Imuldosa Injection
NDC Package 69448-017-63

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

Package Information

Imuldosa (ustekinumab-srlf) injection is iMULDOSA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in IMULDOSA[ see Warnings and Precautions ( 5.5) ]. This formulation utilizes a injection delivery system. Marketed by Accord Biopharma Inc., this product is identified by NDC 69448-017 and is authorized under FDA application BLA761364.

Identification & Billing

NDC Package Code
69448-017-63
Package Description
1 BLISTER PACK in 1 CARTON / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE
Product Code
69448-017
11-Digit Billing Format
69448001763
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Imuldosa
Non-Proprietary Name
Ustekinumab-srlf
Substance Name
Ustekinumab-srlf
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
USTEKINUMAB-SRLF 45 mg/.5mL
Pharmacologic Class
Usage Information
IMULDOSA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in IMULDOSA[ see Warnings and Precautions ( 5.5) ].

Regulatory & Marketing

Labeler Name
Accord Biopharma Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761364
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-14-2024
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 69448-017-63 identifies a specific commercial package of 1 blister pack in 1 carton / 1 syringe in 1 blister pack / .5 ml in 1 syringe of Imuldosa, a human prescription drug labeled by Accord Biopharma Inc.. This injection is formulated for subcutaneous use and contains ustekinumab-srlf 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 Accord Biopharma Inc. on October 14, 2024. The current certification is valid through December 31, 2027.

How is this Accord Biopharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69448001763. 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)
69448-017-63
11-Digit CMS (5-4-2)
69448-0017-63

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