NDC Package 0054-0395-13 Dutasteride

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:

0054-0395-13

Package Description:

30 CAPSULE in 1 BOTTLE

Product Code:

0054-0395

Proprietary Name:

Dutasteride

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.

11-Digit NDC Billing Format:

00054039513

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

30 EA

Labeler Name:

West-ward Pharmaceuticals Corp.

Sample Package:

FDA Application Number:

ANDA202204

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

11-23-2015

End Marketing Date:

01-02-2020

Listing Expiration Date:

01-02-2020

Exclude Flag:

Code Structure:

0054 - West-ward Pharmaceuticals Corp.
- 0054-0395 - Dutasteride
  - 0054-0395-13 - 30 CAPSULE in 1 BOTTLE

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 Code	Package Description
0054-0395-22	90 CAPSULE in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0054-0395-13?

The NDC Packaged Code 0054-0395-13 is assigned to a package of 30 capsule in 1 bottle of Dutasteride, labeled by West-ward Pharmaceuticals Corp.. The product's dosage form is and is administered via form.

Is NDC 0054-0395 included in the NDC Directory?

No, Dutasteride with product code 0054-0395 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by West-ward Pharmaceuticals Corp. on November 23, 2015 and its listing in the NDC Directory is set to expire on January 02, 2020 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0054-0395-13?

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 30.

What is the 11-digit format for NDC 0054-0395-13?

The 11-digit format is 00054039513. 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 4-4-2 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0054-0395-13	5-4-2	00054-0395-13

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