Quetiapine Fumarate Tablet, Film Coated
NDC Package 87002-005-00

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Quetiapine Fumarate 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 delivery system. Marketed by Klocke Pharma-service Gmbh, this product is identified by NDC 87002-005.

Identification & Billing

NDC Package Code
87002-005-00
Package Description
2 BAG in 1 BOX / 4878 TABLET, FILM COATED in 1 BAG
Product Code
87002-005
11-Digit Billing Format
87002000500

Clinical Specifications

Proprietary Name
Quetiapine Fumarate
Non-Proprietary Name
Quetiapine Fumarate
Substance Name
Quetiapine Fumarate
Dosage Form
Tablet, Film Coated - 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.
Active Ingredient(s)
QUETIAPINE FUMARATE 400 mg/1
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
Klocke Pharma-service Gmbh
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
03-16-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (87002-005). Click a package code to view its specific billing and regulatory data.

87002-005-01
2 BAG in 1 BOX / 9756 TABLET, FILM COATED in 1 BAG

* 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 87002-005-00 identifies a specific commercial package of 2 bag in 1 box / 4878 tablet, film coated in 1 bag of Quetiapine Fumarate (UNFINISHED drug), drug for further processing labeled by Klocke Pharma-service Gmbh. This tablet, film coated is formulated for 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 Klocke Pharma-service Gmbh on March 16, 2026. The current certification is valid through December 31, 2027.

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 Klocke Pharma-service Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 87002000500. 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)
87002-005-00
11-Digit CMS (5-4-2)
87002-0005-00

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