Careone Nighttime Sleep Aid Tablet
NDC Package 41520-634-64

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

Package Information

Careone Nighttime Sleep Aid (doxylamine succinate) tablets is •adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor•children under 12 years of age: do not use. This formulation utilizes a tablet delivery system. Marketed by American Sales Company, this product is identified by NDC 41520-634 and is authorized under FDA application ANDA040167.

Identification & Billing

NDC Package Code
41520-634-64
Package Description
32 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
Product Code
41520-634
11-Digit Billing Format
41520063464
RxNorm Crosswalk
RxCUI: 1101446 - doxylamine succinate 25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Careone Nighttime Sleep Aid
Non-Proprietary Name
Doxylamine Succinate
Substance Name
Doxylamine Succinate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DOXYLAMINE SUCCINATE 25 mg/1
Pharmacologic Class
Usage Information
•adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor•children under 12 years of age: do not use

Regulatory & Marketing

Labeler Name
American Sales Company
Product Type
Human Otc Drug
FDA Application #
ANDA040167
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-06-2016
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 41520-634-64 identifies a specific commercial package of 32 blister pack in 1 carton / 1 tablet in 1 blister pack of Careone Nighttime Sleep Aid, a human over the counter drug labeled by American Sales Company. This tablet is formulated for oral use and contains doxylamine succinate 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 American Sales Company on May 06, 2016. The current certification is valid through December 31, 2026.

How is this American Sales Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41520063464. 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)
41520-634-64
11-Digit CMS (5-4-2)
41520-0634-64

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