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  5. NDC Package Code: 53345-002-02 Diphenhydramine Hydrochloride

NDC Package 53345-002-02 Diphenhydramine Hydrochloride

Capsule, Liquid Filled 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:
53345-002-02
Package Description:
1 BAG in 1 BOX / 20000 CAPSULE, LIQUID FILLED in 1 BAG
Product Code:
53345-002
Proprietary Name:
Diphenhydramine Hydrochloride
Non-Proprietary Name:
Diphenhydramine Hydrochloride
Substance Name:
Diphenhydramine Hydrochloride
Usage Information:
Take only one dose per day (24 hours) -  see Overdose warningadults & children12 yrs & over                     One dose = TWO 25 mg softgels (50 mg)                     at bedtime if needed or as directed by a doctor
11-Digit NDC Billing Format:
53345000202
NDC to RxNorm Crosswalk:
  • RxCUI: 1049909 - diphenhydrAMINE HCl 25 MG Oral Capsule
  • RxCUI: 1049909 - diphenhydramine hydrochloride 25 MG Oral Capsule
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Humanwell Puracap Pharmaceutical (wuhan), Ltd.
    Dosage Form:
    Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
    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:
    part338
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    04-15-2013
    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.

    Frequently Asked Questions

    What is NDC 53345-002-02?

    The NDC Packaged Code 53345-002-02 is assigned to a package of 1 bag in 1 box / 20000 capsule, liquid filled in 1 bag of Diphenhydramine Hydrochloride, a human over the counter drug labeled by Humanwell Puracap Pharmaceutical (wuhan), Ltd.. The product's dosage form is capsule, liquid filled and is administered via oral form.

    Is NDC 53345-002 included in the NDC Directory?

    Yes, Diphenhydramine Hydrochloride with product code 53345-002 is active and included in the NDC Directory. The product was first marketed by Humanwell Puracap Pharmaceutical (wuhan), Ltd. on April 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 53345-002-02?

    The 11-digit format is 53345000202. 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
    5-3-253345-002-025-4-253345-0002-02