Ibuprofen Tablet, Coated
NDC Package 57344-212-05

11-digit billing NDC: 57344021205
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Ibuprofen tablets is ■  do not take more than directed■  the smallest effective dose should be used■ adults and children 12 years and older:    ■ take 1 caplet every 4 to 6 hours while symptoms persist   ■ if pain or fever does not respond to 1 caplet, 2 caplets may be used   ■ do not exceed 6 caplets in 24 hours, unless directed by a doctor■ children under 12 years:  ask a doctor. This formulation utilizes a tablet, coated delivery system. Marketed by Aaa Pharmaceutical, Inc., this product is identified by NDC 57344-212 and is authorized under FDA application ANDA202312.

Identification & Billing

NDC Package Code
57344-212-05
Package Description
500 TABLET, COATED in 1 PACKAGE
Product Code
57344-212
11-Digit Billing Format
57344021205

Clinical Specifications

Proprietary Name
Ibuprofen
Non-Proprietary Name
Ibuprofen
Substance Name
Ibuprofen
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
IBUPROFEN 200 mg/1
Pharmacologic Class
Usage Information
■  do not take more than directed■  the smallest effective dose should be used■ adults and children 12 years and older:    ■ take 1 caplet every 4 to 6 hours while symptoms persist   ■ if pain or fever does not respond to 1 caplet, 2 caplets may be used   ■ do not exceed 6 caplets in 24 hours, unless directed by a doctor■ children under 12 years:  ask a doctor

Regulatory & Marketing

Labeler Name
Aaa Pharmaceutical, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA202312
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-16-2026
Listing Expiration
12-31-2027
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 (57344-212). Click a package code to view its specific billing and regulatory data.

57344-212-03
1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, COATED 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 57344-212-05 identifies a specific commercial package of 500 tablet, coated in 1 package of Ibuprofen, a human over the counter drug labeled by Aaa Pharmaceutical, Inc.. This tablet, coated 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 Aaa Pharmaceutical, Inc. on February 16, 2026. The current certification is valid through December 31, 2027.

How is this Aaa Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57344021205. 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)
57344-212-05
11-Digit CMS (5-4-2)
57344-0212-05

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