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  5. NDC Package Code: 85043-025-02 Vabrinty

NDC Package 85043-025-02 Vabrinty

Leuprolide Acetate Injection, Suspension, Extended Release 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:
85043-025-02
Package Description:
1 SYRINGE in 1 CARTON / .375 mL in 1 SYRINGE
Product Code:
85043-025
Proprietary Name:
Vabrinty
Non-Proprietary Name:
Leuprolide Acetate
Substance Name:
Leuprolide Acetate
Usage Information:
Leuprolide is used to treat advanced prostate cancer in men. It is not a cure. Most types of prostate cancer need the male hormone testosterone to grow and spread. Leuprolide works by reducing the amount of testosterone that the body makes. This helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. Talk to your doctor about the risks and benefits of treatment.
11-Digit NDC Billing Format:
85043002502
Product Type:
Human Prescription Drug
Labeler Name:
Uronova Pharmaceuticals, Inc.
Dosage Form:
Injection, Suspension, Extended Release - A sterile preparation intended for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route(s):
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s):
LEUPROLIDE ACETATE 22.5 mg/.375mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA021379
Marketing Category:
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date:
08-04-2025
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 85043-025-02?

The NDC Packaged Code 85043-025-02 is assigned to a package of 1 syringe in 1 carton / .375 ml in 1 syringe of Vabrinty, a human prescription drug labeled by Uronova Pharmaceuticals, Inc.. The product's dosage form is injection, suspension, extended release and is administered via subcutaneous form.

Is NDC 85043-025 included in the NDC Directory?

Yes, Vabrinty with product code 85043-025 is active and included in the NDC Directory. The product was first marketed by Uronova Pharmaceuticals, Inc. on August 04, 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 85043-025-02?

The 11-digit format is 85043002502. 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
5-3-285043-025-025-4-285043-0025-02