Home NDC 76297-006 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 Ingredient Strength TRISODIUM CITRATE DIHYDRATE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B22547B95K Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76297-006-02 Anticoagulant Sodium Citrate 250 mL in 1 BAG SOLUTION 250 7 76297-006-03 Anticoagulant Sodium Citrate 30 in 1 CARTON SOLUTION 30 7 76297-006-04 Anticoagulant Sodium Citrate 39 in 1 CARTON SOLUTION 39 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76297-006 ANTICOAGULANT SODIUM CITRATE (TRISODIUM CITRATE DIHYDRATE) SOLUTION [LABORATORIOS GRIFOLS SA] 6 Current NDC, Legacy NDC, 3 package rows 20240403_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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76297-006-01 76297000601 28 BAG in 1 CARTON (76297-006-01) > 250 mL in 1 BAG (76297-006-02) 28 bag 2019-10-25 0000-00-00 No No Current 76297-006-02 76297000602 250 mL in 1 BAG 250 ml Historical 76297-006-03 76297000603 30 BAG in 1 CARTON (76297-006-03) / 250 mL in 1 BAG (76297-006-02) 30 bag 2019-10-25 No No Current 76297-006-04 76297000604 39 BAG in 1 CARTON (76297-006-04) / 250 mL in 1 BAG (76297-006-02) 39 bag 2019-10-25 No No Current