1. Home
  2. Labeler Index
  3. Slate Pharma
  4. 43773-1001
  5. NDC Package Code: 43773-1001-3 Testopel

NDC Package 43773-1001-3 Testopel

View Billable Units, 11-Digit Format, RxNorm

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.

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:
43773-1001-3
Package Description:
100 AMPULE in 1 BOX / 1 PELLET in 1 AMPULE
Product Code:
43773-1001
Proprietary Name:
Testopel
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).
11-Digit NDC Billing Format:
43773100103
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
Labeler Name:
Slate Pharma
Sample Package:
No
FDA Application Number:
ANDA080911
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-21-2009
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.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
43773-1001-210 AMPULE in 1 BOX / 1 PELLET in 1 AMPULE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 43773-1001-3?

The NDC Packaged Code 43773-1001-3 is assigned to a package of 100 ampule in 1 box / 1 pellet in 1 ampule of Testopel, labeled by Slate Pharma. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package.

Is NDC 43773-1001 included in the NDC Directory?

No, Testopel with product code 43773-1001 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Slate Pharma on July 21, 2009 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 NDC billing unit for package 43773-1001-3?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

What is the 11-digit format for NDC 43773-1001-3?

The 11-digit format is 43773100103. 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
5-4-143773-1001-35-4-243773-1001-03