Tamsulosin Hydrochloride
NDC Package 53002-1663-3

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.

Tamsulosin Hydrochloride is capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-1663 and is authorized under FDA application ANDA202433.

Identification & Billing

NDC Package Code
53002-1663-3
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
53002-1663
11-Digit Billing Format
53002166303
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tamsulosin Hydrochloride
Dosage Form
-
Usage Information
Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA202433
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-30-2013
Listing Expiration
12-31-2024
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 (53002-1663). Click a package code to view its specific billing and regulatory data.

53002-1663-0
100 CAPSULE 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 53002-1663-3 identifies a specific commercial package of 30 capsule in 1 bottle of Tamsulosin Hydrochloride, labeled by Rpk Pharmaceuticals, Inc.. 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 Rpk Pharmaceuticals, Inc. on April 30, 2013. The current certification is valid through December 31, 2024.

How is this Rpk Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002166303. 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 (5-4-1)
53002-1663-3
11-Digit CMS (5-4-2)
53002-1663-03

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