Mepsevii Injection
NDC Package 69794-001-01

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

Package Information

Mepsevii (vestronidase alfa) injection is mEPSEVII is indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome). Limitations of UseThe effect of MEPSEVII on the central nervous system manifestations of MPS VII has not been determined. This formulation utilizes a injection delivery system. Marketed by Ultragenyx Pharmaceutical Inc., this product is identified by NDC 69794-001 and is authorized under FDA application BLA761047.

Identification & Billing

NDC Package Code
69794-001-01
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE
Product Code
69794-001
11-Digit Billing Format
69794000101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mepsevii
Non-Proprietary Name
Vestronidase Alfa
Substance Name
Vestronidase Alfa
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)
VESTRONIDASE ALFA 2 mg/mL
Pharmacologic Class
Lysosomal beta Glucuronidase - [EPC] (Established Pharmacologic Class)
Usage Information
MEPSEVII is indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome). Limitations of UseThe effect of MEPSEVII on the central nervous system manifestations of MPS VII has not been determined.

Regulatory & Marketing

Labeler Name
Ultragenyx Pharmaceutical Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761047
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-15-2017
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J3397
Source: OPPS
Inj., vestronidase alfa-vjbk
HCPCS Dosage 1 MG
Units / Pkg 10

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 69794-001-01 identifies a specific commercial package of 1 vial, single-use in 1 carton / 5 ml in 1 vial, single-use of Mepsevii, a human prescription drug labeled by Ultragenyx Pharmaceutical Inc.. This injection is formulated for intravenous use and contains vestronidase 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 Ultragenyx Pharmaceutical Inc. on November 15, 2017. The current certification is valid through December 31, 2026.

How is this Ultragenyx Pharmaceutical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69794000101. 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)
69794-001-01
11-Digit CMS (5-4-2)
69794-0001-01

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