Sprix Spray, Metered
NDC Package 69344-144-53

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

Package Information

Sprix (ketorolac tromethamine) sprays is ketorolac is used for the short-term treatment (up to 5 days) of moderate to severe pain in adults, such as after surgery. This formulation utilizes a spray, metered delivery system. Marketed by Zyla Life Sciences Us Llc, this product is identified by NDC 69344-144 and is authorized under FDA application NDA022382.

Identification & Billing

NDC Package Code
69344-144-53
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)
Product Code
69344-144
11-Digit Billing Format
69344014453
RxNorm Crosswalk
  • RxCUI: 1797855 - ketorolac tromethamine 15.75 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797855 - ketorolac tromethamine 15.8 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797857 - SPRIX 15.75 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797857 - ketorolac tromethamine 15.8 MG/ACTUAT Metered Dose Nasal Spray [Sprix]
  • RxCUI: 1797857 - Sprix 15.75 MG/ACTUAT Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Sprix
Non-Proprietary Name
Ketorolac Tromethamine
Substance Name
Ketorolac Tromethamine
Dosage Form
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
KETOROLAC TROMETHAMINE 15.75 mg/1
Pharmacologic Class
Usage Information
Ketorolac is used for the short-term treatment (up to 5 days) of moderate to severe pain in adults, such as after surgery. Reducing pain helps you recover more comfortably so you can return to your normal daily activities. This medication is a nonsteroidal anti-inflammatory drug (NSAID). It works by decreasing inflammation, swelling, and pain.

Regulatory & Marketing

Labeler Name
Zyla Life Sciences Us Llc
Product Type
Human Prescription Drug
FDA Application #
NDA022382
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-26-2011
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69344-144). Click a package code to view its specific billing and regulatory data.

69344-144-43
5 CARTON in 1 CARTON / 1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)

* 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 69344-144-53 identifies a specific commercial package of 1 bottle, spray in 1 carton / 8 spray, metered in 1 bottle, spray (69344-144-63) of Sprix, a human prescription drug labeled by Zyla Life Sciences Us Llc. This spray, metered is formulated for nasal 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 Zyla Life Sciences Us Llc on April 26, 2011. 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 (up to 5 days) of moderate to severe pain in adults, such as after surgery. Reducing pain helps you recover more comfortably so you can return to your normal daily activities. This medication is a nonsteroidal anti-inflammatory drug (NSAID). It works by decreasing inflammation, swelling, and pain.

How is this Zyla Life Sciences Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69344014453. 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)
69344-144-53
11-Digit CMS (5-4-2)
69344-0144-53

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