Chlordiazepoxide Hydrochloride Capsule, Gelatin Coated
NDC Package 42806-565-01

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

Package Information

Chlordiazepoxide Hydrochloride capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Epic Pharma, Llc, this product is identified by NDC 42806-565 and is authorized under FDA application ANDA085472.

Identification & Billing

NDC Package Code
42806-565-01
Package Description
100 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
42806-565
11-Digit Billing Format
42806056501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Chlordiazepoxide Hydrochloride
Non-Proprietary Name
Chlordiazepoxide Hydrochloride
Substance Name
Chlordiazepoxide Hydrochloride
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1
Pharmacologic Class
Usage Information
Chlordiazepoxide Hydrochloride Capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.The effectiveness of chlordiazepoxide hydrochloride capsules in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Epic Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA085472
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-13-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42806-565-01 identifies a specific commercial package of 100 capsule, gelatin coated in 1 bottle of Chlordiazepoxide Hydrochloride, a human prescription drug labeled by Epic Pharma, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This capsule, gelatin coated is formulated for oral use and contains chlordiazepoxide hydrochloride 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 Epic Pharma, Llc on August 13, 2021. The current certification is valid through December 31, 2026.

How is this Epic Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42806056501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
42806-565-01
11-Digit CMS (5-4-2)
42806-0565-01

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