Levofloxacin Injection, Solution
NDC Package 44567-435-24
Package Information
Levofloxacin injection is levofloxacin is used to treat a variety of bacterial infections. This formulation utilizes a injection, solution delivery system. Marketed by Wg Critical Care, Llc, this product is identified by NDC 44567-435 and is authorized under FDA application ANDA090343.
Identification & Billing
- RxCUI: 1665497 - levoFLOXacin 250 MG in 50 ML Injection
- RxCUI: 1665497 - 50 ML levofloxacin 5 MG/ML Injection
- RxCUI: 1665497 - levofloxacin 250 MG per 50 ML Injection
- RxCUI: 1665507 - levoFLOXacin 500 MG in 100 ML Injection
- RxCUI: 1665507 - 100 ML levofloxacin 5 MG/ML Injection
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 44567 - Wg Critical Care, Llc
- 44567-435 - Levofloxacin
- 44567-435-24 - 24 POUCH in 1 CARTON / 1 BAG in 1 POUCH / 50 mL in 1 BAG
- 44567-435 - Levofloxacin
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 44567-435-24 identifies a specific commercial package of 24 pouch in 1 carton / 1 bag in 1 pouch / 50 ml in 1 bag of Levofloxacin, a human prescription drug labeled by Wg Critical Care, Llc. This injection, solution is formulated for intravenous use and contains levofloxacin 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 Wg Critical Care, Llc on April 14, 2016. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
Levofloxacin is used to treat a variety of bacterial infections. This medication belongs to a class of drugs known as quinolone antibiotics. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
How is this Wg Critical Care, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 44567043524. 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.