Prescription drug · ANDA
Ranolazine NDC 72578-065
Ranolazine 1000 mg/1 · Tablet, Extended release · Oral · Viona Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-065-01 | 72578006501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-01)Marketed from Sep 10, 2019 | |
| 72578-065-05 | 72578006505 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-05)Marketed from Sep 10, 2019 | |
| 72578-065-14 | 72578006514 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-14)Marketed from Sep 10, 2019 | |
| 72578-065-77 | 72578006577 | 10 BLISTER PACK in 1 CARTON (72578-065-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (72578-065-30)Marketed from Sep 10, 2019 |
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, Extended release
- Route
- Oral
- Labeler
- Viona Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210188
- 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 72578-065_ca6a476b-e330-4618-8661-08ac1125fc3eSPL ID ca6a476b-e330-4618-8661-08ac1125fc3eSPL set ID 00979fb3-d70f-493d-94ca-2914cbadaa9dRxCUI 616749, 728231UNII A6IEZ5M406
- 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
N472578006501followed by a unit qualifier and the quantityPackage 72578-0065-01. 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)
Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine extended-release tablet 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 tablet is an antianginal indicated for the treatment of chronic angina. ( 1 )
Excerpt only. Read the full label for complete information.