Tobramycin
NDC Package 0703-9402-04

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 discontinued by the firm.

Tobramycin is a medication used to treat eye infections. Marketed by Teva Parenteral Medicines, Inc., this product is identified by NDC 0703-9402 and is authorized under FDA application ANDA063100.

Identification & Billing

NDC Package Code
0703-9402-04
Package Description
25 VIAL, MULTI-DOSE in 1 CARTON / 2 mL in 1 VIAL, MULTI-DOSE (0703-9402-01)
Product Code
0703-9402
11-Digit Billing Format
00703940204
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Tobramycin
Dosage Form
-
Usage Information
This medication is used to treat eye infections. Tobramycin belongs to a class of drugs called aminoglycoside antibiotics. It works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Teva Parenteral Medicines, Inc.
FDA Application #
ANDA063100
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-1992
End Marketing Date
11-30-2019
Listing Expiration
11-30-2019
Exclude Flag
D
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 0703-9402-04 identifies a specific commercial package of 25 vial, multi-dose in 1 carton / 2 ml in 1 vial, multi-dose (0703-9402-01) of Tobramycin, labeled by Teva Parenteral Medicines, Inc.. 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 Teva Parenteral Medicines, Inc. on February 01, 1992. The current certification is valid through November 30, 2019.

What are the primary indications for this medication?

This medication is used to treat eye infections. Tobramycin belongs to a class of drugs called aminoglycoside antibiotics. It works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

How is this Teva Parenteral Medicines, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00703940204. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0703-9402-04
11-Digit CMS (5-4-2)
00703-9402-04

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