Ibuprofen Kit
NDC Package 76420-981-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Ibuprofen kits is ibuprofen is used to help relieve mild to moderate pain. This formulation utilizes a kit delivery system. Marketed by Asclemed Usa, Inc., this product is identified by NDC 76420-981.

Identification & Billing

NDC Package Code
76420-981-01
Package Description
1 KIT in 1 KIT * 108 g in 1 BOTTLE, PLASTIC * 12 g in 1 BOTTLE, PLASTIC
Product Code
76420-981
11-Digit Billing Format
76420098101

Clinical Specifications

Proprietary Name
Ibuprofen
Non-Proprietary Name
Ibuprofen
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Ibuprofen is used to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as 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.

Regulatory & Marketing

Labeler Name
Asclemed Usa, Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
02-05-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 76420-981-01 identifies a specific commercial package of 1 kit in 1 kit * 108 g in 1 bottle, plastic * 12 g in 1 bottle, plastic of Ibuprofen (UNFINISHED drug), a bulk ingredient labeled by Asclemed Usa, Inc.. This kit is formulated for 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 Asclemed Usa, Inc. on February 05, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ibuprofen is used to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as 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.

How is this Asclemed Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76420098101. 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)
76420-981-01
11-Digit CMS (5-4-2)
76420-0981-01

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