Testopel
NDC Package 43773-1001-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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

Testopel is mALESAndrogens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Marketed by Slate Pharma, this product is identified by NDC 43773-1001 and is authorized under FDA application ANDA080911.

Identification & Billing

NDC Package Code
43773-1001-2
Package Description
10 AMPULE in 1 BOX / 1 PELLET in 1 AMPULE
Product Code
43773-1001
11-Digit Billing Format
43773100102
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Testopel
Dosage Form
-
Usage Information
MALESAndrogens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. a.Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome; or orchiectomy.b.Hypogonadotrophic hypogonadism (congenital or acquired) - idiopathic or gonadotropic LHRH deficiency, or pituitary - hypothalamic injury from tumors, trauma or radiation.If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sex characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.c.Androgens may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An x-ray of the hand and wrist to determine bone age should be taken every 6 months to assess the effect of treatment on epiphyseal centers (see WARNINGS).

Regulatory & Marketing

Labeler Name
Slate Pharma
FDA Application #
ANDA080911
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-21-2009
Listing Expiration
12-31-2017
Exclude Flag
I
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 (43773-1001). Click a package code to view its specific billing and regulatory data.

43773-1001-3
100 AMPULE in 1 BOX / 1 PELLET in 1 AMPULE

* 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 43773-1001-2 identifies a specific commercial package of 10 ampule in 1 box / 1 pellet in 1 ampule of Testopel, labeled by Slate Pharma. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Slate Pharma on July 21, 2009. The current certification is valid through December 31, 2017.

How is this Slate Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43773100102. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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 (5-4-1)
43773-1001-2
11-Digit CMS (5-4-2)
43773-1001-02

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