ELOTUZUMAB- elotuzumab injection, powder, lyophilized, for solution 
Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company

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elotuzumab for export

Storage and Handling

REFRIGERATE AT 2°C TO 8°C (36°F TO 46°F). DO NOT FREEZE OR SHAKE. PROTECT FROM LIGHT.

Package/Label Display Panel

For Export
ELOTUZUMAB INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
300MG/1VIAL BNU
LIST 1324383 SAP FIN# 1324383
LOT ???????     QTY 144
EXP. ???????     MFG. ???????

144 VIALS X 300 MILLIGRAM

CAUTION: FOR MANUFACTURING, PROCESSING, OR
REPACKING. UNITED STATES LAW PROHIBITS
DISPENSING WITHOUT PRESCRIPTION.

SEE ENCLOSED PACKAGE INSERT FOR USAGE
INFORMATION.

REFRIGERATE AT 2°C TO 8°C (36°F TO 46°F).
DO NOT FREEZE OR SHAKE.
PROTECT FROM LIGHT.


MFD. BY: BRISTOL-MYERS SQUIBB HOLDINGS PHARMA,
LTD. LIABILITY COMPANY
BO. TIERRAS NUEVAS, RT. 686, KM 2.3
MANATI, PR 00674

300mg-elotu-bnulabel.jpg

Package/Label Display Panel

For Export
ELOTUZUMAB INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
400MG/1VIAL BNU
LIST 1345536 SAP FIN# 1345536
LOT ???????     QTY 144
EXP. ???????     MFG. ???????

144 VIALS X 400 MILLIGRAM

CAUTION: FOR MANUFACTURING, PROCESSING, OR
REPACKING. UNITED STATES LAW PROHIBITS
DISPENSING WITHOUT PRESCRIPTION.

SEE ENCLOSED PACKAGE INSERT FOR USAGE
INFORMATION.

REFRIGERATE AT 2°C TO 8°C (36°F TO 46°F).
DO NOT FREEZE OR SHAKE.
PROTECT FROM LIGHT.


MFD. BY: BRISTOL-MYERS SQUIBB HOLDINGS PHARMA,
LTD. LIABILITY COMPANY
BO. TIERRAS NUEVAS, RT. 686, KM 2.3
MANATI, PR 00674

400mg-elotu-bnulabel.jpg
ELOTUZUMAB 
elotuzumab injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0590-2291
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ELOTUZUMAB (UNII: 1351PE5UGS) (ELOTUZUMAB - UNII:1351PE5UGS) ELOTUZUMAB300 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0590-2291-09144 in 1 CARTON; Type 0: Not a Combination Product11/30/201511/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only11/30/201511/30/2015
ELOTUZUMAB 
elotuzumab injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0590-4522
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ELOTUZUMAB (UNII: 1351PE5UGS) (ELOTUZUMAB - UNII:1351PE5UGS) ELOTUZUMAB300 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0590-4522-09144 in 1 CARTON; Type 0: Not a Combination Product11/30/201511/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only11/30/201511/30/2015
Labeler - Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company (090413568)

Revised: 8/2017
Document Id: d4b313a2-f352-4005-98a7-4cb4d9bd7bf8
Set id: f8021ff8-b3f7-47dc-9cf2-9523ee237cfe
Version: 3
Effective Time: 20170823
 
Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company