Label: ANTICOAGULANT SODIUM CITRATE- trisodium citrate dihydrate solution
- NDC Code(s): 76297-006-01, 76297-006-02, 76297-006-03, 76297-006-04
- Packager: LABORATORIOS GRIFOLS SA
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 5, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ANTICOAGULANT SODIUM CITRATE 4% w/v SOLUTION USP
- CAUTION
- SPL UNCLASSIFIED SECTION
- RECOMMENDED STORAGE:
- SPL UNCLASSIFIED SECTION
-
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
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
-
INGREDIENTS AND APPEARANCE
ANTICOAGULANT SODIUM CITRATE
trisodium citrate dihydrate solutionProduct 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:76297-006-03 30 in 1 CARTON 1 NDC:76297-006-02 250 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC:76297-006-01 28 in 1 CARTON 2 NDC:76297-006-02 250 mL in 1 BAG; Type 0: Not a Combination Product 3 NDC:76297-006-04 39 in 1 CARTON 3 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) , pack(76297-006) , label(76297-006) Establishment Name Address ID/FEI Business Operations LABORATORIOS GRIFOLS SA 461842294 analysis(76297-006)