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  5. NDC Package Code: 42385-927-01 Hydroxychloroquine Sulfate

NDC Package 42385-927-01 Hydroxychloroquine Sulfate

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:
42385-927-01
Package Description:
100 TABLET, FILM COATED in 1 BOTTLE
Product Code:
42385-927
Proprietary Name:
Hydroxychloroquine Sulfate
Non-Proprietary Name:
Hydroxychloroquine Sulfate
Substance Name:
Hydroxychloroquine Sulfate
Usage Information:
Hydroxychloroquine is used to prevent or treat malaria caused by mosquito bites. The United States Center for Disease Control provides updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before traveling to areas where malaria occurs. This medication is also used to treat certain auto-immune diseases (lupus, rheumatoid arthritis). It belongs to a class of medications known as disease-modifying antirheumatic drugs (DMARDs). It can reduce skin problems in lupus and prevent swelling/pain in arthritis. Hydroxychloroquine is not recommended for coronavirus infection, also known as COVID-19, unless you are enrolled in a study. Talk to your doctor about the risks and benefits.
11-Digit NDC Billing Format:
42385092701
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: 979092 - hydroxychloroquine sulfate 200 MG Oral Tablet
  • RxCUI: 979092 - hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Laurus Labs Limited
    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):
  • HYDROXYCHLOROQUINE SULFATE 200 mg/1
    • Pharmacologic Class(es):
  • Antimalarial - [EPC] (Established Pharmacologic Class)
  • Antirheumatic Agent - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA210959
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-05-2019
    End Marketing Date:
    02-28-2025
    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
    42385-927-05500 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 42385-927-01?

    The NDC Packaged Code 42385-927-01 is assigned to a package of 100 tablet, film coated in 1 bottle of Hydroxychloroquine Sulfate, a human prescription drug labeled by Laurus Labs Limited. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 42385-927 included in the NDC Directory?

    Yes, Hydroxychloroquine Sulfate with product code 42385-927 is active and included in the NDC Directory. The product was first marketed by Laurus Labs Limited on September 05, 2019.

    What is the NDC billing unit for package 42385-927-01?

    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 42385-927-01?

    The 11-digit format is 42385092701. 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
    5-3-242385-927-015-4-242385-0927-01