Topcare Ibuprofen
NDC Package 36800-897-34

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Topcare Ibuprofen is •this product does not contain directions or complete warnings for adult use•do not give more than directed•shake well before using•mL = milliliter•find right dose on chart. Marketed by Topco Associates Llc, this product is identified by NDC 36800-897 and is authorized under FDA application ANDA074937.

Identification & Billing

NDC Package Code
36800-897-34
Package Description
2 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
Product Code
36800-897
11-Digit Billing Format
36800089734
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Topcare Ibuprofen
Dosage Form
-
Usage Information
•this product does not contain directions or complete warnings for adult use•do not give more than directed•shake well before using•mL = 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 every 6-8 hours•do not use more than 4 times a day •replace original bottle cap to maintain child resistance•wash dosage cup after each useDosing ChartWeight (lb)Age (yr)Dose (mL)**under 24 lbsunder 2 yearsask a doctor24-35 lbs2-3 years5 mL36-47 lbs4-5 years7.5 mL48-59 lbs6-8 years10 mL60-71 lbs9-10 years12.5 mL72-95 lbs11 years  15 mL**or as directed by a doctor

Regulatory & Marketing

Labeler Name
Topco Associates Llc
FDA Application #
ANDA074937
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-31-1998
Listing Expiration
12-31-2025
Exclude Flag
I
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 (36800-897). Click a package code to view its specific billing and regulatory data.

36800-897-26
1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
36800-897-28
1 BOTTLE in 1 CARTON / 150 mL in 1 BOTTLE

* 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 36800-897-34 identifies a specific commercial package of 2 bottle in 1 carton / 120 ml in 1 bottle of Topcare Ibuprofen, labeled by Topco Associates Llc. 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 Topco Associates Llc on December 31, 1998. The current certification is valid through December 31, 2025.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800089734. 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)
36800-897-34
11-Digit CMS (5-4-2)
36800-0897-34

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