Prescription drug · ANDA
Ropinirole Hydrochloride NDC 71335-0829
Ropinirole hydrochloride 1 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0829-1 | 7133508290171335082901 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0829-1)Marketed from May 15, 2018 | |
| 71335-0829-2 | 7133508290271335082902 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-0829-2)Marketed from Jan 29, 2025 | |
| 71335-0829-3 | 7133508290371335082903 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0829-3)Marketed from Jan 29, 2025 | |
| 71335-0829-4 | 7133508290471335082904 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0829-4)Marketed from Jan 29, 2025 | |
| 71335-0829-5 | 7133508290571335082905 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-0829-5)Marketed from Jan 29, 2025 |
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 Hydrochloride
- Generic name (nonproprietary)
- ropinirole hydrochloride
- Active ingredients
- Ropinirole hydrochloride — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090429
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 71335-0829_19c09308-7bea-4f2e-93d5-d635e4c6fdf5SPL ID 19c09308-7bea-4f2e-93d5-d635e4c6fdf5SPL set ID 3b8bb729-e084-4d45-9774-63cae192be32RxCUI 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
N471335082901followed by a unit qualifier and the quantityPackage 71335-0829-01. 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 71335-0829
- What is NDC 71335-0829?
- 71335-0829 is the product NDC for Ropinirole Hydrochloride, Ropinirole hydrochloride 1 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ropinirole Hydrochloride.
- What is the active ingredient?
- Ropinirole hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 Hydrochloride?
- 37 other product NDCs are listed under this name. See all Ropinirole Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ropinirole Hydrochloride 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 hydrochloride | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-741 | 50268-0741-15 |
| ropinirole hydrochloride | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-742 | 50268-0742-15 |
| ropinirole hydrochloride | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-743 | 50268-0743-15 |
| ropinirole hydrochloride | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-744 | 50268-0744-15 |
| ropinirole hydrochloride | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-577 | 60687-0577-01 |
| ropinirole hydrochloride | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-588 | 60687-0588-01 |
| ropinirole hydrochloride | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-360 | 51655-0360-26 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8188 | 00615-8188-39 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8189 | 00615-8189-39 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8190 | 00615-8190-39 |
Other NDCs under ANDA 090429
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 | Major Pharmaceuticals | 0904-6373 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6374 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-030 |
| Ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-031 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-032 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-033 |
| Ropinirole | Ropinirole hydrochloride 3 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-034 |
| Ropinirole | Ropinirole hydrochloride 4 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-035 |
| Ropinirole | Ropinirole hydrochloride 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-036 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7633 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7888 |
| Ropinirole | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-030 |
| Ropinirole | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-031 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-032 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-033 |
| Ropinirole | Ropinirole hydrochloride 3 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-034 |
| Ropinirole | Ropinirole hydrochloride 4 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-035 |
| Ropinirole | Ropinirole hydrochloride 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-036 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1489 |
| Ropinirole | Ropinirole hydrochloride 3 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1490 |
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