LEVOFLOXACIN- levofloxacin injection, solution 
Cadila Healthcare Limited

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LEVOFLOXACIN INJECTION

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

20 mL container label

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

20 mL carton label

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

30 mL container label

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

30 mL carton label
LEVOFLOXACIN 
levofloxacin injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1079
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) LEVOFLOXACIN ANHYDROUS25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1079-220 mL in 1 VIAL; Type 0: Not a Combination Product08/01/2017
2NDC:70771-1079-330 mL in 1 VIAL; Type 0: Not a Combination Product08/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20596808/01/2017
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1079) , MANUFACTURE(70771-1079)

Revised: 10/2020
Document Id: aabf0379-95a8-44bd-82e5-787a33a48433
Set id: 74ffa693-6859-4b92-998b-775b3245d45d
Version: 6
Effective Time: 20201012
 
Cadila Healthcare Limited