NDC Package 75834-249-01 Tadalafil

Tablet, Film Coated 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:
75834-249-01
Package Description:
1000 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Tadalafil
Non-Proprietary Name:
Tadalafil
Substance Name:
Tadalafil
Usage Information:
Tadalafil is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise.
11-Digit NDC Billing Format:
75834024901
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1000 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 402019 - tadalafil 20 MG Oral Tablet
  • RxCUI: 403957 - tadalafil 5 MG Oral Tablet
  • RxCUI: 484814 - tadalafil 10 MG Oral Tablet
  • RxCUI: 757707 - tadalafil 2.5 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Nivagen Pharmaceuticals, Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA211298
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-02-2020
    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
    75834-249-1030 TABLET, FILM COATED in 1 BLISTER PACK
    75834-249-3030 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 75834-249-01?

    The NDC Packaged Code 75834-249-01 is assigned to a package of 1000 tablet, film coated in 1 bottle of Tadalafil, a human prescription drug labeled by Nivagen Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 75834-249 included in the NDC Directory?

    Yes, Tadalafil with product code 75834-249 is active and included in the NDC Directory. The product was first marketed by Nivagen Pharmaceuticals, Inc. on November 02, 2020 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 75834-249-01?

    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 1000.

    What is the 11-digit format for NDC 75834-249-01?

    The 11-digit format is 75834024901. 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
    5-3-275834-249-015-4-275834-0249-01