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

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

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