Anticoagulant Sodium Citrate

Product NDC
76297-006
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

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 Identifiers#

Field, Values table
FieldValues
UniiB22547B95K

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76297-006-017629700060128 BAG in 1 CARTON (76297-006-01) > 250 mL in 1 BAG (76297-006-02) 28 bag2019-10-250000-00-00NoNoCurrent
76297-006-0276297000602250 mL in 1 BAG250 mlHistorical
76297-006-037629700060330 BAG in 1 CARTON (76297-006-03) / 250 mL in 1 BAG (76297-006-02) 30 bag2019-10-25NoNoHistorical
76297-006-047629700060439 BAG in 1 CARTON (76297-006-04) / 250 mL in 1 BAG (76297-006-02) 39 bag2019-10-25NoNoHistorical