NDC 0006-0081-31 Janumet XR

Sitagliptin And Metformin Hydrochloride

NDC Package Code 0006-0081-31

Field Name Field Value
NDC Code 0006-0081-31
Package Description 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Proprietary Name Janumet XR Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Sitagliptin And Metformin Hydrochloride Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
11-Digit NDC Billing Format 00006008131 Additional informationCallout TooltipNDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Product Type Human Prescription Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Labeler Name Merck Sharp & Dohme Corp.
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)
  • SITAGLIPTIN PHOSPHATE 100 mg/1
  • METFORMIN HYDROCHLORIDE 1000 mg/1
Pharmacological Class(es)
  • Dipeptidyl Peptidase 4 Inhibitor - [EPC] (Established Pharmacologic Class)
  • Dipeptidyl Peptidase 4 Inhibitors - [MoA] (Mechanism of Action)
  • Biguanide - [EPC] (Established Pharmacologic Class)
  • Biguanides - [Chemical/Ingredient]
Marketing Category NDA - A product marketed under an approved New Drug Application. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NDA202270 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Start Marketing Date 02-02-2012 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

The NDC Code 0006-0081-31 is assigned to Janumet XR, a human prescription drug labeled by Merck Sharp & Dohme Corp.. The product's dosage form is tablet, film coated, extended release and is administered via oral form.


Code Structure
  • 0006 - Merck Sharp & Dohme Corp.
    • 0006-0081 - Janumet
      • 0006-0081-31 - 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

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.

Pill Identification

24 HR Metformin hydrochloride 1000 MG / sitagliptin 100 MG Extended Release Oral Tablet [Janumet]

24 HR Metformin hydrochloride 1000 MG / sitagliptin 100 MG Extended Release Oral Tablet [Janumet]
Image Labeler: Merck Sharp & Dohme Corp.

Physical Characteristics

What does janumet xr look like?
Janumet XR may look like a blue oval shaped tablet, film coated, extended release; approximately 22 millimeters in size. The medicine is imprinted with debossed code(s) 81.

Shape: OVAL
Size: 22 mm
Color: BLUE
Imprint: 81
Imprint Type: DEBOSSED

Other Product Packages

The following packages are also available for Janumet with product NDC 0006-0081.

NDC Package CodePackage Description
0006-0081-142 BOTTLE in 1 CARTON > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0081-07)
0006-0081-5490 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
0006-0081-821000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

* Please review the disclaimer below.

Previous Code
0006-0080
Next Code
0006-0106