Ropinirole
- Product NDC
- 64850-253
- 11-digit product format
- 648500253
- Labeler code
- 64850
- Product ID
- 64850-253_0ca68ebf-b908-4be4-a1a0-f9b3359375a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ropinirole
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Elite Laboratories, Inc.
- Application
- ANDA217862
- Marketing category
- ANDA
- Marketing start
- 2025-11-10
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 8 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 HYDROCHLORIDE | 8 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | D7ZD41RZI9 |
| Rxcui | 799054, 799055, 799056, 824959, 848582 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| dc920868-8845-b908-7ca8-0dee3e345af5 | Product name | 2 | 20230123 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| e24bc1b4-1e16-908e-3d09-29da3ca2fb1f | Product name | 2 | 20170517 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64850-253-30 | Ropinirole | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64850-253-30 | EA - Each | 64850-253 | 2cbd91a0-8c9b-438e-b683-78f8eb7e449d | 1 | 2026-04-20 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 824959 | rOPINIRole 12 MG 24HR Extended Release Oral Tablet | PSN | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 799055 | rOPINIRole 2 MG 24HR Extended Release Oral Tablet | PSN | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 799056 | rOPINIRole 4 MG 24HR Extended Release Oral Tablet | PSN | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 848582 | rOPINIRole 6 MG 24HR Extended Release Oral Tablet | PSN | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 799054 | rOPINIRole 8 MG 24HR Extended Release Oral Tablet | PSN | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 824959 | 24 HR ropinirole 12 MG Extended Release Oral Tablet | SCD | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 799055 | 24 HR ropinirole 2 MG Extended Release Oral Tablet | SCD | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 799056 | 24 HR ropinirole 4 MG Extended Release Oral Tablet | SCD | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 848582 | 24 HR ropinirole 6 MG Extended Release Oral Tablet | SCD | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 799054 | 24 HR ropinirole 8 MG Extended Release Oral Tablet | SCD | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 824959 | ropinirole 12 MG (as ropinirole hydrochloride 13.68 MG) 24 HR Extended Release Oral Tablet | SY | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 824959 | ropinirole 12 MG 24 HR Extended Release Oral Tablet | SY | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 799055 | ropinirole 2 MG (as ropinirole hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet | SY | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 799055 | ropinirole 2 MG 24 HR Extended Release Oral Tablet | SY | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 799056 | ropinirole 4 MG (as ropinirole hydrochloride 4.56 MG) 24 HR Extended Release Oral Tablet | SY | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 799056 | ropinirole 4 MG 24 HR Extended Release Oral Tablet | SY | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 848582 | ropinirole 6 MG (ropinirole hydrochloride 6.84 MG) 24 HR Extended Release Oral Tablet | SY | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 848582 | ropinirole 6 MG 24 HR Extended Release Oral Tablet | SY | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 799054 | ropinirole 8 MG (as ropinirole hydrochloride 9.12 MG) 24 HR Extended Release Oral Tablet | SY | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 799054 | ropinirole 8 MG 24 HR Extended Release Oral Tablet | SY | 307411be-1c4e-44f7-b94d-737a3384c107 | 6 |
| 799054 | rOPINIRole 8 MG 24HR Extended Release Oral Tablet | PSN | bdd6181f-f582-49c2-8adc-c771f5b01010 | 2 |
| 799054 | 24 HR ropinirole 8 MG Extended Release Oral Tablet | SCD | bdd6181f-f582-49c2-8adc-c771f5b01010 | 2 |
| 799054 | ropinirole 8 MG (as ropinirole hydrochloride 9.12 MG) 24 HR Extended Release Oral Tablet | SY | bdd6181f-f582-49c2-8adc-c771f5b01010 | 2 |
| 799054 | ropinirole 8 MG 24 HR Extended Release Oral Tablet | SY | bdd6181f-f582-49c2-8adc-c771f5b01010 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 64850-253-30 | 64850025330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (64850-253-30) | 2025-11-10 | No | No | Current |