Promethazine Hydrochloride And Codeine Phosphate
NDC Package 17856-0139-1

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 Codeine Phosphate is promethazine HCl and Codeine Phosphate 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 [see Use in Specific Populations (8.4)].Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4)].Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4)].Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Promethazine HCl and Codeine Phosphate 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. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-0139 and is authorized under FDA application ANDA214238.

Identification & Billing

NDC Package Code
17856-0139-1
Package Description
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 5 mL in 1 CUP, UNIT-DOSE
Product Code
17856-0139
11-Digit Billing Format
17856013901
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 Hydrochloride And Codeine Phosphate
Dosage Form
-
Usage Information
Promethazine HCl and Codeine Phosphate 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 [see Use in Specific Populations (8.4)].Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4)].Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4)].Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Promethazine HCl and Codeine Phosphate 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
Atlantic Biologicals Corp.
FDA Application #
ANDA214238
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-08-2020
Listing Expiration
12-31-2022
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 17856-0139-1 identifies a specific commercial package of 72 cup, unit-dose in 1 box, unit-dose / 5 ml in 1 cup, unit-dose of Promethazine Hydrochloride And Codeine Phosphate, labeled by Atlantic Biologicals Corp.. 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 Atlantic Biologicals Corp. on October 08, 2020. The current certification is valid through December 31, 2022.

How is this Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856013901. 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)
17856-0139-1
11-Digit CMS (5-4-2)
17856-0139-01

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