Loratadine And Pseudoephedrine Tablet, Extended Release
NDC Package 46122-383-22

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Loratadine And Pseudoephedrine tablets is •do not divide, crush, chew or dissolve the tablet•adults and children 12 years and over: 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours•children under 12 years of age: ask a doctor•consumers with liver or kidney disease: ask a. This formulation utilizes a tablet, extended release delivery system. Marketed by Amerisource Bergen, this product is identified by NDC 46122-383 and is authorized under FDA application ANDA076557.

Identification & Billing

NDC Package Code
46122-383-22
Package Description
15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
46122-383
11-Digit Billing Format
46122038322
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
15 EA
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

Clinical Specifications

Proprietary Name
Loratadine And Pseudoephedrine
Non-Proprietary Name
Loratadine And Pseudoephedrine
Substance Name
Loratadine; Pseudoephedrine Sulfate
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
•do not divide, crush, chew or dissolve the tablet•adults and children 12 years and over: 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours•children under 12 years of age: ask a doctor•consumers with liver or kidney disease: ask a

Regulatory & Marketing

Labeler Name
Amerisource Bergen
Product Type
Human Otc Drug
FDA Application #
ANDA076557
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-02-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 46122-383-22 identifies a specific commercial package of 15 tablet, extended release in 1 blister pack of Loratadine And Pseudoephedrine, a human over the counter drug labeled by Amerisource Bergen. This tablet, extended release is formulated for oral use and contains loratadine; pseudoephedrine sulfate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amerisource Bergen on August 02, 2017. The current certification is valid through December 31, 2026.

How is this Amerisource Bergen product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46122038322. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 15 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
46122-383-22
11-Digit CMS (5-4-2)
46122-0383-22

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.