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  5. NDC Package Code: 0310-6350-00 Dapagliflozin And Metformin Hydrochloride

NDC Package 0310-6350-00 Dapagliflozin And Metformin Hydrochloride

Tablet, Film Coated, Extended Release - 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:
0310-6350-00
Package Description:
180000 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM
Product Code:
0310-6350
Non-Proprietary Name:
Dapagliflozin And Metformin Hydrochloride
Substance Name:
Dapagliflozin Propanediol; Metformin Hydrochloride
11-Digit NDC Billing Format:
00310635000
Product Type:
Drug For Further Processing
Labeler Name:
Astrazeneca Pharmaceuticals Lp
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.
Active Ingredient(s):
  • DAPAGLIFLOZIN PROPANEDIOL 5 mg/1
  • METFORMIN HYDROCHLORIDE 500 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:
    05-19-2022
    Listing Expiration Date:
    12-31-2024
    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 0310-6350-00?

    The NDC Packaged Code 0310-6350-00 is assigned to an UNFINISHED drug package of 180000 tablet, film coated, extended release in 1 drum of Dapagliflozin And Metformin Hydrochloride, drug for further processing labeled by Astrazeneca Pharmaceuticals Lp. The product's dosage form is tablet, film coated, extended release and is administered via form.

    Is NDC 0310-6350 included in the NDC Directory?

    Yes, Dapagliflozin And Metformin Hydrochloride is an UNFINISHED PRODUCT with code 0310-6350 that is active and included in the NDC Directory. The product was first marketed by Astrazeneca Pharmaceuticals Lp on May 19, 2022 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 11-digit format for NDC 0310-6350-00?

    The 11-digit format is 00310635000. 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
    4-4-20310-6350-005-4-200310-6350-00