Sprix
NDC Package 0517-8880-05

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Sprix is ketorolac is used for the short-term treatment (up to 5 days) of moderate to severe pain in adults, such as after surgery. Marketed by American Regent, Inc., this product is identified by NDC 0517-8880 and is authorized under FDA application NDA022382.

Identification & Billing

NDC Package Code
0517-8880-05
Package Description
5 BOTTLE, SPRAY in 1 CARTON / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (0517-8880-01)
Product Code
0517-8880
11-Digit Billing Format
00517888005
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
5 EA

Clinical Specifications

Proprietary Name
Sprix
Dosage Form
-
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
American Regent, Inc.
FDA Application #
NDA022382
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-26-2011
End Marketing Date
01-14-2016
Listing Expiration
01-14-2016
Exclude Flag
D
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 0517-8880-05 identifies a specific commercial package of 5 bottle, spray in 1 carton / 8 spray, metered in 1 bottle, spray (0517-8880-01) of Sprix, labeled by American Regent, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by American Regent, Inc. on April 26, 2011. The current certification is valid through January 14, 2016.

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 American Regent, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00517888005. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 5 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 (4-4-2)
0517-8880-05
11-Digit CMS (5-4-2)
00517-8880-05

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