TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative
- Product NDC
- 53877-008
- Requested package NDC
- 53877-008-71
- 11-digit product format
- 538770008
- Labeler code
- 53877
- Product ID
- 53877-008_223f098a-ed15-410d-921e-c075c1330bd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative
- Dosage form
- KIT
- Route
- INTRAVENOUS
- Labeler
- Terumo Corporation
- Application
- BN880217
- Marketing category
- NDA
- Marketing start
- 2010-05-05
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 53877-008 | 53877-008-71 | I | Inactivated by FDA | 2026-10-02 |
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 |
|---|---|---|---|---|---|
| 53877-008-61 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a5a6-d83d-e063-dadaa90ab31f | TERUFLEX® BLOOD BAG SYSTEM WITH DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTION |
| 53877-008-71 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-69b1-d83d-e063-dadaa90ab31f | TERUFLEX ® BLOOD BAG SYSTEM with Diversion Blood Sampling Arm ® CPD/OPTISOL ® SOLUTION |
| 53877-008-81 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7d92-d83d-e063-dadaa90ab31f | TERUFLEX® BLOOD BAG SYSTEM WITH DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTION |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53877-008-71 | TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative | 18 in 1 CASE | KIT | 18 | 6 | |
| 53877-008-71 | TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative | 1 in 1 BAG | KIT | 1 | 6 | |
| 53877-008-61 | TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative | 1 in 1 BAG | KIT | 1 | 5 | |
| 53877-008-61 | TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative | 24 in 1 CASE | KIT | 24 | 5 | |
| 53877-008-81 | TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative | 1 in 1 BAG | KIT | 1 | 4 | |
| 53877-008-81 | TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative | 18 in 1 CASE | KIT | 18 | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53877-008 | TERUFLEX BLOOD BAG SYSTEM WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION] | 6 | Legacy NDC, 2 package rows | 20191227_33c014b7-e647-4512-b814-dda13eb34632.zip |
| 53877-008 | TERUFLEX BLOOD BAG SYSTEM WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION] | 5 | Legacy NDC, 2 package rows | 20191209_e5e7beb3-3b95-4c3e-b2cc-2855dd28da4b.zip |
| 53877-008 | TERUFLEX BLOOD BAG SYSTEM WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION] | 4 | Legacy NDC, 2 package rows | 20191217_f664b3fd-374c-4f04-abea-1a266dfea0e2.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.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53877-008-71 | 53877000871 | 18 BAG in 1 CASE (53877-008-71) > 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG | 18 bag | 2010-05-05 | 0000-00-00 | No | No | Current |