ANTICOAGULANT SODIUM CITRATE- trisodium citrate dihydrate solution 
LABORATORIOS GRIFOLS SA

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Anticoagulant Sodium Citrate

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.

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.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76297-006-03

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  XXXXXX          EXP  YYYY-MM

30 x 250 mL

Num.:

GRIFOLS
Laboratorios Grifols, S. A. SPAIN

carton-76297-006-03.jpg

LOT: XXXXXX          EXP: YYYY-MM

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

container-76297-006-02.jpg
ANTICOAGULANT SODIUM CITRATE 
trisodium citrate dihydrate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76297-006
Route of AdministrationEXTRACORPOREAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76297-006-0330 in 1 CARTON
1NDC:76297-006-02250 mL in 1 BAG; Type 0: Not a Combination Product
2NDC:76297-006-0128 in 1 CARTON
2NDC:76297-006-02250 mL in 1 BAG; Type 0: Not a Combination Product
3NDC:76297-006-0439 in 1 CARTON
3NDC:76297-006-02250 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDABA12569710/25/2019
Labeler - LABORATORIOS GRIFOLS SA (461842294)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIOS GRIFOLS SA463719725manufacture(76297-006) , pack(76297-006) , label(76297-006)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIOS GRIFOLS SA461842294analysis(76297-006)

Revised: 4/2024
Document Id: e5f4806b-7428-43a9-b3da-6ffeb4240d86
Set id: db8334be-5b8b-4811-811a-efbe32b6d147
Version: 6
Effective Time: 20240405
 
LABORATORIOS GRIFOLS SA