Anticoagulant Citrate Dextrose (ACD-A)

Product NDC
14537-820
11-digit product format
145370820
Labeler code
14537
Product ID
14537-820_73126eb8-5fba-4a43-b84a-057382d4f0f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextrose Monohydrate, sodium citrate, unspecified form, and Citric Acid Monohydrate
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Terumo BCT, Ltd
Application
BA110057
Marketing category
ANDA
Marketing start
2023-07-18
Substance
CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE, UNSPECIFIED FORM
Active strength
.08; .245; .22 g/10mL; g/10mL; g/10mL
Pharmacologic classes
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Anticoagulant Citrate Dextrose (ACD-A)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITRIC ACID MONOHYDRATE.08 g/10mL
DEXTROSE MONOHYDRATE.245 g/10mL
SODIUM CITRATE, UNSPECIFIED FORM.22 g/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2968PHW8QP, LX22YL083G, 1Q73Q2JULR

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14537-820-00Anticoagulant Citrate Dextrose (ACD-A)50 mL in 1 BAGSOLUTION502
14537-820-01Anticoagulant Citrate Dextrose (ACD-A)1 in 1 POUCHSOLUTION12
14537-820-03Anticoagulant Citrate Dextrose (ACD-A)50 in 1 CASESOLUTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14537-820ANTICOAGULANT CITRATE DEXTROSE (ACD-A) (DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATE) SOLUTION [TERUMO BCT, LTD]2Current NDC, 3 package rows20250124_0130d7c8-d067-4528-beb7-166559c33be9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14537-820-001453708200050 mL in 1 BAG50 mlHistorical
14537-820-01145370820011 in 1 POUCHHistorical
14537-820-031453708200350 POUCH in 1 CASE (14537-820-03) / 1 BAG in 1 POUCH (14537-820-01) / 50 mL in 1 BAG (14537-820-00) 50 pouch2023-07-18NoNoCurrent