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  5. NDC Package Code: 0310-0520-10 Quetiapine

NDC Package 0310-0520-10 Quetiapine

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

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
0310-0520-10
Package Description:
16667 TABLET, EXTENDED RELEASE in 1 BAG
Product Code:
0310-0520
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:
00310052010
Product Type:
Drug For Further Processing
Labeler Name:
Astrazeneca Pharmaceuticals Lp
Dosage Form:
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Active Ingredient(s):
  • QUETIAPINE FUMARATE 200 mg/1
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    04-22-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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.

    Frequently Asked Questions

    What is NDC 0310-0520-10?

    The NDC Packaged Code 0310-0520-10 is assigned to an UNFINISHED drug package of 16667 tablet, extended release in 1 bag of Quetiapine, drug for further processing labeled by Astrazeneca Pharmaceuticals Lp. The product's dosage form is tablet, extended release and is administered via form.

    Is NDC 0310-0520 included in the NDC Directory?

    Yes, Quetiapine is an UNFINISHED PRODUCT with code 0310-0520 that is active and included in the NDC Directory. The product was first marketed by Astrazeneca Pharmaceuticals Lp on April 22, 2022 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 0310-0520-10?

    The 11-digit format is 00310052010. 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 4-4-2 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
    4-4-20310-0520-105-4-200310-0520-10