Benztropine Mesylate
NDC Package 0615-7675-31

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.

Benztropine Mesylate is benztropine is used to treat symptoms of Parkinson's disease or involuntary movements due to the side effects of certain psychiatric drugs (antipsychotics such as chlorpromazine/haloperidol). Marketed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs, this product is identified by NDC 0615-7675 and is authorized under FDA application ANDA040103.

Identification & Billing

NDC Package Code
0615-7675-31
Package Description
31 TABLET in 1 BLISTER PACK
Product Code
0615-7675
11-Digit Billing Format
00615767531

Clinical Specifications

Proprietary Name
Benztropine Mesylate
Dosage Form
-
Usage Information
Benztropine is used to treat symptoms of Parkinson's disease or involuntary movements due to the side effects of certain psychiatric drugs (antipsychotics such as chlorpromazine/haloperidol). Benztropine belongs to a class of medication called anticholinergics that work by blocking a certain natural substance (acetylcholine). This helps decrease muscle stiffness, sweating, and the production of saliva, and helps improve walking ability in people with Parkinson's disease. Anticholinergics can stop severe muscle spasms of the back, neck, and eyes that are sometimes caused by psychiatric drugs. It can also decrease other side effects such as muscle stiffness/rigidity (extrapyramidal signs-EPS). It is not helpful in treating movement problems caused by tardive dyskinesia and may worsen them. Benztropine should not be used by children younger than 3 years.

Regulatory & Marketing

Labeler Name
Ncs Healthcare Of Ky, Llc Dba Vangard Labs
FDA Application #
ANDA040103
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-12-1996
End Marketing Date
02-28-2019
Listing Expiration
02-28-2019
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 (0615-7675). Click a package code to view its specific billing and regulatory data.

0615-7675-39
30 TABLET in 1 BLISTER PACK

* 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 0615-7675-31 identifies a specific commercial package of 31 tablet in 1 blister pack of Benztropine Mesylate, labeled by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. 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 Ncs Healthcare Of Ky, Llc Dba Vangard Labs on December 12, 1996. The current certification is valid through February 28, 2019.

What are the primary indications for this medication?

Benztropine is used to treat symptoms of Parkinson's disease or involuntary movements due to the side effects of certain psychiatric drugs (antipsychotics such as chlorpromazine/haloperidol). Benztropine belongs to a class of medication called anticholinergics that work by blocking a certain natural substance (acetylcholine). This helps decrease muscle stiffness, sweating, and the production of saliva, and helps improve walking ability in people with Parkinson's disease. Anticholinergics can stop severe muscle spasms of the back, neck, and eyes that are sometimes caused by psychiatric drugs. It can also decrease other side effects such as muscle stiffness/rigidity (extrapyramidal signs-EPS). It is not helpful in treating movement problems caused by tardive dyskinesia and may worsen them. Benztropine should not be used by children younger than 3 years.

How is this Ncs Healthcare Of Ky, Llc Dba Vangard Labs product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00615767531. 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 (4-4-2)
0615-7675-31
11-Digit CMS (5-4-2)
00615-7675-31

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