NDC Package 80425-0107-3 Quetiapine

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:

80425-0107-3

Package Description:

90 TABLET, FILM COATED in 1 BOTTLE

Product Code:

80425-0107

Proprietary Name:

Quetiapine

Usage Information:

1 INDICATIONS AND USAGE1.1 SchizophreniaQuetiapine tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see CLINICAL STUDIES (14.1)].1.2 Bipolar DisorderQuetiapine tablet is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see CLINICAL STUDIES (14.2)] .Quetiapine tablet is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see CLINICAL STUDIES (14.2)] .Quetiapine tablet is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see CLINICAL STUDIES (14.2)] .1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I DisorderPediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.

11-Digit NDC Billing Format:

80425010703

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

90 EA

Labeler Name:

Advanced Rx Of Tennessee, Llc

Sample Package:

FDA Application Number:

ANDA202152

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

12-01-2015

End Marketing Date:

03-31-2025

Listing Expiration Date:

03-31-2025

Exclude Flag:

Code Structure:

80425 - Advanced Rx Of Tennessee, Llc
- 80425-0107 - Quetiapine
  - 80425-0107-3 - 90 TABLET, FILM COATED 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.

Frequently Asked Questions

What is NDC 80425-0107-3?

The NDC Packaged Code 80425-0107-3 is assigned to a package of 90 tablet, film coated in 1 bottle of Quetiapine, labeled by Advanced Rx Of Tennessee, Llc. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package.

Is NDC 80425-0107 included in the NDC Directory?

No, Quetiapine with product code 80425-0107 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Advanced Rx Of Tennessee, Llc on December 01, 2015 and its listing in the NDC Directory is set to expire on March 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 80425-0107-3?

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 90.

What is the 11-digit format for NDC 80425-0107-3?

The 11-digit format is 80425010703. 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 5-4-1 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
5-4-1	80425-0107-3	5-4-2	80425-0107-03

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