NDC codes

FDA NDC Directory
Product NDC (as listed)50268-723Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50268-0723Add 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 NDC11-digit (billing)PackageCopy
50268-723-135026807231330 BLISTER PACK in 1 BOX (50268-723-13) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-723-11)Marketed from Sep 20, 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 — 1000 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
AvPAK
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209953
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 50268-723_47fc05ed-b529-4ae7-e063-6394a90ae1ddSPL ID 47fc05ed-b529-4ae7-e063-6394a90ae1ddSPL set ID e92350e8-5b0b-95d3-e053-2995a90a959bRxCUI 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

N450268072313 followed by a unit qualifier and the quantity

Package 50268-0723-13. 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 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 209953

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

FDA NDC Directory listings under ANDA 209953
ProductStrengthForm · routeLabelerProduct NDC
RanolazineRanolazine 1000 mg/1Tablet, Film coated, Extended releaseOralAscend Laboratories, LLC67877-526
RanolazineRanolazine 500 mg/1Tablet, Film coated, Extended releaseOralAscend Laboratories, LLC67877-525
RanolazineRanolazine 500 mg/1Tablet, Film coated, Extended releaseOralAvPAK50268-722
RanolazineRanolazine 500 mg/1Tablet, Film coated, Extended releaseOralMajor Pharmaceuticals0904-7506

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Ranolazine NDC 50268-723 | Med-Code