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  5. NDC Package Code: 55370-003-00 Sitagliptin And Metformin Hydrochloride

NDC Package 55370-003-00 Sitagliptin And Metformin Hydrochloride

Tablet, Film Coated - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
55370-003-00
Package Description:
19231 TABLET, FILM COATED in 1 CONTAINER
Product Code:
55370-003
Non-Proprietary Name:
Sitagliptin And Metformin Hydrochloride
Substance Name:
Metformin Hydrochloride; Sitagliptin Phosphate
11-Digit NDC Billing Format:
55370000300
Product Type:
Drug For Further Processing
Labeler Name:
Patheon Puerto Rico, Inc.
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.
Active Ingredient(s):
  • METFORMIN HYDROCHLORIDE 1000 mg/1
  • SITAGLIPTIN PHOSPHATE 50 mg/1
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    03-30-2007
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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.

    Frequently Asked Questions

    What is NDC 55370-003-00?

    The NDC Packaged Code 55370-003-00 is assigned to an UNFINISHED drug package of 19231 tablet, film coated in 1 container of Sitagliptin And Metformin Hydrochloride, drug for further processing labeled by Patheon Puerto Rico, Inc.. The product's dosage form is tablet, film coated and is administered via form.

    Is NDC 55370-003 included in the NDC Directory?

    Yes, Sitagliptin And Metformin Hydrochloride is an UNFINISHED PRODUCT with code 55370-003 that is active and included in the NDC Directory. The product was first marketed by Patheon Puerto Rico, Inc. on March 30, 2007 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 55370-003-00?

    The 11-digit format is 55370000300. 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 5-3-2 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
    5-3-255370-003-005-4-255370-0003-00