Prescription drug · ANDA
Ranolazine NDC 82804-118
Ranolazine 500 mg/1 · Tablet, Film coated, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-118-60 | 82804011860 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-118-60)Marketed from Jul 5, 2024 |
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)
- Ranolazine
- Generic name (nonproprietary)
- ranolazine
- Active ingredients
- Ranolazine — 500 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211829
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 82804-118_c7ed8234-e6bd-4f19-a1ce-40f272a79036SPL ID c7ed8234-e6bd-4f19-a1ce-40f272a79036SPL set ID c7ed8234-e6bd-4f19-a1ce-40f272a79036RxCUI 616749UNII A6IEZ5M406UPC 0382804118601
- Pharmacologic class
- Anti-anginal
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
N482804011860followed by a unit qualifier and the quantityPackage 82804-0118-60. 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)
Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. Ranolazine extended-release tablets are an antianginal indicated for the treatment of chronic angina. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211829
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 |
|---|---|---|---|---|
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Radha Pharmaceuticals, Inc | 77771-424 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-293 |
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-294 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-971 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | Radha Pharmaceuticals, Inc | 77771-423 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 71205-867 |
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 71205-868 |
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-424 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-423 |