Tamsulosin Hydrochloride Capsule
NDC Package 68084-299-65

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

Tamsulosin Hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)]. This formulation utilizes a capsule delivery system. Marketed by American Health Packaging, this product is identified by NDC 68084-299 and is authorized under FDA application ANDA078225.

Identification & Billing

NDC Package Code
68084-299-65
Package Description
50 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK (68084-299-11)
Product Code
68084-299
11-Digit Billing Format
68084029965
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
50 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tamsulosin Hydrochloride
Non-Proprietary Name
Tamsulosin Hydrochloride
Substance Name
Tamsulosin Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TAMSULOSIN HYDROCHLORIDE .4 mg/1
Pharmacologic Class
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
American Health Packaging
Product Type
Human Prescription Drug
FDA Application #
ANDA078225
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-17-2014
Listing Expiration
12-31-2026
Exclude Flag
N
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 (68084-299). Click a package code to view its specific billing and regulatory data.

68084-299-01
100 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 CAPSULE in 1 BLISTER PACK (68084-299-11)

* 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 68084-299-65 identifies a specific commercial package of 50 blister pack in 1 carton / 1 capsule in 1 blister pack (68084-299-11) of Tamsulosin Hydrochloride, a human prescription drug labeled by American Health Packaging. This capsule is formulated for oral 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 American Health Packaging on January 17, 2014. The current certification is valid through December 31, 2026.

How is this American Health Packaging product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68084029965. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 50 total billable units per package. 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)
68084-299-65
11-Digit CMS (5-4-2)
68084-0299-65

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