Hydrocodone Bitartrate And Ibuprofen Tablet, Film Coated
NDC Package 13107-004-99

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

Hydrocodone Bitartrate And Ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseCarefully 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 dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation). This formulation utilizes a tablet, film coated delivery system. Marketed by Aurolife Pharma, Llc, this product is identified by NDC 13107-004 and is authorized under FDA application ANDA204575.

Identification & Billing

NDC Package Code
13107-004-99
Package Description
1000 TABLET, FILM COATED in 1 BOTTLE
Product Code
13107-004
11-Digit Billing Format
13107000499
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
Non-Proprietary Name
Hydrocodone Bitartrate And Ibuprofen
Substance Name
Hydrocodone Bitartrate; Ibuprofen
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Hydrocodone Bitartrate and Ibuprofen Tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseCarefully 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 dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation). Do not use Hydrocodone Bitartrate and Ibuprofen Tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis.Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (seeWARNINGS: Addiction, Abuse, and Misuse), reserve Hydrocodone Bitartrate and Ibuprofen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):•   Have not been tolerated, or are not expected to be tolerated,•   Have not provided adequate analgesia, or are not expected to provide adequate analgesia
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Aurolife Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA204575
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-02-2016
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 (13107-004). Click a package code to view its specific billing and regulatory data.

13107-004-01
100 TABLET, FILM COATED in 1 BOTTLE
13107-004-05
500 TABLET, FILM COATED in 1 BOTTLE
13107-004-11
10 TABLET, FILM COATED in 1 BOTTLE

* 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 13107-004-99 identifies a specific commercial package of 1000 tablet, film coated in 1 bottle of Hydrocodone Bitartrate And Ibuprofen, a human prescription drug labeled by Aurolife Pharma, Llc. This tablet, film coated is formulated for oral use and contains hydrocodone bitartrate; ibuprofen 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 Aurolife Pharma, Llc on June 02, 2016. The current certification is valid through December 31, 2026.

How is this Aurolife Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13107000499. 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)
13107-004-99
11-Digit CMS (5-4-2)
13107-0004-99

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