Reprexain
NDC Package 16590-276-40

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Reprexain is iNDICATIONS AND USAGECarefully consider the potential benefits and risks of REPREXAIN™ and other treatment options before deciding to use REPREXAIN™. Marketed by Stat Rx Usa, this product is identified by NDC 16590-276 and is authorized under FDA application ANDA076642.

Identification & Billing

NDC Package Code
16590-276-40
Package Description
40 TABLET in 1 BOTTLE, PLASTIC
Product Code
16590-276
11-Digit Billing Format
16590027640
RxNorm Crosswalk
  • RxCUI: 858778 - HYDROcodone bitartrate 5 MG / ibuprofen 200 MG Oral Tablet
  • RxCUI: 858778 - hydrocodone bitartrate 5 MG / ibuprofen 200 MG Oral Tablet
  • RxCUI: 858784 - REPREXAIN 5 MG / 200 MG Oral Tablet
  • RxCUI: 858784 - hydrocodone bitartrate 5 MG / ibuprofen 200 MG Oral Tablet [Reprexain]
  • RxCUI: 858784 - Reprexain 5/200 (hydrocodone / ibuprofen) Oral Tablet

Clinical Specifications

Proprietary Name
Reprexain
Dosage Form
-
Usage Information
INDICATIONS AND USAGECarefully consider the potential benefits and risks of REPREXAIN™ and other treatment options before deciding to use REPREXAIN™. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). REPREXAIN™ tablets are indicated for the short-term (generally less than 10 days) management of acute pain. REPREXAIN™ is not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis.

Regulatory & Marketing

Labeler Name
Stat Rx Usa
FDA Application #
ANDA076642
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-16-2008
Listing Expiration
12-31-2017
Exclude Flag
I
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 (16590-276). Click a package code to view its specific billing and regulatory data.

16590-276-30
60 TABLET in 1 BOTTLE, PLASTIC
16590-276-60
60 TABLET in 1 BOTTLE, PLASTIC
16590-276-71
100 TABLET in 1 BOTTLE, PLASTIC
16590-276-90
90 TABLET in 1 BOTTLE, PLASTIC

* 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 16590-276-40 identifies a specific commercial package of 40 tablet in 1 bottle, plastic of Reprexain, labeled by Stat Rx Usa. 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 Stat Rx Usa on December 16, 2008. The current certification is valid through December 31, 2017.

How is this Stat Rx Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590027640. 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)
16590-276-40
11-Digit CMS (5-4-2)
16590-0276-40

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