Sodium Citrate 4% w/v Anticoagulant

Product NDC
14537-881
11-digit product format
145370881
Labeler code
14537
Product ID
14537-881_dc65eed1-d14f-4b51-8a84-479852e44ddf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRISODIUM CITRATE DIHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Terumo BCT, Ltd
Application
BA125608
Marketing category
ANDA
Marketing start
2018-06-26
Substance
TRISODIUM CITRATE DIHYDRATE
Active strength
4 g/100mL
Pharmacologic classes
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Citrate 4% w/v Anticoagulant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRISODIUM CITRATE DIHYDRATE4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB22547B95K

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14537-881-25Sodium Citrate 4% w/v Anticoagulant30 in 1 CARTONINJECTION, SOLUTION302
14537-881-25Sodium Citrate 4% w/v Anticoagulant250 mL in 1 BAGINJECTION, SOLUTION2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14537-881SODIUM CITRATE 4% W/V ANTICOAGULANT (TRISODIUM CITRATE DIHYDRATE) INJECTION, SOLUTION [TERUMO BCT, LTD]2Current NDC, Legacy NDC, 2 package rows20250125_0775912f-f14a-4967-ac00-c8c1b36040bf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14537-881-251453708812530 BAG in 1 CARTON (14537-881-25) / 250 mL in 1 BAG30 bag2018-06-260000-00-00NoNoCurrent