Sterile Penicillin G Benzathine Powder
NDC Package 43858-511-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Sterile Penicillin G Benzathine powders is penicillin G benzathine is used to treat a wide variety of bacterial infections. This formulation utilizes a powder delivery system. Marketed by Sandoz Gmbh, this product is identified by NDC 43858-511.

Identification & Billing

NDC Package Code
43858-511-00
Package Description
10 kg in 1 BOX
Product Code
43858-511
11-Digit Billing Format
43858051100

Clinical Specifications

Proprietary Name
Sterile Penicillin G Benzathine
Non-Proprietary Name
Sterile Penicillin G Benzathine
Substance Name
Penicillin G Benzathine
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)
PENICILLIN G BENZATHINE 10 kg/10kg
Usage Information
Penicillin G benzathine is used to treat a wide variety of bacterial infections. It may also be used to prevent certain bacterial infections (such as rheumatic fever). This medication is a long-acting penicillin antibiotic. It works by stopping the growth of bacteria.

Regulatory & Marketing

Labeler Name
Sandoz Gmbh
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-01-2010
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 43858-511-00 identifies a specific commercial package of 10 kg in 1 box of Sterile Penicillin G Benzathine (UNFINISHED drug), a bulk ingredient labeled by Sandoz Gmbh. This powder is formulated for use and contains penicillin g benzathine 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 Sandoz Gmbh on February 01, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Penicillin G benzathine is used to treat a wide variety of bacterial infections. It may also be used to prevent certain bacterial infections (such as rheumatic fever). This medication is a long-acting penicillin antibiotic. It works by stopping the growth of bacteria.

How is this Sandoz Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43858051100. 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)
43858-511-00
11-Digit CMS (5-4-2)
43858-0511-00

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