Ezetimibe NDC 71335-1127

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1127Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1127Add 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
71335-1127-1	71335112701	30 TABLET in 1 BOTTLE (71335-1127-1)Marketed from Mar 6, 2019
71335-1127-2	71335112702	90 TABLET in 1 BOTTLE (71335-1127-2)Marketed from Feb 27, 2019
71335-1127-3	71335112703	28 TABLET in 1 BOTTLE (71335-1127-3)Marketed from May 30, 2024
71335-1127-4	71335112704	18 TABLET in 1 BOTTLE (71335-1127-4)Marketed from May 30, 2024
71335-1127-5	71335112705	60 TABLET in 1 BOTTLE (71335-1127-5)Marketed from Jun 17, 2020

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: Bryant Ranch Prepack
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 71335-1127_a25c5ee6-c4fd-4842-8412-ebd8e8085ec0SPL ID a25c5ee6-c4fd-4842-8412-ebd8e8085ec0SPL set ID c92292f5-5444-4247-927e-db7bf6816109RxCUI 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

N471335112701 followed by a unit qualifier and the quantity

Package 71335-1127-01. 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 Jul 17, 2025.

Indications (excerpt from the label)

Ezetimibe Tablets 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 …

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	A-S Medication Solutions	50090-3657
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	A-S Medication Solutions	50090-7236
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	American Health Packaging	60687-373