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  5. NDC Package Code: 68083-104-01 Ketorolac Tromethamine

NDC Package 68083-104-01 Ketorolac Tromethamine

Injection, Solution Intramuscular; Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
68083-104-01
Package Description:
10 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
Product Code:
68083-104
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:
68083010401
NDC to RxNorm Crosswalk:
  • RxCUI: 860113 - ketorolac tromethamine 15 MG in 1 ML Prefilled Syringe
  • RxCUI: 860113 - 1 ML ketorolac tromethamine 15 MG/ML Prefilled Syringe
  • RxCUI: 860113 - ketorolac tromethamine 15 MG per 1 ML Prefilled Syringe
  • RxCUI: 860114 - ketorolac tromethamine 30 MG in 1 ML Prefilled Syringe
  • RxCUI: 860114 - 1 ML ketorolac tromethamine 30 MG/ML Prefilled Syringe
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Gland Pharma Limited
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • KETOROLAC TROMETHAMINE 30 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:
    ANDA076722
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-24-2015
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    68083-104-0210 SYRINGE in 1 CARTON / 2 mL in 1 SYRINGE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68083-104-01?

    The NDC Packaged Code 68083-104-01 is assigned to a package of 10 syringe in 1 carton / 1 ml in 1 syringe of Ketorolac Tromethamine, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection, solution and is administered via intramuscular; intravenous form.

    Is NDC 68083-104 included in the NDC Directory?

    Yes, Ketorolac Tromethamine with product code 68083-104 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on July 24, 2015 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 68083-104-01?

    The 11-digit format is 68083010401. 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
    5-3-268083-104-015-4-268083-0104-01