FDA.reportPublic FDA data

Leukotrap WB System

Product NDC
87069-136
11-digit product format
870690136
Labeler code
87069
Product ID
87069-136_54fd8a72-0528-df0c-e063-6294a90abe75
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; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE; CITRIC ACID MONOHYDRATE
Active strength
.019 g/70mL; .229 g/70mL; 2.23 g/70mL; 1.84 g/70mL; .155 g/70mL
Pharmacologic classes
Acidifying Activity [MoA]; Anti-coagulant [EPC]; Calcium Chelating Activity [MoA]; Calculi Dissolution Agent [EPC]; Decreased Coagulation Factor Activity [PE]
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leukotrap WB System
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE.019 g/70mL
SODIUM CITRATE.229 g/70mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE2.23 g/70mL
ADENINE1.84 g/70mL
CITRIC ACID MONOHYDRATE.155 g/70mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54fd8a72-0527-df0c-e063-6294a90abe75Available 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
ndc (product): 87069-136
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
application number: BN800077
ndc (product): 87069-136
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
application number: BN800077

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
87069-136-62870690136626 POUCH in 1 CARTON (87069-136-62) / 3 BAG in 1 POUCH / 70 mL in 1 BAG6 pouch2026-06-240Current
87069-136-64870690136646 POUCH in 1 CARTON (87069-136-64) / 3 BAG in 1 POUCH / 70 mL in 1 BAG6 pouch2026-06-240Current