Prescription drug · ANDA
Ranolazine NDC 42291-774
Ranolazine 1000 mg/1 · Tablet, Film coated, Extended release · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-774-60 | 42291077460 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-774-60)Marketed from Oct 27, 2020 |
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 — 1000 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- AvKARENDC labeler code 42291
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212781
- 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 42291-774_48750ca3-393e-d2ec-e063-6294a90ab8f2SPL ID 48750ca3-393e-d2ec-e063-6294a90ab8f2SPL set ID b2a8dc3e-a880-5241-e053-2995a90a933aRxCUI 616749, 728231UNII A6IEZ5M406UPC 0342291774605, 0342291773608
- 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
N442291077460followed by a unit qualifier and the quantityPackage 42291-0774-60. 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 antianginal indicated for the treatment of chronic angina. (1)
Excerpt only. Read the full label for complete information.
About NDC 42291-774
- What is NDC 42291-774?
- 42291-774 is the product NDC for Ranolazine, Ranolazine 1000 mg/1 tablet, film coated, extended release, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ranolazine.
- What is the active ingredient?
- Ranolazine.
- Who is the labeler?
- AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ranolazine?
- 53 other product NDCs are listed under this name. See all Ranolazine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ranolazine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Extended releaseOral | Umedica Laboratories USA Inc. | 60290-055 | 60290-0055-0160290-0055-03 |
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Extended releaseOral | Umedica Laboratories USA Inc. | 60290-056 | 60290-0056-0160290-0056-03 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | Torrent Pharma, Inc. | 13668-759 | 13668-0759-60 |
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Torrent Pharma, Inc. | 13668-760 | 13668-0760-60 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | Zameer Pharmaceuticals LLC | 90096-151 | 90096-0151-60 |
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Zameer Pharmaceuticals LLC | 90096-152 | 90096-0152-60 |
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Radha Pharmaceuticals, Inc | 77771-424 | 77771-0424-60 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | Radha Pharmaceuticals, Inc | 77771-423 | 77771-0423-60 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-971 | 71610-0971-42 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | A2A Integrated Pharmaceuticals | 73141-021 | 73141-0021-02 |
Other NDCs under ANDA 212781
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 500 mg/1 | Tablet, Film coated, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-518 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | SunGen Pharma LLC | 70625-206 |
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Film coated, Extended releaseOral | SunGen Pharma LLC | 70625-207 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | AvKARE | 42291-773 |