Ibuprofen Tablet, Film Coated
NDC Package 83324-059-01

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

Ibuprofen tablets is ibuprofen is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. This formulation utilizes a tablet, film coated delivery system. Marketed by Chain Drug Marketing Association, Inc., this product is identified by NDC 83324-059 and is authorized under FDA application ANDA075010.

Identification & Billing

NDC Package Code
83324-059-01
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
83324-059
11-Digit Billing Format
83324005901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ibuprofen
Non-Proprietary Name
Ibuprofen
Substance Name
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)
IBUPROFEN 200 mg/1
Pharmacologic Class
Usage Information
Ibuprofen is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Regulatory & Marketing

Labeler Name
Chain Drug Marketing Association, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA075010
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-17-2024
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 (83324-059). Click a package code to view its specific billing and regulatory data.

83324-059-24
1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
83324-059-50
1 BOTTLE, PLASTIC in 1 CARTON / 50 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 83324-059-01 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 100 tablet, film coated in 1 bottle, plastic of Ibuprofen, a human over the counter drug labeled by Chain Drug Marketing Association, Inc.. This tablet, film coated is formulated for oral use and contains 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 Chain Drug Marketing Association, Inc. on September 17, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ibuprofen is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

How is this Chain Drug Marketing Association, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83324005901. 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)
83324-059-01
11-Digit CMS (5-4-2)
83324-0059-01

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