Januvia Tablet, Film Coated
NDC Package 55154-5040-8

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Januvia (sitagliptin) tablets is sitagliptin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. This formulation utilizes a tablet, film coated delivery system. Marketed by Cardinal Health 107, Llc, this product is identified by NDC 55154-5040 and is authorized under FDA application NDA021995.

Identification & Billing

NDC Package Code
55154-5040-8
Package Description
2340 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
55154-5040
11-Digit Billing Format
55154504008
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Januvia
Non-Proprietary Name
Sitagliptin
Substance Name
Sitagliptin Phosphate
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SITAGLIPTIN PHOSPHATE 50 mg/1
Pharmacologic Class
Usage Information
Sitagliptin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Sitagliptin is a diabetes drug that works by increasing levels of natural substances called incretins. Incretins help to control blood sugar by increasing insulin release, especially after a meal. They also decrease the amount of sugar your liver makes.

Regulatory & Marketing

Labeler Name
Cardinal Health 107, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021995
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-16-2006
Listing Expiration
12-31-2026
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 55154-5040-8 identifies a specific commercial package of 2340 tablet, film coated in 1 bottle, plastic of Januvia, a human prescription drug labeled by Cardinal Health 107, Llc. This tablet, film coated is formulated for oral use and contains sitagliptin phosphate 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 Cardinal Health 107, Llc on October 16, 2006. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Sitagliptin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Sitagliptin is a diabetes drug that works by increasing levels of natural substances called incretins. Incretins help to control blood sugar by increasing insulin release, especially after a meal. They also decrease the amount of sugar your liver makes.

How is this Cardinal Health 107, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55154504008. 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 (5-4-1)
55154-5040-8
11-Digit CMS (5-4-2)
55154-5040-08

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