Ibu Tablet
NDC Package 55111-682-94

11-digit billing NDC: 55111068294
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Ibu (ibuprofen) tablets is carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual 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. This formulation utilizes a tablet delivery system. Marketed by Dr. Reddy's Laboratories Limited, this product is identified by NDC 55111-682 and is authorized under FDA application ANDA075682.

Identification & Billing

NDC Package Code
55111-682-94
Package Description
4000 TABLET in 1 POUCH
Product Code
55111-682
11-Digit Billing Format
55111068294
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ibu
Non-Proprietary Name
Ibuprofen
Substance Name
Ibuprofen
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual 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
Dr. Reddy's Laboratories Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA075682
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-20-2008
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55111-682). Click a package code to view its specific billing and regulatory data.

55111-682-01
100 TABLET in 1 BOTTLE
55111-682-05
500 TABLET in 1 BOTTLE
55111-682-09
90 TABLET in 1 BOTTLE

* 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 55111-682-94 identifies a specific commercial package of 4000 tablet in 1 pouch of Ibu, a human prescription drug labeled by Dr. Reddy's Laboratories Limited. This tablet 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 Dr. Reddy's Laboratories Limited on November 20, 2008. The current certification is valid through December 31, 2027.

How is this Dr. Reddy's Laboratories Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55111068294. 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)
55111-682-94
11-Digit CMS (5-4-2)
55111-0682-94

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