1. Home
  2. Labeler Index
  3. Epic Pharma, Llc
  4. 42806-328
  5. NDC Package Code: 42806-328-05 Labetalol Hydrochloride

NDC Package 42806-328-05 Labetalol Hydrochloride

Tablet 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:
42806-328-05
Package Description:
500 TABLET in 1 BOTTLE
Product Code:
42806-328
Proprietary Name:
Labetalol Hydrochloride
Non-Proprietary Name:
Labetalol Hydrochloride
Substance Name:
Labetalol Hydrochloride
Usage Information:
Labetalol Hydrochloride Tablets, USP are indicated in the management of hypertension. Labetalol Hydrochloride Tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
11-Digit NDC Billing Format:
42806032805
NDC to RxNorm Crosswalk:
  • RxCUI: 896758 - labetalol HCl 100 MG Oral Tablet
  • RxCUI: 896758 - labetalol hydrochloride 100 MG Oral Tablet
  • RxCUI: 896762 - labetalol HCl 200 MG Oral Tablet
  • RxCUI: 896762 - labetalol hydrochloride 200 MG Oral Tablet
  • RxCUI: 896766 - labetalol HCl 300 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Epic Pharma, Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • LABETALOL HYDROCHLORIDE 200 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:
    ANDA212990
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-30-2021
    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
    42806-328-01100 TABLET in 1 BOTTLE
    42806-328-101000 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 42806-328-05?

    The NDC Packaged Code 42806-328-05 is assigned to a package of 500 tablet in 1 bottle of Labetalol Hydrochloride, a human prescription drug labeled by Epic Pharma, Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 42806-328 included in the NDC Directory?

    Yes, Labetalol Hydrochloride with product code 42806-328 is active and included in the NDC Directory. The product was first marketed by Epic Pharma, Llc on September 30, 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 42806-328-05?

    The 11-digit format is 42806032805. 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
    5-3-242806-328-055-4-242806-0328-05