NDC Package 80148-001-01 Sambrosa Night

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:

80148-001-01

Package Description:

1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE

Product Code:

80148-001

Proprietary Name:

Sambrosa Night

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:

80148000101

NDC to RxNorm Crosswalk:

RxCUI: 2390292 - doxylamine succinate 9.78 MG in 3 mL Oral Solution
RxCUI: 2390292 - doxylamine succinate 3.26 MG/ML Oral Solution
RxCUI: 2390292 - doxylamine succinate 9.78 MG per 3 mL Oral Solution

Labeler Name:

Lelypharma Bv

Sample Package:

FDA Application Number:

M012

Marketing Category:

OTC MONOGRAPH DRUG -

Start Marketing Date:

01-10-2020

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

80148 - Lelypharma Bv
- 80148-001 - Sambrosa
  - 80148-001-01 - 1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE

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 Code	Package Description
80148-001-02	1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
80148-001-03	1 BOTTLE in 1 CARTON / 300 mL in 1 BOTTLE
80148-001-04	3 mL in 1 POUCH

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 80148-001-01?

The NDC Packaged Code 80148-001-01 is assigned to a package of 1 bottle in 1 carton / 100 ml in 1 bottle of Sambrosa Night, labeled by Lelypharma Bv. The product's dosage form is and is administered via form.

Is NDC 80148-001 included in the NDC Directory?

No, Sambrosa Night with product code 80148-001 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. 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 80148-001-01?

The 11-digit format is 80148000101. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	80148-001-01	5-4-2	80148-0001-01

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