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  5. NDC Package Code: 55758-042-08 Sanatos Nighttime

NDC Package 55758-042-08 Sanatos Nighttime

Acetaminophen,Dextromethorphan Hbr,Doxylamine Succinate Capsule, Liquid Filled Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
55758-042-08
Package Description:
1 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code:
55758-042
Proprietary Name:
Sanatos Nighttime
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate
Usage Information:
Do not exceed recommended dosage (see Liver warning)do not exceed 4 doses in a 24 hour period or as directed by a doctorAge Doseadults and children 12 years and older 2 softgels every 6 hourschildren 4 to under 12 yearsconsult a doctorchildren under 4 years do not use
11-Digit NDC Billing Format:
55758004208
NDC to RxNorm Crosswalk:
  • RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule
  • RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule
  • RxCUI: 1094549 - APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule
Product Type:
Human Otc Drug
Labeler Name:
Pharmadel Llc
Dosage Form:
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
M012
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
04-04-2023
Listing Expiration Date:
12-31-2026
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.

Frequently Asked Questions

What is NDC 55758-042-08?

The NDC Packaged Code 55758-042-08 is assigned to a package of 1 blister pack in 1 carton / 8 capsule, liquid filled in 1 blister pack of Sanatos Nighttime, a human over the counter drug labeled by Pharmadel Llc. The product's dosage form is capsule, liquid filled and is administered via oral form.

Is NDC 55758-042 included in the NDC Directory?

Yes, Sanatos Nighttime with product code 55758-042 is active and included in the NDC Directory. The product was first marketed by Pharmadel Llc on April 04, 2023 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 55758-042-08?

The 11-digit format is 55758004208. 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
5-3-255758-042-085-4-255758-0042-08