Granisetron
NDC Package 63323-319-04

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Granisetron is hydrochloride Injection, USP is a serotonin-3 (5-HT 3) receptor antagonist indicated for: The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.The prevention and treatment of postoperative nausea and vomiting in adults. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-319 and is authorized under FDA application ANDA078090.

Identification & Billing

NDC Package Code
63323-319-04
Package Description
1 VIAL in 1 BOX / 4 mL in 1 VIAL
Product Code
63323-319
11-Digit Billing Format
63323031904
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Granisetron
Dosage Form
-
Usage Information
Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT 3) receptor antagonist indicated for: The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.The prevention and treatment of postoperative nausea and vomiting in adults. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided during the postoperative period, granisetron hydrochloride injection, USP is recommended even where the incidence of postoperative nausea and/or vomiting is low.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
FDA Application #
ANDA078090
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-20-2009
End Marketing Date
05-31-2024
Listing Expiration
05-31-2024
Exclude Flag
D
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1626
Source: PDAC
INJECTION, GRANISETRON HYDROCHLORIDE, 100 MCG
HCPCS Dosage 100 MCG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 63323-319-04 identifies a specific commercial package of 1 vial in 1 box / 4 ml in 1 vial of Granisetron, labeled by Fresenius Kabi Usa, Llc. 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 Fresenius Kabi Usa, Llc on November 20, 2009. The current certification is valid through May 31, 2024.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323031904. 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)
63323-319-04
11-Digit CMS (5-4-2)
63323-0319-04

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