Ibuprofen
NDC Package 81522-700-04

11-digit billing NDC: 81522070004
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Ibuprofen is this product does not contain directions or complete warnings for adult usedo not give more than directedshake well before usingmL = milliliter find right dose on chart. Marketed by Fsa Store Inc. (caring Mills), this product is identified by NDC 81522-700 and is authorized under FDA application ANDA074916.

Identification & Billing

NDC Package Code
81522-700-04
Package Description
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code
81522-700
11-Digit Billing Format
81522070004

Clinical Specifications

Proprietary Name
Ibuprofen Childrens
Dosage Form
-
Usage Information
This product does not contain directions or complete warnings for adult usedo not give more than directedshake well before usingmL = milliliter find right dose on chart. if possible, use weight to dose; otherwise use age.use only enclosed dosing cup. Do not use any other dosing device.if needed, repeat dose ever 6-8 hoursdo not use more than 4 times a dayreplace original bottle cap to maintain child resistance                       Dosing ChartWeight (lb)Age (yr)Dose (mL)*under 24under 2 yearsask a doctor24-35 lbs2-3 years5 mL36-47 lbs4-5 years7.5 mL48-59 lbs6-8 years 10 mL60-71 lbs9-10 years12.5 mL72-95 lbs11 years15 mL*or as directed by a doctor

Regulatory & Marketing

Labeler Name
Fsa Store Inc. (caring Mills)
FDA Application #
ANDA074916
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-21-2022
End Marketing Date
09-01-2026
Listing Expiration
09-01-2026
Exclude Flag
D
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 81522-700-04 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Ibuprofen Childrens, labeled by Fsa Store Inc. (caring Mills). This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Fsa Store Inc. (caring Mills) on April 21, 2022. The current certification is valid through September 01, 2026.

How is this Fsa Store Inc. (caring Mills) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81522070004. 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)
81522-700-04
11-Digit CMS (5-4-2)
81522-0700-04

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