FDA.reportPublic FDA data

ACD

Product NDC
14537-810
11-digit product format
145370810
Labeler code
14537
Product ID
14537-810_7ca66901-24d8-4bdb-995d-c538cb238306
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
2026-06-01
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
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
ACD
Brand name suffix
A
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITRIC ACID MONOHYDRATE.8 g/100mL
DEXTROSE MONOHYDRATE2.45 g/100mL
TRISODIUM CITRATE DIHYDRATE2.2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2968PHW8QPInternal UNII lookup
LX22YL083GInternal UNII lookup
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
8e255bc7-a120-460a-a32d-43931f8115deAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
application number: BA010228
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
application number: BA010228
ndc (product): 14537-810
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
application number: BA010228

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14537-810-121453708101212 BAG in 1 CARTON (14537-810-12) / 750 mL in 1 BAG (14537-810-75) 12 bag2026-06-01NoNoCurrent