FDA.reportPublic FDA data

Anticoagulant Sodium Citrate

Product NDC
76297-006
Requested package NDC
76297-006-04
11-digit product format
762970006
Labeler code
76297
Product ID
76297-006_fa83d193-9cfc-40c0-b924-b1685c50d08a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trisodium Citrate Dihydrate
Dosage form
SOLUTION
Route
EXTRACORPOREAL
Labeler
LABORATORIOS GRIFOLS SA
Application
BA125697
Marketing category
ANDA
Marketing start
2019-10-25
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Anticoagulant Sodium Citrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRISODIUM CITRATE DIHYDRATE40 mg/mL

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
db8334be-5b8b-4811-811a-efbe32b6d147Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76297-006-02Anticoagulant Sodium Citrate250 mL in 1 BAGSOLUTION2507
76297-006-03Anticoagulant Sodium Citrate30 in 1 CARTONSOLUTION307
76297-006-04Anticoagulant Sodium Citrate39 in 1 CARTONSOLUTION397

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76297-006ANTICOAGULANT SODIUM CITRATE (TRISODIUM CITRATE DIHYDRATE) SOLUTION [LABORATORIOS GRIFOLS SA]6Current NDC, Legacy NDC, 3 package rows20240403_db8334be-5b8b-4811-811a-efbe32b6d147.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticoagulant Sodium CitrateTRISODIUM CITRATE DIHYDRATELABORATORIOS GRIFOLS SAdb8334be-5b8b-4811-811a-efbe32b6d1472026-04-14WarningsExact identifier
application number: BA125697
ndc (package): 76297-006-04
ndc (product): 76297-006
ndc11 (package): 76297000604

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76297-006-047629700060439 BAG in 1 CARTON (76297-006-04) / 250 mL in 1 BAG (76297-006-02) 39 bag2019-10-25NoNoCurrent