Topcare Sleep Aid Tablet
NDC Package 76162-159-67

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

Topcare 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 Topco Associates Llc, this product is identified by NDC 76162-159 and is authorized under FDA application ANDA040167.

Identification & Billing

NDC Package Code
76162-159-67
Package Description
48 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
Product Code
76162-159
11-Digit Billing Format
76162015967
RxNorm Crosswalk
RxCUI: 1101446 - doxylamine succinate 25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Topcare 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
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
ANDA040167
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-16-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76162-159). Click a package code to view its specific billing and regulatory data.

76162-159-62
24 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK

* 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 76162-159-67 identifies a specific commercial package of 48 blister pack in 1 carton / 1 tablet in 1 blister pack of Topcare Sleep Aid, a human over the counter drug labeled by Topco Associates Llc. 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 Topco Associates Llc on June 16, 2023. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76162015967. 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)
76162-159-67
11-Digit CMS (5-4-2)
76162-0159-67

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