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  5. NDC Package Code: 0378-4615-01 Doxylamine Succinate And Pyridoxine Hydrochloride

NDC Package 0378-4615-01 Doxylamine Succinate And Pyridoxine Hydrochloride

Tablet, Delayed Release 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:
0378-4615-01
Package Description:
100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
0378-4615
Proprietary Name:
Doxylamine Succinate And Pyridoxine Hydrochloride
Non-Proprietary Name:
Doxylamine Succinate And Pyridoxine Hydrochloride
Substance Name:
Doxylamine Succinate; Pyridoxine Hydrochloride
Usage Information:
Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use: Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum.
11-Digit NDC Billing Format:
00378461501
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals 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:
    No
    FDA Application Number:
    ANDA207825
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-21-2020
    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 0378-4615-01?

    The NDC Packaged Code 0378-4615-01 is assigned to a package of 100 tablet, delayed release in 1 bottle, plastic of Doxylamine Succinate And Pyridoxine Hydrochloride, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is tablet, delayed release and is administered via oral form.

    Is NDC 0378-4615 included in the NDC Directory?

    Yes, Doxylamine Succinate And Pyridoxine Hydrochloride with product code 0378-4615 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on July 21, 2020 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 0378-4615-01?

    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 100.

    What is the 11-digit format for NDC 0378-4615-01?

    The 11-digit format is 00378461501. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20378-4615-015-4-200378-4615-01