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  5. NDC Package Code: 45802-122-60 Loratadine D

NDC Package 45802-122-60 Loratadine D

Loratadine,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:
45802-122-60
Package Description:
20 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
45802-122
Proprietary Name:
Loratadine D
Non-Proprietary Name:
Loratadine, 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 every 12 hours; not more than 2 tablets in 24 hourschildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor
11-Digit NDC Billing Format:
45802012260
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
20 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1242399 - pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1242399 - 12 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet
  • RxCUI: 1242399 - loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Padagis Israel Pharmaceuticals Ltd
    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 5 mg/1
  • PSEUDOEPHEDRINE SULFATE 120 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:
    ANDA076050
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-10-2018
    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
    45802-122-4610 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
    45802-122-6530 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 45802-122-60?

    The NDC Packaged Code 45802-122-60 is assigned to a package of 20 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack of Loratadine D, a human over the counter drug labeled by Padagis Israel Pharmaceuticals Ltd. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 45802-122 included in the NDC Directory?

    Yes, Loratadine D with product code 45802-122 is active and included in the NDC Directory. The product was first marketed by Padagis Israel Pharmaceuticals Ltd on April 10, 2018 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 45802-122-60?

    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 20.

    What is the 11-digit format for NDC 45802-122-60?

    The 11-digit format is 45802012260. 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
    5-3-245802-122-605-4-245802-0122-60