Ropinirole
- Product NDC
- 0378-5501
- 11-digit product format
- 003785501
- Labeler code
- 0378
- Product ID
- 0378-5501_626decf2-0627-4789-9b7c-600d8d75b2a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA078881
- Marketing category
- ANDA
- Marketing start
- 2008-05-05
- Marketing end
- 2023-04-30
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-5501-01 | EA - Each | 0378-5501 | 261f7f3a-ad73-451d-b575-8df820390efe | 1 | 2012-07-24 |
| 0378-5501-02 | EA - Each | 0378-5501 | 47d6a322-4506-4ffd-a21c-b293ac9d5069 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314208 | rOPINIRole HCl 1 MG Oral Tablet | PSN | a543b4fb-186a-40f4-8c88-861b7db2b3e9 | 1 |
| 312847 | rOPINIRole HCl 2 MG Oral Tablet | PSN | a543b4fb-186a-40f4-8c88-861b7db2b3e9 | 1 |
| 314208 | ropinirole 1 MG Oral Tablet | SCD | a543b4fb-186a-40f4-8c88-861b7db2b3e9 | 1 |
| 312847 | ropinirole 2 MG Oral Tablet | SCD | a543b4fb-186a-40f4-8c88-861b7db2b3e9 | 1 |
| 314208 | ropinirole 1 MG (as ropinirole hydrochloride) Oral Tablet | SY | a543b4fb-186a-40f4-8c88-861b7db2b3e9 | 1 |
| 312847 | ropinirole 2 MG (as ropinirole hydrochloride) Oral Tablet | SY | a543b4fb-186a-40f4-8c88-861b7db2b3e9 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0378-5501-01 | 00378550101 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-5501-01) | 100 tablet | 2008-05-05 | 0000-00-00 | No | No | Current |