365 Whole Foods Market Ibuprofen Tablet, Film Coated
NDC Package 42681-0026-1

11-digit billing NDC: 42681002601
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

365 Whole Foods Market Ibuprofen (ibuprofen) tablets is •do not take more than directed•the smallest effective dose should be usedadults and children 12 years and older•take 1 tablet every 4 to 6 hours while symptoms persist•if pain or fever does not respond to 1 tablet, 2 tablets may be used•do not exceed 6 tablets in 24 hours, unless directed by a doctorchildren under 12 years•ask a doctor. This formulation utilizes a tablet, film coated delivery system. Marketed by Whole Foods Market, Inc., this product is identified by NDC 42681-0026 and is authorized under FDA application ANDA072096.

Identification & Billing

NDC Package Code
42681-0026-1
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE
Product Code
42681-0026
11-Digit Billing Format
42681002601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
365 Whole Foods Market 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
•do not take more than directed•the smallest effective dose should be usedadults and children 12 years and older•take 1 tablet every 4 to 6 hours while symptoms persist•if pain or fever does not respond to 1 tablet, 2 tablets may be used•do not exceed 6 tablets in 24 hours, unless directed by a doctorchildren under 12 years•ask a doctor

Regulatory & Marketing

Labeler Name
Whole Foods Market, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA072096
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-24-2020
End Marketing Date
03-31-2027
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 42681-0026-1 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet, film coated in 1 bottle of 365 Whole Foods Market Ibuprofen, a human over the counter drug labeled by Whole Foods Market, 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 Whole Foods Market, Inc. on August 24, 2020.

How is this Whole Foods Market, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42681002601. 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 (5-4-1)
42681-0026-1
11-Digit CMS (5-4-2)
42681-0026-01

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