Probufen
NDC Package 49789-050-01

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

Probufen is uses1. Marketed by Samsung Pharm Ind. Co., Ltd., this product is identified by NDC 49789-050 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
49789-050-01
Package Description
537 mg in 1 BLISTER PACK
Product Code
49789-050
11-Digit Billing Format
49789005001
RxNorm Crosswalk
RxCUI: 197805 - ibuprofen 400 MG Oral Tablet

Clinical Specifications

Proprietary Name
Probufen
Dosage Form
-
Usage Information
Uses1. Major effects Fever and pain due to rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis (degenerative joint disease), common cold, back pain, dysmenorrhea, and post-operative pain. 2. This can be used also for the following diseases. Ankylosing spondilytis, headache, toothache, myalgia, neuragia, acute gout, psoriatic arthritis, soft tissue injury (sprain, contusion), non-articular rheumatism (tendinitis, tendosynovitis, synovitis)

Regulatory & Marketing

Labeler Name
Samsung Pharm Ind. Co., Ltd.
FDA Application #
part343
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
12-01-2011
Listing Expiration
12-31-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49789-050-01 identifies a specific commercial package of 537 mg in 1 blister pack of Probufen, labeled by Samsung Pharm Ind. Co., Ltd.. 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 Samsung Pharm Ind. Co., Ltd. on December 01, 2011. The current certification is valid through December 31, 2017.

How is this Samsung Pharm Ind. Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49789005001. 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)
49789-050-01
11-Digit CMS (5-4-2)
49789-0050-01

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