NDC Package 51013-190-09 Dutasteride

Capsule, Liquid Filled Oral - View Billable Units, 11-Digit Format, RxNorm

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:
51013-190-09
Package Description:
90 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code:
Proprietary Name:
Dutasteride
Non-Proprietary Name:
Dutasteride
Substance 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:
51013019009
NDC to RxNorm Crosswalk:
  • RxCUI: 351172 - dutasteride 0.5 MG Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Puracap Pharmaceutical Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA209909
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-29-2018
    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
    51013-190-3030 CAPSULE, LIQUID FILLED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 51013-190-09?

    The NDC Packaged Code 51013-190-09 is assigned to a package of 90 capsule, liquid filled in 1 bottle of Dutasteride, a human prescription drug labeled by Puracap Pharmaceutical Llc. The product's dosage form is capsule, liquid filled and is administered via oral form.

    Is NDC 51013-190 included in the NDC Directory?

    Yes, Dutasteride with product code 51013-190 is active and included in the NDC Directory. The product was first marketed by Puracap Pharmaceutical Llc on May 29, 2018 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 11-digit format for NDC 51013-190-09?

    The 11-digit format is 51013019009. 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
    5-3-251013-190-095-4-251013-0190-09