Papzimeos Injection, Suspension
NDC Package 84768-511-01

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

Papzimeos (zopapogene imadenovec) injection is pAPZIMEOS is indicated for the treatment of adults with recurrent respiratory papillomatosis. This formulation utilizes a injection, suspension delivery system. Marketed by Precigen, Inc., this product is identified by NDC 84768-511 and is authorized under FDA application BLA125832.

Identification & Billing

NDC Package Code
84768-511-01
Package Description
1 POUCH in 1 CARTON / 1 VIAL in 1 POUCH / 1 mL in 1 VIAL
Product Code
84768-511
11-Digit Billing Format
84768051101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2723367 - zopapogene imadenovec-drba 500,000,000,000 PU in 1 ML Injection
  • RxCUI: 2723367 - 1 ML zopapogene imadenovec-drba 500000000000 UNT/ML Injection
  • RxCUI: 2723367 - zopapogene imadenovec-drba 500000000000 PU per 1 ML Injection
  • RxCUI: 2723374 - Papzimeos 500,000,000,000 PU in 1 ML Injection
  • RxCUI: 2723374 - 1 ML zopapogene imadenovec-drba 500000000000 UNT/ML Injection [Papzimeos]

Clinical Specifications

Proprietary Name
Papzimeos
Non-Proprietary Name
Zopapogene Imadenovec
Substance Name
Zopapogene Imadenovec
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
ZOPAPOGENE IMADENOVEC 500000000000 {VP}/mL
Usage Information
PAPZIMEOS is indicated for the treatment of adults with recurrent respiratory papillomatosis.

Regulatory & Marketing

Labeler Name
Precigen, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125832
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-15-2025
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.

J3404
Source: OPPS
Inj zopapogene per ther dose
HCPCS Dosage Per Therapeutic Dose
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 84768-511-01 identifies a specific commercial package of 1 pouch in 1 carton / 1 vial in 1 pouch / 1 ml in 1 vial of Papzimeos, a human prescription drug labeled by Precigen, Inc.. This injection, suspension is formulated for subcutaneous use and contains zopapogene imadenovec 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 Precigen, Inc. on September 15, 2025. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84768051101. 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)
84768-511-01
11-Digit CMS (5-4-2)
84768-0511-01

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