Granisetron Powder
NDC Package 54871-1091-0

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.

Granisetron powders is a medication used to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). This formulation utilizes a powder delivery system. Marketed by Syn-tech Chem. & Pharm. Co., Ltd., this product is identified by NDC 54871-1091.

Identification & Billing

NDC Package Code
54871-1091-0
Package Description
10 kg in 1 DRUM
Product Code
54871-1091
11-Digit Billing Format
54871109100

Clinical Specifications

Proprietary Name
Granisetron
Non-Proprietary Name
Granisetron
Substance Name
Granisetron
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)
GRANISETRON 1 kg/kg
Usage Information
This medication is used to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). It works by blocking one of the body's natural substances (serotonin) that can cause vomiting.

Regulatory & Marketing

Labeler Name
Syn-tech Chem. & Pharm. Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-25-2012
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 54871-1091-0 identifies a specific commercial package of 10 kg in 1 drum of Granisetron (UNFINISHED drug), a bulk ingredient labeled by Syn-tech Chem. & Pharm. Co., Ltd.. This powder is formulated for use and contains granisetron 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 Syn-tech Chem. & Pharm. Co., Ltd. on July 25, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). It works by blocking one of the body's natural substances (serotonin) that can cause vomiting.

How is this Syn-tech Chem. & Pharm. Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54871109100. 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)
54871-1091-0
11-Digit CMS (5-4-2)
54871-1091-00

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