Sambrosa Syrup
NDC Package 60665-003-01

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

Sambrosa (doxylamine succinate) syrups is take only as directeduse provided measurement spoon, look at calibration marks. This formulation utilizes a syrup delivery system. Marketed by Sambrosa Care, Inc., this product is identified by NDC 60665-003 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
60665-003-01
Package Description
1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE
Product Code
60665-003
11-Digit Billing Format
60665000301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sambrosa Night
Non-Proprietary Name
Doxylamine Succinate
Substance Name
Doxylamine Succinate
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DOXYLAMINE SUCCINATE 9.78 mg/3mL
Pharmacologic Class
Usage Information
Take only as directeduse provided measurement spoon, look at calibration marks. A full spoon equals 5 mL.adults and children 6 years of age and over: take 3mL every 4 to 6 hours. Do not exceed 35mL in 24 hours.children under 6 years of age: consult a physician

Regulatory & Marketing

Labeler Name
Sambrosa Care, Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-10-2020
Listing Expiration
12-31-2027
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 (60665-003). Click a package code to view its specific billing and regulatory data.

60665-003-02
1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
60665-003-03
1 BOTTLE in 1 CARTON / 300 mL in 1 BOTTLE
60665-003-04
3 mL in 1 POUCH

* 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 60665-003-01 identifies a specific commercial package of 1 bottle in 1 carton / 100 ml in 1 bottle of Sambrosa Night, a human over the counter drug labeled by Sambrosa Care, Inc.. This syrup 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 Sambrosa Care, Inc. on January 10, 2020. The current certification is valid through December 31, 2027.

How is this Sambrosa Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60665000301. 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)
60665-003-01
11-Digit CMS (5-4-2)
60665-0003-01

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