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Anticoagulant Citrate Dextrose (ACD-A)

These highlights do not include all the information needed to use ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A safely and effectively. See full prescribing information for ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A. ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A Sterile Fluid Polyolefin Container (solution bag) Clear Overwrap Initial U.S. Approval: 2012

Approved
Approval ID

0130d7c8-d067-4528-beb7-166559c33be9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 25, 2023

Manufacturers
FDA

Terumo BCT, Ltd

DUNS: 233649834

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dextrose Monohydrate, sodium citrate, unspecified form, and Citric Acid Monohydrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14537-820
Application NumberBA110057
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextrose Monohydrate, sodium citrate, unspecified form, and Citric Acid Monohydrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 28, 2023
FDA Product Classification

INGREDIENTS (4)

Dextrose MonohydrateActive
Quantity: 0.245 g in 10 mL
Code: LX22YL083G
Classification: ACTIB
Citric Acid MonohydrateActive
Quantity: 0.08 g in 10 mL
Code: 2968PHW8QP
Classification: ACTIM
Sodium Citrate, Unspecified FormActive
Quantity: 0.220 g in 10 mL
Code: 1Q73Q2JULR
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 7/25/2023

16 HOW SUPPLIED/STORAGE AND HANDLING

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is a clear sterile solution supplied in non-pyrogenic polyolefin solution bags. Each solution bag is individually wrapped in a clear overwrap. Each clear overwrap is then individually foil wrapped. Neither the clear overwrap nor the foil overwrap can be considered a sterile barrier. This product has a sterile fluid pathway only.

SIZE

CATALOG NUMBER

NDC NUMBER

50 mL

40820

Case:

14537-820-03

Foil:

14537-820-01

Bag:

14537-820-00

STORAGE

Store up to 25 °C [See USP Controlled Room Temperature].
Avoid excessive heat. Protect from freezing.

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Anticoagulant Citrate Dextrose (ACD-A) - FDA Drug Approval Details