ezetimibe NDC 48433-161

NDC codes

FDA NDC Directory

Product NDC (as listed)48433-161Labeler and product segments. Claims need a package NDC.

Product NDC at billing width48433-0161Add 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
48433-161-03	48433016103	30 BLISTER PACK in 1 CARTON (48433-161-03) / 1 TABLET in 1 BLISTER PACK (48433-161-01)Marketed from Sep 2, 2026

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: Safecor Health, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204331
Marketing start: Sep 2, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Cholesterol Absorption (Physiologic effect)
Identifiers: Product ID 48433-161_5b25cdf6-84ae-762f-e063-6294a90a8a1eSPL ID 5b25cdf6-84ae-762f-e063-6294a90a8a1e
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

N448433016103 followed by a unit qualifier and the quantity

Package 48433-0161-03. 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

The FDA listing for this product does not reference a label (SPL) set.

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	Quallent Pharmaceuticals Health LLC	82009-024