Ranolazine NDC 71610-518

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-518Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0518Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
71610-518-42	71610051842	1800 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-518-42)Marketed from Apr 1, 2024
71610-518-83	71610051883	3600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-518-83)Marketed from Jan 22, 2021

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: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212781
Marketing start: Oct 27, 2020
Listing expires: Dec 31, 2026
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 71610-518_1524482d-40bd-a0f9-e063-6394a90a1a37SPL ID 1524482d-40bd-a0f9-e063-6394a90a1a37SPL set ID abb32182-46ba-49d2-b2ac-13de2ecf802dRxCUI 616749UNII 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

N471610051842 followed by a unit qualifier and the quantity

Package 71610-0518-42. 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 Apr 2, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212781

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212781
Product	Strength	Form · route	Labeler	Product NDC
Ranolazine	Ranolazine 1000 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	42291-774
Ranolazine	Ranolazine 500 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	42291-773
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