Promethazine And Phenylephrine Hcl, And Codeine Phosphate Syrup
NDC Package 65162-694-86

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 And Phenylephrine Hcl, And Codeine Phosphate (promethazine, phenylephrine, codeine) syrups is promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. This formulation utilizes a syrup delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 65162-694 and is authorized under FDA application ANDA200963.

Identification & Billing

NDC Package Code
65162-694-86
Package Description
118 mL in 1 BOTTLE
Product Code
65162-694
11-Digit Billing Format
65162069486
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: 996757 - codeine phosphate 10 MG / phenylephrine HCl 5 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution
  • RxCUI: 996757 - codeine phosphate 2 MG/ML / phenylephrine hydrochloride 1 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution
  • RxCUI: 996757 - codeine phosphate 10 MG / phenylephrine hydrochloride 5 MG / promethazine hydrochloride 6.25 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Promethazine And Phenylephrine Hcl, And Codeine Phosphate
Non-Proprietary Name
Promethazine, Phenylephrine, Codeine
Substance Name
Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, 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, Phenylephrine 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
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA200963
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2013
Listing Expiration
12-31-2027
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 (65162-694). Click a package code to view its specific billing and regulatory data.

65162-694-90
473 mL in 1 BOTTLE

* 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 65162-694-86 identifies a specific commercial package of 118 ml in 1 bottle of Promethazine And Phenylephrine Hcl, And Codeine Phosphate, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This syrup is formulated for oral use and contains codeine phosphate; phenylephrine hydrochloride; 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 Amneal Pharmaceuticals Llc on November 01, 2013. The current certification is valid through December 31, 2027.

How is this Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65162069486. 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)
65162-694-86
11-Digit CMS (5-4-2)
65162-0694-86

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