ezetimibe NDC 68382-773

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-773Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0773Add 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
68382-773-01	68382077301	100 TABLET in 1 BOTTLE (68382-773-01)Marketed from Aug 9, 2017
68382-773-05	68382077305	500 TABLET in 1 BOTTLE (68382-773-05)Marketed from Aug 9, 2017
68382-773-06	68382077306	30 TABLET in 1 BOTTLE (68382-773-06)Marketed from Aug 9, 2017
68382-773-10	68382077310	1000 TABLET in 1 BOTTLE (68382-773-10)Marketed from Aug 9, 2017
68382-773-16	68382077316	90 TABLET in 1 BOTTLE (68382-773-16)Marketed from Aug 9, 2017
68382-773-77	68382077377	10 BLISTER PACK in 1 CARTON (68382-773-77) / 10 TABLET in 1 BLISTER PACK (68382-773-30)Marketed from Aug 9, 2017

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: Zydus Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204331
Marketing start: Aug 9, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Cholesterol Absorption (Physiologic effect)
Identifiers: Product ID 68382-773_ebb60f24-14be-4be0-b5e2-31e695eae876SPL ID ebb60f24-14be-4be0-b5e2-31e695eae876SPL set ID f852b12f-e25f-415b-b1e2-58955d609507RxCUI 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

N468382077301 followed by a unit qualifier and the quantity

Package 68382-0773-01. 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 Feb 27, 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	Quallent Pharmaceuticals Health LLC	82009-024
ezetimibe	Ezetimibe 10 mg/1	TabletOral	Safecor Health, LLC	48433-161