NDC Package 69315-161-01 Doxepin Hydrochloride

Capsule 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:
69315-161-01
Package Description:
100 CAPSULE in 1 PACKAGE
Product Code:
Proprietary Name:
Doxepin Hydrochloride
Non-Proprietary Name:
Doxepin Hydrochloride
Substance Name:
Doxepin Hydrochloride
Usage Information:
Doxepin Hydrochloride is recommended for the treatment of:Psychoneurotic patients with depression and/or anxiety.Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.Clinical experience has shown that doxepin hydrochloride is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride is not recommended for use in children under 12 years of age.
11-Digit NDC Billing Format:
69315016101
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: 1000048 - doxepin HCl 10 MG Oral Capsule
  • RxCUI: 1000048 - doxepin 10 MG Oral Capsule
  • RxCUI: 1000048 - doxepin (as doxepin HCl) 10 MG Oral Capsule
  • RxCUI: 1000058 - doxepin HCl 100 MG Oral Capsule
  • RxCUI: 1000058 - doxepin 100 MG Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Leading Pharma, Llc
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA211619
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-15-2021
    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
    69315-161-101000 CAPSULE in 1 PACKAGE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69315-161-01?

    The NDC Packaged Code 69315-161-01 is assigned to a package of 100 capsule in 1 package of Doxepin Hydrochloride, a human prescription drug labeled by Leading Pharma, Llc. The product's dosage form is capsule and is administered via oral form.

    Is NDC 69315-161 included in the NDC Directory?

    Yes, Doxepin Hydrochloride with product code 69315-161 is active and included in the NDC Directory. The product was first marketed by Leading Pharma, Llc on April 15, 2021 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 69315-161-01?

    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 69315-161-01?

    The 11-digit format is 69315016101. 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
    5-3-269315-161-015-4-269315-0161-01