Promethazine With Codeine
NDC Package 52959-118-08

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

Package Information

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

Promethazine With Codeine is oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.Important Limitations of UseNot indicated for pediatric patients under 18 years of age.Contraindicated in pediatric patients under 12 years of age.Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy. Marketed by H.j. Harkins Company,inc., this product is identified by NDC 52959-118 and is authorized under FDA application ANDA088875.

Identification & Billing

NDC Package Code
52959-118-08
Package Description
236 mL in 1 BOTTLE, PLASTIC
Product Code
52959-118
11-Digit Billing Format
52959011808
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
236 ML
RxNorm Crosswalk
  • RxCUI: 991486 - codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution
  • RxCUI: 991486 - codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution
  • RxCUI: 991486 - codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup

Clinical Specifications

Proprietary Name
Promethazine With Codeine
Dosage Form
-
Usage Information
Promethazine with Codeine Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.Important Limitations of UseNot indicated for pediatric patients under 18 years of age.Contraindicated in pediatric patients under 12 years of age.Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Promethazine with Codeine Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

Regulatory & Marketing

Labeler Name
H.j. Harkins Company,inc.
FDA Application #
ANDA088875
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-08-2015
Listing Expiration
12-31-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (52959-118). Click a package code to view its specific billing and regulatory data.

52959-118-04
118 mL in 1 BOTTLE, PLASTIC

* 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 52959-118-08 identifies a specific commercial package of 236 ml in 1 bottle, plastic of Promethazine With Codeine, labeled by H.j. Harkins Company,inc.. This product is billed per "ML" milliliter and contains an estimated amount of 236 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 H.j. Harkins Company,inc. on December 08, 2015. The current certification is valid through December 31, 2019.

How is this H.j. Harkins Company,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52959011808. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 236 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)
52959-118-08
11-Digit CMS (5-4-2)
52959-0118-08

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