Pseudoephedrine Hydrochloride Tablet, Extended Release
NDC Package 0363-6611-10

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

Package Information

Pseudoephedrine Hydrochloride tablets is adults and children12 years and overswallow one whole tablet with water every 24 hoursdo not exceed one tablet in 24 hoursdo not divide, crush, chew or dissolve the tabletthe tablet does not completely dissolve and may be seen in the stool (this is normal)children under 12 yearsdo not use this product in children under 12 years of age. This formulation utilizes a tablet, extended release delivery system. Marketed by Walgreen Co., this product is identified by NDC 0363-6611 and is authorized under FDA application ANDA218854.

Identification & Billing

NDC Package Code
0363-6611-10
Package Description
1 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
0363-6611
11-Digit Billing Format
00363661110
RxNorm Crosswalk
  • RxCUI: 1049670 - pseudoephedrine HCl 240 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1049670 - 24 HR pseudoephedrine hydrochloride 240 MG Extended Release Oral Tablet
  • RxCUI: 1049670 - pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Pseudoephedrine Hydrochloride
Non-Proprietary Name
Pseudoephedrine Hydrochloride
Substance Name
Pseudoephedrine Hydrochloride
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)
PSEUDOEPHEDRINE HYDROCHLORIDE 240 mg/1
Pharmacologic Class
Usage Information
Adults and children12 years and overswallow one whole tablet with water every 24 hoursdo not exceed one tablet in 24 hoursdo not divide, crush, chew or dissolve the tabletthe tablet does not completely dissolve and may be seen in the stool (this is normal)children under 12 yearsdo not use this product in children under 12 years of age

Regulatory & Marketing

Labeler Name
Walgreen Co.
Product Type
Human Otc Drug
FDA Application #
ANDA218854
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-30-2026
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 0363-6611-10 identifies a specific commercial package of 1 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack of Pseudoephedrine Hydrochloride, a human over the counter drug labeled by Walgreen Co.. This tablet, 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 Walgreen Co. on January 30, 2026. The current certification is valid through December 31, 2027.

How is this Walgreen Co. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00363661110. 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 (4-4-2)
0363-6611-10
11-Digit CMS (5-4-2)
00363-6611-10

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