NDC Package 65162-694-90 Promethazine Hcl, Phenylephrine Hcl, Codeine Phosphate

Promethazine,Phenylephrine,Codeine Syrup Oral - View Billable Units, 11-Digit Format, RxNorm

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Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

65162-694-90

Package Description:

473 mL in 1 BOTTLE

Product Code:

65162-694

Proprietary Name:

Promethazine Hcl, Phenylephrine Hcl, Codeine Phosphate

Non-Proprietary Name:

Promethazine, Phenylephrine, Codeine

Substance Name:

Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride

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.

11-Digit NDC Billing Format:

65162069490

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

473 ML

NDC to 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

Product Type:

Human Prescription Drug

Labeler Name:

Amneal Pharmaceuticals Llc

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(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

CODEINE PHOSPHATE 10 mg/5mL

PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL

PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL

Pharmacologic Class(es):

Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)

Full Opioid Agonists - [MoA] (Mechanism of Action)

Opioid Agonist - [EPC] (Established Pharmacologic Class)

Phenothiazine - [EPC] (Established Pharmacologic Class)

Phenothiazines - [CS]

alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)

DEA Schedule:

Schedule V (CV) Substances

Sample Package:

FDA Application Number:

ANDA200963

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

11-01-2013

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

65162 - Amneal Pharmaceuticals Llc
- 65162-694 - Promethazine Hcl, Phenylephrine Hcl, Codeine Phosphate
  - 65162-694-90 - 473 mL in 1 BOTTLE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
65162-694-86	118 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 65162-694-90?

The NDC Packaged Code 65162-694-90 is assigned to a package of 473 ml in 1 bottle of Promethazine Hcl, Phenylephrine Hcl, Codeine Phosphate, a human prescription drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is syrup and is administered via oral form.

Is NDC 65162-694 included in the NDC Directory?

Yes, Promethazine Hcl, Phenylephrine Hcl, Codeine Phosphate with product code 65162-694 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Llc on November 01, 2013 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 65162-694-90?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 473.

What is the 11-digit format for NDC 65162-694-90?

The 11-digit format is 65162069490. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	65162-694-90	5-4-2	65162-0694-90

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