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 | 72189022230 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-222-30)Marketed from May 20, 2021 | |
| 72189-222-60 | 72189022260 | 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 RX
- 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 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 | Accord Healthcare Inc. | 16729-232 |
| ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-235 |
| ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-233 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-364 |
| ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-234 |
| 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 1 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1982 |
| ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1231 |