Andembry Injection, Solution
NDC Package 63833-925-01

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

Package Information

Andembry (garadacimab) injection is aNDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. This formulation utilizes a injection, solution delivery system. Marketed by Csl, this product is identified by NDC 63833-925 and is authorized under FDA application BLA761367.

Identification & Billing

NDC Package Code
63833-925-01
Package Description
1 SYRINGE, GLASS in 1 CARTON / 1.2 mL in 1 SYRINGE, GLASS (63833-925-20)
Product Code
63833-925
11-Digit Billing Format
63833092501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Andembry
Non-Proprietary Name
Garadacimab
Substance Name
Garadacimab
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
GARADACIMAB 200 mg/1.2mL
Usage Information
ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

Regulatory & Marketing

Labeler Name
Csl
Product Type
Human Prescription Drug
FDA Application #
BLA761367
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-16-2025
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 63833-925-01 identifies a specific commercial package of 1 syringe, glass in 1 carton / 1.2 ml in 1 syringe, glass (63833-925-20) of Andembry, a human prescription drug labeled by Csl. This injection, solution is formulated for subcutaneous use and contains garadacimab 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 Csl on June 16, 2025. The current certification is valid through December 31, 2026.

How is this Csl product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63833092501. 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)
63833-925-01
11-Digit CMS (5-4-2)
63833-0925-01

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