Prescription drug · ANDA
Ropinirole NDC 64850-251
Ropinirole hydrochloride 4 mg/1 · Tablet, Extended release · Oral · Elite Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64850-251-30 | 64850025130 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (64850-251-30)Marketed from Nov 10, 2025 |
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, Extended release
- Route
- Oral
- Labeler
- Elite Laboratories, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217862
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 64850-251_0ca68ebf-b908-4be4-a1a0-f9b3359375a4SPL ID 0ca68ebf-b908-4be4-a1a0-f9b3359375a4SPL set ID 307411be-1c4e-44f7-b94d-737a3384c107RxCUI 799054, 799055, 799056, 824959, 848582UNII D7ZD41RZI9UPC 0364850251303, 0364850254304, 0364850252300, 0364850253307, 0364850250306
- 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
N464850025130followed by a unit qualifier and the quantityPackage 64850-0251-30. 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 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 217862
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 2 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2602 |
| Ropinirole | Ropinirole hydrochloride 12 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2606 |
| Ropinirole | Ropinirole hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2603 |
| Ropinirole | Ropinirole hydrochloride 6 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2604 |
| Ropinirole | Ropinirole hydrochloride 8 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2605 |
| Ropinirole | Ropinirole hydrochloride 8 mg/1 | Tablet, Extended releaseOral | Elite Laboratories, Inc. | 64850-253 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Elite Laboratories, Inc. | 64850-250 |
| Ropinirole | Ropinirole hydrochloride 6 mg/1 | Tablet, Extended releaseOral | Elite Laboratories, Inc. | 64850-252 |
| Ropinirole | Ropinirole hydrochloride 12 mg/1 | Tablet, Extended releaseOral | Elite Laboratories, Inc. | 64850-254 |