Prescription drug · ANDA
Ropinirole NDC 72162-2200
Ropinirole hydrochloride .5 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2200-1 | 7216222000172162220001 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72162-2200-1)Marketed from Dec 15, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — .5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 72162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079229
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 72162-2200_16c2232a-0143-4456-98b8-80ced633e628SPL ID 16c2232a-0143-4456-98b8-80ced633e628SPL set ID e9ba4108-7095-4771-840e-bf1e08b5f4daRxCUI 312846UNII 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
N472162220001followed by a unit qualifier and the quantityPackage 72162-2200-01. 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 tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2) 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 72162-2200
- What is NDC 72162-2200?
- 72162-2200 is the product NDC for Ropinirole, Ropinirole hydrochloride .5 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. 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?
- Bryant Ranch Prepack, NDC labeler code 72162. 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 079229
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 4 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7445 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-356 |
| Ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-357 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-358 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-359 |
| Ropinirole | Ropinirole hydrochloride 3 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-360 |
| Ropinirole | Ropinirole hydrochloride 4 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-361 |
| Ropinirole | Ropinirole hydrochloride 5 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-362 |
| Ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4318 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2515 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2793 |
| Ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9653 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9656 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-494 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | ASCLEMED USA INC. | 87063-198 |
| Ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | ASCLEMED USA INC. | 87063-199 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | ASCLEMED USA INC. | 87063-200 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | ASCLEMED USA INC. | 87063-201 |