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  5. NDC Package Code: 0078-0630-35 Tobi Podhaler

NDC Package 0078-0630-35 Tobi Podhaler

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
0078-0630-35
Package Description:
224 PACKAGE in 1 BOX, UNIT-DOSE / 56 BLISTER PACK in 1 PACKAGE (0078-0630-56) / 4 CAPSULE in 1 BLISTER PACK (0078-0630-11)
Product Code:
0078-0630
Proprietary Name:
Tobi Podhaler
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:
00078063035
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
224 EA
Labeler Name:
Novartis Pharmaceuticals Corporation
Sample Package:
No
FDA Application Number:
NDA201688
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
03-22-2013
End Marketing Date:
07-31-2022
Listing Expiration Date:
07-31-2022
Exclude Flag:
D
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 0078-0630-35?

The NDC Packaged Code 0078-0630-35 is assigned to a package of 224 package in 1 box, unit-dose / 56 blister pack in 1 package (0078-0630-56) / 4 capsule in 1 blister pack (0078-0630-11) of Tobi Podhaler, labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 224 billable units per package.

Is NDC 0078-0630 included in the NDC Directory?

No, Tobi Podhaler with product code 0078-0630 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Novartis Pharmaceuticals Corporation on March 22, 2013 and its listing in the NDC Directory is set to expire on July 31, 2022 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0078-0630-35?

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 0078-0630-35?

The 11-digit format is 00078063035. 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 4-4-2 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
4-4-20078-0630-355-4-200078-0630-35