Ibuprofen And Pseudoephedrine Hydrochloride Tablet, Coated
NDC Package 58602-839-13

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

Package Information

Ibuprofen And Pseudoephedrine Hydrochloride tablets is do not take more than directedthe smallest effective dose should be usedadults and children 12 years of age and over:take 1 caplet every 4 to 6 hours while symptoms persist. This formulation utilizes a tablet, coated delivery system. Marketed by Aurohealth Llc, this product is identified by NDC 58602-839 and is authorized under FDA application ANDA213565.

Identification & Billing

NDC Package Code
58602-839-13
Package Description
4 BLISTER PACK in 1 CARTON / 8 TABLET, COATED in 1 BLISTER PACK
Product Code
58602-839
11-Digit Billing Format
58602083913
RxNorm Crosswalk
  • RxCUI: 1299021 - ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral Tablet
  • RxCUI: 1299021 - ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet

Clinical Specifications

Proprietary Name
Ibuprofen And Pseudoephedrine Hydrochloride
Non-Proprietary Name
Ibuprofen And Pseudoephedrine Hydrochloride
Substance Name
Ibuprofen; Pseudoephedrine Hydrochloride
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)
Pharmacologic Class
Usage Information
Do not take more than directedthe smallest effective dose should be usedadults and children 12 years of age and over:take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.do not use more than 6 caplets in any 24-hour period unless directed by a doctorchildren under 12 years of age: do not useOther informationstore at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40°C (104°F).read all warnings and directions before use. Keep carton.

Regulatory & Marketing

Labeler Name
Aurohealth Llc
Product Type
Human Otc Drug
FDA Application #
ANDA213565
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-10-2023
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 58602-839-13 identifies a specific commercial package of 4 blister pack in 1 carton / 8 tablet, coated in 1 blister pack of Ibuprofen And Pseudoephedrine Hydrochloride, a human over the counter drug labeled by Aurohealth Llc. This tablet, coated is formulated for oral use and contains ibuprofen; pseudoephedrine hydrochloride 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 Aurohealth Llc on March 10, 2023. The current certification is valid through December 31, 2026.

How is this Aurohealth Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58602083913. 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)
58602-839-13
11-Digit CMS (5-4-2)
58602-0839-13

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