Ibuprofen And Diphenhydramine Citrate Tablet, Coated
NDC Package 58602-867-92

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 And Diphenhydramine Citrate tablets is do not take more than directedadults and children 12 years and over: take 2 capsules at bedtimedo not take more than 2 capsules in 24 hoursOther informationread all warnings and directions before use. This formulation utilizes a tablet, coated delivery system. Marketed by Aurohealth Llc, this product is identified by NDC 58602-867 and is authorized under FDA application ANDA216204.

Identification & Billing

NDC Package Code
58602-867-92
Package Description
180 TABLET, COATED in 1 BOTTLE, PLASTIC
Product Code
58602-867
11-Digit Billing Format
58602086792
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 And Diphenhydramine Citrate
Non-Proprietary Name
Ibuprofen And Diphenhydramine Citrate
Substance Name
Diphenhydramine Citrate; 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)
Pharmacologic Class
Usage Information
Do not take more than directedadults and children 12 years and over: take 2 capsules at bedtimedo not take more than 2 capsules in 24 hoursOther informationread all warnings and directions before use. Keep carton.store at 20° to 25°C (68° to 77°F)avoid excessive heat above 40°C (104°F)

Regulatory & Marketing

Labeler Name
Aurohealth Llc
Product Type
Human Otc Drug
FDA Application #
ANDA216204
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-31-2022
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 (58602-867). Click a package code to view its specific billing and regulatory data.

58602-867-09
1 BOTTLE in 1 CARTON / 30 TABLET, COATED in 1 BOTTLE
58602-867-12
1 BOTTLE in 1 CARTON / 40 TABLET, COATED in 1 BOTTLE
58602-867-14
1 BOTTLE in 1 CARTON / 50 TABLET, COATED in 1 BOTTLE
58602-867-18
1 BOTTLE in 1 CARTON / 80 TABLET, COATED in 1 BOTTLE
58602-867-21
1 BOTTLE in 1 CARTON / 100 TABLET, COATED in 1 BOTTLE
58602-867-23
1 BOTTLE in 1 CARTON / 120 TABLET, COATED in 1 BOTTLE
58602-867-27
140 TABLET, COATED in 1 BOTTLE
58602-867-32
180 TABLET, COATED in 1 BOTTLE
58602-867-34
200 TABLET, COATED in 1 BOTTLE
58602-867-46
140 TABLET, COATED in 1 BOTTLE, PLASTIC
58602-867-70
1 BOTTLE, PLASTIC in 1 CARTON / 40 TABLET, COATED in 1 BOTTLE, PLASTIC
58602-867-72
1 BOTTLE, PLASTIC in 1 CARTON / 80 TABLET, COATED in 1 BOTTLE, PLASTIC
58602-867-73
1 BOTTLE in 1 CARTON / 20 TABLET, COATED in 1 BOTTLE
58602-867-78
1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, COATED in 1 BOTTLE, PLASTIC
58602-867-80
200 TABLET, COATED in 1 BOTTLE, PLASTIC
58602-867-97
120 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 58602-867-92 identifies a specific commercial package of 180 tablet, coated in 1 bottle, plastic of Ibuprofen And Diphenhydramine Citrate, a human over the counter drug labeled by Aurohealth Llc. This tablet, coated 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 Aurohealth Llc on May 31, 2022. 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: 58602086792. 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)
58602-867-92
11-Digit CMS (5-4-2)
58602-0867-92

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