Home NDC 53157-136-92 Leukotrap WB System
Product NDC 53157-136
Requested package NDC 53157-136-92
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 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53157-136-94 Leukotrap WB System 18 in 1 CARTON SOLUTION 18 5 53157-136-94 Leukotrap WB System 70 mL in 1 BAG SOLUTION 70 5 53157-136-92 Leukotrap WB System 70 mL in 1 BAG SOLUTION 70 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53157-136 LEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS CORPORATION] 5 Legacy NDC, 2 package rows 20200103_b47462f0-b43f-470f-a3f7-4ce17a14a769.zip 53157-136 LEUKOTRAP WB SYSTEM (CPDA-1 BLOOD BAG COLLECTION SYSTEM) SOLUTION [HAEMONETICS CORPORATION] 4 Legacy NDC, 1 package rows 20200103_cd05ee40-f7de-4d1b-b701-648ff2dfdb3e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53157-136-92 53157013692 70 mL in 1 BAG (53157-136-92) 70 ml 1980-11-06 0000-00-00 No No Current