Prescription drug · ANDA
Ropinirole NDC 62332-035
Ropinirole hydrochloride 4 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)62332-035Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62332-0035Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-035-31 | 6233200353162332003531 | 100 TABLET, FILM COATED in 1 BOTTLE (62332-035-31)Marketed from Jan 29, 2016 |
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, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.NDC labeler code 62332
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090429
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 62332-035_52b190b9-df29-4b6e-ac43-c6c910d81efdSPL ID 52b190b9-df29-4b6e-ac43-c6c910d81efd
- 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
N462332003531followed by a unit qualifier and the quantityPackage 62332-0035-31. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 62332-035
- What is NDC 62332-035?
- 62332-035 is the product NDC for Ropinirole, Ropinirole hydrochloride 4 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ropinirole.
- What is the active ingredient?
- Ropinirole hydrochloride.
- Who is the labeler?
- Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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?
- 110 other product NDCs are listed under this name. See all Ropinirole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ropinirole 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 | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4138 | 68788-4138-03 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2602 | 72162-2602-0372162-2602-09 |
| Ropinirole | Ropinirole hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2603 | 72162-2603-0372162-2603-09 |
| Ropinirole | Ropinirole hydrochloride 6 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2604 | 72162-2604-0372162-2604-09 |
| Ropinirole | Ropinirole hydrochloride 8 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2605 | 72162-2605-0372162-2605-09 |
| Ropinirole | Ropinirole hydrochloride 12 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2606 | 72162-2606-0372162-2606-09 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Elite Laboratories, Inc. | 64850-250 | 64850-0250-30 |
| Ropinirole | Ropinirole hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Elite Laboratories, Inc. | 64850-251 | 64850-0251-30 |
| Ropinirole | Ropinirole hydrochloride 6 mg/1 | Tablet, Extended releaseOral | Elite Laboratories, Inc. | 64850-252 | 64850-0252-30 |
| Ropinirole | Ropinirole hydrochloride 8 mg/1 | Tablet, Extended releaseOral | Elite Laboratories, Inc. | 64850-253 | 64850-0253-30 |
Other NDCs under ANDA 090429
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 .25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6373 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6374 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-030 |
| Ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-031 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-032 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-033 |
| Ropinirole | Ropinirole hydrochloride 3 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-034 |
| Ropinirole | Ropinirole hydrochloride 4 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-035 |
| Ropinirole | Ropinirole hydrochloride 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-036 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7633 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7888 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-030 |
| Ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-031 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-032 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-033 |
| Ropinirole | Ropinirole hydrochloride 3 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-034 |
| Ropinirole | Ropinirole hydrochloride 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-036 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1489 |
| Ropinirole | Ropinirole hydrochloride 3 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1490 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8188 |
Showing 20 of 25.