Promethazine Hydrochloride And Codeine Phosphate Solution
NDC Package 17856-0065-2

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

Promethazine Hydrochloride And Codeine Phosphate solution 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. This formulation utilizes a solution delivery system. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-0065 and is authorized under FDA application ANDA200386.

Identification & Billing

NDC Package Code
17856-0065-2
Package Description
1 CUP, UNIT-DOSE in 1 BAG / 5 mL in 1 CUP, UNIT-DOSE
Product Code
17856-0065
11-Digit Billing Format
17856006502
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
Non-Proprietary Name
Promethazine Hydrochloride And Codeine Phosphate
Substance Name
Codeine Phosphate; Promethazine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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.
DEA Schedule
Schedule V (CV) Substances

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corp.
Product Type
Human Prescription Drug
FDA Application #
ANDA200386
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-12-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (17856-0065). Click a package code to view its specific billing and regulatory data.

17856-0065-1
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 5 mL in 1 CUP, UNIT-DOSE

* 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 17856-0065-2 identifies a specific commercial package of 1 cup, unit-dose in 1 bag / 5 ml in 1 cup, unit-dose of Promethazine Hydrochloride And Codeine Phosphate, a human prescription drug labeled by Atlantic Biologicals Corp.. This solution is formulated for oral use and contains codeine phosphate; 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 Atlantic Biologicals Corp. on March 12, 2018. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856006502. 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)
17856-0065-2
11-Digit CMS (5-4-2)
17856-0065-02

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