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  5. NDC Package Code: 70000-0467-1 Leader Sleep Aid

NDC Package 70000-0467-1 Leader Sleep Aid

Diphenhydramine Hydrochloride Tablet, Film Coated 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:
70000-0467-1
Package Description:
12 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
70000-0467
Proprietary Name:
Leader Sleep Aid
Non-Proprietary Name:
Diphenhydramine Hydrochloride
Substance Name:
Diphenhydramine Hydrochloride
Usage Information:
Adults and children 12 years and overtake 2 caplets at bedtime if needed, or as directed by a doctorchildren under 12 yearsdo not use
11-Digit NDC Billing Format:
70000046701
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:
    Cardinal Health 110, Llc. Dba Leader
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    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:
    02-25-2019
    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 70000-0467-1?

    The NDC Packaged Code 70000-0467-1 is assigned to a package of 12 blister pack in 1 carton / 2 tablet, film coated in 1 blister pack of Leader Sleep Aid, a human over the counter drug labeled by Cardinal Health 110, Llc. Dba Leader. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 70000-0467 included in the NDC Directory?

    Yes, Leader Sleep Aid with product code 70000-0467 is active and included in the NDC Directory. The product was first marketed by Cardinal Health 110, Llc. Dba Leader on February 25, 2019 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 70000-0467-1?

    The 11-digit format is 70000046701. 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 5-4-1 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
    5-4-170000-0467-15-4-270000-0467-01