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ACD

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 Bag Initial U.S. Approval: 1987

Approved
Approval ID

395aec48-198a-4aed-8e38-7accfb3232f9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 10, 2019

Manufacturers
FDA

Terumo BCT, Ltd.

DUNS: 233649834

Products 2

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

Citric Acid Monohydrate, Dextrose Monohydrate, and Trisodium Citrate Dihydrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14537-817
Application NumberBA010228
Product Classification
M
Marketing Category
C73584
G
Generic Name
Citric Acid Monohydrate, Dextrose Monohydrate, and Trisodium Citrate Dihydrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2017
FDA Product Classification

INGREDIENTS (4)

Citric Acid MonohydrateActive
Quantity: 0.8 g in 100 mL
Code: 2968PHW8QP
Classification: ACTIM
Dextrose MonohydrateActive
Quantity: 2.45 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Trisodium Citrate DihydrateActive
Quantity: 2.2 g in 100 mL
Code: B22547B95K
Classification: ACTIM

Citric Acid Monohydrate, Dextrose Monohydrate, and Trisodium Citrate Dihydrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14537-815
Application NumberBA010228
Product Classification
M
Marketing Category
C73584
G
Generic Name
Citric Acid Monohydrate, Dextrose Monohydrate, and Trisodium Citrate Dihydrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2017
FDA Product Classification

INGREDIENTS (4)

Citric Acid MonohydrateActive
Quantity: 0.8 g in 100 mL
Code: 2968PHW8QP
Classification: ACTIM
Dextrose MonohydrateActive
Quantity: 2.45 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Trisodium Citrate DihydrateActive
Quantity: 2.2 g in 100 mL
Code: B22547B95K
Classification: ACTIM

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ACD - FDA Drug Approval Details