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  5. NDC Package Code: 62207-814-38 Naproxen Sodium And Diphenhydramine Hcl

NDC Package 62207-814-38 Naproxen Sodium And Diphenhydramine Hcl

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
62207-814-38
Package Description:
37500 TABLET, FILM COATED in 1 POUCH
Product Code:
62207-814
Proprietary Name:
Naproxen Sodium And Diphenhydramine Hcl
Non-Proprietary Name:
Naproxen Sodium And Diphenhydramine Hcl
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 bedtime • do not take more than 2 caplets in 24 hours • if taken with food, this product may take longer to work
11-Digit NDC Billing Format:
62207081438
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:
    Granules India Ltd
    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
  • 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:
    02-20-2021
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    62207-814-397500 TABLET, FILM COATED in 1 POUCH
    62207-814-47500 TABLET, FILM COATED in 1 BOTTLE
    62207-814-951 BOTTLE in 1 CARTON / 20 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 62207-814-38?

    The NDC Packaged Code 62207-814-38 is assigned to a package of 37500 tablet, film coated in 1 pouch of Naproxen Sodium And Diphenhydramine Hcl, a human over the counter drug labeled by Granules India Ltd. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 62207-814 included in the NDC Directory?

    Yes, Naproxen Sodium And Diphenhydramine Hcl with product code 62207-814 is active and included in the NDC Directory. The product was first marketed by Granules India Ltd on February 20, 2021 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 62207-814-38?

    The 11-digit format is 62207081438. 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
    5-3-262207-814-385-4-262207-0814-38