CPD/ADSOL Red Cell Preservation Solution System (PL 2209)

Product NDC
0942-6478
11-digit product format
009426478
Labeler code
0942
Product ID
0942-6478_00e3ef6f-49b0-407d-8917-18e5a6664b71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution
Dosage form
KIT
Labeler
Fenwal, Inc.
Application
BN900223
Marketing category
NDA
Marketing start
2008-01-31
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0942-6478DDiscontinued by firm2026-08-17
excluded packagepackage0942-64780942-6478-03DDiscontinued by firm2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0942-6478-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0942-6478-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0942-6478-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0942-6478-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0942-6478-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0942-6478-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0942-6478-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0942-6478-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0942-6478-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0942-6478-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0942-6478-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0942-6478-03557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ADENINEACTIVE INGREDIENTJAC85A2161CPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION) KIT [FENWAL, INC.]5
ANHYDROUS CITRIC ACIDACTIVE INGREDIENTXF417D3PSLCPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION) KIT [FENWAL, INC.]5
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GCPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION) KIT [FENWAL, INC.]5
MANNITOLACTIVE INGREDIENT3OWL53L36ACPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION) KIT [FENWAL, INC.]5
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XCPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION) KIT [FENWAL, INC.]5
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEACTIVE INGREDIENT593YOG76RNCPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION) KIT [FENWAL, INC.]5
Trisodium Citrate DihydrateACTIVE INGREDIENTB22547B95KCPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION) KIT [FENWAL, INC.]5
ADENINEACTIVE MOIETYJAC85A2161CPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION) KIT [FENWAL, INC.]5
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLCPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION) KIT [FENWAL, INC.]5
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKCPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION) KIT [FENWAL, INC.]5
MANNITOLACTIVE MOIETY3OWL53L36ACPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION) KIT [FENWAL, INC.]5
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRCPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION) KIT [FENWAL, INC.]5
SODIUM CATIONACTIVE MOIETYLYR4M0NH37CPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION) KIT [FENWAL, INC.]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION) KIT [FENWAL, INC.]5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0942-6478-03009426478031 KIT in 1 KIT (0942-6478-03) * 70 mL in 1 BAG * 110 mL in 1 BAG1 kit2008-01-310000-00-00NoNoCurrent