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  5. NDC Package Code: 76457-002-00 Diphenhydramine Hydrochloride

NDC Package 76457-002-00 Diphenhydramine Hydrochloride

Tablet 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:
76457-002-00
Package Description:
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE
Product Code:
76457-002
Proprietary Name:
Diphenhydramine Hydrochloride
Non-Proprietary Name:
Diphenhydramine Hydrochloride
Substance Name:
Diphenhydramine Hydrochloride
Usage Information:
Take every 4 to 6 hoursdo not take more than 6 does in 24 hoursAdult and children 12 years of age and over - 1 to 2 tabletChildren 6 to 12 years of age - 1 tabletChildren 6 years of age - do not use this product in children under 6 years
11-Digit NDC Billing Format:
76457000200
NDC to RxNorm Crosswalk:
  • RxCUI: 1049630 - diphenhydrAMINE HCl 25 MG Oral Tablet
  • RxCUI: 1049630 - diphenhydramine hydrochloride 25 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Simpex Pharma Pvt. Ltd
    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):
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    02-09-2018
    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 76457-002-00?

    The NDC Packaged Code 76457-002-00 is assigned to a package of 1 bottle in 1 carton / 100 tablet in 1 bottle of Diphenhydramine Hydrochloride, a human over the counter drug labeled by Simpex Pharma Pvt. Ltd. The product's dosage form is tablet and is administered via oral form.

    Is NDC 76457-002 included in the NDC Directory?

    Yes, Diphenhydramine Hydrochloride with product code 76457-002 is active and included in the NDC Directory. The product was first marketed by Simpex Pharma Pvt. Ltd on February 09, 2018 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 76457-002-00?

    The 11-digit format is 76457000200. 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
    5-3-276457-002-005-4-276457-0002-00