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  4. NDC Product Code: 54868-6406 Axiron

NDC 54868-6406 Axiron

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 54868-6406?
  4. Axiron Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54868-6406
Proprietary Name:
Axiron
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
3b40e56a-51bb-4357-8861-325bb1195049
Start Marketing Date: [9]
09-06-2013
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 54868-6406-0

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON / 90 mL in 1 BOTTLE, WITH APPLICATOR

Product Details

What is NDC 54868-6406?

The NDC code 54868-6406 is assigned by the FDA to the product Axiron which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-6406-0 1 bottle, with applicator in 1 carton / 90 ml in 1 bottle, with applicator. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Axiron?

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.

Which are Axiron UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Axiron Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Axiron?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".