Quetiapine Fumarate
NDC Package 51407-075-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Quetiapine Fumarate is a medication used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder, sudden episodes of mania or depression associated with bipolar disorder). Marketed by Golden State Medical Supply, Inc., this product is identified by NDC 51407-075 and is authorized under FDA application ANDA208947.

Identification & Billing

NDC Package Code
51407-075-60
Package Description
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
51407-075
11-Digit Billing Format
51407007560
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA

Clinical Specifications

Proprietary Name
Quetiapine Fumarate
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Golden State Medical Supply, Inc.
FDA Application #
ANDA208947
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-29-2017
End Marketing Date
10-31-2024
Listing Expiration
10-31-2024
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51407-075-60 identifies a specific commercial package of 60 tablet, extended release in 1 bottle of Quetiapine Fumarate, labeled by Golden State Medical Supply, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Golden State Medical Supply, Inc. on November 29, 2017. The current certification is valid through October 31, 2024.

What are the primary indications for this medication?

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.

How is this Golden State Medical Supply, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51407007560. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
51407-075-60
11-Digit CMS (5-4-2)
51407-0075-60

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.