Penicillin V Potasium
NDC Package 10544-975-40

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Penicillin V Potasium is penicillin V potassium tablets are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Marketed by Blenheim Pharmacal, Inc., this product is identified by NDC 10544-975 and is authorized under FDA application ANDA064071.

Identification & Billing

NDC Package Code
10544-975-40
Package Description
40 TABLET in 1 BOTTLE
Product Code
10544-975
11-Digit Billing Format
10544097540
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Penicillin V Potasium
Dosage Form
-
Usage Information
Penicillin V potassium tablets are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response.NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed.The following infections will usually respond to adequate dosage of penicillin V.

Regulatory & Marketing

Labeler Name
Blenheim Pharmacal, Inc.
FDA Application #
ANDA064071
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-12-2016
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (10544-975). Click a package code to view its specific billing and regulatory data.

10544-975-30
30 TABLET in 1 BOTTLE

* 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 10544-975-40 identifies a specific commercial package of 40 tablet in 1 bottle of Penicillin V Potasium, labeled by Blenheim Pharmacal, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Blenheim Pharmacal, Inc. on April 12, 2016. The current certification is valid through December 31, 2017.

How is this Blenheim Pharmacal, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10544097540. 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)
10544-975-40
11-Digit CMS (5-4-2)
10544-0975-40

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