FDA.reportPublic FDA data

Leukotrap WB System - CP2D

Product NDC
53157-126
11-digit product format
531570126
Labeler code
53157
Product ID
53157-126_9b2d582f-29e4-4bb3-e053-2995a90a710c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CP2D/AS-3 Anticoagulant and Additive System
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Haemonetics Corporation
Application
BN820915
Marketing category
NDA
Marketing start
2015-10-07
Marketing end
0000-00-00
Substance
DEXTROSE
Active strength
4 g/70mL
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53157-126IInactivated by FDA2026-09-14
excluded productproduct53157-126IInactivated by FDA2026-09-14
excluded productproduct53157-126IInactivated by FDA2026-09-14
excluded packagepackage53157-12653157-126-92IInactivated by FDA2026-09-14
excluded packagepackage53157-12653157-126-62IInactivated by FDA2026-09-14
excluded packagepackage53157-12653157-126-63IInactivated by FDA2026-09-14

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 · 12 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53157-126-62d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53157-126-92d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53157-126-63d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53157-126-62f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53157-126-92f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53157-126-63f5e01cc5f278…a2eaf40c39c3…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
53157-126-622025-07-29C16284748780-13b156c62-2794-fb37-e063-e6dba90a4e07Leukotrap WB System
53157-126-632025-07-29C16284748780-13b156c62-334f-fb37-e063-e6dba90a4e07Leukotrap WB System
53157-126-922025-07-29C16284748780-13b156c62-330d-fb37-e063-e6dba90a4e07Leukotrap WB System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53157-126-92Leukotrap WB System - CP2D3 in 1 POUCHSOLUTION33
53157-126-92Leukotrap WB System - CP2D6 in 1 BOXSOLUTION63
53157-126-62Leukotrap WB System - CP2D3 in 1 POUCHSOLUTION31
53157-126-62Leukotrap WB System - CP2D18 in 1 BOXSOLUTION181
53157-126-63Leukotrap WB System - CP2D3 in 1 POUCHSOLUTION31
53157-126-63Leukotrap WB System - CP2D18 in 1 BOXSOLUTION181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53157-126LEUKOTRAP WB SYSTEM - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]3Legacy NDC, 2 package rows20240802_88f1259b-ea94-2a3b-e053-2a95a90a5338.zip
53157-126LEUKOTRAP WB SYSTEM - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1Legacy NDC, 2 package rows20240802_1ea16640-de0e-b71d-e063-6394a90a41d8.zip
53157-126LEUKOTRAP WB SYSTEM - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1Legacy NDC, 2 package rows20240802_1ea1b2cc-a118-75d1-e063-6294a90a0b6b.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC4c0dec79-1648-1cfd-e063-6394a90a88cc2026-07-03Exact identifier
application number: BN820915
Leukotrap WB System - CP2DCP2D/AS-3 - ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC44a82ea8-69bf-f061-e063-6394a90af3da2026-07-03Exact identifier
application number: BN820915
Leukotrap WB system - CP2DCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC42ece7e1-1da1-7e5a-e063-6294a90ac8032026-07-03Exact identifier
application number: BN820915
Leukotrap WB System - CP2DCP2D/AS-3 - ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC44a7d200-13cb-c0b0-e063-6294a90aafad2026-07-03Exact identifier
application number: BN820915
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eab581-bc48-f9f0-e063-6394a90a4b932026-06-25Exact identifier
application number: BN820915
Leukotrap WB system - CP2DCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54fdf3cf-41df-af7d-e063-6294a90ab1e62026-06-24Exact identifier
application number: BN820915
Blood Collection SystemCP2D/AS-3 TRIPLE WITH SAMPLING SYSTEMGVS TM INC54e8cfd2-f91b-8381-e063-6394a90a3f772026-06-23Exact identifier
application number: BN820915
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54e9a497-7a94-44c9-e063-6294a90a84da2026-06-23Exact identifier
application number: BN820915
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eb0462-cd00-4467-e063-6394a90aa3712026-06-23Exact identifier
application number: BN820915
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eb3c81-5cc8-03c4-e063-6294a90a20652026-06-23Exact identifier
application number: BN820915
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54ebb700-3bcf-d0e3-e063-6394a90a57c82026-06-23Exact identifier
application number: BN820915
AS-3AS-3GVS TM INC3dfa3397-fc13-4659-e063-6394a90a5abc2025-11-06WarningsExact identifier
application number: BN820915
CP2DCP2DGVS TM INC3fa2e438-2ff0-a2df-e063-6394a90ac7b52025-11-06WarningsExact identifier
application number: BN820915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53157-126-62531570126623 in 1 POUCHHistorical
53157-126-63531570126633 in 1 POUCHHistorical
53157-126-92531570126926 POUCH in 1 BOX (53157-126-92) > 3 BAG in 1 POUCH > 70 mL in 1 BAG6 pouch2015-10-070000-00-00NoNoCurrent