Ezetimibe NDC 76333-170

NDC codes

FDA NDC Directory

Product NDC (as listed)76333-170Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76333-0170Add 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
76333-170-12	76333017012	1000 TABLET in 1 BOTTLE (76333-170-12)Marketed from Nov 13, 2023
76333-170-13	76333017013	500 TABLET in 1 BOTTLE (76333-170-13)Marketed from Nov 13, 2023
76333-170-14	76333017014	90 TABLET in 1 BOTTLE (76333-170-14)Marketed from Nov 13, 2023
76333-170-15	76333017015	30 TABLET in 1 BOTTLE (76333-170-15)Marketed from Jun 30, 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: Orient Pharma Co., Ltd.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215693
Marketing start: Jun 30, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Cholesterol Absorption (Physiologic effect)
Identifiers: Product ID 76333-170_161b88d8-6679-e793-e063-6394a90a481bSPL ID 161b88d8-6679-e793-e063-6394a90a481bSPL set ID b6e77d9b-a553-63e0-e053-2a95a90a18feRxCUI 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

N476333017012 followed by a unit qualifier and the quantity

Package 76333-0170-12. 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 Apr 15, 2024.

Indications (excerpt from the label)

Ezetimibe tablet 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 y…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215693

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

FDA NDC Directory listings under ANDA 215693
Product	Strength	Form · route	Labeler	Product NDC
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-787