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  5. NDC Package Code: 0310-8280-60 Quetiapine Fumarate Extended Release

NDC Package 0310-8280-60 Quetiapine Fumarate Extended Release

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory .

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:
0310-8280-60
Package Description:
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code:
0310-8280
Proprietary Name:
Quetiapine Fumarate Extended Release
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:
00310828060
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
Labeler Name:
Astrazeneca Pharmaceuticals Lp
Sample Package:
No
FDA Application Number:
NDA022047
Marketing Category:
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date:
05-01-2017
End Marketing Date:
05-31-2020
Listing Expiration Date:
05-31-2020
Exclude Flag:
D
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 0310-8280-60?

The NDC Packaged Code 0310-8280-60 is assigned to a package of 60 tablet, film coated, extended release in 1 bottle of Quetiapine Fumarate Extended Release, labeled by Astrazeneca Pharmaceuticals Lp. The product's dosage form is and is administered via form.

Is NDC 0310-8280 included in the NDC Directory?

The product was first marketed by Astrazeneca Pharmaceuticals Lp on May 01, 2017 and its listing in the NDC Directory is set to expire on May 31, 2020 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0310-8280-60?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

What is the 11-digit format for NDC 0310-8280-60?

The 11-digit format is 00310828060. 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
4-4-20310-8280-605-4-200310-8280-60