Granisetron Hydrochloride Tablet, Film Coated
NDC Package 63850-0005-2

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

Granisetron Hydrochloride tablets is uSP are indicated for the prevention of: Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. This formulation utilizes a tablet, film coated delivery system. Marketed by Natco Pharma Limited, this product is identified by NDC 63850-0005 and is authorized under FDA application ANDA078969.

Identification & Billing

NDC Package Code
63850-0005-2
Package Description
2 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
63850-0005
11-Digit Billing Format
63850000502
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Granisetron Hydrochloride
Non-Proprietary Name
Granisetron Hydrochloride
Substance Name
Granisetron Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GRANISETRON HYDROCHLORIDE 1 mg/1
Pharmacologic Class
Usage Information
Granisetron hydrochloride tablets USP are indicated for the prevention of: Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.

Regulatory & Marketing

Labeler Name
Natco Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA078969
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-22-2009
Listing Expiration
12-31-2026
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 (63850-0005). Click a package code to view its specific billing and regulatory data.

63850-0005-1
10 TABLET, FILM COATED in 1 BLISTER PACK

* 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 63850-0005-2 identifies a specific commercial package of 2 tablet, film coated in 1 blister pack of Granisetron Hydrochloride, a human prescription drug labeled by Natco Pharma Limited. This tablet, film coated is formulated for oral use and contains granisetron hydrochloride 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 Natco Pharma Limited on June 22, 2009. The current certification is valid through December 31, 2026.

How is this Natco Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63850000502. 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)
63850-0005-2
11-Digit CMS (5-4-2)
63850-0005-02

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