Toronova Ii Suik Injection, Solution
NDC Package 76420-252-01

11-digit billing NDC: 76420025201 · Billing unit: EA · 2 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Toronova Ii Suik (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 Asclemed Usa, Inc., this product is identified by NDC 76420-252.

Identification & Billing

NDC Package Code
76420-252-01
Package Description
2 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE
Product Code
76420-252
11-Digit Billing Format
76420025201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA

Clinical Specifications

Proprietary Name
Toronova Ii Suik
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
Asclemed Usa, Inc.
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
06-05-1997
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 76420-252-01 identifies a specific commercial package of 2 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose of Toronova Ii Suik, a human prescription drug labeled by Asclemed Usa, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. 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 Asclemed Usa, Inc. on June 05, 1997. The current certification is valid through December 31, 2027.

How is this Asclemed Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76420025201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 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)
76420-252-01
11-Digit CMS (5-4-2)
76420-0252-01

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