Ketorolac Tromethamine Powder
NDC Package 66577-045-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Ketorolac Tromethamine powders is a medication used to temporarily relieve itching eyes caused by seasonal allergies. This formulation utilizes a powder delivery system. Marketed by Vasudha Pharma Chem Limited, this product is identified by NDC 66577-045.

Identification & Billing

NDC Package Code
66577-045-01
Package Description
25 kg in 1 DRUM
Product Code
66577-045
11-Digit Billing Format
66577004501

Clinical Specifications

Proprietary Name
Ketorolac Tromethamine
Non-Proprietary Name
Ketorolac Tromethamine
Substance Name
Ketorolac Tromethamine
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
KETOROLAC TROMETHAMINE 1 kg/kg
Usage Information
This medication is used to temporarily relieve itching eyes caused by seasonal allergies. It is also used to prevent and treat eye swelling due to a certain type of eye surgery (cataract removal). Ketorolac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking certain natural substances in your body to reduce pain and swelling.

Regulatory & Marketing

Labeler Name
Vasudha Pharma Chem Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
05-16-1997
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 66577-045-01 identifies a specific commercial package of 25 kg in 1 drum of Ketorolac Tromethamine (UNFINISHED drug), a bulk ingredient labeled by Vasudha Pharma Chem Limited. This powder is formulated for 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 Vasudha Pharma Chem Limited on May 16, 1997. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to temporarily relieve itching eyes caused by seasonal allergies. It is also used to prevent and treat eye swelling due to a certain type of eye surgery (cataract removal). Ketorolac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking certain natural substances in your body to reduce pain and swelling.

How is this Vasudha Pharma Chem Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66577004501. 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)
66577-045-01
11-Digit CMS (5-4-2)
66577-0045-01

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