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  5. NDC Package Code: 85151-0001-1 Leuprolide Acetate

NDC Package 85151-0001-1 Leuprolide Acetate

Powder - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
85151-0001-1
Package Description:
50 g in 1 BAG
Product Code:
85151-0001
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:
85151000101
Product Type:
Bulk Ingredient
Labeler Name:
Shanxi Tongda Pharmaceutical Co., Ltd.
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s):
LEUPROLIDE ACETATE 1 g/g
Sample Package:
N/A
Marketing Category:
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date:
02-01-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Unfinished Product:
Yes
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.

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 85151-0001-1?

The NDC Packaged Code 85151-0001-1 is assigned to an UNFINISHED drug package of 50 g in 1 bag of Leuprolide Acetate, a bulk ingredient labeled by Shanxi Tongda Pharmaceutical Co., Ltd.. The product's dosage form is powder and is administered via form.

Is NDC 85151-0001 included in the NDC Directory?

Yes, Leuprolide Acetate is an UNFINISHED PRODUCT with code 85151-0001 that is active and included in the NDC Directory. The product was first marketed by Shanxi Tongda Pharmaceutical Co., Ltd. on February 01, 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 85151-0001-1?

The 11-digit format is 85151000101. 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 5-4-1 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
5-4-185151-0001-15-4-285151-0001-01