Ezetimibe NDC 0904-7103

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7103Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7103Add 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
0904-7103-04	00904710304	30 BLISTER PACK in 1 CARTON (0904-7103-04) / 1 TABLET in 1 BLISTER PACKMarketed from Dec 23, 2017
0904-7103-10	00904710310	20 BLISTER PACK in 1 CARTON (0904-7103-10) / 1 TABLET in 1 BLISTER PACKMarketed from Aug 25, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Major Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209234
Marketing start: Dec 23, 2017
Marketing end: Aug 31, 2027
Other FDA classes: Decreased Cholesterol Absorption (Physiologic effect)
Identifiers: Product ID 0904-7103_9d9c10bc-c999-4534-839f-4f2fdb1c81d2SPL ID 9d9c10bc-c999-4534-839f-4f2fdb1c81d2SPL set ID e257ed7f-5015-4f1d-93f4-5adf5797643dRxCUI 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

N400904710304 followed by a unit qualifier and the quantity

Package 00904-7103-04. 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 May 21, 2026.

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 pati…

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	Bryant Ranch Prepack	71335-1127
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