Levofloxacin Injection, Solution
NDC Package 44567-435-24

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

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

NDC Package Code
44567-435-24
Package Description
24 POUCH in 1 CARTON / 1 BAG in 1 POUCH / 50 mL in 1 BAG
Product Code
11-Digit Billing Format
44567043524
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Levofloxacin
Non-Proprietary Name
Levofloxacin
Substance Name
Levofloxacin
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Usage Information
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.

Regulatory & Marketing

Labeler Name
Wg Critical Care, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA090343
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-14-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

Source: PDAC
INJECTION, LEVOFLOXACIN, 250 MG
HCPCS Dosage 250 MG
Units / Pkg

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:

10-Digit Format (5-3-2)
44567-435-24
11-Digit CMS (5-4-2)
44567-0435-24

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.