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  5. NDC Package Code: 49348-543-01 Loratadine And Pseudoephedrine Sulfate

NDC Package 49348-543-01 Loratadine And Pseudoephedrine Sulfate

Tablet, Film Coated, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
49348-543-01
Package Description:
10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
49348-543
Proprietary Name:
Loratadine And Pseudoephedrine Sulfate
Non-Proprietary Name:
Loratadine And Pseudoephedrine Sulfate
Substance Name:
Loratadine; Pseudoephedrine Sulfate
Usage Information:
Do not divide, crush, chew or dissolve the tabletadults and children 12 years and over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hourschildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor
11-Digit NDC Billing Format:
49348054301
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
10 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1117562 - pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1117562 - 24 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral Tablet
  • RxCUI: 1117562 - loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Strategic Sourcing Services
    Dosage Form:
    Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • LORATADINE 10 mg/1
  • PSEUDOEPHEDRINE SULFATE 240 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
  • alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA076557
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-17-2004
    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
    49348-543-5715 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 49348-543-01?

    The NDC Packaged Code 49348-543-01 is assigned to a package of 10 tablet, film coated, extended release in 1 blister pack of Loratadine And Pseudoephedrine Sulfate, a human over the counter drug labeled by Strategic Sourcing Services. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 49348-543 included in the NDC Directory?

    Yes, Loratadine And Pseudoephedrine Sulfate with product code 49348-543 is active and included in the NDC Directory. The product was first marketed by Strategic Sourcing Services on November 17, 2004 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 49348-543-01?

    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 10.

    What is the 11-digit format for NDC 49348-543-01?

    The 11-digit format is 49348054301. 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
    5-3-249348-543-015-4-249348-0543-01