NDC Package 58657-604-01 Labetalol Hydrochloride

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:
58657-604-01
Package Description:
100 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Labetalol Hydrochloride
Non-Proprietary Name:
Labetalol Hydrochloride
Substance Name:
Labetalol
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:
58657060401
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: 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:
    Method Pharmaceuticals, Llc
    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:
    ANDA075215
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-22-2019
    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
    58657-604-50500 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58657-604-01?

    The NDC Packaged Code 58657-604-01 is assigned to a package of 100 tablet, film coated in 1 bottle of Labetalol Hydrochloride, a human prescription drug labeled by Method Pharmaceuticals, Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 58657-604 included in the NDC Directory?

    Yes, Labetalol Hydrochloride with product code 58657-604 is active and included in the NDC Directory. The product was first marketed by Method Pharmaceuticals, Llc on November 22, 2019 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 58657-604-01?

    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 58657-604-01?

    The 11-digit format is 58657060401. 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
    5-3-258657-604-015-4-258657-0604-01