Haemonetics Anticoagulant Sodium Citrate (Trisodium Citrate Dihydrate) Solution [Haemonetics Corporation] -

HAEMONETICS ANTICOAGULANT SODIUM CITRATE (TRISODIUM CITRATE DIHYDRATE) SOLUTION [HAEMONETICS CORPORATION]
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NDC	57826-420-02
Set ID	447528e6-55cd-4a9b-868e-2a741b2693d3
Category	HUMAN PRESCRIPTION DRUG LABEL
Packager	Haemonetics Corporation
Generic Name
Product Class	Anti-coagulant
Product Number
Application Number	BLA980123

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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

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

Labeler - Haemonetics Corporation (942344649)

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