Dutasteride And Tamsulosin Hydrochloride
NDC Package 42291-031-30

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.

Dutasteride And Tamsulosin Hydrochloride is capsules are contraindicated for use in:Pregnancy. Marketed by Avkare, this product is identified by NDC 42291-031 and is authorized under FDA application ANDA202509.

Identification & Billing

NDC Package Code
42291-031-30
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
42291-031
11-Digit Billing Format
42291003130
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
Dosage Form
-
Usage Information
Dutasteride and tamsulosin hydrochloride capsules are contraindicated for use in:Pregnancy. Dutasteride use is contraindicated in females who are pregnant. 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 female.  [seeWarnings and Precautions ( 5.6), Use in Specific Populations ( 8.1) ]. Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, or any other component of dutasteride and tamsulosin hydrochloride capsules [seeAdverse Reactions ( 6.2) ].

Regulatory & Marketing

Labeler Name
Avkare
FDA Application #
ANDA202509
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-15-2023
Listing Expiration
12-31-2027
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 42291-031-30 identifies a specific commercial package of 30 capsule in 1 bottle of Dutasteride And Tamsulosin Hydrochloride, labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Avkare on November 15, 2023. The current certification is valid through December 31, 2027.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291003130. 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)
42291-031-30
11-Digit CMS (5-4-2)
42291-0031-30

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