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
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 53157-136 | 53157-136-92 | I | Inactivated by FDA | 2026-10-05 |
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.
| 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53157-136-92 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-afbb-d83d-e063-dadaa90ab31f | Leukotrap WB System, CPDA-1 Blood Collection Set with WBF2 Filter and Sampling System |
| 53157-136-94 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8cec-d83d-e063-dadaa90ab31f | Leukotrap WB System, CPDA-1 Blood Collection Set with WBF2 Filter and Sampling System |
DailyMed Package Descriptions#
| 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 | 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 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Leukotrap WB System | CPDA-1 BLOOD BAG COLLECTION SYSTEM | GVS TM INC | 54fd8a72-0527-df0c-e063-6294a90abe75 | 2026-06-24 | BN800077 | |
| Leukotrap WB System | CPDA-1 BLOOD BAG COLLECTION SYSTEM | GVS TM INC | 54fddca1-b40c-7af0-e063-6294a90a410e | 2026-06-24 | BN800077 | |
| Leukotrap WB System | CPDA-1 BLOOD BAG COLLECTION SYSTEM | GVS TM INC | 54fdf83e-f641-1f69-e063-6394a90ab750 | 2026-06-24 | BN800077 |
Packages#
| 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 |