MedPath

ACD

Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A

Approved
Approval ID

570770de-9b48-4fc1-a1ee-06002ca9504f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 10, 2019

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, and Citric Acid Monohydrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14537-967
Application NumberBA010228
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextrose Monohydrate, Sodium Citrate, and Citric Acid Monohydrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 10, 2019
FDA Product Classification

INGREDIENTS (3)

Dextrose MonohydrateActive
Quantity: 2.45 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
Citric Acid MonohydrateActive
Quantity: 0.80 g in 100 mL
Code: 2968PHW8QP
Classification: ACTIM
SODIUM CITRATE, UNSPECIFIED FORMActive
Quantity: 2.2 g in 100 mL
Code: 1Q73Q2JULR
Classification: ACTIB

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ACD - FDA Drug Approval Details