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  5. NDC Package Code: 65085-0055-8 Baclofen (process-b)

NDC Package 65085-0055-8 Baclofen (process-b)

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:
65085-0055-8
Package Description:
10 kg in 1 DRUM
Product Code:
65085-0055
Non-Proprietary Name:
Baclofen (process-b)
Substance Name:
Baclofen
Usage Information:
Baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury/disease). It works by helping to relax the muscles.
11-Digit NDC Billing Format:
65085005508
Product Type:
Bulk Ingredient
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):
  • BACLOFEN 25 kg/25kg
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    01-14-2016
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65085-0055-15 kg in 1 DRUM
    65085-0055-210 kg in 1 DRUM
    65085-0055-315 kg in 1 DRUM
    65085-0055-420 kg in 1 DRUM
    65085-0055-525 kg in 1 DRUM
    65085-0055-65 kg in 1 DRUM
    65085-0055-710 kg in 1 DRUM
    65085-0055-925 kg in 1 DRUM

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65085-0055-8?

    The NDC Packaged Code 65085-0055-8 is assigned to an UNFINISHED drug package of 10 kg in 1 drum of Baclofen (process-b), a bulk ingredient labeled by Piramal Pharma Limited. The product's dosage form is powder and is administered via form.

    Is NDC 65085-0055 included in the NDC Directory?

    Yes, Baclofen (process-b) is an UNFINISHED PRODUCT with code 65085-0055 that is active and included in the NDC Directory. The product was first marketed by Piramal Pharma Limited on January 14, 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 65085-0055-8?

    The 11-digit format is 65085005508. 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
    5-4-165085-0055-85-4-265085-0055-08