NDC 36000-295-24 Levofloxacin
Injection, Solution Intravenous

Package Information

What is NDC 36000-295-24?

The NDC Packaged Code 36000-295-24 is assigned to a package of 100 ml in 1 bag of Levofloxacin, a human prescription drug labeled by Baxter Healthcare Corporation. The product's dosage form is injection, solution and is administered via intravenous form.This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package. The following table has all the important details about this NDC code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

Field Name	Field Value
NDC Package Code	36000-295-24
Package Description	100 mL in 1 BAG
Product Code	36000-295
Proprietary Name What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.	Levofloxacin
Non-Proprietary Name What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.	Levofloxacin
Substance Name What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.	Levofloxacin
Usage Information Product Usage Information The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.	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.
11-Digit NDC Billing Format NDC Format for Billing For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.	36000029524
Billing Unit	ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package	100 ML
NDC to RxNorm Crosswalk	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
Product Type What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.	Human Prescription Drug
Labeler Name	Baxter Healthcare Corporation
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(s)	Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)	LEVOFLOXACIN 5 mg/mL
Sample Package Sample Package? This field Indicates whether this package is a sample packaging or not.	No
Marketing Category What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.	ANDA - A product marketed under an approved Abbreviated New Drug Application.
FDA Application Number What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.	ANDA091397
Start Marketing Date What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.	07-01-2013
Listing Expiration Date What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.	12-31-2023
Exclude Flag What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".	N
NDC Code Structure	36000 - Baxter Healthcare Corporation 36000-295 - Levofloxacin 36000-295-24 - 100 mL in 1 BAG

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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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 36000-295-24 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
36000029524	J1956	Levofloxacin injection	250 MG	100	24	2	48

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