Anticoagulant Sodium Citrate

Product NDC
81839-782
11-digit product format
818390782
Labeler code
81839
Product ID
81839-782_2f9d0600-c8af-4701-aadb-ee29592f7a12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trisodium Citrate Dihydrate
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
CSL Plasma Inc.
Application
BA125750
Marketing category
ANDA
Marketing start
2022-07-01
Substance
TRISODIUM CITRATE DIHYDRATE
Active strength
40 mg/mL
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
Anticoagulant Sodium Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRISODIUM CITRATE DIHYDRATE40 mg/mL

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
81839-782-01Anticoagulant Sodium Citrate250 mL in 1 BAGSOLUTION2504
81839-782-02Anticoagulant Sodium Citrate30 in 1 CARTONSOLUTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81839-782ANTICOAGULANT SODIUM CITRATE (TRISODIUM CITRATE DIHYDRATE) SOLUTION [CSL PLASMA INC.]4Current NDC, Legacy NDC, 2 package rows20240111_1798dd96-5ae7-4a8b-b433-24ca9b38d863.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81839-782-0181839078201250 mL in 1 BAG250 mlHistorical
81839-782-028183907820230 BAG in 1 CARTON (81839-782-02) / 250 mL in 1 BAG (81839-782-01) 30 bag2022-07-010000-00-00NoNoCurrent