Janumet
NDC Package 70518-2548-0

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Janumet is this combination medication is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-2548 and is authorized under FDA application NDA022044.

Identification & Billing

NDC Package Code
70518-2548-0
Package Description
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
70518-2548
11-Digit Billing Format
70518254800

Clinical Specifications

Proprietary Name
Janumet
Dosage Form
-
Usage Information
This combination medication is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes. This product contains 2 medications. 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. Metformin works by helping to restore your body's proper response to the insulin you naturally produce. It also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb. 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.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
FDA Application #
NDA022044
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-20-2020
End Marketing Date
01-14-2021
Listing Expiration
01-14-2021
Exclude Flag
D
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 70518-2548-0 identifies a specific commercial package of 90 tablet, film coated in 1 bottle, plastic of Janumet, labeled by Remedyrepack Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Remedyrepack Inc. on January 20, 2020. The current certification is valid through January 14, 2021.

What are the primary indications for this medication?

This combination medication is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes. This product contains 2 medications. 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. Metformin works by helping to restore your body's proper response to the insulin you naturally produce. It also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb. 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.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518254800. 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)
70518-2548-0
11-Digit CMS (5-4-2)
70518-2548-00

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