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  5. NDC Package Code: 55494-100-99 Diclegis

NDC Package 55494-100-99 Diclegis

Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
55494-100-99
Package Description:
12 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code:
55494-100
Proprietary Name:
Diclegis
Non-Proprietary Name:
Doxylamine Succinate And Pyridoxine Hydrochloride
Substance Name:
Doxylamine Succinate; Pyridoxine Hydrochloride
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.
11-Digit NDC Billing Format:
55494010099
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Duchesnay Usa, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DOXYLAMINE SUCCINATE 10 mg/1
  • PYRIDOXINE HYDROCHLORIDE 10 mg/1
    • Pharmacologic Class(es):
  • Analogs/Derivatives - [Chemical/Ingredient]
  • Antihistamine - [EPC] (Established Pharmacologic Class)
  • Histamine Receptor Antagonists - [MoA] (Mechanism of Action)
  • Vitamin B 6 - [Chemical/Ingredient]
  • Vitamin B6 Analog - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    Yes
    FDA Application Number:
    NDA021876
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-15-2013
    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
    55494-100-10100 TABLET, DELAYED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 55494-100-99?

    The NDC Packaged Code 55494-100-99 is assigned to a package of 12 tablet, delayed release in 1 bottle of Diclegis, a human prescription drug labeled by Duchesnay Usa, Inc.. The product's dosage form is tablet, delayed release and is administered via oral form.

    Is NDC 55494-100 included in the NDC Directory?

    Yes, Diclegis with product code 55494-100 is active and included in the NDC Directory. The product was first marketed by Duchesnay Usa, Inc. on May 15, 2013 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 11-digit format for NDC 55494-100-99?

    The 11-digit format is 55494010099. 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
    5-3-255494-100-995-4-255494-0100-99