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  5. NDC Package Code: 63548-0197-8 Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg

NDC Package 63548-0197-8 Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg

Ibuprofen,Diphenhydramine Citrate Tablet 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:
63548-0197-8
Package Description:
8 TABLET in 1 BOTTLE, PLASTIC
Product Code:
63548-0197
Proprietary Name:
Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg
Non-Proprietary Name:
Ibuprofen, Diphenhydramine Citrate
Substance Name:
Diphenhydramine Citrate; Ibuprofen
Usage Information:
Do not take more than directedadults and childlren 12 years and over: take 2 caplets at bedtime do not take more than 2 caplets in 24 hours
11-Digit NDC Billing Format:
63548019708
NDC to RxNorm Crosswalk:
  • RxCUI: 895664 - ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral Tablet
  • RxCUI: 895664 - diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Pld Acquisitions Llc Dba Av�ma Pharma Solutions
    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 CITRATE 38 mg/1
  • IBUPROFEN 200 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:
    ANDA211404
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-11-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    63548-0197-21 BOTTLE, PLASTIC in 1 BOX / 20 TABLET in 1 BOTTLE, PLASTIC
    63548-0197-3300 TABLET in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63548-0197-8?

    The NDC Packaged Code 63548-0197-8 is assigned to a package of 8 tablet in 1 bottle, plastic of Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg, a human over the counter drug labeled by Pld Acquisitions Llc Dba Av�ma Pharma Solutions. The product's dosage form is tablet and is administered via oral form.

    Is NDC 63548-0197 included in the NDC Directory?

    Yes, Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg with product code 63548-0197 is active and included in the NDC Directory. The product was first marketed by Pld Acquisitions Llc Dba Av�ma Pharma Solutions on April 11, 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 63548-0197-8?

    The 11-digit format is 63548019708. 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
    5-4-163548-0197-85-4-263548-0197-08