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  5. NDC Package Code: 69168-446-39 Nighttime Sleep Aid

NDC Package 69168-446-39 Nighttime Sleep Aid

Liquid 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:
69168-446-39
Package Description:
354 mL in 1 BOTTLE
Product Code:
69168-446
Proprietary Name:
Nighttime Sleep Aid
Non-Proprietary Name:
Nighttime Sleep Aid
Substance Name:
Diphenhydramine Hydrochloride
Usage Information:
Take only as recommendeduse dosage cup or tablespoonAge                                   DoseAdults & children12 years & over: One Dose = 2 tablespoons (30 mL) at bed time if needed or as directed by a doctor  Children under 12 yrs:   Do not use
11-Digit NDC Billing Format:
69168044639
NDC to RxNorm Crosswalk:
  • RxCUI: 1248354 - diphenhydrAMINE HCl 50 MG in 30 mL Oral Solution
  • RxCUI: 1248354 - diphenhydramine hydrochloride 1.67 MG/ML Oral Solution
  • RxCUI: 1248354 - diphenhydramine HCl 1.667 MG/ML Oral Solution
  • RxCUI: 1248354 - diphenhydramine HCl 50 MG per 30 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Allegiant Health
    Dosage Form:
    Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL
    • 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:
    M010
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    01-16-2024
    Listing Expiration Date:
    12-31-2025
    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 69168-446-39?

    The NDC Packaged Code 69168-446-39 is assigned to a package of 354 ml in 1 bottle of Nighttime Sleep Aid, a human over the counter drug labeled by Allegiant Health. The product's dosage form is liquid and is administered via oral form.

    Is NDC 69168-446 included in the NDC Directory?

    Yes, Nighttime Sleep Aid with product code 69168-446 is active and included in the NDC Directory. The product was first marketed by Allegiant Health on January 16, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 69168-446-39?

    The 11-digit format is 69168044639. 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
    5-3-269168-446-395-4-269168-0446-39