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  5. NDC Package Code: 53746-670-01 Acebutolol Hydrochloride

NDC Package 53746-670-01 Acebutolol Hydrochloride

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:
53746-670-01
Package Description:
100 CAPSULE in 1 BOTTLE
Product Code:
53746-670
Proprietary Name:
Acebutolol Hydrochloride
Non-Proprietary Name:
Acebutolol Hydrochloride
Substance Name:
Acebutolol Hydrochloride
Usage Information:
HypertensionAcebutolol HCl capsules are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.Ventricular ArrhythmiasAcebutolol HCl capsules are indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and R-on-T beats.
11-Digit NDC Billing Format:
53746067001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 998685 - acebutolol HCl 400 MG Oral Capsule
  • RxCUI: 998685 - acebutolol 400 MG Oral Capsule
  • RxCUI: 998685 - acebutolol (as acebutolol HCl) 400 MG Oral Capsule
  • RxCUI: 998689 - acebutolol HCl 200 MG Oral Capsule
  • RxCUI: 998689 - acebutolol 200 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Of New York Llc
    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):
  • ACEBUTOLOL HYDROCHLORIDE 400 mg/1
    • Pharmacologic Class(es):
  • Adrenergic beta-Antagonists - [MoA] (Mechanism of Action)
  • beta-Adrenergic Blocker - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA075047
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-01-2009
    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
    53746-670-05500 CAPSULE in 1 BOTTLE
    53746-670-3030 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53746-670-01?

    The NDC Packaged Code 53746-670-01 is assigned to a package of 100 capsule in 1 bottle of Acebutolol Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. The product's dosage form is capsule and is administered via oral form.

    Is NDC 53746-670 included in the NDC Directory?

    Yes, Acebutolol Hydrochloride with product code 53746-670 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Of New York Llc on December 01, 2009 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 53746-670-01?

    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 100.

    What is the 11-digit format for NDC 53746-670-01?

    The 11-digit format is 53746067001. 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
    5-3-253746-670-015-4-253746-0670-01