Dutasteride And Tamsulosin Hydrochloride Capsule
NDC Package 10370-280-11

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

Dutasteride And Tamsulosin Hydrochloride capsules are contraindicated for use in:Pregnancy. This formulation utilizes a capsule delivery system. Marketed by Endo Usa, Inc., this product is identified by NDC 10370-280 and is authorized under FDA application ANDA202509.

Identification & Billing

NDC Package Code
10370-280-11
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
10370-280
11-Digit Billing Format
10370028011
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 996097 - dutasteride 0.5 MG / tamsulosin HCl 0.4 MG Oral Capsule
  • RxCUI: 996097 - dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule

Clinical Specifications

Proprietary Name
Dutasteride And Tamsulosin Hydrochloride
Non-Proprietary Name
Dutasteride And Tamsulosin Hydrochloride
Substance Name
Dutasteride; 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)
Pharmacologic Class
Usage Information
Dutasteride and tamsulosin hydrochloride capsules are contraindicated for use in:Pregnancy. In animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. Therefore, dutasteride and tamsulosin hydrochloride capsules may cause fetal harm when administered to a pregnant woman. If dutasteride and tamsulosin hydrochloride capsules are used during pregnancy, or if the patient becomes pregnant while taking dutasteride and tamsulosin hydrochloride capsules, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)].Women of childbearing potential [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)].Pediatric patients [see Use in Specific Populations (8.4)].Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema, urticarial, pruritus, respiratory symptoms) to dutasteride, other 5 alpha-reductase inhibitors, tamsulosin, or any other component of dutasteride and tamsulosin hydrochloride capsules [see Adverse Reactions (6.2)].

Regulatory & Marketing

Labeler Name
Endo Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202509
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-18-2015
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 (10370-280). Click a package code to view its specific billing and regulatory data.

10370-280-09
90 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 10370-280-11 identifies a specific commercial package of 30 capsule in 1 bottle of Dutasteride And Tamsulosin Hydrochloride, a human prescription drug labeled by Endo Usa, Inc.. This capsule is formulated for oral use and contains dutasteride; 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 Endo Usa, Inc. on November 18, 2015. The current certification is valid through December 31, 2026.

How is this Endo Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10370028011. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
10370-280-11
11-Digit CMS (5-4-2)
10370-0280-11

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