Ketorolac Tromethamine
NDC Package 69784-601-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Ketorolac Tromethamine is ketorolac is used for the short-term treatment of moderate to severe pain. Marketed by Woodward Pharma Services Llc, this product is identified by NDC 69784-601 and is authorized under FDA application ANDA216407.

Identification & Billing

NDC Package Code
69784-601-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
69784-601
11-Digit Billing Format
69784060101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Ketorolac Tromethamine
Dosage Form
-
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
Woodward Pharma Services Llc
FDA Application #
ANDA216407
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-14-2023
End Marketing Date
03-31-2025
Listing Expiration
03-31-2025
Exclude Flag
D
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 69784-601-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Ketorolac Tromethamine, labeled by Woodward Pharma Services Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Woodward Pharma Services Llc on February 14, 2023. The current certification is valid through March 31, 2025.

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 Woodward Pharma Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69784060101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
69784-601-01
11-Digit CMS (5-4-2)
69784-0601-01

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