NDC Package 50383-804-04 Promethazine Hydrochloride And Codeine Phosphate

View Billable Units, 11-Digit Format, RxNorm

Package Information
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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:

50383-804-04

Package Description:

118 mL in 1 BOTTLE

Product Code:

50383-804

Proprietary Name:

Promethazine Hydrochloride And Codeine Phosphate

Usage Information:

Promethazine hydrochloride and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

11-Digit NDC Billing Format:

50383080404

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:

Akorn

Sample Package:

FDA Application Number:

ANDA040151

Marketing Category:

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

Start Marketing Date:

08-26-1997

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

50383 - Akorn
- 50383-804 - Promethazine Hydrochloride And Codeine Phosphate
  - 50383-804-04 - 118 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
50383-804-16	473 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 50383-804-04?

The NDC Packaged Code 50383-804-04 is assigned to a package of 118 ml in 1 bottle of Promethazine Hydrochloride And Codeine Phosphate, labeled by Akorn. The product's dosage form is and is administered via form.

Is NDC 50383-804 included in the NDC Directory?

No, Promethazine Hydrochloride And Codeine Phosphate with product code 50383-804 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Akorn on August 26, 1997 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 50383-804-04?

The 11-digit format is 50383080404. 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	50383-804-04	5-4-2	50383-0804-04

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