Pyrilamine Maleate And Dextromethorphan Hydrobromide Liquid
NDC Package 69367-398-16

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

Package Information

Pyrilamine Maleate And Dextromethorphan Hydrobromide liquids is do not exceed recommended dosage.Adults and children 12 years of age and over:4 teaspoonfuls every 6-8 hours, not to exceed 16 teaspoonfuls in 24 hours, or as directed by a doctorChildren 6 to under 12 years of age:2 teaspoonfuls every 6-8 hours, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctorChildren under 6 years of age:Consult a doctor. This formulation utilizes a liquid delivery system. Marketed by Westminster Pharmaceuticals, Llc, this product is identified by NDC 69367-398 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
69367-398-16
Package Description
473 mL in 1 BOTTLE
Product Code
69367-398
11-Digit Billing Format
69367039816
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk
  • RxCUI: 1423307 - dextromethorphan HBr 7.5 MG / pyrilamine maleate 7.5 MG in 5 mL Oral Solution
  • RxCUI: 1423307 - dextromethorphan hydrobromide 1.5 MG/ML / pyrilamine maleate 1.5 MG/ML Oral Solution
  • RxCUI: 1423307 - dextromethorphan hydrobromide 7.5 MG / pyrilamine maleate 7.5 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Pyrilamine Maleate And Dextromethorphan Hydrobromide
Non-Proprietary Name
Pyrilamine Maleate And Dextromethorphan Hydrobromide
Substance Name
Dextromethorphan Hydrobromide; Pyrilamine Maleate
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not exceed recommended dosage.Adults and children 12 years of age and over:4 teaspoonfuls every 6-8 hours, not to exceed 16 teaspoonfuls in 24 hours, or as directed by a doctorChildren 6 to under 12 years of age:2 teaspoonfuls every 6-8 hours, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctorChildren under 6 years of age:Consult a doctor

Regulatory & Marketing

Labeler Name
Westminster Pharmaceuticals, Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-15-2024
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 69367-398-16 identifies a specific commercial package of 473 ml in 1 bottle of Pyrilamine Maleate And Dextromethorphan Hydrobromide, a human over the counter drug labeled by Westminster Pharmaceuticals, Llc. This liquid is formulated for oral use and contains dextromethorphan hydrobromide; pyrilamine maleate 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 Westminster Pharmaceuticals, Llc on July 15, 2024. The current certification is valid through December 31, 2026.

How is this Westminster Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69367039816. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
69367-398-16
11-Digit CMS (5-4-2)
69367-0398-16

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