1. Home
  2. Labeler Index
  3. Piramal Pharma Limited
  4. 65085-0068
  5. NDC Package Code: 65085-0068-2 Dapagliflozin Propanediol Monohydrate

NDC Package 65085-0068-2 Dapagliflozin Propanediol Monohydrate

Powder - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
65085-0068-2
Package Description:
10 kg in 1 DRUM
Product Code:
65085-0068
Non-Proprietary Name:
Dapagliflozin Propanediol Monohydrate
Substance Name:
Dapagliflozin Propanediol
Usage Information:
Dapagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. 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. This medication is also used in people with type 2 diabetes and heart disease to lower the risk of going to the hospital for heart failure. Dapagliflozin works by increasing the removal of sugar by your kidneys. Dapagliflozin is also used to treat heart failure. It may help you live longer and lower your risk of going to the hospital for heart failure. Dapagliflozin works by increasing the removal of sodium by your kidneys.
11-Digit NDC Billing Format:
65085006802
Product Type:
Drug For Further Processing
Labeler Name:
Piramal Pharma Limited
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s):
  • DAPAGLIFLOZIN PROPANEDIOL 1 kg/kg
    • 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:
    01-02-2023
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65085-0068-15 kg in 1 DRUM
    65085-0068-315 kg in 1 DRUM
    65085-0068-420 kg in 1 DRUM

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65085-0068-2?

    The NDC Packaged Code 65085-0068-2 is assigned to an UNFINISHED drug package of 10 kg in 1 drum of Dapagliflozin Propanediol Monohydrate, drug for further processing labeled by Piramal Pharma Limited. The product's dosage form is powder and is administered via form.

    Is NDC 65085-0068 included in the NDC Directory?

    Yes, Dapagliflozin Propanediol Monohydrate is an UNFINISHED PRODUCT with code 65085-0068 that is active and included in the NDC Directory. The product was first marketed by Piramal Pharma Limited on January 02, 2023 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 65085-0068-2?

    The 11-digit format is 65085006802. 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 5-4-1 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
    5-4-165085-0068-25-4-265085-0068-02