Ketorolac Tromethamine Solution/ Drops
NDC Package 65862-770-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ketorolac Tromethamine solution/ dropses is ketorolac is used for the short-term treatment of moderate to severe pain. This formulation utilizes a solution/ drops delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-770 and is authorized under FDA application ANDA205190.

Identification & Billing

NDC Package Code
65862-770-05
Package Description
1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE
Product Code
65862-770
11-Digit Billing Format
65862077005
RxNorm Crosswalk
  • RxCUI: 860107 - ketorolac tromethamine 0.5 % Ophthalmic Solution
  • RxCUI: 860107 - ketorolac tromethamine 5 MG/ML Ophthalmic Solution

Clinical Specifications

Proprietary Name
Ketorolac Tromethamine
Non-Proprietary Name
Ketorolac Tromethamine
Substance Name
Ketorolac Tromethamine
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
KETOROLAC TROMETHAMINE 5 mg/mL
Pharmacologic Class
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).

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA205190
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-03-2020
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 65862-770-05 identifies a specific commercial package of 1 bottle in 1 carton / 5 ml in 1 bottle of Ketorolac Tromethamine, a human prescription drug labeled by Aurobindo Pharma Limited. This solution/ drops is formulated for ophthalmic 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 Aurobindo Pharma Limited on December 03, 2020. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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).

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862077005. 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)
65862-770-05
11-Digit CMS (5-4-2)
65862-0770-05

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