Cladribine Injection, Solution
NDC Package 42658-010-91
Package Information
Cladribine injection is cladribine is used to treat a certain type of cancer (hairy cell leukemia). This formulation utilizes a injection, solution delivery system. Marketed by Hisun Pharmaceuticals Usa, Inc., this product is identified by NDC 42658-010 and is authorized under FDA application ANDA210856.
Identification & Billing
- RxCUI: 240754 - cladribine 10 MG in 10 ML Injection
- RxCUI: 240754 - 10 ML cladribine 1 MG/ML Injection
- RxCUI: 240754 - cladribine 10 MG per 10 ML Injection
Clinical Specifications
- Intravenous - Administration within or into a vein or veins.
- Intravenous - Administration within or into a vein or veins.
Regulatory & Marketing
Hierarchy Structure
- 42658 - Hisun Pharmaceuticals Usa, Inc.
- 42658-010 - Cladribine
- 42658-010-91 - 1 mL in 1 VIAL, SINGLE-DOSE
- 42658-010 - Cladribine
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.
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 (42658-010). 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 42658-010-91 identifies a specific commercial package of 1 ml in 1 vial, single-dose of Cladribine, a human prescription drug labeled by Hisun Pharmaceuticals Usa, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 1 billable units per package. This injection, solution is formulated for intravenous use and contains cladribine 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 Hisun Pharmaceuticals Usa, Inc. on May 18, 2020. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
Cladribine is used to treat a certain type of cancer (hairy cell leukemia). It works by stopping the growth of cancer cells.
How is this Hisun Pharmaceuticals Usa, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 42658001091. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1 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.
