NDC Package 61919-642-05 Tobramycin

Solution/ Drops Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

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:

61919-642-05

Package Description:

5 mL in 1 BOTTLE

Product Code:

61919-642

Proprietary Name:

Tobramycin

Non-Proprietary Name:

Tobramycin

Substance Name:

Tobramycin

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.

11-Digit NDC Billing Format:

61919064205

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

5 ML

NDC to RxNorm Crosswalk:

RxCUI: 313415 - tobramycin 0.3 % Ophthalmic Solution

RxCUI: 313415 - tobramycin 3 MG/ML Ophthalmic Solution

Product Type:

Human Prescription Drug

Labeler Name:

Directrx

Dosage Form:

Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Administration Route(s):

Ophthalmic - Administration to the external eye.

Active Ingredient(s):

TOBRAMYCIN 3 mg/mL

Pharmacologic Class(es):

Aminoglycoside Antibacterial - [EPC] (Established Pharmacologic Class)

Aminoglycosides - [CS]

Sample Package:

FDA Application Number:

ANDA207444

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

04-23-2019

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

61919 - Directrx
- 61919-642 - Tobramycin
  - 61919-642-05 - 5 mL in 1 BOTTLE

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 61919-642-05?

The NDC Packaged Code 61919-642-05 is assigned to a package of 5 ml in 1 bottle of Tobramycin, a human prescription drug labeled by Directrx. The product's dosage form is solution/ drops and is administered via ophthalmic form.This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package.

Is NDC 61919-642 included in the NDC Directory?

Yes, Tobramycin with product code 61919-642 is active and included in the NDC Directory. The product was first marketed by Directrx on April 23, 2019 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 61919-642-05?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 5.

What is the 11-digit format for NDC 61919-642-05?

The 11-digit format is 61919064205. 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 5-3-2 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	61919-642-05	5-4-2	61919-0642-05

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