Temozolomide
NDC Package 43975-252-14
Package Information
Temozolomide is a medication used to treat certain types of brain cancer. Marketed by Ani Pharmaceuticals, Inc., this product is identified by NDC 43975-252 and is authorized under FDA application ANDA203490.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 43975 - Ani Pharmaceuticals, Inc.
- 43975-252 - Temozolomide
- 43975-252-14 - 14 CAPSULE in 1 BOTTLE, GLASS
- 43975-252 - Temozolomide
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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Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* 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 (43975-252). 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 43975-252-14 identifies a specific commercial package of 14 capsule in 1 bottle, glass of Temozolomide, labeled by Ani Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 14 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 Ani Pharmaceuticals, Inc. on July 13, 2016. The current certification is valid through November 30, 2021.
What are the primary indications for this medication?
This medication is used to treat certain types of brain cancer. Temozolomide belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.
How is this Ani Pharmaceuticals, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 43975025214. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 14 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.
