Ibupak Kit
NDC Package 59088-756-00

11-digit billing NDC: 59088075600

Package Information

Ibupak (ibuprofen) kits is carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. This formulation utilizes a kit delivery system. Marketed by Puretek Corporation, this product is identified by NDC 59088-756.

Identification & Billing

NDC Package Code
59088-756-00
Package Description
1 KIT in 1 KIT * 100 TABLET, FILM COATED in 1 BOTTLE (67877-320-01)
Product Code
11-Digit Billing Format
59088075600
RxNorm Crosswalk
RxCUI: 197806 - ibuprofen 600 MG Oral Tablet

Clinical Specifications

Proprietary Name
Ibupak
Non-Proprietary Name
Ibuprofen
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.Ibuprofen tablets are indicated for relief of mild to moderate pain.Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.

Regulatory & Marketing

Labeler Name
Puretek Corporation
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
05-22-2020
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 59088-756-00 identifies a specific commercial package of 1 kit in 1 kit * 100 tablet, film coated in 1 bottle (67877-320-01) of Ibupak, a human prescription drug labeled by Puretek Corporation. This kit is formulated for oral use and contains 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 Puretek Corporation on May 22, 2020. The current certification is valid through December 31, 2026.

How is this Puretek Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59088075600. 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)
59088-756-00
11-Digit CMS (5-4-2)
59088-0756-00

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