Ezetimibe NDC 50090-3657

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-3657Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-3657Add 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
50090-3657-0	50090365700	30 TABLET in 1 BOTTLE, PLASTIC (50090-3657-0)Marketed from Dec 23, 2017
50090-3657-1	50090365701	90 TABLET in 1 BOTTLE (50090-3657-1)Marketed from Oct 11, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: A-S Medication Solutions
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209234
Marketing start: Dec 23, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Cholesterol Absorption (Physiologic effect)
Identifiers: Product ID 50090-3657_ec0339aa-f360-45c5-82f8-3f60df9c2cf7SPL ID ec0339aa-f360-45c5-82f8-3f60df9c2cf7SPL set ID 9a04678f-e961-45aa-b3bb-e38e66856edcRxCUI 349556UNII EOR26LQQ24
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

N450090365700 followed by a unit qualifier and the quantity

Package 50090-3657-00. 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 Sep 21, 2023.

Indications (excerpt from the label)

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Ezetimibe Tablet is an inhibitor of intestinal cholesterol (and related phytosterol) absorption indicated as an adjunct to diet to: Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin) (1.1) Re…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209234

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

FDA NDC Directory listings under ANDA 209234
Product	Strength	Form · route	Labeler	Product NDC
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	Proficient Rx LP	71205-277
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	Ascend Laboratories, LLC	67877-490
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	Major Pharmaceuticals	0904-7103
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-1127
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	A-S Medication Solutions	50090-7236
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	American Health Packaging	60687-373