ACD

Product NDC
14537-817
11-digit product format
145370817
Labeler code
14537
Product ID
14537-817_867eaa34-08fc-4e51-b16d-dc03c2154104
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citric Acid Monohydrate, Dextrose Monohydrate, and Trisodium Citrate Dihydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Terumo BCT, Ltd.
Application
BA010228
Marketing category
ANDA
Marketing start
2002-02-25
Substance
CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE
Active strength
.8; 2.45; 2.2 g/100mL; g/100mL; g/100mL
Pharmacologic classes
Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14537-817-75ACD A750 mL in 1 BAGINJECTION, SOLUTION7505
14537-817-75ACD A12 in 1 CARTONINJECTION, SOLUTION125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14537-817ACD A (CITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE) INJECTION, SOLUTION [TERUMO BCT, LTD.]5Current NDC, Legacy NDC, 2 package rows20250124_395aec48-198a-4aed-8e38-7accfb3232f9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14537-817-751453708177512 BAG in 1 CARTON (14537-817-75) / 750 mL in 1 BAG12 bag2002-02-250000-00-00NoNoCurrent