ANTICOAGULANT SODIUM CITRATE- trisodium citrate dihydrate solution

Anticoagulant Sodium Citrate by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 4.0 g
(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:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing.

SPL UNCLASSIFIED SECTION

Laboratorios Grifols, S. A.
SPAIN
Revision: 10/2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 76297-006-01

Anticoagulant Sodium Citrate 4% w/v
Solution, USP       250 mL

Rx Only

Intended for use only with automated apheresis devices.

Not for direct intravenous infusion.

RECOMMENDED STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Brief exposure up to 40°C (104°F) does not adversely affect the product.
Protect from freezing.  

LOT              EXP              1001344

28 x 250 mL

Num.:

GRIFOLS
Laboratorios Grifols, S. A. SPAIN

LOT

EXP

NDC: 76297-006-02

Anticoagulant Sodium Citrate 4% w/v
Solution, USP       250 mL

Rx Only

Intended for use only with automated apheresis devices

Each 100 mL contains:
     Sodium Citrate (Dihydrate), USP   4.0 g
     (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.

STERILE, nonpyrogenic fluid path.

RECOMMENDED STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. 

Laboratorios Grifols, S. A. SPAIN

GRIFOLS

INGREDIENTS AND APPEARANCE

ANTICOAGULANT SODIUM CITRATE 
trisodium citrate dihydrate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 76297-006
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)
Citric Acid Monohydrate (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76297-006-01	28 in 1 CARTON
1	NDC: 76297-006-02	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
ANDA	BA125697	10/25/2019

Labeler - LABORATORIOS GRIFOLS SA (461842294)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATORIOS GRIFOLS SA		463719725	manufacture(76297-006)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATORIOS GRIFOLS SA		461842294	analysis(76297-006)