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  5. NDC Package Code: 69681-125-90 Entadfi

NDC Package 69681-125-90 Entadfi

Finasteride And Tadalafil 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:
69681-125-90
Package Description:
90 CAPSULE in 1 BOTTLE
Product Code:
69681-125
Proprietary Name:
Entadfi
Non-Proprietary Name:
Finasteride And Tadalafil
Substance Name:
Finasteride; Tadalafil
Usage Information:
ENTADFI is indicated to initiate treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks.Limitations of UseENTADFI is not recommended for more than 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit beyond 26 weeks is unknown [see Clinical Studies (14)].
11-Digit NDC Billing Format:
69681012590
NDC to RxNorm Crosswalk:
  • RxCUI: 2587741 - finasteride 5 MG / tadalafil 5 MG Oral Capsule
  • RxCUI: 2587741 - FIN5C 5 MG / tadalafil 5 MG Oral Capsule
  • RxCUI: 2587747 - ENTADFI 5 MG / 5 MG Oral Capsule
  • RxCUI: 2587747 - finasteride 5 MG / tadalafil 5 MG Oral Capsule [Entadfi]
  • RxCUI: 2587747 - Entadfi (finasteride 5 MG / tadalafil 5 MG) Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Veru 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):
  • FINASTERIDE 5 mg/1
  • TADALAFIL 5 mg/1
    • Pharmacologic Class(es):
  • 5-alpha Reductase Inhibitor - [EPC] (Established Pharmacologic Class)
  • 5-alpha Reductase Inhibitors - [MoA] (Mechanism of Action)
  • Phosphodiesterase 5 Inhibitor - [EPC] (Established Pharmacologic Class)
  • Phosphodiesterase 5 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA215423
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-12-2021
    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
    69681-125-3030 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69681-125-90?

    The NDC Packaged Code 69681-125-90 is assigned to a package of 90 capsule in 1 bottle of Entadfi, a human prescription drug labeled by Veru Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 69681-125 included in the NDC Directory?

    Yes, Entadfi with product code 69681-125 is active and included in the NDC Directory. The product was first marketed by Veru Inc. on December 12, 2021 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 69681-125-90?

    The 11-digit format is 69681012590. 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
    5-3-269681-125-905-4-269681-0125-90