NDC Code(s) : 41616-176-40, 41616-178-40
Packager : Sun Pharma Global Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OXALIPLATIN OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:41616-176
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXALIPLATIN(UNII: 04ZR38536J)
(OXALIPLATIN - UNII:04ZR38536J) 		OXALIPLATIN50 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41616-176-4010 mL in 1 VIAL Type 0: Not a Combination Product19/08/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078818 08/19/2009 12/21/2016
OXALIPLATIN OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:41616-178
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXALIPLATIN(UNII: 04ZR38536J)
(OXALIPLATIN - UNII:04ZR38536J) 		OXALIPLATIN100 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41616-178-4020 mL in 1 VIAL Type 0: Not a Combination Product19/08/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078818 08/19/2009 12/21/2016

PRINCIPAL DISPLAY PANEL

NDC 41616-176-40
Oxaliplatin For Injection
50 mg
Cytotoxic Agent
FOR INTRAVENEOUS USE ONLY
SINGLE USE VIAL
Sterile Iyophilized Powder-Pres ervative Free
Mus t be recons tituted and diluted before use
DO NOT RECONSTITUTE WITH SODIUM CHLORIDE/CHLORIDE-CONTAINING SOLUTIONS
Rx only           Sun Pharmaceutical Industries Ltd.
spl-oxaliplatin-label-50mg

PRINCIPAL DISPLAY PANEL

NDC 41616-176-40
Oxaliplatin For Injection
50 mg
Cytotoxic Agent
FOR INTRAVENEOUS USE ONLY
SINGLE USE VIAL
Sterile Iyophilized Powder-Preservative Free
Must be reconstituted and diluted before use
DO NOT RECONSTITUTE WITH SODIUM CHLORIDE/CHLORIDE-CONTAINING SOLUTIONS
Rx only          Sun Pharmaceutical Industries Ltd.
spl-oxaliplatin-showbox-50mg

PRINCIPAL DISPLAY PANEL

NDC 41616-178-40
Oxaliplatin For Injection
100 mg
Cytotoxic Agent
FOR INTRAVENEOUS USE ONLY
SINGLE USE VIAL
Sterile Iyophilized Powder-Preservative Free
Must be reconstituted and diluted before use
DO NOT RECONSTITUTE WITH SODIUM CHLORIDE/CHLORIDE-CONTAINING SOLUTIONS
Rx only            Sun Pharmaceutical Industries Ltd.
spl-oxaliplatin-showbox-100mg

PRINCIPAL DISPLAY PANEL

NDC 41616-178-40
Oxaliplatin For Injection
100 mg
Cytotoxic Agent
FOR INTRAVENEOUS USE ONLY
SINGLE USE VIAL
Sterile Iyophilized Powder-Preservative Free
Must be reconstituted and diluted before use
DO NOT RECONSTITUTE WITH SODIUM CHLORIDE/CHLORIDE-CONTAINING SOLUTIONS
Rx only           Sun Pharmaceutical Industries Ltd.
spl-oxaliplatin-label-100mg