NDC Package 0168-0178-03 Gentamicin Sulfate

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory .

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:
0168-0178-03
Package Description:
1 BOTTLE, DROPPER in 1 BOX / 5 mL in 1 BOTTLE, DROPPER
Product Code:
Proprietary Name:
Gentamicin Sulfate
Usage Information:
This medication is used to treat bacterial infections (such as blepharitis, conjunctivitis) of the eye and the skin around the eyes (such as eyelids). It is also used to prevent infection after eye injury or surgery. It belongs to a class of drugs known as aminoglycoside antibiotics. Gentamicin works by killing the bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.
11-Digit NDC Billing Format:
00168017803
Labeler Name:
E. Fougera & Co., A Division Of Fougera Pharmaceuticals Inc.
Sample Package:
No
FDA Application Number:
ANDA065121
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
01-30-2004
End Marketing Date:
01-30-2004
Listing Expiration Date:
01-30-2004
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.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0168-0178-151 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0168-0178-03?

The NDC Packaged Code 0168-0178-03 is assigned to a package of 1 bottle, dropper in 1 box / 5 ml in 1 bottle, dropper of Gentamicin Sulfate, labeled by E. Fougera & Co., A Division Of Fougera Pharmaceuticals Inc.. The product's dosage form is and is administered via form.

Is NDC 0168-0178 included in the NDC Directory?

The product was first marketed by E. Fougera & Co., A Division Of Fougera Pharmaceuticals Inc. on January 30, 2004 and its listing in the NDC Directory is set to expire on January 30, 2004 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0168-0178-03?

The 11-digit format is 00168017803. 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
4-4-20168-0178-035-4-200168-0178-03