Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral
NDC Package 53002-4262-1

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.

Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral is solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-4262 and is authorized under FDA application ANDA040649.

Identification & Billing

NDC Package Code
53002-4262-1
Package Description
118 mL in 1 BOTTLE
Product Code
53002-4262
11-Digit Billing Format
53002426201
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 Oral
Dosage Form
-
Usage Information
Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA040649
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-05-2020
Listing Expiration
12-31-2024
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 53002-4262-1 identifies a specific commercial package of 118 ml in 1 bottle of Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral, labeled by Rpk 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 Rpk Pharmaceuticals, Inc. on October 05, 2020. The current certification is valid through December 31, 2024.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002426201. 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 (5-4-1)
53002-4262-1
11-Digit CMS (5-4-2)
53002-4262-01

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