Ketrolac Tromethamine Injection, Solution
NDC Package 83854-021-10

11-digit billing NDC: 83854002110
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Ketrolac Tromethamine (ketorolac tromethamine) injection is a medication used to temporarily relieve itching eyes caused by seasonal allergies. This formulation utilizes a injection, solution delivery system. Marketed by Anthea Pharma Private Limited, this product is identified by NDC 83854-021 and is authorized under FDA application ANDA221041.

Identification & Billing

NDC Package Code
83854-021-10
Package Description
10 VIAL in 1 CARTON / 1 mL in 1 VIAL (83854-021-01)
Product Code
83854-021
11-Digit Billing Format
83854002110

Clinical Specifications

Proprietary Name
Ketrolac Tromethamine
Non-Proprietary Name
Ketorolac Tromethamine
Substance Name
Ketorolac Tromethamine
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
KETOROLAC TROMETHAMINE 15 mg/mL
Pharmacologic Class
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
Anthea Pharma Private Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA221041
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-25-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (83854-021). Click a package code to view its specific billing and regulatory data.

83854-021-25
25 VIAL in 1 CARTON / 1 mL in 1 VIAL (83854-021-01)

* 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 83854-021-10 identifies a specific commercial package of 10 vial in 1 carton / 1 ml in 1 vial (83854-021-01) of Ketrolac Tromethamine, a human prescription drug labeled by Anthea Pharma Private Limited. This injection, solution 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 Anthea Pharma Private Limited on September 25, 2026. 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 Anthea Pharma Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83854002110. 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)
83854-021-10
11-Digit CMS (5-4-2)
83854-0021-10

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