Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (CP2D)

Product NDC
57826-455
11-digit product format
578260455
Labeler code
57826
Product ID
57826-455_b09089ac-5238-65bb-e053-2995a90aabd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CITRIC ACID MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ANHYDROUS DEXTROSE
Dosage form
SOLUTION
Route
EXTRACORPOREAL
Labeler
Haemonetics Corporation
Application
BN000127
Marketing category
NDA
Marketing start
2013-01-10
Marketing end
0000-00-00
Substance
CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ANHYDROUS DEXTROSE
Active strength
33 mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes
Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct57826-455IInactivated by FDA2026-08-10
excluded packagepackage57826-45557826-455-02IInactivated by FDA2026-08-10

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57826-455-02IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57826-455-02IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57826-455-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57826-455-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57826-455-02IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57826-455-02IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57826-455-02UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57826-455-02UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57826-455-02UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57826-455-022025-01-30C16284748780-12cef2736-8a8b-d83d-e063-dadaa90ab31fHaemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (CP2D)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57826-455-02Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (CP2D)250 mL in 1 BAGSOLUTION2508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANHYDROUS DEXTROSEACTIVE INGREDIENT5SL0G7R0OKHAEMONETICS ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D) (CITRIC ACID MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ANHYDROUS DEXTROSE) SOLUTION [HAEMONETICS CORPORATION]5
CITRIC ACID MONOHYDRATEACTIVE INGREDIENT2968PHW8QPHAEMONETICS ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D) (CITRIC ACID MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ANHYDROUS DEXTROSE) SOLUTION [HAEMONETICS CORPORATION]5
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEACTIVE INGREDIENT593YOG76RNHAEMONETICS ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D) (CITRIC ACID MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ANHYDROUS DEXTROSE) SOLUTION [HAEMONETICS CORPORATION]5
TRISODIUM CITRATE DIHYDRATEACTIVE INGREDIENTB22547B95KHAEMONETICS ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D) (CITRIC ACID MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ANHYDROUS DEXTROSE) SOLUTION [HAEMONETICS CORPORATION]5
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLHAEMONETICS ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D) (CITRIC ACID MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ANHYDROUS DEXTROSE) SOLUTION [HAEMONETICS CORPORATION]5
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKHAEMONETICS ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D) (CITRIC ACID MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ANHYDROUS DEXTROSE) SOLUTION [HAEMONETICS CORPORATION]5
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRHAEMONETICS ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D) (CITRIC ACID MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ANHYDROUS DEXTROSE) SOLUTION [HAEMONETICS CORPORATION]5
WATERINACTIVE INGREDIENT059QF0KO0RHAEMONETICS ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D) (CITRIC ACID MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ANHYDROUS DEXTROSE) SOLUTION [HAEMONETICS CORPORATION]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57826-455HAEMONETICS ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D) (CITRIC ACID MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ANHYDROUS DEXTROSE) SOLUTION [HAEMONETICS CORPORATION]8Legacy NDC, 1 package rows20201224_1c149b86-5f9d-4e60-8f17-4ec03ca80563.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57826-455-0257826045502250 mL in 1 BAG (57826-455-02) 250 ml2013-01-100000-00-00NoNoCurrent