FDA.reportPublic FDA data

Sodium Citrate w/v Anticoagulant

Product NDC
14537-883
Requested package NDC
14537-883-03
11-digit product format
145370883
Labeler code
14537
Product ID
14537-883_4e4eaf1d-b071-4ee8-83ea-739e6388b3b4
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage14537-88314537-883-03UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage14537-88314537-883-03UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B22547B95KInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9d0e9c8-379f-4895-b272-329efab575c4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14537-883-00Sodium Citrate w/v Anticoagulant250 mL in 1 BAGINJECTION, SOLUTION2502
14537-883-03Sodium Citrate w/v Anticoagulant30 in 1 CARTONINJECTION, SOLUTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14537-883SODIUM CITRATE W/V ANTICOAGULANT (TRISODIUM CITRATE DIHYDRATE) INJECTION, SOLUTION [TERUMO BCT, LTD]2Current NDC, Legacy NDC, 2 package rows20250129_c9d0e9c8-379f-4895-b272-329efab575c4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Citrate w/v AnticoagulantTRISODIUM CITRATE DIHYDRATETerumo BCT, Ltdc9d0e9c8-379f-4895-b272-329efab575c42025-01-24Warnings, Adverse reactionsExact identifier
application number: BA125608
ndc (package): 14537-883-03
ndc (product): 14537-883
ndc11 (package): 14537088303
Sodium Citrate 4% w/v AnticoagulantTRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd0775912f-f14a-4967-ac00-c8c1b36040bf2025-01-23Warnings, Adverse reactionsExact identifier
application number: BA125608

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14537-883-031453708830330 BAG in 1 CARTON (14537-883-03) / 250 mL in 1 BAG (14537-883-00) 30 bag2018-06-260000-00-00NoNoCurrent