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  5. NDC Package Code: 58103-122-50 Ibuprofen

NDC Package 58103-122-50 Ibuprofen

Granule - 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:
58103-122-50
Package Description:
50 kg in 1 DRUM
Product Code:
58103-122
Non-Proprietary Name:
Ibuprofen
Substance Name:
Ibuprofen
Usage Information:
Ibuprofen is used to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.
11-Digit NDC Billing Format:
58103012250
Product Type:
Bulk Ingredient
Labeler Name:
Spi Pharma Inc
Dosage Form:
Granule - A small particle or grain.
Active Ingredient(s):
  • IBUPROFEN 91 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:
    12-18-2018
    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 58103-122-50?

    The NDC Packaged Code 58103-122-50 is assigned to an UNFINISHED drug package of 50 kg in 1 drum of Ibuprofen, a bulk ingredient labeled by Spi Pharma Inc. The product's dosage form is granule and is administered via form.

    Is NDC 58103-122 included in the NDC Directory?

    Yes, Ibuprofen is an UNFINISHED PRODUCT with code 58103-122 that is active and included in the NDC Directory. The product was first marketed by Spi Pharma Inc on December 18, 2018 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 58103-122-50?

    The 11-digit format is 58103012250. 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
    5-3-258103-122-505-4-258103-0122-50