Dexchlorpheniramine Maleate, Phenylephrine Hcl
NDC Package 66576-080-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Dexchlorpheniramine Maleate, Phenylephrine Hcl is do not exceed recommended dosage.Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctorChildren 6 to under 12 years of age:1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctorChildren under 6 years of age:Consult a doctor. Marketed by Syntho Pharmaceuticals Inc., this product is identified by NDC 66576-080 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
66576-080-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
66576-080
11-Digit Billing Format
66576008001
RxNorm Crosswalk
  • RxCUI: 2184108 - dexchlorpheniramine maleate 2 MG / phenylephrine HCl 10 MG Oral Tablet
  • RxCUI: 2184108 - dexchlorpheniramine maleate 2 MG / phenylephrine hydrochloride 10 MG Oral Tablet

Clinical Specifications

Proprietary Name
Dexchlorpheniramine Maleate, Phenylephrine Hcl
Dosage Form
-
Usage Information
Do not exceed recommended dosage.Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctorChildren 6 to under 12 years of age:1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctorChildren under 6 years of age:Consult a doctor.

Regulatory & Marketing

Labeler Name
Syntho Pharmaceuticals Inc.
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
11-02-2022
Listing Expiration
12-31-2023
Exclude Flag
I
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 66576-080-01 identifies a specific commercial package of 100 tablet in 1 bottle of Dexchlorpheniramine Maleate, Phenylephrine Hcl, labeled by Syntho Pharmaceuticals Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Syntho Pharmaceuticals Inc. on November 02, 2022. The current certification is valid through December 31, 2023.

How is this Syntho Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66576008001. 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)
66576-080-01
11-Digit CMS (5-4-2)
66576-0080-01

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