Prescription drug · ANDA
Ropinirole Hydrochloride NDC 42291-717
Ropinirole hydrochloride 12 mg/1 · Tablet, Film coated, Extended release · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-717-30 | 4229107173042291071730 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-717-30)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 — 12 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- AvKARENDC labeler code 42291
- 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 42291-717_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
N442291071730followed by a unit qualifier and the quantityPackage 42291-0717-30. 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.
About NDC 42291-717
- What is NDC 42291-717?
- 42291-717 is the product NDC for Ropinirole Hydrochloride, Ropinirole hydrochloride 12 mg/1 tablet, film coated, extended release, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ropinirole Hydrochloride.
- What is the active ingredient?
- Ropinirole hydrochloride.
- Who is the labeler?
- AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ropinirole Hydrochloride?
- 37 other product NDCs are listed under this name. See all Ropinirole Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ropinirole Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| ropinirole hydrochloride | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-741 | 50268-0741-15 |
| ropinirole hydrochloride | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-742 | 50268-0742-15 |
| ropinirole hydrochloride | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-743 | 50268-0743-15 |
| ropinirole hydrochloride | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-744 | 50268-0744-15 |
| ropinirole hydrochloride | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-577 | 60687-0577-01 |
| ropinirole hydrochloride | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-588 | 60687-0588-01 |
| ropinirole hydrochloride | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-360 | 51655-0360-26 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8188 | 00615-8188-39 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8189 | 00615-8189-39 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8190 | 00615-8190-39 |
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 2 mg/1 | Tablet, Film coated, Extended releaseOral | AvKARE | 42291-713 |
| 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 8 mg/1 | Tablet, Film coated, Extended releaseOral | AvKARE | 42291-716 |