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  5. NDC Package Code: 21130-814-05 Naproxen Sodium Diphenhydramine Hydrochloride

NDC Package 21130-814-05 Naproxen Sodium 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:
21130-814-05
Package Description:
50 TABLET in 1 BOTTLE
Product Code:
21130-814
Proprietary Name:
Naproxen Sodium Diphenhydramine Hydrochloride
Non-Proprietary Name:
Naproxen Sodium Diphenhydramine Hydrochloride
Substance Name:
Diphenhydramine Hydrochloride; Naproxen Sodium
Usage Information:
■ do not take more than directed■ drink a full glass of water with each dose■ adults and children 12 years and over:take 2 caplets at bedtimedo not take more than 2 caplets in 24 hoursif taken with food, this product may take longer to work
11-Digit NDC Billing Format:
21130081405
NDC to RxNorm Crosswalk:
  • RxCUI: 1550957 - diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral Tablet
  • RxCUI: 1550957 - diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Safeway
    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
  • NAPROXEN SODIUM 220 mg/1
    • Pharmacologic Class(es):
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA213663
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-30-2023
    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 21130-814-05?

    The NDC Packaged Code 21130-814-05 is assigned to a package of 50 tablet in 1 bottle of Naproxen Sodium Diphenhydramine Hydrochloride, a human over the counter drug labeled by Safeway. The product's dosage form is tablet and is administered via oral form.

    Is NDC 21130-814 included in the NDC Directory?

    Yes, Naproxen Sodium Diphenhydramine Hydrochloride with product code 21130-814 is active and included in the NDC Directory. The product was first marketed by Safeway on June 30, 2023 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 21130-814-05?

    The 11-digit format is 21130081405. 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
    5-3-221130-814-055-4-221130-0814-05