Ezetimibe Tablet
NDC Package 48433-161-03

11-digit billing NDC: 48433016103
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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 years of age and older with homozygous familial hypercholesterolemia (HoFH).As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.When ezetimibe tablets are used in combination with a statin, fenofibrate, or other LDL-C lowering therapies, refer to the Prescribing Information of these products for information on the safe and effective use. This formulation utilizes a tablet delivery system. Marketed by Safecor Health, Llc, this product is identified by NDC 48433-161 and is authorized under FDA application ANDA204331.

Identification & Billing

NDC Package Code
48433-161-03
Package Description
30 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (48433-161-01)
Product Code
48433-161
11-Digit Billing Format
48433016103
RxNorm Crosswalk
RxCUI: 349556 - ezetimibe 10 MG Oral Tablet

Clinical Specifications

Proprietary Name
Ezetimibe
Non-Proprietary Name
Ezetimibe
Substance Name
Ezetimibe
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
EZETIMIBE 10 mg/1
Pharmacologic Class
Usage Information
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 years of age and older with homozygous familial hypercholesterolemia (HoFH).As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.When ezetimibe tablets are used in combination with a statin, fenofibrate, or other LDL-C lowering therapies, refer to the Prescribing Information of these products for information on the safe and effective use.

Regulatory & Marketing

Labeler Name
Safecor Health, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA204331
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-02-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 48433-161-03 identifies a specific commercial package of 30 blister pack in 1 carton / 1 tablet in 1 blister pack (48433-161-01) of Ezetimibe, a human prescription drug labeled by Safecor Health, Llc. This tablet is formulated for oral use and contains ezetimibe as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Safecor Health, Llc on September 02, 2026. The current certification is valid through December 31, 2027.

How is this Safecor Health, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48433016103. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
48433-161-03
11-Digit CMS (5-4-2)
48433-0161-03

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.