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  5. NDC Package Code: 43598-605-58 Tobramycin Inhalation Solution

NDC Package 43598-605-58 Tobramycin Inhalation Solution

Inhalant Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

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:
43598-605-58
Package Description:
56 POUCH in 1 CARTON / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE
Product Code:
43598-605
Proprietary Name:
Tobramycin Inhalation Solution
Non-Proprietary Name:
Tobramycin Inhalation Solution
Substance Name:
Tobramycin
Usage Information:
This medication is used to treat people with a certain inherited condition (cystic fibrosis) who have a persistent lung infection with a certain bacteria (Pseudomonas aeruginosa). People with cystic fibrosis produce thick, sticky mucus that can plug up the tubes, ducts and passageways in the lungs. This can result in serious breathing problems and infections in the lungs. Tobramycin belongs to a class of drugs known as aminoglycoside antibiotics. Tobramycin inhalation solution works by stopping the growth of a certain bacteria (Pseudomonas aeruginosa) that commonly infects the lungs of people with cystic fibrosis. This effect decreases lung infections and damage, and helps to improve breathing.
11-Digit NDC Billing Format:
43598060558
NDC to RxNorm Crosswalk:
  • RxCUI: 348719 - tobramycin 300 MG in 5 ML Inhalation Solution
  • RxCUI: 348719 - tobramycin 60 MG/ML Inhalation Solution
  • RxCUI: 348719 - tobramycin 300 MG per 5 ML Inhalation Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dr. Reddy's Laboratories Inc.
    Dosage Form:
    Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.
    Administration Route(s):
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Active Ingredient(s):
  • TOBRAMYCIN 300 mg/5mL
    • Pharmacologic Class(es):
  • Aminoglycoside Antibacterial - [EPC] (Established Pharmacologic Class)
  • Aminoglycosides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA207080
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-14-2019
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 43598-605-58 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    43598060558J7682Tobramycin non-comp unit300 MG556156

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    43598-605-5614 POUCH in 1 CARTON / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43598-605-58?

    The NDC Packaged Code 43598-605-58 is assigned to a package of 56 pouch in 1 carton / 1 ampule in 1 pouch (43598-605-11) / 5 ml in 1 ampule of Tobramycin Inhalation Solution, a human prescription drug labeled by Dr. Reddy's Laboratories Inc.. The product's dosage form is inhalant and is administered via respiratory (inhalation) form.

    Is NDC 43598-605 included in the NDC Directory?

    Yes, Tobramycin Inhalation Solution with product code 43598-605 is active and included in the NDC Directory. The product was first marketed by Dr. Reddy's Laboratories Inc. on May 14, 2019 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 11-digit format for NDC 43598-605-58?

    The 11-digit format is 43598060558. 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
    5-3-243598-605-585-4-243598-0605-58