Prescription drug · ANDA
Ropinirole NDC 67046-1489
Ropinirole hydrochloride 2 mg/1 · Tablet, Film coated · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1489-3 | 67046148903 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1489-3)Marketed from Jan 29, 2025 |
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 — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090429
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 67046-1489_2cdaf99a-56b8-4d61-e063-6294a90a3bc3SPL ID 2cdaf99a-56b8-4d61-e063-6294a90a3bc3SPL set ID 2cdae415-479b-c14c-e063-6394a90adb6cRxCUI 312847UNII 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
N467046148903followed by a unit qualifier and the quantityPackage 67046-1489-03. 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 090429
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 1 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-032 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-033 |
| Ropinirole | Ropinirole hydrochloride 3 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-034 |
| Ropinirole | Ropinirole hydrochloride 4 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-035 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8190 |
| Ropinirole | Ropinirole hydrochloride 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-036 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8191 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0829 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7633 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7888 |
| Ropinirole | Ropinirole hydrochloride 3 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1490 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6373 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6374 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0727 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8188 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-032 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-030 |
| Ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-031 |
| Ropinirole | Ropinirole hydrochloride 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-036 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-033 |
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