Tamsulosin Hydrochloride Capsule, Gelatin Coated
NDC Package 43579-011-98

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.

Tamsulosin Hydrochloride capsules is a drug for further processing. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Synthon Hispania S.l., this product is identified by NDC 43579-011.

Identification & Billing

NDC Package Code
43579-011-98
Package Description
20000 CAPSULE, GELATIN COATED in 1 DRUM
Product Code
43579-011
11-Digit Billing Format
43579001198

Clinical Specifications

Proprietary Name
Tamsulosin Hydrochloride
Non-Proprietary Name
Tamsulosin Hydrochloride
Substance Name
Tamsulosin Hydrochloride
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Active Ingredient(s)
TAMSULOSIN HYDROCHLORIDE .4 mg/1

Regulatory & Marketing

Labeler Name
Synthon Hispania S.l.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
04-27-2010
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 43579-011-98 identifies a specific commercial package of 20000 capsule, gelatin coated in 1 drum of Tamsulosin Hydrochloride (UNFINISHED drug), drug for further processing labeled by Synthon Hispania S.l.. This capsule, gelatin coated is formulated for use and contains tamsulosin hydrochloride 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 Synthon Hispania S.l. on April 27, 2010. The current certification is valid through December 31, 2026.

How is this Synthon Hispania S.l. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43579001198. 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)
43579-011-98
11-Digit CMS (5-4-2)
43579-0011-98

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