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  5. NDC Package Code: 16714-119-03 Tobramycin Inhalation Solution

NDC Package 16714-119-03 Tobramycin Inhalation Solution

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

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
16714-119-03
Package Description:
14 POUCH in 1 CARTON / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02)
Product Code:
16714-119
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:
16714011903
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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:
    Northstar Rxllc
    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:
    05-21-2020
    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 16714-119-03 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    16714011903J7682Tobramycin non-comp unit300 MG556156

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 16714-119-03?

    The NDC Packaged Code 16714-119-03 is assigned to a package of 14 pouch in 1 carton / 4 ampule in 1 pouch / 5 ml in 1 ampule (16714-119-02) of Tobramycin Inhalation Solution, a human prescription drug labeled by Northstar Rxllc. The product's dosage form is inhalant and is administered via respiratory (inhalation) form.

    Is NDC 16714-119 included in the NDC Directory?

    Yes, Tobramycin Inhalation Solution with product code 16714-119 is active and included in the NDC Directory. The product was first marketed by Northstar Rxllc on May 21, 2020 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 16714-119-03?

    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 16714-119-03?

    The 11-digit format is 16714011903. 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
    5-3-216714-119-035-4-216714-0119-03