TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)
- Product NDC
- 53877-001
- Requested package NDC
- 53877-001-10
- 11-digit product format
- 538770001
- Labeler code
- 53877
- Product ID
- 53877-001_ddc359d4-cffe-4f5c-8265-7e3893086d97
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Terumo Corporation
- Application
- BN820528
- Marketing category
- NDA
- Marketing start
- 2009-12-10
- Marketing end
- 0000-00-00
- Substance
- ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE; ADENINE
- Active strength
- 3 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL
- 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
- 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 | 53877-001 | 53877-001-10 | D | Discontinued by firm | 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 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | D | Discontinued by firm | 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| efd58dcf-540a-4531-8766-e713129ca6f2 | Product name | 1 | 20250307 |
| 4b7700e3-6e0e-45e5-9d22-6f754d61386e | Product name | 2 | 20250304 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53877-001-01 | TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) | 35 mL in 1 BAG | SOLUTION | 35 | 6 | |
| 53877-001-01 | TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) | 30 in 1 CASE | SOLUTION | 30 | 6 | |
| 53877-001-02 | TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) | 30 in 1 CASE | SOLUTION | 30 | 4 | |
| 53877-001-02 | TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) | 63 mL in 1 BAG | SOLUTION | 63 | 4 | |
| 53877-001-03 | TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) | 60 in 1 CASE | SOLUTION | 60 | 4 | |
| 53877-001-03 | TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) | 63 mL in 1 BAG | SOLUTION | 63 | 4 | |
| 53877-001-11 | TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) | 63 mL in 1 BAG | SOLUTION | 63 | 2 | |
| 53877-001-11 | TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) | 30 in 1 CASE | SOLUTION | 30 | 2 | |
| 53877-001-12 | TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) | 24 in 1 CASE | SOLUTION | 24 | 2 | |
| 53877-001-12 | TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) | 63 mL in 1 BAG | SOLUTION | 63 | 2 | |
| 53877-001-13 | TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) | 70 mL in 1 BAG | SOLUTION | 70 | 2 | |
| 53877-001-13 | TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) | 30 in 1 CASE | SOLUTION | 30 | 2 | |
| 53877-001-14 | TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) | 24 in 1 CASE | SOLUTION | 24 | 2 | |
| 53877-001-14 | TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) | 70 mL in 1 BAG | SOLUTION | 70 | 2 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53877-001 | TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION] | 6 | Legacy NDC, 2 package rows | 20181219_991fb1d2-eb44-4ab7-904e-79476b2190f0.zip |
| 53877-001 | TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION] | 4 | Legacy NDC, 4 package rows | 20181219_14b53ad8-3e44-401e-bd9b-ca81848a6b18.zip |
| 53877-001 | TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION] | 2 | Legacy NDC, 8 package rows | 20181219_123381eb-3b2a-4a9e-9ee7-f9d7aa7b8979.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 |
|---|---|---|---|---|---|---|
| teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1 | ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINE | Terumo Corporation | 86b3a329-c83f-4977-92f5-0e9dfe1872d7 | 2024-10-10 | Warnings | BN820528 |
| TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1 | ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINE | Terumo Corporation | 39f2e11c-5a31-469f-b725-d096c1674421 | 2024-10-03 | Warnings | BN820528 |
| TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood | ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINE | Terumo Corporation | 02015040-9b71-4dbe-8f8d-e0d0951e8f93 | 2024-09-19 | Warnings | BN820528 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53877-001-10 | 53877000110 | 36 BAG in 1 CASE (53877-001-10) > 63 mL in 1 BAG | 36 bag | 2009-12-14 | 0000-00-00 | No | No | Current |