Hydrocodone Bitartrate And Ibuprofen Tablet
NDC Package 53746-116-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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. This formulation utilizes a tablet delivery system. Marketed by Amneal Pharmaceuticals Of New York Llc, this product is identified by NDC 53746-116 and is authorized under FDA application ANDA076642.

Identification & Billing

NDC Package Code
53746-116-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
53746-116
11-Digit Billing Format
53746011601
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 858770 - HYDROcodone bitartrate 2.5 MG / ibuprofen 200 MG Oral Tablet
  • RxCUI: 858770 - hydrocodone bitartrate 2.5 MG / ibuprofen 200 MG Oral Tablet
  • RxCUI: 858778 - HYDROcodone bitartrate 5 MG / ibuprofen 200 MG Oral Tablet
  • RxCUI: 858778 - hydrocodone bitartrate 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 - A solid dosage form containing medicinal substances with or without suitable diluents.
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 (see WARNINGS: 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
Amneal Pharmaceuticals Of New York Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA076642
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-18-2010
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53746-116-01 identifies a specific commercial package of 100 tablet in 1 bottle of Hydrocodone Bitartrate And Ibuprofen, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet 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 Amneal Pharmaceuticals Of New York Llc on February 18, 2010. The current certification is valid through December 31, 2026.

How is this Amneal Pharmaceuticals Of New York Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53746011601. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (5-3-2)
53746-116-01
11-Digit CMS (5-4-2)
53746-0116-01

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