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  5. NDC Package Code: 49348-104-04 Sunmark Cold And Flu Severe

NDC Package 49348-104-04 Sunmark Cold And Flu Severe

Acetaminophen,Dextromethorphan Hbr,Guaifenesin,Phenylephrine Hcl Tablet, Film Coated 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:
49348-104-04
Package Description:
12 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
49348-104
Proprietary Name:
Sunmark Cold And Flu Severe
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
•do not take more than directed (see overdose warning)adults and children 12 years and over•take 2 caplets every 4 hours•swallow whole – do not crush, chew or dissolve•do not take more than 10 caplets in 24 hourschildren under 12 yearsask a doctor
11-Digit NDC Billing Format:
49348010404
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
12 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1110988 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1110988 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1110988 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Strategic Sourcing Services Llc
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 325 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
  • GUAIFENESIN 200 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [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:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    03-19-2008
    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 49348-104-04?

    The NDC Packaged Code 49348-104-04 is assigned to a package of 12 blister pack in 1 carton / 2 tablet, film coated in 1 blister pack of Sunmark Cold And Flu Severe, a human over the counter drug labeled by Strategic Sourcing Services Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 49348-104 included in the NDC Directory?

    Yes, Sunmark Cold And Flu Severe with product code 49348-104 is active and included in the NDC Directory. The product was first marketed by Strategic Sourcing Services Llc on March 19, 2008 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 NDC billing unit for package 49348-104-04?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 12.

    What is the 11-digit format for NDC 49348-104-04?

    The 11-digit format is 49348010404. 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
    5-3-249348-104-045-4-249348-0104-04