Promethazine Hydrochloride And Dextromethorphan Hydrobromide Syrup
NDC Package 0116-4024-16

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

Package Information

Promethazine Hydrochloride And Dextromethorphan Hydrobromide syrups is promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. This formulation utilizes a syrup delivery system. Marketed by Xttrium Laboratories, Inc, this product is identified by NDC 0116-4024 and is authorized under FDA application ANDA088864.

Identification & Billing

NDC Package Code
0116-4024-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
0116-4024
11-Digit Billing Format
00116402416
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: 991528 - promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution
  • RxCUI: 991528 - dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution
  • RxCUI: 991528 - dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Promethazine Hydrochloride And Dextromethorphan Hydrobromide
Non-Proprietary Name
Promethazine Hydrochloride And Dextromethorphan Hydrobromide
Substance Name
Dextromethorphan Hydrobromide; Promethazine Hydrochloride
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

Regulatory & Marketing

Labeler Name
Xttrium Laboratories, Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA088864
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-07-2025
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 0116-4024-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Promethazine Hydrochloride And Dextromethorphan Hydrobromide, a human prescription drug labeled by Xttrium Laboratories, Inc. This syrup is formulated for oral use and contains dextromethorphan hydrobromide; promethazine 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 Xttrium Laboratories, Inc on April 07, 2025. The current certification is valid through December 31, 2026.

How is this Xttrium Laboratories, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00116402416. 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 (4-4-2)
0116-4024-16
11-Digit CMS (5-4-2)
00116-4024-16

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