NDC Package 53002-9232-1 Tobramycin

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

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:
53002-9232-1
Package Description:
5 mL in 1 BOTTLE, DROPPER
Product Code:
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:
53002923201
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:
    Rpk Pharmaceuticals, Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA062535
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-09-1995
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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.

    Frequently Asked Questions

    What is NDC 53002-9232-1?

    The NDC Packaged Code 53002-9232-1 is assigned to a package of 5 ml in 1 bottle, dropper of Tobramycin, a human prescription drug labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is solution and is administered via ophthalmic form.

    Is NDC 53002-9232 included in the NDC Directory?

    Yes, Tobramycin with product code 53002-9232 is active and included in the NDC Directory. The product was first marketed by Rpk Pharmaceuticals, Inc. on January 09, 1995 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53002-9232-1?

    The 11-digit format is 53002923201. 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 5-4-1 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
    5-4-153002-9232-15-4-253002-9232-01