NDC Package 63323-010-20 Gentamicin

Gentamicin Sulfate Injection, Solution Intramuscular; 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:
63323-010-20
Package Description:
25 VIAL in 1 TRAY / 20 mL in 1 VIAL (63323-010-03)
Product Code:
Proprietary Name:
Gentamicin
Non-Proprietary Name:
Gentamicin Sulfate
Substance Name:
Gentamicin Sulfate
Usage Information:
This medication is used to treat bacterial infections (such as blepharitis, conjunctivitis) of the eye and the skin around the eyes (such as eyelids). It is also used to prevent infection after eye injury or surgery. It belongs to a class of drugs known as aminoglycoside antibiotics. Gentamicin works by killing the bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.
11-Digit NDC Billing Format:
63323001020
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 313996 - gentamicin sulfate 40 MG/ML Injectable Solution
  • RxCUI: 313996 - gentamicin 40 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):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    ANDA062366
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-10-2000
    Listing Expiration Date:
    12-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    63323-010-0225 VIAL in 1 TRAY / 2 mL in 1 VIAL (63323-010-01)
    63323-010-9425 VIAL, MULTI-DOSE in 1 TRAY / 2 mL in 1 VIAL, MULTI-DOSE (63323-010-41)
    63323-010-9525 VIAL, MULTI-DOSE in 1 TRAY / 20 mL in 1 VIAL, MULTI-DOSE (63323-010-42)
    63323-010-9625 VIAL, MULTI-DOSE in 1 TRAY / 20 mL in 1 VIAL, MULTI-DOSE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63323-010-20?

    The NDC Packaged Code 63323-010-20 is assigned to a package of 25 vial in 1 tray / 20 ml in 1 vial (63323-010-03) of Gentamicin, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection, solution and is administered via intramuscular; intravenous form.

    Is NDC 63323-010 included in the NDC Directory?

    Yes, Gentamicin with product code 63323-010 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on August 10, 2000 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 63323-010-20?

    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 63323-010-20?

    The 11-digit format is 63323001020. 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
    5-3-263323-010-205-4-263323-0010-20