HAEMONETICS ANTICOAGULANT SODIUM CITRATE- trisodium citrate dihydrate solution

Haemonetics Anticoagulant Sodium Citrate by

Drug Labeling and Warnings

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

Drug Details [pdf]

HAEMONETICS ANTICOAGULANT SODIUM CITRATE 4% w/v SOLUTION USP

Rx only                        250 mL 

Intended for use only with automated apheresis devices.

Each 100 mL contains: Sodium Citrate (Dihydrate), USP 4.0g 
(pH adjusted with Citric Acid, Monohydrate, USP)

CAUTION:

Not for direct intravenous infusion. The pouch is a moisture barrier. Do not use unless solution is clear and no leaks detected. Single use container. Discard unused portion.

SPL UNCLASSIFIED SECTION

STERILE, nonpyrogenic fluid path.

RECOMMENDED STORAGE:

Room temperature (25°C/77°F). Avoid excess heat. Protect from freezing.

Product code

Product Code 420A
117881-00, Rev. AA-XXX

Haemonetics Corporation
400 Wood Road
Braintree, MA 02184 USA

Product Labeling

INGREDIENTS AND APPEARANCE

HAEMONETICS ANTICOAGULANT SODIUM CITRATE 
trisodium citrate dihydrate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 57826-420
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	40 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: 57826-420-02	250 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
NDA	BN980123	01/10/2013

Labeler - Haemonetics Corporation (057827420)