NDC 0006-5363-09 Steglatro

Ertugliflozin

NDC Package Code 0006-5363-09

Field Name Field Value
NDC Code 0006-5363-09
Package Description 2 BOTTLE in 1 CARTON > 7 TABLET, FILM COATED in 1 BOTTLE (0006-5363-08)
Proprietary Name Steglatro 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 Ertugliflozin 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 00006536309 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.
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 - 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(s)
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
  • ERTUGLIFLOZIN PIDOLATE 5 mg/1
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 NDA209803 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 12-19-2017 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 0006-5363-09 is assigned to Steglatro, a human prescription drug labeled by Merck Sharp & Dohme Corp.. The product's dosage form is tablet, film coated and is administered via oral form.


Code Structure
  • 0006 - Merck Sharp & Dohme Corp.
    • 0006-5363 - Steglatro
      • 0006-5363-09 - 2 BOTTLE in 1 CARTON

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 Steglatro with product NDC 0006-5363.

NDC Package CodePackage Description
0006-5363-0330 TABLET, FILM COATED in 1 BOTTLE
0006-5363-0690 TABLET, FILM COATED in 1 BOTTLE
0006-5363-07500 TABLET, FILM COATED in 1 BOTTLE
0006-5363-1030 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

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