Haemonetics Anticoagulant Citrate Dextrose Solution (Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Dextrose Monohydrate) Solution [Haemonetics Corporation] -

HAEMONETICS ANTICOAGULANT CITRATE DEXTROSE SOLUTION (ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, DEXTROSE MONOHYDRATE) SOLUTION [HAEMONETICS CORPORATION]
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NDC	57826-426-04
Set ID	2db86c06-bcbc-4b35-83f4-6d7b48985284
Category	HUMAN PRESCRIPTION DRUG LABEL
Packager	Haemonetics Corporation
Generic Name
Product Class	Anti-coagulant
Product Number
Application Number	BA980728

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

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

Labeler - Haemonetics Corporation (942344649)

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

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HAEMONETICS ANTICOAGULANT CITRATE DEXTROSE SOLUTION (ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, DEXTROSE MONOHYDRATE) SOLUTION [HAEMONETICS CORPORATION]

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