NDC Package 68016-878-16 Nighttime Cold And Flu Relief

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

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:
68016-878-16
Package Description:
8 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK
Product Code:
Proprietary Name:
Nighttime Cold And Flu Relief
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hbr And Doxylamine Succinate
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate
Usage Information:
Take only as directed – see Overdose warningdo not exceed 4 doses per 24 hoursadults & children 12 yrs & over 2 capsules with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
11-Digit NDC Billing Format:
68016087816
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:
    Chain Drug Consortium, Llc
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    07-12-2019
    Listing Expiration Date:
    12-31-2024
    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
    68016-878-2412 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68016-878-16?

    The NDC Packaged Code 68016-878-16 is assigned to a package of 8 blister pack in 1 carton / 2 capsule in 1 blister pack of Nighttime Cold And Flu Relief, a human over the counter drug labeled by Chain Drug Consortium, Llc. The product's dosage form is capsule and is administered via oral form.

    Is NDC 68016-878 included in the NDC Directory?

    Yes, Nighttime Cold And Flu Relief with product code 68016-878 is active and included in the NDC Directory. The product was first marketed by Chain Drug Consortium, Llc on July 12, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 68016-878-16?

    The 11-digit format is 68016087816. 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
    5-3-268016-878-165-4-268016-0878-16