Prescription drug · ANDA
Ropinirole NDC 55111-661
Ropinirole hydrochloride 4 mg/1 · Tablet, Film coated, Extended release · Oral · Dr. Reddys Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-661-05 | 5511106610555111066105 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-661-05)Marketed from Jun 6, 2012 | |
| 55111-661-30 | 5511106613055111066130 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-661-30)Marketed from Jun 6, 2012 | |
| 55111-661-90 | 5511106619055111066190 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-661-90)Marketed from Jun 6, 2012 |
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, Extended release
- Route
- Oral
- Labeler
- Dr. Reddys Laboratories LimitedNDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201576
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 55111-661_78d63517-2d1a-fc70-4ffb-3ebbfa065218SPL ID 78d63517-2d1a-fc70-4ffb-3ebbfa065218SPL set ID ec0612a1-ccb1-bb51-8881-04faf491e093RxCUI 799054, 799055, 799056, 824959, 848582UNII D7ZD41RZI9
- 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
N455111066105followed by a unit qualifier and the quantityPackage 55111-0661-05. 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) Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.
Excerpt only. Read the full label for complete information.
About NDC 55111-661
- What is NDC 55111-661?
- 55111-661 is the product NDC for Ropinirole, Ropinirole hydrochloride 4 mg/1 tablet, film coated, extended release, listed with the FDA by Dr. Reddys Laboratories Limited. It has 3 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?
- Dr. Reddys Laboratories Limited, NDC labeler code 55111. 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 8 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2605 | 72162-2605-0372162-2605-09 |
| 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 12 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2606 | 72162-2606-0372162-2606-09 |
| Ropinirole | Ropinirole hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Elite Laboratories, Inc. | 64850-251 | 64850-0251-30 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Elite Laboratories, Inc. | 64850-250 | 64850-0250-30 |
| Ropinirole | Ropinirole hydrochloride 12 mg/1 | Tablet, Extended releaseOral | Elite Laboratories, Inc. | 64850-254 | 64850-0254-30 |
| Ropinirole | Ropinirole hydrochloride 6 mg/1 | Tablet, Extended releaseOral | Elite Laboratories, Inc. | 64850-252 | 64850-0252-30 |
Other NDCs under ANDA 201576
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 | Dr. Reddys Laboratories Limited | 55111-659 |
| Ropinirole | Ropinirole hydrochloride 8 mg/1 | Tablet, Film coated, Extended releaseOral | Dr. Reddys Laboratories Limited | 55111-662 |
| Ropinirole | Ropinirole hydrochloride 6 mg/1 | Tablet, Film coated, Extended releaseOral | Dr. Reddys Laboratories Limited | 55111-727 |
| Ropinirole | Ropinirole hydrochloride 12 mg/1 | Tablet, Film coated, Extended releaseOral | Dr. Reddys Laboratories Limited | 55111-728 |