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

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		057827420	manufacture (57826-426)

Revised: 01/2021 Haemonetics Corporation