Pemgarda Injection
NDC Package 81960-031-03

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

Pemgarda (pemivibart) injection is pEMGARDA is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any component of PEMGARDA. This formulation utilizes a injection delivery system. Marketed by Invivyd, Inc, this product is identified by NDC 81960-031 and is authorized under FDA application EUA000122.

Identification & Billing

NDC Package Code
81960-031-03
Package Description
9 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE
Product Code
81960-031
11-Digit Billing Format
81960003103
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pemgarda
Non-Proprietary Name
Pemivibart
Substance Name
Pemivibart
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)
PEMIVIBART 125 mg/mL
Usage Information
PEMGARDA is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any component of PEMGARDA.

Regulatory & Marketing

Labeler Name
Invivyd, Inc
Product Type
Human Prescription Drug
FDA Application #
EUA000122
Marketing Category
EMERGENCY USE AUTHORIZATION -
Start Marketing Date
03-22-2024
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.

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.

Q0224
Source: AWP
Pemivibart injection
HCPCS Dosage 4500 MG
Units / Pkg 1

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 81960-031-03 identifies a specific commercial package of 9 vial, single-dose in 1 carton / 4 ml in 1 vial, single-dose of Pemgarda, a human prescription drug labeled by Invivyd, Inc. This injection is formulated for intravenous use and contains pemivibart 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 Invivyd, Inc on March 22, 2024. The current certification is valid through December 31, 2027.

How is this Invivyd, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81960003103. 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)
81960-031-03
11-Digit CMS (5-4-2)
81960-0031-03

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