Ketorolac Tromethamine Tablet, Film Coated
NDC Package 70710-1710-1

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

Package Information

Ketorolac Tromethamine tablets is ketorolac is used for the short-term treatment of moderate to severe pain. This formulation utilizes a tablet, film coated delivery system. Marketed by Zydus Pharmaceuticals (usa) Inc., this product is identified by NDC 70710-1710 and is authorized under FDA application ANDA217038.

Identification & Billing

NDC Package Code
70710-1710-1
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
70710-1710
11-Digit Billing Format
70710171001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
RxCUI: 834022 - ketorolac tromethamine 10 MG Oral Tablet

Clinical Specifications

Proprietary Name
Ketorolac Tromethamine
Non-Proprietary Name
Ketorolac Tromethamine
Substance Name
Ketorolac Tromethamine
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
KETOROLAC TROMETHAMINE 10 mg/1
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
Zydus Pharmaceuticals (usa) Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217038
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-10-2022
Listing Expiration
12-31-2026
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 70710-1710-1 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Ketorolac Tromethamine, a human prescription drug labeled by Zydus Pharmaceuticals (usa) Inc.. This tablet, film coated is formulated for oral 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 Zydus Pharmaceuticals (usa) Inc. on November 10, 2022. The current certification is valid through December 31, 2026.

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 Zydus Pharmaceuticals (usa) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710171001. 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 (5-4-1)
70710-1710-1
11-Digit CMS (5-4-2)
70710-1710-01

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