Prescription drug · ANDA
Ropinirole NDC 10135-678
Ropinirole hydrochloride 4 mg/1 · Tablet, Film coated · Oral · Marlex Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-678-01 | 10135067801 | 100 TABLET, FILM COATED in 1 BOTTLE (10135-678-01)Marketed from Mar 15, 2019 |
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 — 4 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079165
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 10135-678_441e0572-3413-1a21-e063-6294a90a8e6aSPL ID 441e0572-3413-1a21-e063-6294a90a8e6aSPL set ID 35d90f6f-3116-4afa-be2d-b65c160e8ab3RxCUI 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
N410135067801followed by a unit qualifier and the quantityPackage 10135-0678-01. 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 tablet is 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 079165
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 .25 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals Inc | 10135-673 |
| Ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals Inc | 10135-674 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals Inc | 10135-675 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals Inc | 10135-676 |
| Ropinirole | Ropinirole hydrochloride 3 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals Inc | 10135-677 |
| Ropinirole | Ropinirole hydrochloride 5 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals Inc | 10135-679 |