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Levofloxacin - Medication Information

Product NDC Code 70771-1079
Drug Name

Levofloxacin

Type Generic
Active Ingredients
Levofloxacin 25 mg/ml
Route INTRAVENOUS
Dosage Form INJECTION, SOLUTION
RxCUI drug identifier 1665517,
1665519
Application Number ANDA205968
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
70771-1079-2 20 ml in 1 vial (70771-1079-2)
70771-1079-3 30 ml in 1 vial (70771-1079-3)
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Spl product data elements

Usually a list of ingredients in a drug product.
levofloxacin levofloxacin LEVOFLOXACIN LEVOFLOXACIN ANHYDROUS HYDROCHLORIC ACID SODIUM HYDROXIDE WATER

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 MG/20 ML CONTAINER LABEL NDC 70771-1079-2 Levofloxacin Injection 500 mg/20 mL (25 mg/mL) For Intravenous Infusion Attention Pharmacist: Dispense the accompanying Medication Guide to each patient. 20 mL Single-Dose Vial Rx only zydus pharmaceuticals PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 MG/20 ML CARTON LABEL NDC 70771-1079-2 Levofloxacin Injection 500 mg/20 mL (25 mg/mL) For Intravenous Infusion Further Dilution Required Attention Pharmacist: Dispense the accompanying Medication Guide to each patient. 20 mL Single-Dose Vial Rx only zydus pharmaceuticals PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 750 MG/30 ML CONTAINER LABEL NDC 70771-1079-3 Levofloxacin Injection 750 mg/30 mL (25 mg/mL) For Intravenous Infusion Attention Pharmacist: Dispense the accompanying Medication Guide to each patient. 30 mL Single-Dose Vial Rx only zydus pharmaceuticals PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 750 MG/30 ML CARTON LABEL NDC 70771-1079-3 Levofloxacin Injection 750 mg/30 mL (25 mg/mL) For Intravenous Infusion Further Dilution Required Attention Pharmacist: Dispense the accompanying Medication Guide to each patient. 30 mL Single-Dose Vial Rx only zydus pharmaceuticals 20 mL container label 20 mL carton label 30 mL container label 30 mL carton label

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
SPL MEDGUIDE

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API