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  5. NDC Package Code: 65015-901-61 Olsalazine Sodium

NDC Package 65015-901-61 Olsalazine 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:
65015-901-61
Package Description:
100 kg in 1 DRUM
Product Code:
65015-901
Non-Proprietary Name:
Olsalazine Sodium
Substance Name:
Olsalazine Sodium
Usage Information:
Olsalazine is used to treat a certain type of bowel disease called ulcerative colitis. It does not cure ulcerative colitis, but it may decrease symptoms such as stomach pain, diarrhea, and rectal bleeding caused by irritation/swelling of the colon/rectum. After an attack is treated, olsalazine is used to increase the amount of time between attacks. Olsalazine is a salicylate anti-inflammatory drug. It is believed to work by blocking the production of certain natural substances (e.g., prostaglandins) that may cause pain and swelling.
11-Digit NDC Billing Format:
65015090161
Product Type:
Bulk Ingredient
Labeler Name:
Mylan Laboratories 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):
  • OLSALAZINE 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:
    03-26-2024
    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 65015-901-61?

    The NDC Packaged Code 65015-901-61 is assigned to an UNFINISHED drug package of 100 kg in 1 drum of Olsalazine Sodium, a bulk ingredient labeled by Mylan Laboratories Limited. The product's dosage form is powder and is administered via form.

    Is NDC 65015-901 included in the NDC Directory?

    Yes, Olsalazine Sodium is an UNFINISHED PRODUCT with code 65015-901 that is active and included in the NDC Directory. The product was first marketed by Mylan Laboratories Limited on March 26, 2024 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 65015-901-61?

    The 11-digit format is 65015090161. 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
    5-3-265015-901-615-4-265015-0901-61