NDC Package 0078-0494-71 Tobi

View Billable Units, 11-Digit Format, RxNorm

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:
0078-0494-71
Package Description:
56 POUCH in 1 CARTON / 4 AMPULE in 1 POUCH (0078-0494-91) / 5 mL in 1 AMPULE (0078-0494-61)
Product Code:
Proprietary Name:
Tobi
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:
00078049471
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Labeler Name:
Novartis Pharmaceuticals Corporation
Sample Package:
No
FDA Application Number:
NDA050753
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
12-22-1997
End Marketing Date:
12-31-2022
Listing Expiration Date:
12-31-2022
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.

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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 0078-0494-71 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
00078049471J7682Tobramycin non-comp unit300 MG556156

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Frequently Asked Questions

What is NDC 0078-0494-71?

The NDC Packaged Code 0078-0494-71 is assigned to a package of 56 pouch in 1 carton / 4 ampule in 1 pouch (0078-0494-91) / 5 ml in 1 ampule (0078-0494-61) of Tobi, labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is and is administered via form.

Is NDC 0078-0494 included in the NDC Directory?

No, Tobi with product code 0078-0494 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Novartis Pharmaceuticals Corporation on December 22, 1997 and its listing in the NDC Directory is set to expire on December 31, 2022 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0078-0494-71?

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 0078-0494-71?

The 11-digit format is 00078049471. 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
4-4-20078-0494-715-4-200078-0494-71