Bisoprolol Fumarate Powder
NDC Package 57451-1192-0

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.

Bisoprolol Fumarate powders is bisoprolol is used with or without other medications to treat high blood pressure (hypertension). This formulation utilizes a powder delivery system. Marketed by Ipca Laboratories Limited, this product is identified by NDC 57451-1192.

Identification & Billing

NDC Package Code
57451-1192-0
Package Description
25 kg in 1 DRUM
Product Code
57451-1192
11-Digit Billing Format
57451119200

Clinical Specifications

Proprietary Name
Bisoprolol Fumarate
Non-Proprietary Name
Bisoprolol Fumarate
Substance Name
Bisoprolol
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)
BISOPROLOL 1 kg/kg
Usage Information
Bisoprolol is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication belongs to a class of drugs known as beta blockers. It works by blocking the action of certain natural chemicals in your body such as epinephrine on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart.

Regulatory & Marketing

Labeler Name
Ipca Laboratories Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-12-2010
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 57451-1192-0 identifies a specific commercial package of 25 kg in 1 drum of Bisoprolol Fumarate (UNFINISHED drug), a bulk ingredient labeled by Ipca Laboratories Limited. This powder is formulated for use and contains bisoprolol 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 Ipca Laboratories Limited on October 12, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Bisoprolol is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication belongs to a class of drugs known as beta blockers. It works by blocking the action of certain natural chemicals in your body such as epinephrine on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart.

How is this Ipca Laboratories Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57451119200. 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 (5-4-1)
57451-1192-0
11-Digit CMS (5-4-2)
57451-1192-00

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