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  5. NDC Package Code: 12651-117-02 Rotigotine

NDC Package 12651-117-02 Rotigotine

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:
12651-117-02
Package Description:
20 kg in 1 DRUM
Product Code:
12651-117
Non-Proprietary Name:
Rotigotine
Substance Name:
Rotigotine
Usage Information:
Rotigotine is used alone or with other medications to treat Parkinson's disease. It can improve your ability to move and decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. Rotigotine is also used to treat restless legs syndrome (RLS). Rotigotine is a dopamine agonist that works by helping to restore the balance of a certain natural substance (dopamine) in the brain.
11-Digit NDC Billing Format:
12651011702
Product Type:
Bulk Ingredient
Labeler Name:
Cambrex Karlskoga Ab
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):
  • ROTIGOTINE 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:
    02-22-2016
    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 12651-117-02?

    The NDC Packaged Code 12651-117-02 is assigned to an UNFINISHED drug package of 20 kg in 1 drum of Rotigotine, a bulk ingredient labeled by Cambrex Karlskoga Ab. The product's dosage form is powder and is administered via form.

    Is NDC 12651-117 included in the NDC Directory?

    Yes, Rotigotine is an UNFINISHED PRODUCT with code 12651-117 that is active and included in the NDC Directory. The product was first marketed by Cambrex Karlskoga Ab on February 22, 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 12651-117-02?

    The 11-digit format is 12651011702. 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
    5-3-212651-117-025-4-212651-0117-02