Quetiapine Tablet, Film Coated, Extended Release
NDC Package 68071-3921-6

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

Package Information

Quetiapine tablets 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). This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-3921 and is authorized under FDA application ANDA209635.

Identification & Billing

NDC Package Code
68071-3921-6
Package Description
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
68071-3921
11-Digit Billing Format
68071392106
RxNorm Crosswalk
  • RxCUI: 853201 - QUEtiapine fumarate 50 MG 24HR Extended Release Oral Tablet
  • RxCUI: 853201 - 24 HR quetiapine 50 MG Extended Release Oral Tablet
  • RxCUI: 853201 - quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral Tablet
  • RxCUI: 853201 - quetiapine 50 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Quetiapine Extended Release
Non-Proprietary Name
Quetiapine
Substance Name
Quetiapine Fumarate
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
QUETIAPINE FUMARATE 50 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
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
Nucare Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209635
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-29-2017
Listing Expiration
12-31-2026
Exclude Flag
N
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 68071-3921-6 identifies a specific commercial package of 60 tablet, film coated, extended release in 1 bottle of Quetiapine Extended Release, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. This tablet, film coated, extended release is formulated for oral use and contains quetiapine fumarate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Nucare Pharmaceuticals, Inc. on November 29, 2017. The current certification is valid through December 31, 2026.

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 Nucare Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071392106. 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 (5-4-1)
68071-3921-6
11-Digit CMS (5-4-2)
68071-3921-06

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