Benztropine Mesylate
NDC Package 10135-607-10
Package Information
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 Marlex Pharmaceuticals Inc, this product is identified by NDC 10135-607 and is authorized under FDA application ANDA090168.
Identification & Billing
- RxCUI: 885209 - benztropine mesylate 2 MG Oral Tablet
- RxCUI: 885213 - benztropine mesylate 1 MG Oral Tablet
- RxCUI: 885219 - benztropine mesylate 0.5 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 10135 - Marlex Pharmaceuticals Inc
- 10135-607 - Benztropine Mesylate
- 10135-607-10 - 1000 TABLET in 1 BOTTLE, PLASTIC
- 10135-607 - Benztropine Mesylate
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.
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Other Available Packages
The following commercial packages are registered under the same Product NDC (10135-607). Click a package code to view its specific billing and regulatory data.
* 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 10135-607-10 identifies a specific commercial package of 1000 tablet in 1 bottle, plastic of Benztropine Mesylate, labeled by Marlex Pharmaceuticals Inc. 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 Marlex Pharmaceuticals Inc on December 15, 2017. The current certification is valid through December 31, 2020.
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 Marlex Pharmaceuticals Inc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135060710. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.