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  5. NDC Package Code: 50383-801-04 Promethazine Hydrochloride

NDC Package 50383-801-04 Promethazine Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
50383-801-04
Package Description:
118 mL in 1 BOTTLE
Product Code:
50383-801
Proprietary Name:
Promethazine Hydrochloride
Usage Information:
Promethazine is useful for:Perennial and seasonal allergic rhinitis.Vasomotor rhinitis.Allergic conjunctivitis due to inhalant allergens and foods.Mild, uncomplicated skin manifestations of urticaria and angioedema.Amelioration of allergic reactions to blood or plasma.Dermographism.Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.Preoperative, postoperative or obstetric sedation.Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.Active and prophylactic treatment of motion sickness.Antiemetic therapy in postoperative patients.
11-Digit NDC Billing Format:
50383080104
NDC to RxNorm Crosswalk:
Labeler Name:
Akorn
Sample Package:
No
FDA Application Number:
ANDA040026
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
09-25-1998
Listing Expiration Date:
12-31-2023
Exclude Flag:
I
Code Structure:

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 CodePackage Description
50383-801-08237 mL in 1 BOTTLE
50383-801-16473 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 50383-801-04?

The NDC Packaged Code 50383-801-04 is assigned to a package of 118 ml in 1 bottle of Promethazine Hydrochloride, labeled by Akorn. The product's dosage form is and is administered via form.

Is NDC 50383-801 included in the NDC Directory?

No, Promethazine Hydrochloride with product code 50383-801 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Akorn on September 25, 1998 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 50383-801-04?

The 11-digit format is 50383080104. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-250383-801-045-4-250383-0801-04