Chlordiazepoxide And Amitriptyline Hydrochloride Tablet
NDC Package 42571-302-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package 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. This formulation utilizes a tablet delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-302 and is authorized under FDA application ANDA211925.

Identification & Billing

NDC Package Code
42571-302-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
42571-302
11-Digit Billing Format
42571030201

Clinical Specifications

Proprietary Name
Chlordiazepoxide And Amitriptyline Hydrochloride
Non-Proprietary Name
Chlordiazepoxide And Amitriptyline Hydrochloride
Substance Name
Amitriptyline Hydrochloride; Chlordiazepoxide
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA211925
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42571-302). Click a package code to view its specific billing and regulatory data.

42571-302-05
500 TABLET in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42571-302-01 identifies a specific commercial package of 100 tablet in 1 bottle of Chlordiazepoxide And Amitriptyline Hydrochloride, a human prescription drug labeled by Micro Labs Limited. This tablet is formulated for oral use and contains amitriptyline hydrochloride; chlordiazepoxide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Micro Labs Limited on April 01, 2022. The current certification is valid through December 31, 2026.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571030201. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
42571-302-01
11-Digit CMS (5-4-2)
42571-0302-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.