NDC Package 0378-4810-93 Doxepin Hydrochloride

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

Package Information
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:

0378-4810-93

Package Description:

30 TABLET in 1 BOTTLE, PLASTIC

Product Code:

0378-4810

Proprietary Name:

Doxepin Hydrochloride

Non-Proprietary Name:

Doxepin Hydrochloride

Substance Name:

Doxepin Hydrochloride

Usage Information:

Doxepin hydrochloride tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration [see Clinical Studies (14)].

11-Digit NDC Billing Format:

00378481093

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

30 EA

NDC to RxNorm Crosswalk:

RxCUI: 966787 - doxepin 3 MG Oral Tablet

RxCUI: 966787 - doxepin 3 MG (as doxepin hydrochloride 3.39 MG) Oral Tablet

RxCUI: 966793 - doxepin 6 MG Oral Tablet

RxCUI: 966793 - doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral Tablet

Product Type:

Human Prescription Drug

Labeler Name:

Mylan Pharmaceuticals Inc.

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):

DOXEPIN HYDROCHLORIDE 3 mg/1

Pharmacologic Class(es):

Tricyclic Antidepressant - [EPC] (Established Pharmacologic Class)

Sample Package:

FDA Application Number:

NDA022036

Marketing Category:

NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.

Start Marketing Date:

01-02-2020

End Marketing Date:

04-30-2024

Exclude Flag:

Code Structure:

0378 - Mylan Pharmaceuticals Inc.
- 0378-4810 - Doxepin Hydrochloride
  - 0378-4810-93 - 30 TABLET in 1 BOTTLE, PLASTIC

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 0378-4810-93?

The NDC Packaged Code 0378-4810-93 is assigned to a package of 30 tablet in 1 bottle, plastic of Doxepin Hydrochloride, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is tablet and is administered via oral form.

Is NDC 0378-4810 included in the NDC Directory?

Yes, Doxepin Hydrochloride with product code 0378-4810 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on January 02, 2020.

What is the NDC billing unit for package 0378-4810-93?

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 30.

What is the 11-digit format for NDC 0378-4810-93?

The 11-digit format is 00378481093. 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 4-4-2 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0378-4810-93	5-4-2	00378-4810-93

Table of Contents