FDA.reportPublic FDA data

Leukotrap WB System

Product NDC
87069-736
11-digit product format
870690736
Labeler code
87069
Product ID
87069-736_54fdf83e-f642-1f69-e063-6394a90ab750
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CPDA-1 Blood Bag Collection System
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
GVS TM INC
Application
BN800077
Marketing category
NDA
Marketing start
2026-06-24
Substance
DEXTROSE MONOHYDRATE; ADENINE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Active strength
2.01; .017; 1.66; .206; .14 g/63mL; g/63mL; g/63mL; g/63mL; g/63mL
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
Leukotrap WB System
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE2.01 g/63mL
ADENINE.017 g/63mL
SODIUM CITRATE1.66 g/63mL
CITRIC ACID MONOHYDRATE.206 g/63mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE.14 g/63mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LX22YL083GInternal UNII lookup
JAC85A2161Internal UNII lookup
1Q73Q2JULRInternal UNII lookup
2968PHW8QPInternal UNII lookup
593YOG76RNInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54fdf83e-f641-1f69-e063-6394a90ab750Available on FDA.report

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
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
application number: BN800077
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
application number: BN800077
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
application number: BN800077
ndc (product): 87069-736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87069-736-62870690736626 POUCH in 1 CARTON (87069-736-62) / 3 BAG in 1 POUCH / 63 mL in 1 BAG6 pouch2026-06-24NoNoCurrent