Mycophenolate Mofetil
NDC Package 42658-101-07
Package Information
Mycophenolate Mofetil is mycophenolate is used in combination with other medications to keep your body from attacking and rejecting your transplanted organ (such as kidney, liver, heart). Marketed by Hisun Pharmaceuticals Usa, Inc., this product is identified by NDC 42658-101 and is authorized under FDA application ANDA204076.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 42658 - Hisun Pharmaceuticals Usa, Inc.
- 42658-101 - Mycophenolate Mofetil
- 42658-101-07 - 500 TABLET, FILM COATED in 1 BOTTLE
- 42658-101 - Mycophenolate Mofetil
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 (42658-101). 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 42658-101-07 identifies a specific commercial package of 500 tablet, film coated in 1 bottle of Mycophenolate Mofetil, labeled by Hisun Pharmaceuticals Usa, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 500 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 Hisun Pharmaceuticals Usa, Inc. on September 01, 2023. The current certification is valid through March 04, 2024.
What are the primary indications for this medication?
Mycophenolate is used in combination with other medications to keep your body from attacking and rejecting your transplanted organ (such as kidney, liver, heart). It belongs to a class of medications called immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own.
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: 42658010107. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 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.
