434 mg ATRIGEL® Delivery System
This syringe does not contain the active drug

Sterile
For subcutaneous injection

sanofi aventis

LOT:
EXP:

PRINCIPAL DISPLAY PANEL - 45 mg Diluent
Syringe B

E-045

Rx Only

NDC 0024-0605-44

Eligard® 45 mg

leuprolide acetate for
injectable suspension

Delivers 45 mg leuprolide acetate

Actual content 59.2 mg
lyophilized leuprolide acetate

Dist. by: sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

44503 Rev. 0 5/09

50091082

Lot #

Exp.

ELIGARD
leuprolide acetate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0024-0793
 
Packaging
# NDC Package Description Multilevel Packaging
1 0024-0793-75 1KITIn1CARTON None
 
QUANTITY OF PARTS
Part# Package Quantity Total Product Quantity
Part1 1SYRINGE  0.25mL
Part2 1SYRINGE  0.25mL
 
Part 1of2
LEUPROLIDE ACETATE
leuprolide acetate injection, suspension, extended release
 
Product Information

Route of Administration SUBCUTANEOUS DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
leuprolide acetate(leuprolide) leuprolide 7.5mg in0.25mL
 
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
 
Product Characteristics
Color  Score 
Shape  Size 
Flavor  Imprint Code 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1  0.25mLIn1SYRINGE None
 
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021343 01/23/2002 
 
Part 2of2
ATRIGEL DELIVERY SYSTEM
1-methyl-2-pyrrolidinone and poly(lactic-co-glycolic acid) (50/50, 0.45-0.6 dl/g inherent viscosity) injection, suspension, extended release
 
Product Information

Route of Administration SUBCUTANEOUS DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
No Active Ingredients Found
 
Inactive Ingredients
Ingredient Name Strength
1-methyl-2-pyrrolidinone 160mg in0.25mL
POLY(LACTIC-CO-GLYCOLIC ACID) (50/50, 0.45-0.6 DL/G INHERENT VISCOSITY) 82.5mg in0.25mL
 
Product Characteristics
Color  Score 
Shape  Size 
Flavor  Imprint Code 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1  0.25mLIn1SYRINGE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021343 01/23/2002 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021343 01/23/2002 

ELIGARD
leuprolide acetate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0024-0222
 
Packaging
# NDC Package Description Multilevel Packaging
1 0024-0222-05 1KITIn1CARTON None
 
QUANTITY OF PARTS
Part# Pack