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  5. NDC Package Code: 42571-303-05 Chlordiazepoxide And Amitriptyline Hydrochloride

NDC Package 42571-303-05 Chlordiazepoxide And Amitriptyline 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:
42571-303-05
Package Description:
500 TABLET in 1 BOTTLE
Product Code:
42571-303
Proprietary Name:
Chlordiazepoxide And Amitriptyline Hydrochloride
Non-Proprietary Name:
Chlordiazepoxide And Amitriptyline Hydrochloride
Substance Name:
Amitriptyline Hydrochloride; Chlordiazepoxide
Usage Information:
Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety.The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablets occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone.Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.
11-Digit NDC Billing Format:
42571030305
Product Type:
Human Prescription Drug
Labeler Name:
Micro Labs Limited
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):
  • AMITRIPTYLINE HYDROCHLORIDE 10 mg/1
  • CHLORDIAZEPOXIDE 25 mg/1
    • Pharmacologic Class(es):
  • Benzodiazepine - [EPC] (Established Pharmacologic Class)
  • Benzodiazepines - [CS]
  • Tricyclic Antidepressant - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA211925
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-01-2022
    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
    42571-303-01100 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 42571-303-05?

    The NDC Packaged Code 42571-303-05 is assigned to a package of 500 tablet in 1 bottle of Chlordiazepoxide And Amitriptyline Hydrochloride, a human prescription drug labeled by Micro Labs Limited. The product's dosage form is tablet and is administered via oral form.

    Is NDC 42571-303 included in the NDC Directory?

    Yes, Chlordiazepoxide And Amitriptyline Hydrochloride with product code 42571-303 is active and included in the NDC Directory. The product was first marketed by Micro Labs Limited on April 01, 2022 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 42571-303-05?

    The 11-digit format is 42571030305. 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
    5-3-242571-303-055-4-242571-0303-05