Ibuprofen
NDC Package 70934-080-90

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Ibuprofen is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. Marketed by Denton Pharma, Inc. Dba Northwind Pharmaceuticals, this product is identified by NDC 70934-080 and is authorized under FDA application ANDA091625.

Identification & Billing

NDC Package Code
70934-080-90
Package Description
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
70934-080
11-Digit Billing Format
70934008090
RxNorm Crosswalk
RxCUI: 197806 - ibuprofen 600 MG Oral Tablet

Clinical Specifications

Proprietary Name
Ibuprofen
Dosage Form
-
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
Denton Pharma, Inc. Dba Northwind Pharmaceuticals
FDA Application #
ANDA091625
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-14-2018
Listing Expiration
12-31-2022
Exclude Flag
I
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 (70934-080). Click a package code to view its specific billing and regulatory data.

70934-080-30
30 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 70934-080-90 identifies a specific commercial package of 90 tablet, film coated in 1 bottle, plastic of Ibuprofen, labeled by Denton Pharma, Inc. Dba Northwind Pharmaceuticals. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Denton Pharma, Inc. Dba Northwind Pharmaceuticals on February 14, 2018. The current certification is valid through December 31, 2022.

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 Denton Pharma, Inc. Dba Northwind Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70934008090. 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)
70934-080-90
11-Digit CMS (5-4-2)
70934-0080-90

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