Prescription drug · ANDA
Ropinirole NDC 46708-035
Ropinirole hydrochloride 4 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-035-31 | 46708003531 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-035-31)Marketed from Sep 12, 2013 |
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
- Route
- Oral
- 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 46708-035_aad4b153-ed5a-4781-ba0f-fb4bcf990057SPL ID aad4b153-ed5a-4781-ba0f-fb4bcf990057SPL set ID 9a25f575-09ab-4d32-b73e-5426f08c00c4RxCUI 283858, 312845, 312846, 312847, 312849, 314208, 562704UNII D7ZD41RZI9UPC 0346708030315, 0346708033316, 0346708036317, 0346708034313, 0346708032319, 0346708035310, 0346708031312
- 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
N446708003531followed by a unit qualifier and the quantityPackage 46708-0035-31. 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)
INDICATIONS & USAGE Parkinson’s Disease Ropinirole Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. The effectiveness of Ropinirole Tablets were demonstrated in randomized, controlled trials in patients with early Parkinson’s disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Restless Legs Syndrome Ropinirole Tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpl…
Excerpt only. Read the full label for complete information.
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 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 Hydrochloride | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8190 |
| Ropinirole | Ropinirole hydrochloride 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-036 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8191 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0829 |
| 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 2 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1489 |
| Ropinirole | Ropinirole hydrochloride 3 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1490 |
| 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 Hydrochloride | Ropinirole hydrochloride .5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0727 |
| Ropinirole Hydrochloride | Ropinirole hydrochloride .25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8188 |
| Ropinirole | Ropinirole hydrochloride 1 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-032 |
| 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 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-036 |
| Ropinirole | Ropinirole hydrochloride 2 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-033 |
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