NDC Package 85043-465-60 Leuprolide Acetate For Injectable Suspension

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
85043-465-60
Package Description:
1 SYRINGE in 1 CARTON / .375 mL in 1 SYRINGE
Product Code:
Proprietary Name:
Leuprolide Acetate For Injectable Suspension
Usage Information:
Leuprolide Acetate for Injectable Suspension is indicated for the treatment of advanced prostate cancer.
11-Digit NDC Billing Format:
85043046560
Labeler Name:
Uronova Pharmaceuticals, Inc.
Sample Package:
No
FDA Application Number:
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:
09-01-2025
End Marketing Date:
09-01-2025
Listing Expiration Date:
09-01-2025
Exclude Flag:
D
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 85043-465-60?

The NDC Packaged Code 85043-465-60 is assigned to a package of 1 syringe in 1 carton / .375 ml in 1 syringe of Leuprolide Acetate For Injectable Suspension, labeled by Uronova Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.

Is NDC 85043-465 included in the NDC Directory?

No, Leuprolide Acetate For Injectable Suspension with product code 85043-465 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Uronova Pharmaceuticals, Inc. on September 01, 2025 and its listing in the NDC Directory is set to expire on September 01, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 85043-465-60?

The 11-digit format is 85043046560. 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
5-3-285043-465-605-4-285043-0465-60