Bonjesta Tablet, Extended Release
NDC Package 55494-120-60

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

Bonjesta (doxylamine succinate and pyridoxine hydrochloride) tablets is this combination medication contains 2 ingredients: doxylamine and pyridoxine. This formulation utilizes a tablet, extended release delivery system. Marketed by Duchesnay Usa, Inc., this product is identified by NDC 55494-120 and is authorized under FDA application NDA209661.

Identification & Billing

NDC Package Code
55494-120-60
Package Description
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
55494-120
11-Digit Billing Format
55494012060
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 1999651 - doxylamine succinate 20 MG / pyridoxine HCl 12HR 20 MG Extended Release Oral Tablet
  • RxCUI: 1999651 - 12 HR doxylamine succinate 20 MG / pyridoxine hydrochloride 20 MG Extended Release Oral Tablet
  • RxCUI: 1999651 - 12 HR doxylamine succinate 20 MG / vitamin B6 Hydrochloride 20 MG Extended Release Oral Tablet
  • RxCUI: 1999651 - 12 HR doxylamine succinate 20 MG / vit-B6 Hydrochloride 20 MG Extended Release Oral Tablet
  • RxCUI: 1999651 - doxylamine succinate 20 MG / pyridoxine hydrochloride 12 HR 20 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Bonjesta
Non-Proprietary Name
Doxylamine Succinate And Pyridoxine Hydrochloride
Substance Name
Doxylamine Succinate; Pyridoxine Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This combination medication contains 2 ingredients: doxylamine and pyridoxine. It 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 (such as 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 #
NDA209661
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-19-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55494-120). Click a package code to view its specific billing and regulatory data.

55494-120-10
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
55494-120-94
1 BLISTER PACK in 1 CARTON / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
55494-120-99
6 TABLET, EXTENDED 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 55494-120-60 identifies a specific commercial package of 60 tablet, extended release in 1 bottle of Bonjesta, a human prescription drug labeled by Duchesnay Usa, Inc.. This tablet, extended 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 February 19, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This combination medication contains 2 ingredients: doxylamine and pyridoxine. It 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 (such as 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: 55494012060. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
55494-120-60
11-Digit CMS (5-4-2)
55494-0120-60

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