Ranolazine NDC 63304-017

NDC codes

FDA NDC Directory

Product NDC (as listed)63304-017Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63304-0017Add 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
63304-017-05	63304001705	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-017-05)Marketed from May 28, 2019
63304-017-28	63304001728	180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-017-28)Marketed from May 28, 2019
63304-017-60	63304001760	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-017-60)Marketed from May 28, 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 — 500 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211707
Marketing start: May 28, 2019
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 63304-017_9d320810-99dc-4276-ab06-688b60cc957dSPL ID 9d320810-99dc-4276-ab06-688b60cc957dSPL set ID c5848232-b7fd-4fe5-a543-16d6c4b5c0b1RxCUI 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

N463304001705 followed by a unit qualifier and the quantity

Package 63304-0017-05. 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 Aug 17, 2020.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211707

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

FDA NDC Directory listings under ANDA 211707
Product	Strength	Form · route	Labeler	Product NDC
Ranolazine	Ranolazine 1000 mg/1	Tablet, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	63304-018