NDC Package 63323-319-04 Granisetron

Granisetron Hydrochloride Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
63323-319-04
Package Description:
1 VIAL in 1 BOX / 4 mL in 1 VIAL
Product Code:
Proprietary Name:
Granisetron
Non-Proprietary Name:
Granisetron Hydrochloride
Substance Name:
Granisetron Hydrochloride
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.
11-Digit NDC Billing Format:
63323031904
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1734399 - granisetron HCl 1 MG in 1 ML Injection
  • RxCUI: 1734399 - 1 ML granisetron 1 MG/ML Injection
  • RxCUI: 1734399 - granisetron 1 MG (as granisetron HCl 1.12 MG) per 1 ML Injection
  • RxCUI: 1734399 - granisetron 1 MG per 1 ML Injection
  • RxCUI: 240912 - granisetron HCl 1 MG/ML Injectable Solution
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Fresenius Kabi Usa, Llc
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    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
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 63323-319-04?

    The NDC Packaged Code 63323-319-04 is assigned to a package of 1 vial in 1 box / 4 ml in 1 vial of Granisetron, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 63323-319 included in the NDC Directory?

    Yes, Granisetron with product code 63323-319 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on November 20, 2009.

    What is the NDC billing unit for package 63323-319-04?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 63323-319-04?

    The 11-digit format is 63323031904. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-263323-319-045-4-263323-0319-04