Testosterone Gel
NDC Package 45802-754-39

11-digit billing NDC: 45802075439 · Billing unit: GM · 37.5 GM per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Testosterone gel is 1.62% is indicated for replacement therapy in adult 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. This formulation utilizes a gel delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-754 and is authorized under FDA application ANDA204268.

Identification & Billing

NDC Package Code
45802-754-39
Package Description
30 PACKET in 1 CARTON / 1.25 g in 1 PACKET
Product Code
45802-754
11-Digit Billing Format
45802075439
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
37.5 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Testosterone
Non-Proprietary Name
Testosterone
Substance Name
Testosterone
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
TESTOSTERONE 16.2 mg/g
Pharmacologic Class
Usage Information
Testosterone Gel, 1.62% is indicated for replacement therapy in adult 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 (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.•Hypogonadotropic hypogonadism (congenital or acquired): 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.Limitations of use:•Safety and efficacy of Testosterone Gel, 1.62% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.•Safety and efficacy of Testosterone Gel, 1.62% in males less than 18 years old have not been established [see Use in Specific Populations (8.4)].•Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see Indications and Usage (1), and Clinical Pharmacology (12.3)].
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA204268
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-12-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (45802-754). Click a package code to view its specific billing and regulatory data.

45802-754-01
1 BOTTLE, PUMP in 1 CARTON / 88 g in 1 BOTTLE, PUMP
45802-754-02
2.5 g in 1 PACKET
45802-754-03
1.25 g in 1 PACKET
45802-754-65
30 PACKET in 1 CARTON / 2.5 g in 1 PACKET

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 45802-754-39 identifies a specific commercial package of 30 packet in 1 carton / 1.25 g in 1 packet of Testosterone, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This gel is formulated for topical use and contains testosterone as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Padagis Israel Pharmaceuticals Ltd on October 12, 2018. The current certification is valid through December 31, 2026.

How is this Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802075439. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 37.5 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
45802-754-39
11-Digit CMS (5-4-2)
45802-0754-39

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.