Vabrinty Injection, Suspension, Extended Release
NDC Package 85043-045-04

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

Package Information

Vabrinty (leuprolide acetate) injection is leuprolide is used to treat advanced prostate cancer in men. This formulation utilizes a injection, suspension, extended release delivery system. Marketed by Uronova Pharmaceuticals, Inc., this product is identified by NDC 85043-045 and is authorized under FDA application NDA021731.

Identification & Billing

NDC Package Code
85043-045-04
Package Description
1 SYRINGE in 1 CARTON / .375 mL in 1 SYRINGE
Product Code
85043-045
11-Digit Billing Format
85043004504
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 2720345 - Vabrinty 22.5 MG in 0.375 ML (3 month) Prefilled Syringe
  • RxCUI: 2720345 - 0.375 ML leuprolide acetate 60 MG/ML Prefilled Syringe [Vabrinty]
  • RxCUI: 2720345 - Vabrinty 22.5 MG per 0.375 ML Prefilled Syringe
  • RxCUI: 2720348 - Vabrinty 45 MG in 0.375 ML (6 month) Prefilled Syringe
  • RxCUI: 2720348 - 0.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe [Vabrinty]

Clinical Specifications

Proprietary Name
Vabrinty
Non-Proprietary Name
Leuprolide Acetate
Substance Name
Leuprolide Acetate
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
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
LEUPROLIDE ACETATE 45 mg/.375mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Uronova Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021731
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
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 85043-045-04 identifies a specific commercial package of 1 syringe in 1 carton / .375 ml in 1 syringe of Vabrinty, a human prescription drug labeled by Uronova Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, suspension, extended release is formulated for subcutaneous use and contains leuprolide acetate 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 Uronova Pharmaceuticals, Inc. on August 04, 2025. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85043004504. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
85043-045-04
11-Digit CMS (5-4-2)
85043-0045-04

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