Strensiq Solution
NDC Package 25682-019-12

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

Package Information

Strensiq (asfotase alfa) solution is sTRENSIQ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). This formulation utilizes a solution delivery system. Marketed by Alexion Pharmaceuticals, Inc., this product is identified by NDC 25682-019 and is authorized under FDA application BLA125513.

Identification & Billing

NDC Package Code
25682-019-12
Package Description
12 VIAL in 1 CARTON / .8 mL in 1 VIAL (25682-019-01)
Product Code
25682-019
11-Digit Billing Format
25682001912
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Strensiq
Non-Proprietary Name
Asfotase Alfa
Substance Name
Asfotase Alfa
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
ASFOTASE ALFA 80 mg/.8mL
Pharmacologic Class
Usage Information
STRENSIQ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).

Regulatory & Marketing

Labeler Name
Alexion Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125513
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-23-2015
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 25682-019-12 identifies a specific commercial package of 12 vial in 1 carton / .8 ml in 1 vial (25682-019-01) of Strensiq, a human prescription drug labeled by Alexion Pharmaceuticals, Inc.. This solution is formulated for subcutaneous use and contains asfotase alfa 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 Alexion Pharmaceuticals, Inc. on October 23, 2015. The current certification is valid through December 31, 2026.

How is this Alexion Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 25682001912. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
25682-019-12
11-Digit CMS (5-4-2)
25682-0019-12

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