Dutasteride Capsule, Liquid Filled
NDC Package 68071-4821-9

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Dutasteride capsules is a medication used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). This formulation utilizes a capsule, liquid filled delivery system. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-4821 and is authorized under FDA application ANDA206574.

Identification & Billing

NDC Package Code
68071-4821-9
Package Description
90 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
68071-4821
11-Digit Billing Format
68071482109
RxNorm Crosswalk
RxCUI: 351172 - dutasteride 0.5 MG Oral Capsule

Clinical Specifications

Proprietary Name
Dutasteride
Non-Proprietary Name
Dutasteride
Substance Name
Dutasteride
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DUTASTERIDE .5 mg/1
Pharmacologic Class
Usage Information
This medication is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It works by reducing the size of the enlarged prostate. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). It may also reduce the need for surgery to treat BPH. Dutasteride is not approved for prevention of prostate cancer. It may slightly increase the risk of developing a very serious form of prostate cancer. Talk to your doctor about the benefits and risks. This medication should not be used by women or children.

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA206574
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-24-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68071-4821-9 identifies a specific commercial package of 90 capsule, liquid filled in 1 bottle of Dutasteride, a human prescription drug labeled by Nucare Pharmaceuticals,inc.. This capsule, liquid filled is formulated for oral use and contains dutasteride 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 Nucare Pharmaceuticals,inc. on October 24, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It works by reducing the size of the enlarged prostate. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). It may also reduce the need for surgery to treat BPH. Dutasteride is not approved for prevention of prostate cancer. It may slightly increase the risk of developing a very serious form of prostate cancer. Talk to your doctor about the benefits and risks. This medication should not be used by women or children.

How is this Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071482109. 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)
68071-4821-9
11-Digit CMS (5-4-2)
68071-4821-09

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