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  5. NDC Package Code: 0280-1620-20 Alka-seltzer Plus Maximum Strength Severe Sinus, Allergy And Cough

NDC Package 0280-1620-20 Alka-seltzer Plus Maximum Strength Severe Sinus, Allergy And Cough

Acetaminophen,Dextromethorphan Hydrobromide,Doxylamine Succinate,Phenylephrine - 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:
0280-1620-20
Package Description:
2 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code:
0280-1620
Proprietary Name:
Alka-seltzer Plus Maximum Strength Severe Sinus, Allergy And Cough
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride
Usage Information:
Directions· do not take more than the recommended dose· adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.· children under 12 years: do not use
11-Digit NDC Billing Format:
00280162020
NDC to RxNorm Crosswalk:
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1297288 - APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Bayer Healthcare 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):
  • ACETAMINOPHEN 325 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
  • DOXYLAMINE SUCCINATE 6.25 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Antihistamine - [EPC] (Established Pharmacologic Class)
  • Histamine Receptor Antagonists - [MoA] (Mechanism of Action)
  • Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
  • Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    06-26-2017
    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.

    Frequently Asked Questions

    What is NDC 0280-1620-20?

    The NDC Packaged Code 0280-1620-20 is assigned to a package of 2 blister pack in 1 carton / 10 capsule, liquid filled in 1 blister pack of Alka-seltzer Plus Maximum Strength Severe Sinus, Allergy And Cough, a human over the counter drug labeled by Bayer Healthcare Llc.. The product's dosage form is capsule, liquid filled and is administered via oral form.

    Is NDC 0280-1620 included in the NDC Directory?

    Yes, Alka-seltzer Plus Maximum Strength Severe Sinus, Allergy And Cough with product code 0280-1620 is active and included in the NDC Directory. The product was first marketed by Bayer Healthcare Llc. on June 26, 2017 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 0280-1620-20?

    The 11-digit format is 00280162020. 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 4-4-2 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
    4-4-20280-1620-205-4-200280-1620-20