Concentrated Ibuprofen Infants Suspension/ Drops
NDC Package 83324-005-30

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

Package Information

Concentrated Ibuprofen Infants (ibuprofen) suspension/ dropses is ibuprofen is used to help relieve mild to moderate pain. This formulation utilizes a suspension/ drops delivery system. Marketed by Chain Drug Marketing Association Inc., this product is identified by NDC 83324-005 and is authorized under FDA application ANDA210755.

Identification & Billing

NDC Package Code
83324-005-30
Package Description
1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
Product Code
83324-005
11-Digit Billing Format
83324000530
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Concentrated Ibuprofen Infants
Non-Proprietary Name
Ibuprofen
Substance Name
Ibuprofen
Dosage Form
Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
IBUPROFEN 50 mg/1.25mL
Pharmacologic Class
Usage Information
Ibuprofen is used to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

Regulatory & Marketing

Labeler Name
Chain Drug Marketing Association Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA210755
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-03-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83324-005-30 identifies a specific commercial package of 1 bottle in 1 carton / 30 ml in 1 bottle of Concentrated Ibuprofen Infants, a human over the counter drug labeled by Chain Drug Marketing Association Inc.. This suspension/ drops is formulated for oral use and contains 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 Chain Drug Marketing Association Inc. on November 03, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ibuprofen is used to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

How is this Chain Drug Marketing Association Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83324000530. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-3-2)
83324-005-30
11-Digit CMS (5-4-2)
83324-0005-30

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