NDC Package 57297-450-03 Quetiapine Fumarate

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
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:

57297-450-03

Package Description:

1000 TABLET in 1 BOTTLE

Product Code:

57297-450

Proprietary 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:

57297045003

NDC to RxNorm Crosswalk:

RxCUI: 312743 - QUEtiapine fumarate 100 MG Oral Tablet

RxCUI: 312743 - quetiapine 100 MG Oral Tablet

RxCUI: 312743 - quetiapine (as quetiapine fumarate) 100 MG Oral Tablet

RxCUI: 312744 - QUEtiapine fumarate 25 MG Oral Tablet

RxCUI: 312744 - quetiapine 25 MG Oral Tablet

Labeler Name:

Lupin Limited

Sample Package:

Start Marketing Date:

03-27-2012

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

57297 - Lupin Limited
- 57297-450 - Quetiapine Fumarate
  - 57297-450-03 - 1000 TABLET 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
57297-450-01	100 TABLET in 1 BOTTLE
57297-450-02	500 TABLET in 1 BOTTLE
57297-450-13	10 TABLET in 1 BLISTER PACK

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 57297-450-03?

The NDC Packaged Code 57297-450-03 is assigned to a package of 1000 tablet in 1 bottle of Quetiapine Fumarate, labeled by Lupin Limited. The product's dosage form is and is administered via form.

Is NDC 57297-450 included in the NDC Directory?

No, Quetiapine Fumarate with product code 57297-450 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Lupin Limited on March 27, 2012 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 57297-450-03?

The 11-digit format is 57297045003. 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	57297-450-03	5-4-2	57297-0450-03

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