Steglujan Tablet, Film Coated
NDC Package 0006-5367-07

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

Package Information

Steglujan (ertugliflozin and sitagliptin) tablets is a medication a combination of 2 drugs: ertugliflozin and sitagliptin. This formulation utilizes a tablet, film coated delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0006-5367 and is authorized under FDA application NDA209805.

Identification & Billing

NDC Package Code
0006-5367-07
Package Description
500 TABLET, FILM COATED in 1 BOTTLE
Product Code
0006-5367
11-Digit Billing Format
00006536707
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA
RxNorm Crosswalk
  • RxCUI: 1992826 - ertugliflozin 15 MG / SITagliptin 100 MG Oral Tablet
  • RxCUI: 1992826 - ertugliflozin 15 MG / sitagliptin 100 MG Oral Tablet
  • RxCUI: 1992832 - Steglujan 15 MG / 100 MG Oral Tablet
  • RxCUI: 1992832 - ertugliflozin 15 MG / sitagliptin 100 MG Oral Tablet [Steglujan]
  • RxCUI: 1992832 - Steglujan 15/100 (ertugliflozin 15 MG / sitagliptin 100 MG) Oral Tablet

Clinical Specifications

Proprietary Name
Steglujan
Non-Proprietary Name
Ertugliflozin And Sitagliptin
Substance Name
Ertugliflozin Pidolate; 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)
Pharmacologic Class
Usage Information
This medication is a combination of 2 drugs: ertugliflozin and sitagliptin. It is used with a proper diet and exercise program to control high blood sugar 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. Ertugliflozin works by increasing the removal of sugar by your kidneys. Sitagliptin 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
Merck Sharp & Dohme Llc
Product Type
Human Prescription Drug
FDA Application #
NDA209805
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-19-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0006-5367). Click a package code to view its specific billing and regulatory data.

0006-5367-03
30 TABLET, FILM COATED in 1 BOTTLE
0006-5367-06
90 TABLET, FILM COATED in 1 BOTTLE
0006-5367-09
2 BOTTLE in 1 CARTON / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5367-08)

* 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 0006-5367-07 identifies a specific commercial package of 500 tablet, film coated in 1 bottle of Steglujan, a human prescription drug labeled by Merck Sharp & Dohme Llc. This tablet, film coated is formulated for oral use and contains ertugliflozin pidolate; 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 Merck Sharp & Dohme Llc on December 19, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is a combination of 2 drugs: ertugliflozin and sitagliptin. It is used with a proper diet and exercise program to control high blood sugar 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. Ertugliflozin works by increasing the removal of sugar by your kidneys. Sitagliptin 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 Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00006536707. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 total billable units per package. 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 (4-4-2)
0006-5367-07
11-Digit CMS (5-4-2)
00006-5367-07

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