Reclast
NDC Package 0078-0435-61
Package Information
Reclast is a medication used to treat a certain type of bone disease (Paget's disease) that causes abnormal and weak bones. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0435 and is authorized under FDA application NDA021817.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0078 - Novartis Pharmaceuticals Corporation
- 0078-0435 - Reclast
- 0078-0435-61 - 100 mL in 1 BOTTLE
- 0078-0435 - Reclast
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.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0078-0435-61 identifies a specific commercial package of 100 ml in 1 bottle of Reclast, labeled by Novartis Pharmaceuticals Corporation. 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 Novartis Pharmaceuticals Corporation on April 01, 2007. The current certification is valid through October 31, 2025.
What are the primary indications for this medication?
This medication is used to treat a certain type of bone disease (Paget's disease) that causes abnormal and weak bones. Zoledronic acid is also used to treat bone loss (osteoporosis) in men and in women after menopause who are at high risk of having broken bones (fractures). It may also be used to treat or prevent osteoporosis in people who are taking corticosteroid medications (such as prednisone) for long periods. It works by slowing the breakdown of bone and keeping bones strong. It also helps to reduce the risk of broken bones (fractures). This medication belongs to a class of drugs known as bisphosphonates. Another zoledronic acid product is used to treat bone problems that may occur with cancer. The 2 products should not be used together.
How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078043561. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 100 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 Labeler segment to maintain the 5-4-2 structure.
