Promethazine Hydrochloride And Dextromethorphan Hydrobromide
NDC Package 21695-698-04

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 is syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-698 and is authorized under FDA application ANDA088864.

Identification & Billing

NDC Package Code
21695-698-04
Package Description
118 mL in 1 BOTTLE
Product Code
21695-698
11-Digit Billing Format
21695069804
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
118 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
Dosage Form
-
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
Rebel Distributors Corp
FDA Application #
ANDA088864
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-04-1985
Listing Expiration
12-31-2017
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 21695-698-04 identifies a specific commercial package of 118 ml in 1 bottle of Promethazine Hydrochloride And Dextromethorphan Hydrobromide, labeled by Rebel Distributors Corp. This product is billed per "ML" milliliter and contains an estimated amount of 118 billable units per package. 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 Rebel Distributors Corp on January 04, 1985. The current certification is valid through December 31, 2017.

How is this Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695069804. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 118 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)
21695-698-04
11-Digit CMS (5-4-2)
21695-0698-04

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