TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood
- Product NDC
- 53877-108
- 11-digit product format
- 538770108
- Labeler code
- 53877
- Product ID
- 53877-108_1c357037-16d2-4bd1-9100-611326e8a468
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, and Adenine
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Terumo Corporation
- Application
- BN820528
- Marketing category
- NDA
- Marketing start
- 2009-12-14
- Substance
- ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE
- Active strength
- .275; 2.99; 31.9; 2.22; 26.3 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL
- Pharmacologic classes
- Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ADENINE | .275 g/1000mL |
| ANHYDROUS CITRIC ACID | 2.99 g/1000mL |
| DEXTROSE MONOHYDRATE | 31.9 g/1000mL |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 2.22 g/1000mL |
| TRISODIUM CITRATE DIHYDRATE | 26.3 g/1000mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JAC85A2161, XF417D3PSL, LX22YL083G, 593YOG76RN, B22547B95K |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53877-108-01 | TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood | 4 in 1 BLISTER PACK | SOLUTION | 4 | | 1 |
| 53877-108-02 | TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood | 63 mL in 1 BAG | SOLUTION | 63 | | 1 |
| 53877-108-06 | TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood | 6 in 1 CASE | SOLUTION | 6 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53877-108 | 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) SOLUTION [TERUMO CORPORATION] | 1 | Current NDC, 3 package rows | 20240921_02015040-9b71-4dbe-8f8d-e0d0951e8f93.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 53877-108-01 | 53877010801 | 4 in 1 BLISTER PACK | | | | | Historical |
| 53877-108-02 | 53877010802 | 63 mL in 1 BAG | 63 ml | | | | Historical |
| 53877-108-06 | 53877010806 | 6 BLISTER PACK in 1 CASE (53877-108-06) / 4 BAG in 1 BLISTER PACK (53877-108-01) / 63 mL in 1 BAG (53877-108-02) | 6 blister pack | 2009-12-14 | No | No | Current |