Prescription drug · ANDA
Ropinirole NDC 46708-262
Ropinirole hydrochloride 2 mg/1 · Tablet, Film coated, Extended release · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-262-10 | 46708026210 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (46708-262-10)Marketed from Mar 14, 2013 | |
| 46708-262-30 | 46708026230 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-262-30)Marketed from Mar 14, 2013 | |
| 46708-262-31 | 46708026231 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-262-31)Marketed from Mar 14, 2013 | |
| 46708-262-71 | 46708026271 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-262-71)Marketed from Mar 14, 2013 | |
| 46708-262-90 | 46708026290 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-262-90)Marketed from Mar 14, 2013 | |
| 46708-262-91 | 46708026291 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-262-91)Marketed from Mar 14, 2013 |
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 — 2 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202786
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 46708-262_a1e5da4e-74fc-4482-8e15-599c665f2c2fSPL ID a1e5da4e-74fc-4482-8e15-599c665f2c2fSPL set ID 2e01dbdd-f439-45d7-9085-2d92a1a1fee2RxCUI 799054, 799055, 799056, 824959, 848582UNII D7ZD41RZI9UPC 0346708263300, 0346708262303, 0346708264307, 0346708265304, 0346708266301
- 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
N446708026210followed by a unit qualifier and the quantityPackage 46708-0262-10. 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 non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1) 1.1 Parkinson's Disease Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202786
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 | Alembic Pharmaceuticals Inc. | 62332-109 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-107 |
| Ropinirole | Ropinirole hydrochloride 4 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-108 |
| Ropinirole | Ropinirole hydrochloride 8 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-110 |
| Ropinirole | Ropinirole hydrochloride 12 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-111 |
| Ropinirole | Ropinirole hydrochloride 12 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-266 |
| Ropinirole | Ropinirole hydrochloride 4 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-263 |
| Ropinirole | Ropinirole hydrochloride 6 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-264 |
| Ropinirole | Ropinirole hydrochloride 8 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-265 |