Prescription drug · ANDA
Ropinirole NDC 43547-554
Ropinirole 2 mg/1 · Tablet, Extended release · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-554-03 | 43547055403 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-554-03)Marketed from Mar 22, 2022 |
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 — 2 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Solco Healthcare US, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204413
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 43547-554_9bbec058-00a5-4353-bd58-426ddb0b2020SPL ID 9bbec058-00a5-4353-bd58-426ddb0b2020SPL set ID 213dd2f4-4a71-456c-b3c7-b709c7bd7445RxCUI 799054, 799055, 799056, 824959, 848582UNII 030PYR8953UPC 0343547554033, 0343547557034, 0343547556037, 0343547555030, 0343547558031
- 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
N443547055403followed by a unit qualifier and the quantityPackage 43547-0554-03. 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 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 204413
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 8 mg/1 | Tablet, Extended releaseOral | Solco Healthcare US, LLC | 43547-557 |
| Ropinirole | Ropinirole 4 mg/1 | Tablet, Extended releaseOral | Solco Healthcare US, LLC | 43547-555 |
| Ropinirole | Ropinirole 6 mg/1 | Tablet, Extended releaseOral | Solco Healthcare US, LLC | 43547-556 |
| Ropinirole | Ropinirole 12 mg/1 | Tablet, Extended releaseOral | Solco Healthcare US, LLC | 43547-558 |