Quetiapine
NDC Package 42291-697-10

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

Package Information

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

Quetiapine is hypersensitivity to quetiapine or to any excipients in the quetiapine tablets formulation. Marketed by Avkare, this product is identified by NDC 42291-697 and is authorized under FDA application ANDA077745.

Identification & Billing

NDC Package Code
42291-697-10
Package Description
1000 TABLET, FILM COATED in 1 BOTTLE
Product Code
42291-697
11-Digit Billing Format
42291069710
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1000 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Quetiapine
Dosage Form
-
Usage Information
Hypersensitivity to quetiapine or to any excipients in the quetiapine tablets formulation. Anaphylactic reactions have been reported in patients treated with quetiapine.

Regulatory & Marketing

Labeler Name
Avkare
FDA Application #
ANDA077745
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-25-2022
End Marketing Date
11-30-2025
Listing Expiration
11-30-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42291-697). Click a package code to view its specific billing and regulatory data.

42291-697-90
90 TABLET, FILM COATED in 1 BOTTLE

* 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 42291-697-10 identifies a specific commercial package of 1000 tablet, film coated in 1 bottle of Quetiapine, labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 1000 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 Avkare on May 25, 2022. The current certification is valid through November 30, 2025.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291069710. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1000 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)
42291-697-10
11-Digit CMS (5-4-2)
42291-0697-10

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