Label: LEVOFLOXACIN injection, solution
- NDC Code(s): 70771-1079-2, 70771-1079-3
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 3, 2023
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PRINCIPAL DISPLAY PANEL
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
-
INGREDIENTS AND APPEARANCE
LEVOFLOXACIN
levofloxacin injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1079 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) LEVOFLOXACIN ANHYDROUS 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1079-2 20 mL in 1 VIAL; Type 0: Not a Combination Product 08/01/2017 2 NDC:70771-1079-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 08/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205968 08/01/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1079) , MANUFACTURE(70771-1079)