FDA.reportPublic FDA data

Anticoagulant Citrate Dextrose A ACD-A

Product NDC
43203-852
Requested package NDC
43203-852-47
11-digit product format
432030852
Labeler code
43203
Product ID
43203-852_49c60185-a86d-44a7-a10e-d0ec57df1fbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anticoagulant Citrate Dextrose A ACD-A
Dosage form
INJECTION, SOLUTION
Route
EXTRACORPOREAL
Labeler
Arteriocyte Medical Systems, Inc.
Application
BA110057
Marketing category
ANDA
Marketing start
2011-05-11
Substance
CITRIC ACID MONOHYDRATE; SODIUM CITRATE, UNSPECIFIED FORM; DEXTROSE MONOHYDRATE
Active strength
.08; .22; .245 g/10mL; g/10mL; g/10mL
Pharmacologic classes
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43203-85243203-852-47UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43203-85243203-852-47UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Anticoagulant Citrate Dextrose A ACD-A
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITRIC ACID MONOHYDRATE.08 g/10mL
SODIUM CITRATE, UNSPECIFIED FORM.22 g/10mL
DEXTROSE MONOHYDRATE.245 g/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2968PHW8QPInternal UNII lookup
1Q73Q2JULRInternal UNII lookup
LX22YL083GInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b850deac-161f-4bb0-ac7f-bceac2a230c0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43203-852-47Anticoagulant Citrate Dextrose A ACD-A1 in 1 POUCHINJECTION, SOLUTION14
43203-852-47Anticoagulant Citrate Dextrose A ACD-A50 in 1 CASEINJECTION, SOLUTION504

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITRIC ACID MONOHYDRATEACTIVE INGREDIENT2968PHW8QPANTICOAGULANT CITRATE DEXTROSE A ACD-A INJECTION, SOLUTION [ARTERIOCYTE MEDICAL SYSTEMS, INC.]2
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GANTICOAGULANT CITRATE DEXTROSE A ACD-A INJECTION, SOLUTION [ARTERIOCYTE MEDICAL SYSTEMS, INC.]2
SODIUM CITRATEACTIVE INGREDIENT1Q73Q2JULRANTICOAGULANT CITRATE DEXTROSE A ACD-A INJECTION, SOLUTION [ARTERIOCYTE MEDICAL SYSTEMS, INC.]2
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLANTICOAGULANT CITRATE DEXTROSE A ACD-A INJECTION, SOLUTION [ARTERIOCYTE MEDICAL SYSTEMS, INC.]2
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKANTICOAGULANT CITRATE DEXTROSE A ACD-A INJECTION, SOLUTION [ARTERIOCYTE MEDICAL SYSTEMS, INC.]2
SODIUM CATIONACTIVE MOIETYLYR4M0NH37ANTICOAGULANT CITRATE DEXTROSE A ACD-A INJECTION, SOLUTION [ARTERIOCYTE MEDICAL SYSTEMS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RANTICOAGULANT CITRATE DEXTROSE A ACD-A INJECTION, SOLUTION [ARTERIOCYTE MEDICAL SYSTEMS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43203-852ANTICOAGULANT CITRATE DEXTROSE A ACD-A INJECTION, SOLUTION [ARTERIOCYTE MEDICAL SYSTEMS, INC.]4Current NDC, Legacy NDC, 2 package rows20250125_b850deac-161f-4bb0-ac7f-bceac2a230c0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
application number: BA110057
ndc (package): 43203-852-47
ndc (product): 43203-852
ndc11 (package): 43203085247
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
application number: BA110057

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43203-852-474320308524750 POUCH in 1 CASE (43203-852-47) / 1 BAG in 1 POUCH / 50 mL in 1 BAG50 pouch2011-05-110000-00-00NoNoCurrent