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  5. NDC Package Code: 0006-0080-82 Janumet XR

NDC Package 0006-0080-82 Janumet XR

Sitagliptin And Metformin Hydrochloride Tablet, Film Coated, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0006-0080-82
Package Description:
1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code:
0006-0080
Proprietary Name:
Janumet XR
Non-Proprietary Name:
Sitagliptin And Metformin Hydrochloride
Substance Name:
Metformin Hydrochloride; Sitagliptin Phosphate
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.
11-Digit NDC Billing Format:
00006008082
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1000 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1243827 - SITagliptin 100 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1243827 - 24 HR metformin hydrochloride 1000 MG / sitagliptin 100 MG Extended Release Oral Tablet
  • RxCUI: 1243827 - metformin hydrochloride 1000 MG / sitagliptin (as sitagliptin phosphate monohydrate) 100 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1243833 - Janumet XR 100 MG / 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1243833 - 24 HR metformin hydrochloride 1000 MG / sitagliptin 100 MG Extended Release Oral Tablet [Janumet]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Merck Sharp & Dohme Llc
    Dosage Form:
    Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • METFORMIN HYDROCHLORIDE 1000 mg/1
  • SITAGLIPTIN PHOSPHATE 50 mg/1
    • Pharmacologic Class(es):
  • Biguanide - [EPC] (Established Pharmacologic Class)
  • Biguanides - [CS]
  • Dipeptidyl Peptidase 4 Inhibitor - [EPC] (Established Pharmacologic Class)
  • Dipeptidyl Peptidase 4 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA202270
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-02-2012
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0006-0080-282 BOTTLE in 1 CARTON / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0080-14)
    0006-0080-6160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
    0006-0080-62180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0006-0080-82?

    The NDC Packaged Code 0006-0080-82 is assigned to a package of 1000 tablet, film coated, extended release in 1 bottle of Janumet XR, a human prescription drug labeled by Merck Sharp & Dohme Llc. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 0006-0080 included in the NDC Directory?

    Yes, Janumet XR with product code 0006-0080 is active and included in the NDC Directory. The product was first marketed by Merck Sharp & Dohme Llc on February 02, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0006-0080-82?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1000.

    What is the 11-digit format for NDC 0006-0080-82?

    The 11-digit format is 00006008082. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20006-0080-825-4-200006-0080-82