Ezetimibe NDC 50228-379

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-379Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0379Add 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
50228-379-05	50228037905	500 TABLET in 1 BOTTLE (50228-379-05)Marketed from Oct 23, 2020
50228-379-10	50228037910	1000 TABLET in 1 BOTTLE (50228-379-10)Marketed from Oct 23, 2020
50228-379-30	50228037930	30 TABLET in 1 BOTTLE (50228-379-30)Marketed from Oct 23, 2020
50228-379-90	50228037990	90 TABLET in 1 BOTTLE (50228-379-90)Marketed from Oct 23, 2020

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): Ezetimibe
Generic name (nonproprietary): ezetimibe
Active ingredients: Ezetimibe — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: ScieGen Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210673
Marketing start: Oct 23, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Cholesterol Absorption (Physiologic effect)
Identifiers: Product ID 50228-379_1ab4be5f-4926-88ad-e063-6294a90a0c81SPL ID 1ab4be5f-4926-88ad-e063-6294a90a0c81SPL set ID 11de499b-ad8a-46a6-9021-c8eba72ae414RxCUI 349556UNII EOR26LQQ24UPC 0350228379106, 0350228379052, 0350228379908, 0350228379304
Pharmacologic class: Dietary Cholesterol Absorption Inhibitor

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

N450228037905 followed by a unit qualifier and the quantity

Package 50228-0379-05. 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 Jun 12, 2024.

Indications (excerpt from the label)

Ezetimibe is indicated: In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)