Ibandronate Sodium Injection, Solution
NDC Package 55150-191-83
Package Information
Ibandronate Sodium injection is ibandronate is used to prevent and treat certain types of bone loss (osteoporosis). This formulation utilizes a injection, solution delivery system. Marketed by Eugia Us Llc, this product is identified by NDC 55150-191 and is authorized under FDA application ANDA205332.
Identification & Billing
- RxCUI: 904952 - ibandronate sodium 3 MG in 3 ML Prefilled Syringe
- RxCUI: 904952 - 3 ML ibandronic acid 1 MG/ML Prefilled Syringe
- RxCUI: 904952 - ibandronic acid 3 MG (as ibandronate sodium 3.39 MG) per 3 ML Prefilled Syringe
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 55150 - Eugia Us Llc
- 55150-191 - Ibandronate Sodium
- 55150-191-83 - 1 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS
- 55150-191 - Ibandronate Sodium
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 55150-191-83 identifies a specific commercial package of 1 syringe, glass in 1 carton / 3 ml in 1 syringe, glass of Ibandronate Sodium, a human prescription drug labeled by Eugia Us Llc. This injection, solution is formulated for intravenous use and contains ibandronate sodium 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 Eugia Us Llc on August 19, 2015. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
Ibandronate is used to prevent and treat certain types of bone loss (osteoporosis). Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause, as you age, or if you take corticosteroid medications (such as prednisone) for long periods. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Ibandronate belongs to a class of medications called bisphosphonates.
How is this Eugia Us Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 55150019183. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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.