Prescription drug · ANDA
Ropinirole NDC 62332-110
Ropinirole hydrochloride 8 mg/1 · Tablet, Film coated, Extended release · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-110-10 | 6233201101062332011010 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (62332-110-10)Marketed from Jun 20, 2020 | |
| 62332-110-30 | 6233201103062332011030 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-110-30)Marketed from Jun 20, 2020 | |
| 62332-110-31 | 6233201103162332011031 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-110-31)Marketed from Jun 20, 2020 | |
| 62332-110-71 | 6233201107162332011071 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-110-71)Marketed from Jun 20, 2020 | |
| 62332-110-90 | 6233201109062332011090 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-110-90)Marketed from Jun 20, 2020 | |
| 62332-110-91 | 6233201109162332011091 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-110-91)Marketed from Jun 20, 2020 |
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 — 8 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.NDC labeler code 62332
- 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 62332-110_b8766b5b-290d-4ecb-8a5c-77a3ab4cb3b9SPL ID b8766b5b-290d-4ecb-8a5c-77a3ab4cb3b9SPL set ID 54fb15b7-da35-4841-ba5d-ee3712cd94f3RxCUI 799054, 799055, 799056, 824959, 848582UNII D7ZD41RZI9UPC 0362332107308, 0362332111305, 0362332110308, 0362332109302
- 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
N462332011010followed by a unit qualifier and the quantityPackage 62332-0110-10. 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 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.
About NDC 62332-110
- What is NDC 62332-110?
- 62332-110 is the product NDC for Ropinirole, Ropinirole hydrochloride 8 mg/1 tablet, film coated, extended release, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 6 package NDCs, 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 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 2 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-262 |
| 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 |
| Ropinirole | Ropinirole hydrochloride 12 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-266 |
| 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 6 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-109 |
| Ropinirole | Ropinirole hydrochloride 12 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-111 |