FDA.reportPublic FDA data

ACD-A

Manufacturer
Fenwal, Inc. | Baxter Healthcare Corporation
Effective date
2022-02-11
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 20:40:02

Label at a glance#

ProductACD-A
Active ingredientDextrose Monohydrate, SODIUM CITRATE, UNSPECIFIED FORM, Anhydrous Citric Acid
Label structure2 sections

Label contents#

Full prescribing information#

Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A

SPL UNCLASSIFIED SECTION

CAUTION–

DO NOT REMOVE UNIT FROM OVERWRAP UNTIL READY FOR USE
THE OVERWRAP IS A MOISTURE BARRIER
THE INNER BAG MAINTAINS THE STERILITY OF THE PRODUCT
STORE AT CONTROLLED ROOM TEMPERATURE

CODE 4B7898Q
NDC 0942-0641-03

500 mL

Fenwal™

Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A

EACH 100 mL CONTAINS 2.45 g DEXTROSE (MONOHYDRATE) USP 2.2 g SODIUM CITRATE (DIHYDRATE) USP 730 mg CITRIC ACID (ANHYDROUS) USP

STERILE , NONPYROGENIC

STERILIZED BY STEAM

SINGLE USE CONTAINER

DISCARD UNUSED PORTION

FOR USE WITH CYTAPHERESIS DEVICE ONLY

NOT FOR DIRECT INTRAVENOUS INFUSION

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

DISPOSE OF CONTAINER APPROPRIATELY

SEE CARTON FOR ADDITIONAL PRODUCT AND COUNTRY SPECIFIC INFORMATION

Rx only

PL 146 PLASTIC

Manufactured by:
Baxter Healthcare Corporation
65 Pitts Station Road
Marion, North Carolina 28752

MADE IN USA 07-25-57-867 REV: B

Manufactured for:

logologoFenwal, Inc.
Lake Zurich, IL 60047 USA

PACKAGE/LABEL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A labelAnticoagulant Citrate Dextrose Solution USP (ACD) Formula A label [Enter Package/Label Display Panel here]

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0942-0641-03ACD-A500 mL in 1 BAGSOLUTION5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0942-0641ACD-A (ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A) SOLUTION [FENWAL, INC.]6Current NDC, Legacy NDC, 1 package rows20220212_22805f0d-ba58-41ea-b245-19980abcda22.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0942-0641-03ML - Milliliter0942-0641caf00f1e-f39f-4b45-a173-300dc35ba96012014-01-04
0942-0641-04ML - Milliliter0942-064197325ae8-893e-49a2-bc33-24ef86ab6a0812014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Anhydrous Citric AcidACTIVE INGREDIENTXF417D3PSL4
Dextrose MonohydrateACTIVE INGREDIENTLX22YL083G4
Sodium CitrateACTIVE INGREDIENT1Q73Q2JULR4
Anhydrous Citric AcidACTIVE MOIETYXF417D3PSL4
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OK4
WaterINACTIVE INGREDIENT059QF0KO0R4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0942-06410942-0641-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dextrose MonohydrateLX22YL083GACTIB
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRACTIB
Anhydrous Citric AcidXF417D3PSLACTIB
Water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.ab19b011-0a51-4f04-9881-d9fc7cae95ae2025-11-25Exact identifier
ndc (product): 0942-0641
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
ndc (package): 0942-0641-03
ndc (product): 0942-0641
ndc11 (package): 00942064103
spl id: fc8f1ca0-251a-493a-ad8e-defe2a5c7141
spl set id: 22805f0d-ba58-41ea-b245-19980abcda22

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.