Skytrofa Injection, Powder, Lyophilized, For Solution
NDC Package 73362-005-01

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

Package Information

Skytrofa (lonapegsomatropin-tcgd) injection is sKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH). This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Ascendis Pharma Endocrinology, Inc., this product is identified by NDC 73362-005 and is authorized under FDA application BLA761177.

Identification & Billing

NDC Package Code
73362-005-01
Package Description
4 BLISTER PACK in 1 CARTON / 1 CARTRIDGE in 1 BLISTER PACK (73362-005-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE
Product Code
73362-005
11-Digit Billing Format
73362000501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Skytrofa
Non-Proprietary Name
Lonapegsomatropin-tcgd
Substance Name
Lonapegsomatropin
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
LONAPEGSOMATROPIN 4.3 mg/1
Pharmacologic Class
Usage Information
SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH).

Regulatory & Marketing

Labeler Name
Ascendis Pharma Endocrinology, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761177
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-25-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 73362-005-01 identifies a specific commercial package of 4 blister pack in 1 carton / 1 cartridge in 1 blister pack (73362-005-02) / 1 injection, powder, lyophilized, for solution in 1 cartridge of Skytrofa, a human prescription drug labeled by Ascendis Pharma Endocrinology, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. This injection, powder, lyophilized, for solution is formulated for subcutaneous use and contains lonapegsomatropin 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 Ascendis Pharma Endocrinology, Inc. on August 25, 2021. The current certification is valid through December 31, 2026.

How is this Ascendis Pharma Endocrinology, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73362000501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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)
73362-005-01
11-Digit CMS (5-4-2)
73362-0005-01

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