Ambu-Flex II CONTAINER

PL 146 PLASTIC

BAXTER EXTRANEAL AMBU-FLEX II AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4761237 4886789 6077836 6248726 B1

Carton Label

L5B4974

6-2000 ML
AMBU-FLEX II CONTAINER

7.5%

EXTRANEAL (ICODEXTRIN)
PERITONEAL DIALYSIS SOLUTION

EXP
XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50309410679062

EXTRANEAL 
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride   injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0941-0679
Route of Administration INTRAPERITONEAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ICODEXTRIN (ICODEXTRIN)  ICODEXTRIN 7.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION)  SODIUM CHLORIDE 535 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION)  SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION)  CALCIUM CHLORIDE 25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION)  MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
 
Inactive Ingredients
Ingredient Name Strength
WATER  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
 
Product Characteristics
Color      Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 0941-0679-51 1500 mL In 1 BAG None
2 0941-0679-52 2000 mL In 1 BAG None
3 0941-0679-53 2500 mL In 1 BAG None
4 0941-0679-45 1500 mL In 1 BAG None
5 0941-0679-47 2000 mL In 1 BAG None
6 0941-0679-48 2500 mL In 1 BAG None
7 0941-0679-06 2000 mL In 1 BAG None
8 0941-0679-05 2500 mL In 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021321 12/20/2002 

Labeler - Baxter Healthcare Corporation (005083209) 
Establishment
Name Address ID/FEI Operations
BAXTER HEALTHCARE LIMITED  211243165 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
BAXTER HEALTHCARE CORPORATION  059140764 MANUFACTURE
Revised: 12/2009Baxter Healthcare Corporation