Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg Tablet
NDC Package 63548-0197-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg (ibuprofen, diphenhydramine citrate) tablets is 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. This formulation utilizes a tablet delivery system. Marketed by Pld Acquisitions Llc Dba Av�ma Pharma Solutions, this product is identified by NDC 63548-0197 and is authorized under FDA application ANDA211404.

Identification & Billing

NDC Package Code
63548-0197-2
Package Description
1 BOTTLE, PLASTIC in 1 BOX / 20 TABLET in 1 BOTTLE, PLASTIC
Product Code
63548-0197
11-Digit Billing Format
63548019702
RxNorm Crosswalk
  • RxCUI: 895664 - ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral Tablet
  • RxCUI: 895664 - diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral Tablet

Clinical Specifications

Proprietary Name
Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg
Non-Proprietary Name
Ibuprofen, Diphenhydramine Citrate
Substance Name
Diphenhydramine Citrate; Ibuprofen
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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

Regulatory & Marketing

Labeler Name
Pld Acquisitions Llc Dba Av�ma Pharma Solutions
Product Type
Human Otc Drug
FDA Application #
ANDA211404
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-11-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63548-0197). Click a package code to view its specific billing and regulatory data.

63548-0197-3
300 TABLET in 1 BOTTLE, PLASTIC
63548-0197-8
8 TABLET in 1 BOTTLE, PLASTIC

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63548-0197-2 identifies a specific commercial package of 1 bottle, plastic in 1 box / 20 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. This tablet is formulated for oral use and contains diphenhydramine citrate; ibuprofen as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Pld Acquisitions Llc Dba Av�ma Pharma Solutions on April 11, 2024. The current certification is valid through December 31, 2026.

How is this Pld Acquisitions Llc Dba Av�ma Pharma Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63548019702. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
63548-0197-2
11-Digit CMS (5-4-2)
63548-0197-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.