Testopel Pellet
NDC Package 66887-004-20

11-digit billing NDC: 66887000420 · Billing unit: EA · 100 EA per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Testopel (testosterone) pellets is mALESAndrogens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. This formulation utilizes a pellet delivery system. Marketed by Endo Usa, Inc., this product is identified by NDC 66887-004 and is authorized under FDA application ANDA080911.

Identification & Billing

NDC Package Code
66887-004-20
Package Description
100 AMPULE in 1 BOX / 1 PELLET in 1 AMPULE (66887-004-01)
Product Code
66887-004
11-Digit Billing Format
66887000420
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Testopel
Non-Proprietary Name
Testosterone
Substance Name
Testosterone
Dosage Form
Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
TESTOSTERONE 75 mg/1
Pharmacologic Class
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. Hypogonadotropic hypogonadism (congenital or acquired) - 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.Safety and efficacy of TESTOPEL® (testosterone pellets) in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.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).
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Endo Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA080911
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-31-2014
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1073
Source: OPPS
Testosterone pellet 75 mg
HCPCS Dosage 75 MG
Units / Pkg 100

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 (66887-004). Click a package code to view its specific billing and regulatory data.

66887-004-10
10 AMPULE in 1 BOX / 1 PELLET in 1 AMPULE (66887-004-01)

* 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 66887-004-20 identifies a specific commercial package of 100 ampule in 1 box / 1 pellet in 1 ampule (66887-004-01) of Testopel, a human prescription drug labeled by Endo Usa, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This pellet is formulated for subcutaneous 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 Endo Usa, Inc. on October 31, 2014. The current certification is valid through December 31, 2026.

How is this Endo Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66887000420. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
66887-004-20
11-Digit CMS (5-4-2)
66887-0004-20

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