NDC Package 52959-118-04 Promethazine With Codeine

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

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

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:

52959-118-04

Package Description:

118 mL in 1 BOTTLE, PLASTIC

Product Code:

52959-118

Proprietary Name:

Promethazine With Codeine

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.

11-Digit NDC Billing Format:

52959011804

Billing Unit:

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

NDC to RxNorm Crosswalk:

118 ML

NDC to 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

Labeler Name:

H.j. Harkins Company,inc.

Sample Package:

FDA Application Number:

ANDA088875

Marketing Category:

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

Start Marketing Date:

12-08-2015

Listing Expiration Date:

12-31-2019

Exclude Flag:

Code Structure:

52959 - H.j. Harkins Company,inc.
- 52959-118 - Promethazine With Codeine
  - 52959-118-04 - 118 mL in 1 BOTTLE, PLASTIC

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
52959-118-08	236 mL in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 52959-118-04?

The NDC Packaged Code 52959-118-04 is assigned to a package of 118 ml in 1 bottle, plastic of Promethazine With Codeine, labeled by H.j. Harkins Company,inc.. The product's dosage form is and is administered via form.This product is billed per "ML" milliliter and contains an estimated amount of 118 billable units per package.

Is NDC 52959-118 included in the NDC Directory?

No, Promethazine With Codeine with product code 52959-118 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by H.j. Harkins Company,inc. on December 08, 2015 and its listing in the NDC Directory is set to expire on December 31, 2019 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 52959-118-04?

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 118.

What is the 11-digit format for NDC 52959-118-04?

The 11-digit format is 52959011804. 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	52959-118-04	5-4-2	52959-0118-04

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