NDC Package 72578-115-01 Bisoprolol Fumarate And Hydrochlorothiazide

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:
72578-115-01
Package Description:
100 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Bisoprolol Fumarate And Hydrochlorothiazide
Non-Proprietary Name:
Bisoprolol Fumarate And Hydrochlorothiazide
Substance Name:
Bisoprolol Fumarate; Hydrochlorothiazide
Usage Information:
Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.
11-Digit NDC Billing Format:
72578011501
NDC to RxNorm Crosswalk:
  • RxCUI: 854908 - bisoprolol fumarate 10 MG / hydroCHLOROthiazide 6.25 MG Oral Tablet
  • RxCUI: 854908 - bisoprolol fumarate 10 MG / hydrochlorothiazide 6.25 MG Oral Tablet
  • RxCUI: 854908 - bisoprolol fumarate 10 MG / HCTZ 6.25 MG Oral Tablet
  • RxCUI: 854916 - bisoprolol fumarate 2.5 MG / hydroCHLOROthiazide 6.25 MG Oral Tablet
  • RxCUI: 854916 - bisoprolol fumarate 2.5 MG / hydrochlorothiazide 6.25 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Viona 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.
  • Sample Package:
    No
    FDA Application Number:
    ANDA215666
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-01-2023
    Listing Expiration Date:
    12-31-2025
    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
    72578-115-05500 TABLET, FILM COATED in 1 BOTTLE
    72578-115-0630 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 72578-115-01?

    The NDC Packaged Code 72578-115-01 is assigned to a package of 100 tablet, film coated in 1 bottle of Bisoprolol Fumarate And Hydrochlorothiazide, a human prescription drug labeled by Viona Pharmaceuticals Inc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 72578-115 included in the NDC Directory?

    Yes, Bisoprolol Fumarate And Hydrochlorothiazide with product code 72578-115 is active and included in the NDC Directory. The product was first marketed by Viona Pharmaceuticals Inc on March 01, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 72578-115-01?

    The 11-digit format is 72578011501. 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
    5-3-272578-115-015-4-272578-0115-01