Ranolazine NDC 72319-021

NDC codes

FDA NDC Directory

Product NDC (as listed)72319-021Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72319-0021Add 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
72319-021-02	72319002102	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72319-021-02)Marketed from Jun 15, 2022

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: i3 Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213517
Marketing start: Jun 15, 2022
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 72319-021_163908d8-6b41-4e68-b14c-76faa57c7ac0SPL ID 163908d8-6b41-4e68-b14c-76faa57c7ac0SPL set ID de3185bf-448a-15f7-e053-2995a90a9a2eRxCUI 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

N472319002102 followed by a unit qualifier and the quantity

Package 72319-0021-02. 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 May 4, 2022.

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 is an 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 213517

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

FDA NDC Directory listings under ANDA 213517
Product	Strength	Form · route	Labeler	Product NDC
Ranolazine	Ranolazine 1000 mg/1	Tablet, Film coated, Extended releaseOral	A2A Integrated Pharmaceuticals	73141-022
Ranolazine	Ranolazine 500 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	71335-2556
Ranolazine	Ranolazine 500 mg/1	Tablet, Film coated, Extended releaseOral	A2A Integrated Pharmaceuticals	73141-021
Ranolazine	Ranolazine 1000 mg/1	Tablet, Film coated, Extended releaseOral	i3 Pharmaceuticals, LLC	72319-022