Haemonetics Anticoagulant Citrate Dextrose Solution

HAEMONETICS ANTICOAGULANT CITRATE DEXTROSE SOLUTION — anhydrous citric acid, trisodium citrate dihydrate and dextrose monohydrate solution
Haemonetics Corporation

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

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

Product Label

Label
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANHYDROUS CITRIC ACID (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 73 mg in 1 mL
TRISODIUM CITRATE DIHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 220 mg in 1 mL
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 245 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57826-426-04 500 mL in 1 BAG None
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 Operations
Haemonetics Corporation 942344649 manufacture (57826-426)

Revised: 12/2019 Haemonetics Corporation

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