Ketorolac Tromethamine Injection
NDC Package 85766-299-25

11-digit billing NDC: 85766029925
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ketorolac Tromethamine injection is carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. This formulation utilizes a injection delivery system. Marketed by Sportpharm Llc, this product is identified by NDC 85766-299 and is authorized under FDA application ANDA214456.

Identification & Billing

NDC Package Code
85766-299-25
Package Description
25 VIAL in 1 CARTON / 2 mL in 1 VIAL (85766-299-02)
Product Code
85766-299
11-Digit Billing Format
85766029925

Clinical Specifications

Proprietary Name
Ketorolac Tromethamine
Non-Proprietary Name
Ketorolac Tromethamine
Substance Name
Ketorolac Tromethamine
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
KETOROLAC TROMETHAMINE 60 mg/2mL
Pharmacologic Class
Usage Information
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see  WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.

Regulatory & Marketing

Labeler Name
Sportpharm Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA214456
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-02-2022
Listing Expiration
12-31-2027
Exclude Flag
N
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 85766-299-25 identifies a specific commercial package of 25 vial in 1 carton / 2 ml in 1 vial (85766-299-02) of Ketorolac Tromethamine, a human prescription drug labeled by Sportpharm Llc. This injection is formulated for intramuscular; intravenous use and contains ketorolac tromethamine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sportpharm Llc on November 02, 2022. The current certification is valid through December 31, 2027.

How is this Sportpharm Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85766029925. 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 (5-3-2)
85766-299-25
11-Digit CMS (5-4-2)
85766-0299-25

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