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  5. NDC Package Code: 53044-001-01 Dolutegravir Sodium

NDC Package 53044-001-01 Dolutegravir Sodium

Powder - 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:
53044-001-01
Package Description:
19.5 kg in 1 DRUM
Product Code:
53044-001
Non-Proprietary Name:
Dolutegravir Sodium
Substance Name:
Dolutegravir Sodium
Usage Information:
Dolutegravir is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Dolutegravir belongs to a class of drugs known as integrase inhibitors. It blocks the virus from growing and infecting more cells. Dolutegravir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.
11-Digit NDC Billing Format:
53044000101
Product Type:
Bulk Ingredient
Labeler Name:
Shionogi Pharma Co., Ltd.
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):
  • DOLUTEGRAVIR SODIUM 1 kg/kg
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    06-09-2016
    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 53044-001-01?

    The NDC Packaged Code 53044-001-01 is assigned to an UNFINISHED drug package of 19.5 kg in 1 drum of Dolutegravir Sodium, a bulk ingredient labeled by Shionogi Pharma Co., Ltd.. The product's dosage form is powder and is administered via form.

    Is NDC 53044-001 included in the NDC Directory?

    Yes, Dolutegravir Sodium is an UNFINISHED PRODUCT with code 53044-001 that is active and included in the NDC Directory. The product was first marketed by Shionogi Pharma Co., Ltd. on June 09, 2016 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 53044-001-01?

    The 11-digit format is 53044000101. 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
    5-3-253044-001-015-4-253044-0001-01