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  5. NDC Package Code: 84768-511-01 Papzimeos

NDC Package 84768-511-01 Papzimeos

Zopapogene Imadenovec Injection, Suspension Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Papzimeos
Non-Proprietary Name:
Zopapogene Imadenovec
Substance Name:
Zopapogene Imadenovec
Usage Information:
PAPZIMEOS is indicated for the treatment of adults with recurrent respiratory papillomatosis.
11-Digit NDC Billing Format:
84768051101
Product Type:
Human Prescription Drug
Labeler Name:
Precigen, Inc.
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(s):
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s):
ZOPAPOGENE IMADENOVEC 500000000000 {VP}/mL
Sample Package:
No
FDA Application Number:
BLA125832
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
09-15-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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.

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Frequently Asked Questions

What is NDC 84768-511-01?

The NDC Packaged Code 84768-511-01 is assigned to a 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.. The product's dosage form is injection, suspension and is administered via subcutaneous form.

Is NDC 84768-511 included in the NDC Directory?

Yes, Papzimeos with product code 84768-511 is active and included in the NDC Directory. The product was first marketed by Precigen, Inc. on September 15, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 84768-511-01?

The 11-digit format is 84768051101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-284768-511-015-4-284768-0511-01