Caremotion
NDC Package 80415-004-01

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.

Caremotion is take preferably at bedtime or as directed by a doctoragestarting dosagemaximum dosageadults and children 12 years of age and over2 tablets once a day4 tablets twice a daychildren 6 to under 12years1 tablet once a day2 tablets twice a daychildren 2 to under 6years1 /2 tablet once a day1 tablet twice a daychildren under 2 yearsask a doctorask a doctor. Marketed by Us Drugs Inc., this product is identified by NDC 80415-004 and is authorized under FDA application part334.

Identification & Billing

NDC Package Code
80415-004-01
Package Description
600 TABLET in 1 BOTTLE
Product Code
80415-004
11-Digit Billing Format
80415000401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Caremotion
Dosage Form
-
Usage Information
Take preferably at bedtime or as directed by a doctoragestarting dosagemaximum dosageadults and children 12 years of age and over2 tablets once a day4 tablets twice a daychildren 6 to under 12years1 tablet once a day2 tablets twice a daychildren 2 to under 6years1 /2 tablet once a day1 tablet twice a daychildren under 2 yearsask a doctorask a doctor

Regulatory & Marketing

Labeler Name
Us Drugs Inc.
FDA Application #
part334
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
06-14-2021
Listing Expiration
12-31-2022
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 (80415-004). Click a package code to view its specific billing and regulatory data.

80415-004-02
800 TABLET 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 80415-004-01 identifies a specific commercial package of 600 tablet in 1 bottle of Caremotion, labeled by Us Drugs Inc.. 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 Us Drugs Inc. on June 14, 2021. The current certification is valid through December 31, 2022.

How is this Us Drugs Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80415000401. 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)
80415-004-01
11-Digit CMS (5-4-2)
80415-0004-01

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