Pseudoephedrine Hydrochloride Tablet, Film Coated, Extended Release
NDC Package 45802-107-52

11-digit billing NDC: 45802010752 · Billing unit: EA · 10 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Pseudoephedrine Hydrochloride (pseudoephedrine hcl) tablets is adults and children 12 years and over•take 1 tablet every 12 hours•do not take more than 2 tablets in 24 hourschildren under 12 yearsdo not use this product in children under 12 years of age. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-107 and is authorized under FDA application ANDA075153.

Identification & Billing

NDC Package Code
45802-107-52
Package Description
10 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
45802-107
11-Digit Billing Format
45802010752
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk
  • RxCUI: 1049154 - pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1049154 - 12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
  • RxCUI: 1049154 - pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Pseudoephedrine Hydrochloride
Non-Proprietary Name
Pseudoephedrine Hcl
Substance Name
Pseudoephedrine Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1
Pharmacologic Class
Usage Information
Adults and children 12 years and over•take 1 tablet every 12 hours•do not take more than 2 tablets in 24 hourschildren under 12 yearsdo not use this product in children under 12 years of age

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Otc Drug
FDA Application #
ANDA075153
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-24-2014
Listing Expiration
12-31-2027
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 45802-107-52 identifies a specific commercial package of 10 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack of Pseudoephedrine Hydrochloride, a human over the counter drug labeled by Padagis Israel Pharmaceuticals Ltd. This tablet, film coated, extended release is formulated for oral use and contains pseudoephedrine hydrochloride 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 Padagis Israel Pharmaceuticals Ltd on May 24, 2014. The current certification is valid through December 31, 2027.

How is this Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802010752. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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)
45802-107-52
11-Digit CMS (5-4-2)
45802-0107-52

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