Anticoagulant Citrate Dextrose Solution, USP (ACD), Solution A

Manufacturer
Haemonetics Manufacturing Inc
Effective date
2015-02-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:20:14

Label at a glance#

ProductACD-A
Active ingredientDEXTROSE MONOHYDRATE, SODIUM CITRATE, CITRIC ACID MONOHYDRATE
Label structure8 sections

Indications and uses

For use with automated pheresis equipment only. Use according to equipment manufacturer’s instructions. This unit should be used for pheresis only.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Re-Order Product Code: 796-08

750 mL volume. Single use container.

Sterile, nonpyrogenic fluid path. Sterilized by steam.

Store at room temperature.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For use with automated pheresis equipment only. Use according to equipment manufacturer’s instructions. This unit should be used for pheresis only.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Not for direct intravenous infusion.

WARNINGS

WARNINGS SECTION

Avoid excessive heat. Protect from freezing.

PRECAUTIONS

PRECAUTIONS SECTION

Do not use unless solution is clear and no leaks detected.

General

GENERAL PRECAUTIONS SECTION

Rx only. Discard unused portion.

Recommended Storage: Store at room temperature (25°C / 77°F).

HOW SUPPLIED

HOW SUPPLIED SECTION

750 mL volume bag.

Each 100 ml contains:

0.73 g citric acid (anhydrous), USP

2.20 g sodium citrate (dihydrate), USP

2.45 g dextrose (monohydrate), USP

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hot Stamped Bag

796-08 Hot Stamped Bag
796-08 Hot Stamped Bag

Envelope Label

796-08 Envelope Label
796-08 Envelope Label

References

REFERENCES SECTION

HAEMONETICS and THE Blood Management Company are trademarks of Haemonetics Corporation.

Manufactured for:

Haemonetics Corporation

400 Wood Road

Braintree, MA 02184, USA

By: Haemonetics Manufacturing Inc.

1630 Industrial Park Street

Covina, CA 91722, USA

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
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53157-796-082020-01-31C16284748780-19d75b9d0-591a-f424-e053-dadaa90a57ceAnticoagulant Citrate Dextrose Solution, USP (ACD), Solution A

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53157-796-08ACD-A12 in 1 CARTONSOLUTION121
53157-796-08ACD-A750 mL in 1 BAGSOLUTION7501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53157-796ACD-A (ANTICOAGULANT CITRATE DEXTROSE SOLUTION A) SOLUTION [HAEMONETICS MANUFACTURING INC]1Legacy NDC, 2 package rows20150210_ec28b740-2fd1-453e-9ee9-1aa20d223d6c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CITRIC ACID MONOHYDRATEACTIVE INGREDIENT2968PHW8QP1
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083G1
SODIUM CITRATEACTIVE INGREDIENT1Q73Q2JULR1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSL1
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OK1

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
53157-79653157-796-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ec28b740-2fd1-453e-9ee9-1aa20d223d6cec28b740-2fd1-453e-9ee9-1aa20d223d6c2015-02-09WarningsExact identifier
spl id: ec28b740-2fd1-453e-9ee9-1aa20d223d6c
spl set id: ec28b740-2fd1-453e-9ee9-1aa20d223d6c

Reported adverse events (FAERS/openFDA)#

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