Pseudoephedrine Hydrochloride Tablet, Film Coated, Extended Release
NDC Package 68016-204-69

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 children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours•children under 12 years: ask a doctor. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Chain Drug Consortium, Llc, this product is identified by NDC 68016-204 and is authorized under FDA application ANDA077442.

Identification & Billing

NDC Package Code
68016-204-69
Package Description
10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
68016-204
11-Digit Billing Format
68016020469
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 Hydrochloride
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 older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours•children under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
Chain Drug Consortium, Llc
Product Type
Human Otc Drug
FDA Application #
ANDA077442
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-28-2006
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 68016-204-69 identifies a specific commercial package of 10 tablet, film coated, extended release in 1 blister pack of Pseudoephedrine Hydrochloride, a human over the counter drug labeled by Chain Drug Consortium, Llc. 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 Chain Drug Consortium, Llc on April 28, 2006. The current certification is valid through December 31, 2026.

How is this Chain Drug Consortium, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68016020469. 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)
68016-204-69
11-Digit CMS (5-4-2)
68016-0204-69

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