Sustol Injection
NDC Package 47426-101-01

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

Sustol (granisetron) injection is granisetron is used to help prevent nausea and vomiting caused by cancer chemotherapy. This formulation utilizes a injection delivery system. Marketed by Heron Therapeutics, Inc., this product is identified by NDC 47426-101 and is authorized under FDA application NDA022445.

Identification & Billing

NDC Package Code
47426-101-01
Package Description
1 KIT in 1 CARTON / 1 SYRINGE, GLASS in 1 KIT / .4 mL in 1 SYRINGE, GLASS
Product Code
47426-101
11-Digit Billing Format
47426010101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sustol
Non-Proprietary Name
Granisetron
Substance Name
Granisetron
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
GRANISETRON 10 mg/.4mL
Pharmacologic Class
Usage Information
Granisetron is used to help prevent nausea and vomiting caused by cancer chemotherapy. It works by blocking the effect of a natural substance in your body (serotonin) that may cause nausea or vomiting.

Regulatory & Marketing

Labeler Name
Heron Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022445
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-09-2016
Listing Expiration
12-31-2027
Exclude Flag
N
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 (47426-101). Click a package code to view its specific billing and regulatory data.

47426-101-06
6 KIT in 1 CARTON / 1 SYRINGE, GLASS in 1 KIT / .4 mL in 1 SYRINGE, GLASS

* 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 47426-101-01 identifies a specific commercial package of 1 kit in 1 carton / 1 syringe, glass in 1 kit / .4 ml in 1 syringe, glass of Sustol, a human prescription drug labeled by Heron Therapeutics, Inc.. This injection is formulated for subcutaneous 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 Heron Therapeutics, Inc. on August 09, 2016. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Granisetron is used to help prevent nausea and vomiting caused by cancer chemotherapy. It works by blocking the effect of a natural substance in your body (serotonin) that may cause nausea or vomiting.

How is this Heron Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47426010101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
47426-101-01
11-Digit CMS (5-4-2)
47426-0101-01

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