Hydrocodone Bitartrate And Ibuprofen
NDC Package 33261-378-90

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.

Hydrocodone Bitartrate And Ibuprofen is carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Marketed by Aidarex Pharmaceuticals Llc, this product is identified by NDC 33261-378 and is authorized under FDA application ANDA076604.

Identification & Billing

NDC Package Code
33261-378-90
Package Description
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
33261-378
11-Digit Billing Format
33261037890
RxNorm Crosswalk
  • RxCUI: 858798 - HYDROcodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet
  • RxCUI: 858798 - hydrocodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet

Clinical Specifications

Proprietary Name
Hydrocodone Bitartrate And Ibuprofen
Dosage Form
-
Usage Information
Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term (generally less than 10 days) management of acute pain. Hydrocodone bitartrate and ibuprofen tablets are not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis.

Regulatory & Marketing

Labeler Name
Aidarex Pharmaceuticals Llc
FDA Application #
ANDA076604
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-27-2008
Listing Expiration
12-31-2019
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 (33261-378). Click a package code to view its specific billing and regulatory data.

33261-378-00
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
33261-378-02
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
33261-378-10
10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
33261-378-30
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
33261-378-60
60 TABLET, FILM COATED 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 33261-378-90 identifies a specific commercial package of 90 tablet, film coated in 1 bottle, plastic of Hydrocodone Bitartrate And Ibuprofen, labeled by Aidarex Pharmaceuticals Llc. 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 Aidarex Pharmaceuticals Llc on August 27, 2008. The current certification is valid through December 31, 2019.

How is this Aidarex Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33261037890. 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)
33261-378-90
11-Digit CMS (5-4-2)
33261-0378-90

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