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  5. NDC Package Code: 50228-383-30 Quetiapine Extended Release

NDC Package 50228-383-30 Quetiapine Extended Release

Tablet, Film Coated, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

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:
50228-383-30
Package Description:
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code:
50228-383
Proprietary Name:
Quetiapine Extended Release
Non-Proprietary Name:
Quetiapine
Substance Name:
Quetiapine Fumarate
Usage Information:
This medication is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder, sudden episodes of mania or depression associated with bipolar disorder). Quetiapine is known as an anti-psychotic drug (atypical type). It works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. This medication can decrease hallucinations and improve your concentration. It helps you to think more clearly and positively about yourself, feel less nervous, and take a more active part in everyday life. It may also improve your mood, sleep, appetite, and energy level. Quetiapine can help prevent severe mood swings or decrease how often mood swings occur.
11-Digit NDC Billing Format:
50228038330
NDC to RxNorm Crosswalk:
  • RxCUI: 721791 - QUEtiapine fumarate 200 MG 24HR Extended Release Oral Tablet
  • RxCUI: 721791 - 24 HR quetiapine 200 MG Extended Release Oral Tablet
  • RxCUI: 721791 - quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral Tablet
  • RxCUI: 721791 - quetiapine 200 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 721794 - QUEtiapine fumarate 300 MG 24HR Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sciegen Pharmaceuticals, Inc
    Dosage Form:
    Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • QUETIAPINE FUMARATE 300 mg/1
    • Pharmacologic Class(es):
  • Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA209635
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-29-2017
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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
    50228-383-05500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
    50228-383-6060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50228-383-30?

    The NDC Packaged Code 50228-383-30 is assigned to a package of 30 tablet, film coated, extended release in 1 bottle of Quetiapine Extended Release, a human prescription drug labeled by Sciegen Pharmaceuticals, Inc. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 50228-383 included in the NDC Directory?

    Yes, Quetiapine Extended Release with product code 50228-383 is active and included in the NDC Directory. The product was first marketed by Sciegen Pharmaceuticals, Inc on November 29, 2017 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 50228-383-30?

    The 11-digit format is 50228038330. 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
    5-3-250228-383-305-4-250228-0383-30