1. Home
  2. Labeler Index
  3. Mylan Specialty L.p.
  4. 49502-401
  5. NDC Package Code: 49502-401-24 Tobi Podhaler

NDC Package 49502-401-24 Tobi Podhaler

Tobramycin Capsule Oral; Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    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:
49502-401-24
Package Description:
224 PACKAGE in 1 BOX, UNIT-DOSE / 56 BLISTER PACK in 1 PACKAGE / 4 CAPSULE in 1 BLISTER PACK
Product Code:
49502-401
Proprietary Name:
Tobi Podhaler
Non-Proprietary Name:
Tobramycin
Substance Name:
Tobramycin
Usage Information:
This medication is used to treat people with 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 works by stopping the growth of bacteria, including Pseudomonas aeruginosa, that commonly infect the lungs of people with cystic fibrosis. This effect decreases lung infections and damage, and helps to improve breathing.
11-Digit NDC Billing Format:
49502040124
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
224 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1374569 - tobramycin 28 MG Inhalation Powder Capsule
  • RxCUI: 1374569 - tobramycin 28 MG Inhalation Powder
  • RxCUI: 1374569 - tobramcyin 28 MG Inhalation Powder
  • RxCUI: 1374570 - {224 (tobramycin 28 MG Inhalation Powder) } Pack
  • RxCUI: 1374570 - tobramycin 28 MG inhalation powder 224 Monthly Pack
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Specialty L.p.
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Active Ingredient(s):
  • TOBRAMYCIN 28 mg/1
    • Pharmacologic Class(es):
  • Aminoglycoside Antibacterial - [EPC] (Established Pharmacologic Class)
  • Aminoglycosides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA201688
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    09-01-2021
    End Marketing Date:
    12-31-2026
    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
    49502-401-098 CAPSULE in 1 BOX, UNIT-DOSE
    49502-401-577 BLISTER PACK in 1 BOX, UNIT-DOSE / 8 CAPSULE in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 49502-401-24?

    The NDC Packaged Code 49502-401-24 is assigned to a package of 224 package in 1 box, unit-dose / 56 blister pack in 1 package / 4 capsule in 1 blister pack of Tobi Podhaler, a human prescription drug labeled by Mylan Specialty L.p.. The product's dosage form is capsule and is administered via oral; respiratory (inhalation) form.This product is billed for "EA" each discreet unit and contains an estimated amount of 224 billable units per package.

    Is NDC 49502-401 included in the NDC Directory?

    Yes, Tobi Podhaler with product code 49502-401 is active and included in the NDC Directory. The product was first marketed by Mylan Specialty L.p. on September 01, 2021.

    What is the NDC billing unit for package 49502-401-24?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 224.

    What is the 11-digit format for NDC 49502-401-24?

    The 11-digit format is 49502040124. 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
    5-3-249502-401-245-4-249502-0401-24