Anticoagulant Sodium Citrate Solution Usp

SPL v5

SPL

SPL Set ID ac8971a9-36d0-43c9-9121-ba5e58c28bed

Route

INTRAVENOUS

Published

Effective Date 2022-02-11

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Anhydrous Citric Acid (4 g)

Inactive Ingredients

Water Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status

NDA Active Since 2007-03-01

Description

A standalone direction insert does not exist for this product.

Medication Information

Description

A standalone direction insert does not exist for this product.

Package/label Display Panel

CAUTION–DO NOT REMOVE UNIT FROM OVERWRAP UNTIL READY FOR USE

THE OVERWRAP IS A MOISTURE BARRIER

THE INNER BAG MAINTAINS STERILITY OF THE PRODUCT

STORE AT CONTROLLED ROOM TEMPERATURE.

CODE 4B7889Q

NDC 0942-9504-10

500 mL

Fenwal™

Anticoagulant Sodium Citrate Solution USP

Rx only

EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP

pH ADJUSTED WITH CITRIC ACID

STERILE

NONPYROGENIC

FOR USE WITH CYTAPHERESIS DEVICE ONLY

NOT FOR DIRECT INTRAVENOUS INFUSION

SINGLE USE CONTAINER

DISCARD UNUSED PORTION

DO NOT USE UNLESS SOLUTION IS CLEAR AND NO LEAKS ARE DETECTED

AFTER REMOVING OVERWRAP CHECK FOR MINUTE LEAKS BY SQUEEZING INNER BAG FIRMLY

IF LEAKS ARE FOUND DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED

MANUFACTURED BY:

BAXTER HEALTHCARE CORPORATION

DEERFIELD, IL 60015 USA

MANUFACTURED FOR:

FENWAL, INC.

LAKE ZURICH, IL 60047 USA

MADE IN USA

07-25-58-000

PL 146 PLASTIC

Anticoagulant Sodium Citrate Solution Usp

A standalone direction insert does not exist for this product.

Structured Label Content

Package/label Display Panel (PACKAGE/LABEL DISPLAY PANEL)

CAUTION–DO NOT REMOVE UNIT FROM OVERWRAP UNTIL READY FOR USE

THE OVERWRAP IS A MOISTURE BARRIER

THE INNER BAG MAINTAINS STERILITY OF THE PRODUCT

STORE AT CONTROLLED ROOM TEMPERATURE.

CODE 4B7889Q

NDC 0942-9504-10

500 mL

Fenwal™

Anticoagulant Sodium Citrate Solution USP

Rx only

EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP

pH ADJUSTED WITH CITRIC ACID

STERILE

NONPYROGENIC

FOR USE WITH CYTAPHERESIS DEVICE ONLY

NOT FOR DIRECT INTRAVENOUS INFUSION

SINGLE USE CONTAINER

DISCARD UNUSED PORTION

DO NOT USE UNLESS SOLUTION IS CLEAR AND NO LEAKS ARE DETECTED

AFTER REMOVING OVERWRAP CHECK FOR MINUTE LEAKS BY SQUEEZING INNER BAG FIRMLY

IF LEAKS ARE FOUND DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED

MANUFACTURED BY:

BAXTER HEALTHCARE CORPORATION

DEERFIELD, IL 60015 USA

MANUFACTURED FOR:

FENWAL, INC.

LAKE ZURICH, IL 60047 USA

MADE IN USA

07-25-58-000

PL 146 PLASTIC

Anticoagulant Sodium Citrate Solution Usp (Anticoagulant Sodium Citrate Solution USP)

A standalone direction insert does not exist for this product.

Advanced Ingredient Data

[{"name": "Anhydrous Citric Acid", "unii": "XF417D3PSL", "classCode": "ACTIM", "strengthNumerator": "4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "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)

{"PACKAGE/LABEL DISPLAY PANEL": "CAUTION– DO NOT REMOVE UNIT FROM OVERWRAP UNTIL READY FOR USE THE OVERWRAP IS A MOISTURE BARRIER THE INNER BAG MAINTAINS STERILITY OF THE PRODUCT STORE AT CONTROLLED ROOM TEMPERATURE. CODE 4B7889Q NDC 0942-9504-10 500 mL Fenwal™ Anticoagulant Sodium Citrate Solution USP Rx only EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP pH ADJUSTED WITH CITRIC ACID STERILE NONPYROGENIC FOR USE WITH CYTAPHERESIS DEVICE ONLY NOT FOR DIRECT INTRAVENOUS INFUSION SINGLE USE CONTAINER DISCARD UNUSED PORTION DO NOT USE UNLESS SOLUTION IS CLEAR AND NO LEAKS ARE DETECTED AFTER REMOVING OVERWRAP CHECK FOR MINUTE LEAKS BY SQUEEZING INNER BAG FIRMLY IF LEAKS ARE FOUND DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED MANUFACTURED BY: BAXTER HEALTHCARE CORPORATION DEERFIELD, IL 60015 USA MANUFACTURED FOR: FENWAL, INC. LAKE ZURICH, IL 60047 USA MADE IN USA 07-25-58-000 PL 146 PLASTIC", "Anticoagulant Sodium Citrate Solution USP": "A standalone direction insert does not exist for this product."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:36:39.386142 · Updated: 2026-03-14T21:47:10.458721