Leukotrap WB System

Product NDC
53157-136
11-digit product format
531570136
Labeler code
53157
Product ID
53157-136_9b2d6596-8ea5-7714-e053-2995a90a620f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CPDA-1 Blood Bag Collection System
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Haemonetics Corporation
Application
BN800077
Marketing category
NDA
Marketing start
1980-11-06
Marketing end
0000-00-00
Substance
DEXTROSE MONOHYDRATE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE
Active strength
2 g/70mL; g/70mL; g/70mL; g/70mL; g/70mL
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
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b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
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08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
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6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53157-136-94Leukotrap WB System18 in 1 CARTONSOLUTION185
53157-136-94Leukotrap WB System70 mL in 1 BAGSOLUTION705
53157-136-92Leukotrap WB System70 mL in 1 BAGSOLUTION704

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ADENINEACTIVE INGREDIENTJAC85A2161LEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
ADENINEACTIVE INGREDIENTJAC85A2161LEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
CITRIC ACID MONOHYDRATEACTIVE INGREDIENT2968PHW8QPLEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
CITRIC ACID MONOHYDRATEACTIVE INGREDIENT2968PHW8QPLEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GLEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GLEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
SODIUM CITRATEACTIVE INGREDIENT1Q73Q2JULRLEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
SODIUM CITRATEACTIVE INGREDIENT1Q73Q2JULRLEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEACTIVE INGREDIENT593YOG76RNLEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEACTIVE INGREDIENT593YOG76RNLEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
ADENINEACTIVE MOIETYJAC85A2161LEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
ADENINEACTIVE MOIETYJAC85A2161LEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLLEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLLEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKLEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKLEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37LEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37LEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53157-136LEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS CORPORATION]5Legacy NDC, 2 package rows20200103_b47462f0-b43f-470f-a3f7-4ce17a14a769.zip
53157-136LEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS CORPORATION]4Legacy NDC, 1 package rows20200103_cd05ee40-f7de-4d1b-b701-648ff2dfdb3e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53157-136-925315701369270 mL in 1 BAG (53157-136-92) 70 ml1980-11-060000-00-00NoNoCurrent
53157-136-935315701369318 BAG in 1 CARTON (53157-136-93) > 70 mL in 1 BAG18 bag1980-11-060000-00-00NoNoCurrent
53157-136-945315701369418 BAG in 1 CARTON (53157-136-94) > 70 mL in 1 BAG18 bag1980-11-060000-00-00NoNoCurrent