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  5. NDC Package Code: 10370-280-09 Dutasteride And Tamsulosin Hydrochloride

NDC Package 10370-280-09 Dutasteride And Tamsulosin Hydrochloride

Dutasteride And Tamsulosin Hydrochloride Capsules Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
10370-280-09
Package Description:
90 CAPSULE in 1 BOTTLE
Product Code:
10370-280
Proprietary Name:
Dutasteride And Tamsulosin Hydrochloride
Non-Proprietary Name:
Dutasteride And Tamsulosin Hydrochloride Capsules
Substance Name:
Dutasteride; Tamsulosin Hydrochloride
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)].
11-Digit NDC Billing Format:
10370028009
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
90 EA
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Par Pharmaceutical, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DUTASTERIDE .5 mg/1
  • TAMSULOSIN HYDROCHLORIDE .4 mg/1
    • Pharmacologic Class(es):
  • 5-alpha Reductase Inhibitor - [EPC] (Established Pharmacologic Class)
  • 5-alpha Reductase Inhibitors - [MoA] (Mechanism of Action)
  • Adrenergic alpha-Antagonists - [MoA] (Mechanism of Action)
  • alpha-Adrenergic Blocker - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA202509
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-18-2015
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    10370-280-1130 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 10370-280-09?

    The NDC Packaged Code 10370-280-09 is assigned to a package of 90 capsule in 1 bottle of Dutasteride And Tamsulosin Hydrochloride, a human prescription drug labeled by Par Pharmaceutical, Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 10370-280 included in the NDC Directory?

    Yes, Dutasteride And Tamsulosin Hydrochloride with product code 10370-280 is active and included in the NDC Directory. The product was first marketed by Par Pharmaceutical, Inc. on November 18, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 10370-280-09?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 90.

    What is the 11-digit format for NDC 10370-280-09?

    The 11-digit format is 10370028009. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-210370-280-095-4-210370-0280-09