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  5. NDC Package Code: 49884-122-05 Labetalol Hcl

NDC Package 49884-122-05 Labetalol Hcl

Labetalol Hydrochloride Tablet, Film Coated 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:
49884-122-05
Package Description:
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
49884-122
Proprietary Name:
Labetalol Hcl
Non-Proprietary Name:
Labetalol Hydrochloride
Substance Name:
Labetalol Hydrochloride
Usage Information:
Labetalol is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication is both an alpha blocker and beta blocker. It works by blocking the action of certain natural chemicals in your body such as epinephrine on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart.
11-Digit NDC Billing Format:
49884012205
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
500 EA
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:
    Par Pharmaceutical, 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):
  • LABETALOL HYDROCHLORIDE 100 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:
    ANDA200908
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-24-2012
    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
    49884-122-01100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 49884-122-05?

    The NDC Packaged Code 49884-122-05 is assigned to a package of 500 tablet, film coated in 1 bottle, plastic of Labetalol Hcl, a human prescription drug labeled by Par Pharmaceutical, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 49884-122 included in the NDC Directory?

    Yes, Labetalol Hcl with product code 49884-122 is active and included in the NDC Directory. The product was first marketed by Par Pharmaceutical, Inc. on July 24, 2012 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 49884-122-05?

    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 500.

    What is the 11-digit format for NDC 49884-122-05?

    The 11-digit format is 49884012205. 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
    5-3-249884-122-055-4-249884-0122-05