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  5. NDC Package Code: 54838-512-40 Doxepin Hydrochloride

NDC Package 54838-512-40 Doxepin Hydrochloride

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
54838-512-40
Package Description:
120 mL in 1 BOTTLE, PLASTIC
Product Code:
54838-512
Proprietary Name:
Doxepin Hydrochloride
Non-Proprietary Name:
Doxepin Hydrochloride
Substance Name:
Doxepin Hydrochloride
Usage Information:
Doxepin is contraindicated in individuals who have shown hypersensitivity to the drug. Possibility of cross sensitivity with other dibenzoxepines should be kept in mind. Doxepin is contraindicated in patients with glaucoma or a tendency to urinary retention. These disorders should be ruled out, particularly in older patients.
11-Digit NDC Billing Format:
54838051240
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
120 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1000054 - doxepin HCl 10 MG in 1 mL Concentrate for Oral Solution
  • RxCUI: 1000054 - doxepin 10 MG/ML Oral Solution
  • RxCUI: 1000054 - doxepin hydrochloride 10 MG per 1 ML Concentrate for Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Lannett Company, Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DOXEPIN HYDROCHLORIDE 10 mg/mL
    • Pharmacologic Class(es):
  • Tricyclic Antidepressant - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA074721
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-29-1998
    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.

    Frequently Asked Questions

    What is NDC 54838-512-40?

    The NDC Packaged Code 54838-512-40 is assigned to a package of 120 ml in 1 bottle, plastic of Doxepin Hydrochloride, a human prescription drug labeled by Lannett Company, Inc.. The product's dosage form is solution and is administered via oral form.

    Is NDC 54838-512 included in the NDC Directory?

    Yes, Doxepin Hydrochloride with product code 54838-512 is active and included in the NDC Directory. The product was first marketed by Lannett Company, Inc. on December 29, 1998 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 54838-512-40?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 120.

    What is the 11-digit format for NDC 54838-512-40?

    The 11-digit format is 54838051240. 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
    5-3-254838-512-405-4-254838-0512-40