NDC Package 54868-6406-0 Axiron

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
54868-6406-0
Package Description:
1 BOTTLE, WITH APPLICATOR in 1 CARTON / 90 mL in 1 BOTTLE, WITH APPLICATOR
Product Code:
Proprietary Name:
Axiron
Usage Information:
AXIRON is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.
11-Digit NDC Billing Format:
54868640600
NDC to RxNorm Crosswalk:
  • RxCUI: 1599948 - Axiron 30 MG per 1.5 ML ACTUAT Topical Solution, 60 ACTUAT
  • RxCUI: 1599948 - 60 ACTUAT testosterone 30 MG/ACTUAT Topical Solution [Axiron]
  • RxCUI: 1599948 - Axiron 20 MG/ML Topical Solution
  • RxCUI: 1599948 - Axiron 30 MG per 1.5 ML ACTUAT Topical Solution
  • RxCUI: 1599948 - Axiron 30 MG/ACTUAT Topical Solution
  • Labeler Name:
    Physicians Total Care, Inc.
    Sample Package:
    No
    Start Marketing Date:
    09-06-2013
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    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 54868-6406-0?

    The NDC Packaged Code 54868-6406-0 is assigned to a package of 1 bottle, with applicator in 1 carton / 90 ml in 1 bottle, with applicator of Axiron, labeled by Physicians Total Care, Inc.. The product's dosage form is and is administered via form.

    Is NDC 54868-6406 included in the NDC Directory?

    No, Axiron with product code 54868-6406 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Physicians Total Care, Inc. on September 06, 2013 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 54868-6406-0?

    The 11-digit format is 54868640600. 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
    5-4-154868-6406-05-4-254868-6406-00