Gentak
NDC Package 17478-284-35

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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 inactivated by the FDA.

Gentak is a medication used to treat bacterial infections (such as blepharitis, conjunctivitis) of the eye and the skin around the eyes (such as eyelids). Marketed by Akorn, this product is identified by NDC 17478-284 and is authorized under FDA application ANDA064093.

Identification & Billing

NDC Package Code
17478-284-35
Package Description
1 TUBE in 1 CARTON / 3.5 g in 1 TUBE
Product Code
17478-284
11-Digit Billing Format
17478028435
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
3.5 GM
RxNorm Crosswalk
  • RxCUI: 310466 - gentamicin sulfate 0.3 % (3 MG/GM) Ophthalmic Ointment
  • RxCUI: 310466 - gentamicin 0.003 MG/MG Ophthalmic Ointment
  • RxCUI: 310466 - gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Ointment
  • RxCUI: 545236 - GENTAK 0.3 % (3 MG/GM) Ophthalmic Ointment
  • RxCUI: 545236 - gentamicin 0.003 MG/MG Ophthalmic Ointment [Gentak]

Clinical Specifications

Proprietary Name
Gentak
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Akorn
FDA Application #
ANDA064093
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-08-2006
Listing Expiration
12-31-2023
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 17478-284-35 identifies a specific commercial package of 1 tube in 1 carton / 3.5 g in 1 tube of Gentak, labeled by Akorn. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Akorn on May 08, 2006. The current certification is valid through December 31, 2023.

What are the primary indications for this medication?

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.

How is this Akorn product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17478028435. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 3.5 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
17478-284-35
11-Digit CMS (5-4-2)
17478-0284-35

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.