ezetimibe NDC 82009-024

NDC codes

FDA NDC Directory

Product NDC (as listed)82009-024Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82009-0024Add 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
82009-024-05	82009002405	500 TABLET in 1 BOTTLE (82009-024-05)Marketed from Aug 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): ezetimibe
Generic name (nonproprietary): ezetimibe
Active ingredients: Ezetimibe — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Quallent Pharmaceuticals Health LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204331
Marketing start: Aug 20, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Cholesterol Absorption (Physiologic effect)
Identifiers: Product ID 82009-024_98acb755-ad5c-414a-b9e9-6cd30c10a2e7SPL ID 98acb755-ad5c-414a-b9e9-6cd30c10a2e7SPL set ID 68247ce8-e812-42f2-a3ba-0f6e49acca63RxCUI 349556UNII EOR26LQQ24UPC 0382009024059
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

N482009002405 followed by a unit qualifier and the quantity

Package 82009-0024-05. 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 Mar 20, 2024.

Indications (excerpt from the label)

Ezetimibe tablets are 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204331

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

FDA NDC Directory listings under ANDA 204331
Product	Strength	Form · route	Labeler	Product NDC
ezetimibe	Ezetimibe 10 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1109
ezetimibe	Ezetimibe 10 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-773
ezetimibe	Ezetimibe 10 mg/1	TabletOral	Safecor Health, LLC	48433-161