Isembyld Injection
NDC Package 84717-150-01

11-digit billing NDC: 84717015001
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Isembyld (apitegromab-mstn) injection is iSEMBYLD is indicated for the treatment of spinal muscular atrophy (SMA) in adults and pediatric patients 2 years of age and older who are currently receiving a survival motor neuron 2 (SMN2)-targeted treatment. This formulation utilizes a injection delivery system. Marketed by Scholar Rock, Inc., this product is identified by NDC 84717-150 and is authorized under FDA application BLA761463.

Identification & Billing

NDC Package Code
84717-150-01
Package Description
1 VIAL in 1 CARTON / 3 mL in 1 VIAL
Product Code
84717-150
11-Digit Billing Format
84717015001

Clinical Specifications

Proprietary Name
Isembyld
Non-Proprietary Name
Apitegromab-mstn
Substance Name
Apitegromab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
APITEGROMAB 150 mg/3mL
Usage Information
ISEMBYLD is indicated for the treatment of spinal muscular atrophy (SMA) in adults and pediatric patients 2 years of age and older who are currently receiving a survival motor neuron 2 (SMN2)-targeted treatment.

Regulatory & Marketing

Labeler Name
Scholar Rock, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761463
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-11-2026
Listing Expiration
12-31-2027
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 84717-150-01 identifies a specific commercial package of 1 vial in 1 carton / 3 ml in 1 vial of Isembyld, a human prescription drug labeled by Scholar Rock, Inc.. This injection is formulated for intravenous use and contains apitegromab 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 Scholar Rock, Inc. on September 11, 2026. The current certification is valid through December 31, 2027.

How is this Scholar Rock, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84717015001. 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)
84717-150-01
11-Digit CMS (5-4-2)
84717-0150-01

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