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  5. NDC Package Code: 43598-304-88 Testosterone

NDC Package 43598-304-88 Testosterone

Gel, Metered Transdermal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
43598-304-88
Package Description:
1 BOTTLE, PUMP in 1 CARTON / 88 g in 1 BOTTLE, PUMP
Product Code:
43598-304
Proprietary Name:
Testosterone
Non-Proprietary Name:
Testosterone
Substance Name:
Testosterone
Usage Information:
This medicated gel contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (for example, due to hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels. Testosterone helps the body to develop and maintain the male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire. This drug should not be used by women.
11-Digit NDC Billing Format:
43598030488
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
88 GM
Product Type:
Human Prescription Drug
Labeler Name:
Dr. Reddy's Laboratories, Inc.
Dosage Form:
Gel, Metered - A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation.
Administration Route(s):
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
    • Active Ingredient(s):
  • TESTOSTERONE 1.62 mg/g
    • Pharmacologic Class(es):
  • Androgen Receptor Agonists - [MoA] (Mechanism of Action)
  • Androgen - [EPC] (Established Pharmacologic Class)
  • Androstanes - [CS]
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA208620
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-12-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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 43598-304-88?

    The NDC Packaged Code 43598-304-88 is assigned to a package of 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump of Testosterone, a human prescription drug labeled by Dr. Reddy's Laboratories, Inc.. The product's dosage form is gel, metered and is administered via transdermal form.

    Is NDC 43598-304 included in the NDC Directory?

    Yes, Testosterone with product code 43598-304 is active and included in the NDC Directory. The product was first marketed by Dr. Reddy's Laboratories, Inc. on April 12, 2019 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 NDC billing unit for package 43598-304-88?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 88.

    What is the 11-digit format for NDC 43598-304-88?

    The 11-digit format is 43598030488. 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
    5-3-243598-304-885-4-243598-0304-88