HAEMONETICS ANTICOAGULANT CITRATE DEXTROSE SOLUTION- anhydrous citric acid, trisodium citrate dihydrate, dextrose monohydrate solution

Haemonetics Anticoagulant Citrate Dextrose Solution by

Drug Labeling and Warnings

Haemonetics Anticoagulant Citrate Dextrose Solution by is a Prescription medication manufactured, distributed, or labeled by Haemonetics Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAEMONETICS ANTICOAGULANT CITRATE DEXTROSE SOLUTION, USP, FORMULA A (ACDA)

500 mL for use only with automated apheresis devices  Each 100 mL contains  Citric Acid (anhydrous), USP   0.73 g  Sodium Citrate (hydrous), USP   2.20 g  Dextrose (hydrous), USP   2.45 g

CAUTION:

Not for direct intravenous infusion. Do not use unless solution is clear and no leaks detected. Single use container. Discard unused portion. Sterile, pyrogen free solution.  Rx only.

RECOMMENDED STORAGE:

Room temperature (25 degree C/77 degree F). Avoid excessive heat. Protect from freezing.

Product code

L331-01  Product code 426A  Haemonetics Corporation Braintree, MA 02184 USA  Lot No.    Exp. Date

PRINCIPAL DISPLAY PANEL

HAEMONETICS  ANTICOAGULANT CITRATE DEXTROSE SOLUTION, USP, FORMULA A (ACDA)  500 mL Haemonetics Corporation

Product Label

INGREDIENTS AND APPEARANCE

HAEMONETICS ANTICOAGULANT CITRATE DEXTROSE SOLUTION  
anhydrous citric acid, trisodium citrate dihydrate, dextrose monohydrate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 57826-426
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	73 mg  in 1 mL
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	220 mg  in 1 mL
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	245 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57826-426-04	500 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	BA980728	01/10/2013

Labeler - Haemonetics Corporation (057827420)

Establishment
Name	Address	ID/FEI	Business Operations
Haemonetics Corporation		942344649	manufacture(57826-426)