral Tablet | SY | 213dd2f4-4a71-456c-b3c7-b709c7bd7445 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43547-554-03 | 43547055403 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-554-03) | 2022-03-22 | 0000-00-00 | No | No | Current |
| 43547-554-09 | 43547055409 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-554-09) | 2022-03-22 | 0000-00-00 | No | No | Current |