FDA.reportPublic FDA data

ACD Blood-Pack Units (PL 146 PLASTIC)

Product NDC
0942-9001
Requested package NDC
0942-9001-01
11-digit product format
009429001
Labeler code
0942
Product ID
0942-9001_02a2ae7c-e324-4d5a-aa2a-4a4f7426fd06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anticoagulant Citrate Dextrose (ACD)
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Fenwal, Inc.
Application
BN160918
Marketing category
NDA
Marketing start
2007-03-01
Substance
DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID
Active strength
1.65; 1.48; 493 g/67.5mL; g/67.5mL; mg/67.5mL
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

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 Blood-Pack Units (PL 146 PLASTIC)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE1.65 g/67.5mL
TRISODIUM CITRATE DIHYDRATE1.48 g/67.5mL
ANHYDROUS CITRIC ACID493 mg/67.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LX22YL083GInternal UNII lookup
B22547B95KInternal UNII lookup
XF417D3PSLInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ba894daa-688e-4a9e-bd74-e71797f951bbAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0942-9001-01ACD Blood-Pack Units (PL 146 PLASTIC)67.5 mL in 1 BAGSOLUTION67.59

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANHYDROUS CITRIC ACIDACTIVE INGREDIENTXF417D3PSLACD BLOOD-PACK UNITS (PL 146 PLASTIC) (ANTICOAGULANT CITRATE DEXTROSE (ACD)) SOLUTION [FENWAL, INC.]6
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GACD BLOOD-PACK UNITS (PL 146 PLASTIC) (ANTICOAGULANT CITRATE DEXTROSE (ACD)) SOLUTION [FENWAL, INC.]6
TRISODIUM CITRATE DIHYDRATEACTIVE INGREDIENTB22547B95KACD BLOOD-PACK UNITS (PL 146 PLASTIC) (ANTICOAGULANT CITRATE DEXTROSE (ACD)) SOLUTION [FENWAL, INC.]6
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLACD BLOOD-PACK UNITS (PL 146 PLASTIC) (ANTICOAGULANT CITRATE DEXTROSE (ACD)) SOLUTION [FENWAL, INC.]6
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKACD BLOOD-PACK UNITS (PL 146 PLASTIC) (ANTICOAGULANT CITRATE DEXTROSE (ACD)) SOLUTION [FENWAL, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RACD BLOOD-PACK UNITS (PL 146 PLASTIC) (ANTICOAGULANT CITRATE DEXTROSE (ACD)) SOLUTION [FENWAL, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0942-9001ACD BLOOD-PACK UNITS (PL 146 PLASTIC) (ANTICOAGULANT CITRATE DEXTROSE (ACD)) SOLUTION [FENWAL, INC.]9Current NDC, Legacy NDC, 1 package rows20220428_ba894daa-688e-4a9e-bd74-e71797f951bb.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.ab19b011-0a51-4f04-9881-d9fc7cae95ae2025-11-25Exact identifier
application number: BN160918
ACD Blood-Pack Units (PL 146 PLASTIC)ANTICOAGULANT CITRATE DEXTROSE (ACD)Fenwal, Inc.ba894daa-688e-4a9e-bd74-e71797f951bb2022-04-27Exact identifier
application number: BN160918
ndc (package): 0942-9001-01
ndc (product): 0942-9001
ndc11 (package): 00942900101
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
application number: BN160918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0942-9001-010094290010167.5 mL in 1 BAG (0942-9001-01) 67.5 ml2007-03-010000-00-00NoNoCurrent