Anticoagulant Sodium Citrate

Drug Facts

Composition & Product

Active Ingredients

Anhydrous Citric Acid (40 mg)

Inactive Ingredients

Water Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status

ANDA Active Since 2019-10-25

Medication Information

Description

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)

Section 42229-5

STERILE, nonpyrogenic fluid path.

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.

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.

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

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)

Structured Label Content

Section 42229-5 (42229-5)

STERILE, nonpyrogenic fluid path.

Caution (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.

Recommended Storage: (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.

Package Label.principal Display Panel (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

Anticoagulant Sodium Citrate 4% W/v Solution Usp (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)

Advanced Ingredient Data

[{"name": "Anhydrous Citric Acid", "unii": "XF417D3PSL", "classCode": "ACTIM", "strengthNumerator": "40", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Citric Acid Monohydrate", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"42229-5": "STERILE, nonpyrogenic fluid path.", "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.", "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.", "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", "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)"}