Ketorolac Tromethamine Injection, Solution
NDC Package 68083-133-10

11-digit billing NDC: 68083013310
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ketorolac Tromethamine injection is carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. This formulation utilizes a injection, solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-133 and is authorized under FDA application ANDA204216.

Identification & Billing

NDC Package Code
68083-133-10
Package Description
10 VIAL in 1 CARTON / 1 mL in 1 VIAL (68083-133-01)
Product Code
68083-133
11-Digit Billing Format
68083013310
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ketorolac 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 30 mg/mL
Pharmacologic Class
Usage Information
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA204216
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2016
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 68083-133-10 identifies a specific commercial package of 10 vial in 1 carton / 1 ml in 1 vial (68083-133-01) of Ketorolac Tromethamine, a human prescription drug labeled by Gland Pharma 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 Gland Pharma Limited on December 01, 2016. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083013310. 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)
68083-133-10
11-Digit CMS (5-4-2)
68083-0133-10

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