1. Home
  2. Labeler Index
  3. Medsource Pharmaceuticals
  4. 45865-613
  5. NDC Package Code: 45865-613-01 Ketorolac Tromethamine

NDC Package 45865-613-01 Ketorolac Tromethamine

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

Table of Contents

    1. Package Information
    2. 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:
45865-613-01
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
Product Code:
45865-613
Proprietary Name:
Ketorolac Tromethamine
Non-Proprietary Name:
Ketorolac Tromethamine
Substance Name:
Ketorolac Tromethamine
Usage Information:
Ketorolac is used for the short-term treatment of moderate to severe pain. It is usually used before or after medical procedures or after surgery. Reducing pain helps you recover more comfortably so that you can return to your normal daily activities. This medication is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever. Ketorolac should not be used for mild or long-term painful conditions (such as arthritis).
11-Digit NDC Billing Format:
45865061301
NDC to RxNorm Crosswalk:
  • RxCUI: 860107 - ketorolac tromethamine 0.5 % Ophthalmic Solution
  • RxCUI: 860107 - ketorolac tromethamine 5 MG/ML Ophthalmic Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Medsource Pharmaceuticals
    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):
  • KETOROLAC TROMETHAMINE 5 mg/mL
    • Pharmacologic Class(es):
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Cyclooxygenase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA076109
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-07-2009
    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 45865-613-01?

    The NDC Packaged Code 45865-613-01 is assigned to a package of 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper of Ketorolac Tromethamine, a human prescription drug labeled by Medsource Pharmaceuticals. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 45865-613 included in the NDC Directory?

    Yes, Ketorolac Tromethamine with product code 45865-613 is active and included in the NDC Directory. The product was first marketed by Medsource Pharmaceuticals on December 07, 2009 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 45865-613-01?

    The 11-digit format is 45865061301. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-245865-613-015-4-245865-0613-01