Prescription drug · ANDA
ropinirole NDC 16729-233
Ropinirole hydrochloride .5 mg/1 · Tablet, Film coated · Oral · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-233-01 | 16729023301 | 100 TABLET, FILM COATED in 1 BOTTLE (16729-233-01)Marketed from Oct 17, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — .5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Accord Healthcare Inc.
- 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 16729-233_23980eef-2eb5-2b74-e063-6394a90a68acSPL ID 23980eef-2eb5-2b74-e063-6394a90a68acSPL set ID 4a2a5b63-5b14-6975-e054-00144ff8d46cRxCUI 283858, 312845, 312846, 312847, 312849, 314208, 562704UNII 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
N416729023301followed by a unit qualifier and the quantityPackage 16729-0233-01. 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 .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 .25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4803 |
| 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 |