anticoagulant sodium citrate

Generic: trisodium citrate dihydrate

Labeler: laboratorios grifols sa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anticoagulant sodium citrate
Generic Name trisodium citrate dihydrate
Labeler laboratorios grifols sa
Dosage Form SOLUTION
Routes
EXTRACORPOREAL
Active Ingredients

trisodium citrate dihydrate 40 mg/mL

Manufacturer
LABORATORIOS GRIFOLS SA

Identifiers & Regulatory

Product NDC 76297-006
Product ID 76297-006_e5f4806b-7428-43a9-b3da-6ffeb4240d86
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number BA125697
Listing Expiration 2026-12-31
Marketing Start 2019-10-25

Pharmacologic Class

Classes
acidifying activity [moa] anti-coagulant [epc] calcium chelating activity [moa] calculi dissolution agent [epc] decreased coagulation factor activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76297006
Hyphenated Format 76297-006

Supplemental Identifiers

UNII
B22547B95K

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name anticoagulant sodium citrate (source: ndc)
Generic Name trisodium citrate dihydrate (source: ndc)
Application Number BA125697 (source: ndc)
Routes
EXTRACORPOREAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 28 BAG in 1 CARTON (76297-006-01) / 250 mL in 1 BAG (76297-006-02)
  • 30 BAG in 1 CARTON (76297-006-03) / 250 mL in 1 BAG (76297-006-02)
  • 39 BAG in 1 CARTON (76297-006-04) / 250 mL in 1 BAG (76297-006-02)
source: ndc

Packages (3)

76297-006-01 28 BAG in 1 CARTON (76297-006-01) / 250 mL in 1 BAG (76297-006-02) 76297-006-03 30 BAG in 1 CARTON (76297-006-03) / 250 mL in 1 BAG (76297-006-02) 76297-006-04 39 BAG in 1 CARTON (76297-006-04) / 250 mL in 1 BAG (76297-006-02)

Ingredients (1)

trisodium citrate dihydrate (40 mg/mL)

Linked Drug Pages (1)

Anticoagulant Sodium Citrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EXTRACORPOREAL"], "spl_id": "e5f4806b-7428-43a9-b3da-6ffeb4240d86", "openfda": {"unii": ["B22547B95K"], "spl_set_id": ["db8334be-5b8b-4811-811a-efbe32b6d147"], "manufacturer_name": ["LABORATORIOS GRIFOLS SA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 BAG in 1 CARTON (76297-006-01)  / 250 mL in 1 BAG (76297-006-02)", "package_ndc": "76297-006-01", "marketing_start_date": "20191025"}, {"sample": false, "description": "30 BAG in 1 CARTON (76297-006-03)  / 250 mL in 1 BAG (76297-006-02)", "package_ndc": "76297-006-03", "marketing_start_date": "20191025"}, {"sample": false, "description": "39 BAG in 1 CARTON (76297-006-04)  / 250 mL in 1 BAG (76297-006-02)", "package_ndc": "76297-006-04", "marketing_start_date": "20191025"}], "brand_name": "Anticoagulant Sodium Citrate", "product_id": "76297-006_e5f4806b-7428-43a9-b3da-6ffeb4240d86", "dosage_form": "SOLUTION", "pharm_class": ["Acidifying Activity [MoA]", "Anti-coagulant [EPC]", "Calcium Chelating Activity [MoA]", "Calculi Dissolution Agent [EPC]", "Decreased Coagulation Factor Activity [PE]"], "product_ndc": "76297-006", "generic_name": "Trisodium Citrate Dihydrate", "labeler_name": "LABORATORIOS GRIFOLS SA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Anticoagulant Sodium Citrate", "active_ingredients": [{"name": "TRISODIUM CITRATE DIHYDRATE", "strength": "40 mg/mL"}], "application_number": "BA125697", "marketing_category": "ANDA", "marketing_start_date": "20191025", "listing_expiration_date": "20261231"}