ropinirole
- Product NDC
- 16729-234
- 11-digit product format
- 167290234
- Labeler code
- 16729
- Product ID
- 16729-234_23980eef-2eb5-2b74-e063-6394a90a68ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA204022
- Marketing category
- ANDA
- Marketing start
- 2018-10-17
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 1 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 | 1 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | D7ZD41RZI9 |
| Rxcui | 283858, 312845, 312846, 312847, 312849, 314208, 562704 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| 16729-234-01 | ropinirole | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16729-234-01 | EA - Each | 16729-234 | 4511cf06-35df-41c9-92de-264978406e09 | 1 | 2018-10-11 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314208 | rOPINIRole HCl 1 MG Oral Tablet | PSN | 55bb5cf4-0e12-41b0-bc52-50b26fe408de | 103 |
| 314208 | ropinirole 1 MG Oral Tablet | SCD | 55bb5cf4-0e12-41b0-bc52-50b26fe408de | 103 |
| 314208 | ropinirole 1 MG (as ropinirole hydrochloride) Oral Tablet | SY | 55bb5cf4-0e12-41b0-bc52-50b26fe408de | 103 |
| 312845 | rOPINIRole HCl 0.25 MG Oral Tablet | PSN | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 312846 | rOPINIRole HCl 0.5 MG Oral Tablet | PSN | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 314208 | rOPINIRole HCl 1 MG Oral Tablet | PSN | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 312847 | rOPINIRole HCl 2 MG Oral Tablet | PSN | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 283858 | rOPINIRole HCl 3 MG Oral Tablet | PSN | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 562704 | rOPINIRole HCl 4 MG Oral Tablet | PSN | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 312849 | rOPINIRole HCl 5 MG Oral Tablet | PSN | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 312845 | ropinirole 0.25 MG Oral Tablet | SCD | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 312846 | ropinirole 0.5 MG Oral Tablet | SCD | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 314208 | ropinirole 1 MG Oral Tablet | SCD | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 312847 | ropinirole 2 MG Oral Tablet | SCD | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 283858 | ropinirole 3 MG Oral Tablet | SCD | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 562704 | ropinirole 4 MG Oral Tablet | SCD | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 312849 | ropinirole 5 MG Oral Tablet | SCD | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 312845 | ropinirole 0.25 MG (as ropinirole hydrochloride) Oral Tablet | SY | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 312846 | ropinirole 0.5 MG (as ropinirole hydrochloride) Oral Tablet | SY | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 314208 | ropinirole 1 MG (as ropinirole hydrochloride) Oral Tablet | SY | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 312847 | ropinirole 2 MG (as ropinirole hydrochloride) Oral Tablet | SY | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 283858 | ropinirole 3 MG (as ropinirole hydrochloride) Oral Tablet | SY | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 562704 | ropinirole 4 MG (as ropinirole hydrochloride) Oral Tablet | SY | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 312849 | ropinirole 5 MG (as ropinirole hydrochloride) Oral Tablet | SY | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 8 |
| 314208 | rOPINIRole HCl 1 MG Oral Tablet | PSN | 443e20d7-b459-4d42-8437-098f32bd27ea | 3 |
| 314208 | rOPINIRole HCl 1 MG Oral Tablet | PSN | c2c38b4c-b139-45f2-e053-2995a90a262c | 3 |
| 314208 | ropinirole 1 MG Oral Tablet | SCD | 443e20d7-b459-4d42-8437-098f32bd27ea | 3 |
| 314208 | ropinirole 1 MG Oral Tablet | SCD | c2c38b4c-b139-45f2-e053-2995a90a262c | 3 |
| 314208 | ropinirole 1 MG (as ropinirole hydrochloride) Oral Tablet | SY | c2c38b4c-b139-45f2-e053-2995a90a262c | 3 |
| 314208 | ropinirole 1 MG (as ropinirole hydrochloride) Oral Tablet | SY | 443e20d7-b459-4d42-8437-098f32bd27ea | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 16729-234-01 | 16729023401 | 100 TABLET, FILM COATED in 1 BOTTLE (16729-234-01) | 2018-10-17 | 0000-00-00 | No | No | Current |