Prescription drug · ANDA
ropinirole NDC 50090-4803
Ropinirole hydrochloride .25 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-4803-0 | 50090480300 | 100 TABLET, FILM COATED in 1 BOTTLE (50090-4803-0)Marketed from Dec 20, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- ropinirole
- Generic name (nonproprietary)
- ropinirole
- Active ingredients
- Ropinirole hydrochloride — .25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204022
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 50090-4803_964359dc-018a-469d-a2e6-cf5191a4b2ecSPL ID 964359dc-018a-469d-a2e6-cf5191a4b2ecSPL set ID 4f4729f8-c910-4a09-a4b4-b4243e7f0105RxCUI 312845UNII D7ZD41RZI9
- Pharmacologic class
- Nonergot Dopamine Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090480300followed by a unit qualifier and the quantityPackage 50090-4803-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1, 1.2 ) 1.1 Parkinson’s Disease Ropinirole tablets are indicated for the treatment of Parkinson’s disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204022
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| ropinirole | Ropinirole hydrochloride 3 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-236 |
| ropinirole | Ropinirole hydrochloride 4 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-237 |
| ropinirole | Ropinirole hydrochloride 5 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-238 |
| ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-232 |
| ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-235 |
| ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-233 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-364 |
| ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-234 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-222 |
| ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1167 |
| ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1188 |
| ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1982 |
| ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1231 |