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  5. NDC Package Code: 80148-001-02 Sambrosa Night

NDC Package 80148-001-02 Sambrosa Night

Doxylamine Succinate Syrup Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
80148-001-02
Package Description:
1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
Product Code:
80148-001
Proprietary Name:
Sambrosa Night
Non-Proprietary Name:
Doxylamine Succinate
Substance Name:
Doxylamine Succinate
Usage Information:
Take only as directed use 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
11-Digit NDC Billing Format:
80148000102
Product Type:
Human Otc Drug
Labeler Name:
Lelypharma Bv
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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DOXYLAMINE SUCCINATE 9.78 mg/3mL
    • Pharmacologic Class(es):
  • Antihistamine - [EPC] (Established Pharmacologic Class)
  • Histamine Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    01-10-2020
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    80148-001-011 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE
    80148-001-031 BOTTLE in 1 CARTON / 300 mL in 1 BOTTLE
    80148-001-043 mL in 1 POUCH

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 80148-001-02?

    The NDC Packaged Code 80148-001-02 is assigned to a package of 1 bottle in 1 carton / 30 ml in 1 bottle of Sambrosa Night, a human over the counter drug labeled by Lelypharma Bv. The product's dosage form is syrup and is administered via oral form.

    Is NDC 80148-001 included in the NDC Directory?

    Yes, Sambrosa Night with product code 80148-001 is active and included in the NDC Directory. The product was first marketed by Lelypharma Bv on January 10, 2020 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 80148-001-02?

    The 11-digit format is 80148000102. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-280148-001-025-4-280148-0001-02