Diclegis Tablet, Delayed Release
NDC Package 55494-100-99

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

Diclegis (doxylamine succinate and pyridoxine hydrochloride) tablets is this combination medication (doxylamine with pyridoxine) is used to prevent or reduce nausea and vomiting caused by pregnancy. This formulation utilizes a tablet, delayed release delivery system. Marketed by Duchesnay Usa, Inc., this product is identified by NDC 55494-100 and is authorized under FDA application NDA021876.

Identification & Billing

NDC Package Code
55494-100-99
Package Description
12 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
55494-100
11-Digit Billing Format
55494010099
RxNorm Crosswalk
  • RxCUI: 1375948 - doxylamine succinate 10 MG / pyridoxine HCl 10 MG Delayed Release Oral Tablet
  • RxCUI: 1375948 - doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet
  • RxCUI: 1375948 - doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral Tablet
  • RxCUI: 1375948 - doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral Tablet
  • RxCUI: 1375954 - Diclegis 10 MG / 10 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Diclegis
Non-Proprietary Name
Doxylamine Succinate And Pyridoxine Hydrochloride
Substance Name
Doxylamine Succinate; Pyridoxine Hydrochloride
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This combination medication (doxylamine with pyridoxine) is used to prevent or reduce nausea and vomiting caused by pregnancy. Decreasing nausea and vomiting may improve your health and nutrition during pregnancy. Doxylamine is an antihistamine that is thought to work by affecting certain natural substances (acetylcholine, serotonin) in your body or by acting directly on certain parts of the brain. Pyridoxine is a B vitamin that is important for good health. Most people get enough pyridoxine in their diet, but certain health conditions (e.g., pregnancy, poor diet, alcoholism) can result in a lack of this vitamin.

Regulatory & Marketing

Labeler Name
Duchesnay Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021876
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-15-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 (55494-100). Click a package code to view its specific billing and regulatory data.

55494-100-10
100 TABLET, DELAYED RELEASE 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 55494-100-99 identifies a specific commercial package of 12 tablet, delayed release in 1 bottle of Diclegis, a human prescription drug labeled by Duchesnay Usa, Inc.. This tablet, delayed release is formulated for oral use and contains doxylamine succinate; pyridoxine 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 Duchesnay Usa, Inc. on May 15, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This combination medication (doxylamine with pyridoxine) is used to prevent or reduce nausea and vomiting caused by pregnancy. Decreasing nausea and vomiting may improve your health and nutrition during pregnancy. Doxylamine is an antihistamine that is thought to work by affecting certain natural substances (acetylcholine, serotonin) in your body or by acting directly on certain parts of the brain. Pyridoxine is a B vitamin that is important for good health. Most people get enough pyridoxine in their diet, but certain health conditions (e.g., pregnancy, poor diet, alcoholism) can result in a lack of this vitamin.

How is this Duchesnay Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55494010099. 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)
55494-100-99
11-Digit CMS (5-4-2)
55494-0100-99

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