Prescription drug · ANDA
Ropinirole Hydrochloride NDC 42291-713
Ropinirole hydrochloride 2 mg/1 · Tablet, Film coated, Extended release · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-713-30 | 42291071330 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-713-30)Marketed from Nov 1, 2023 |
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 Hydrochloride
- Generic name (nonproprietary)
- ropinirole hydrochloride
- Active ingredients
- Ropinirole hydrochloride — 2 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090869
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 42291-713_2b47ad1c-e1cb-7b8b-e063-6394a90aee3cSPL ID 2b47ad1c-e1cb-7b8b-e063-6394a90aee3cSPL set ID abd344d9-7635-62a2-d4e1-38fc46937397RxCUI 799054, 799055, 799056, 824959, 848582UNII D7ZD41RZI9UPC 0342291716308, 0342291717305, 0342291714304, 0342291715301, 0342291713307
- 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
N442291071330followed by a unit qualifier and the quantityPackage 42291-0713-30. 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 extended-release tablets are indicated for the treatment of Parkinson’s disease. Ropinirole extended-release tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090869
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 6 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 0228-3640 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 0228-3658 |
| Ropinirole | Ropinirole hydrochloride 4 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 0228-3659 |
| Ropinirole | Ropinirole hydrochloride 8 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 0228-3660 |
| Ropinirole | Ropinirole hydrochloride 12 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 0228-3661 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride 8 mg/1 | Tablet, Film coated, Extended releaseOral | AvKARE | 42291-716 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride 4 mg/1 | Tablet, Film coated, Extended releaseOral | AvKARE | 42291-714 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride 6 mg/1 | Tablet, Film coated, Extended releaseOral | AvKARE | 42291-715 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride 12 mg/1 | Tablet, Film coated, Extended releaseOral | AvKARE | 42291-717 |