Prescription drug · ANDA
Ropinirole NDC 72189-222
Ropinirole hydrochloride 1 mg/1 · Tablet, Film coated · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-222-30 | 7218902223072189022230 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-222-30)Marketed from May 20, 2021 | |
| 72189-222-60 | 7218902226072189022260 | 60 TABLET, FILM COATED in 1 BOTTLE (72189-222-60)Marketed from May 20, 2021 |
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 — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- DIRECT RXNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204022
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 72189-222_2c28281e-fe37-b7e4-e063-6294a90ad4f7SPL ID 2c28281e-fe37-b7e4-e063-6294a90ad4f7SPL set ID c2c38b4c-b139-45f2-e053-2995a90a262cRxCUI 314208UNII 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
N472189022230followed by a unit qualifier and the quantityPackage 72189-0222-30. 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)
1.1 Parkinson’s Disease Ropinirole tablets are indicated for the treatment of Parkinson’s disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Excerpt only. Read the full label for complete information.
About NDC 72189-222
- What is NDC 72189-222?
- 72189-222 is the product NDC for Ropinirole, Ropinirole hydrochloride 1 mg/1 tablet, film coated, listed with the FDA by DIRECT RX. It has 2 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?
- DIRECT RX, NDC labeler code 72189. 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 204022
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 | Accord Healthcare Inc. | 16729-232 |
| ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-233 |
| ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-234 |
| ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-235 |
| ropinirole | Ropinirole hydrochloride 3 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-236 |
| ropinirole | Ropinirole hydrochloride 4 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-237 |
| ropinirole | Ropinirole hydrochloride 5 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-238 |
| ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4803 |
| ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1167 |
| ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1188 |
| ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1231 |
| ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1982 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-364 |