Register entry
- Registered sites
- 3
- Active NDC listings
- 41
- Live patents
- 0
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Analytical testing3Labelling3Finished drug manufacture3Packaging3sterilize3
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Fresenius Kabi Horatev CZ s.r.o.Registrant: Fenwal, Inc. | Hor�tev 104, Hor�tev, Hor�tev 28913, Czech Republic (CZE) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3013246506888854531 |
| Fenwal International, Inc.Registrant: Fenwal, Inc. | Rd 357, Km 0.8, Maricao, Puerto Rico (PR) 00606, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 2627511091164590 |
| FENWAL INTERNATIONAL, INC.Registrant: Fenwal, Inc. | Street 122 Km 0.5 Ave 1, San German, Puerto Rico (PR) 00683, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 1000222291938314754 |
Catalogue
Drug listings by form and route
4141 active NDC listings: 41 human prescription drug. By marketing category: NDA 41.
| Dosage form | NDCs |
|---|---|
| solution | 22 |
| kit | 19 |
| Route | NDCs |
|---|---|
| intravenous | 22 |
| Labeller name on the listing | NDCs |
|---|---|
| fenwal, inc. | 41 |
Catalogue
Marketed products
41| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ACD Blood-Pack Units (PL 146 PLASTIC) | Anticoagulant Citrate Dextrose (ACD) | solution, intravenous | 0942-9001NDA |
| ACD-A | Anticoagulant Citrate Dextrose Solution Formula A | solution, intravenous | 0942-0641NDA |
| ADSOL RED CELL PRESERVATION | anticoagulant citrate phosphate dextrose (cpd) and adsol preservation kit | kit | 0942-6504NDA |
| ADSOL RED CELL PRESERVATION | anticoagulant citrate phosphate dextrose (cpd) and adsol preservation | kit | 0942-6506NDA |
| ADSOL RED CELL PRESERVATION | anticoagulant citrate phosphate dextrose (cpd) and adsol preservation | kit | 0942-6507NDA |
| ADSOL RED CELL PRESERVATION | anticoagulant citrate phosphate dextrose (cpd) and adsol preservation | kit | 0942-6508NDA |
| ADSOL RED CELL PRESERVATION | anticoagulant citrate phosphate dextrose (cpd) and adsol preservation | kit | 0942-6514NDA |
| ADSOL RED CELL PRESERVATION | anticoagulant citrate phosphate dextrose (cpd) and adsol preservation | kit | 0942-6515NDA |
| ADSOL RED CELL PRESERVATION | anticoagulant citrate phosphate dextrose (cpd) and adsol preservation | kit | 0942-6516NDA |
| ADSOL RED CELL PRESERVATION | anticoagulant citrate phosphate dextrose (cpd) and adsol preservation | kit | 0942-6517NDA |
| ADSOL RED CELL PRESERVATION | anticoagulant citrate phosphate dextrose (cpd) and adsol preservation | kit | 0942-6518NDA |
| ADSOL RED CELL PRESERVATION | anticoagulant citrate phosphate dextrose (cpd) and adsol preservation | kit | 0942-6528NDA |
| ADSOL RED CELL PRESERVATION | anticoagulant citrate phosphate dextrose (cpd) and adsol preservation | kit | 0942-6550NDA |
| ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) | Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution | kit | 0942-6430NDA |
| ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) | Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution | kit | 0942-6431NDA |
| ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) | Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution | kit | 0942-6453NDA |
| ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) | Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution | kit | 0942-6459NDA |
| ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) | Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution | kit | 0942-6461NDA |
| ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) | Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution | kit | 0942-6477NDA |
| ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) | Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution | kit | 0942-6493NDA |
| Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic | Anticoagulant Citrate Phosphate Dextrose (CPD) Solution | solution, intravenous | 0942-9201NDA |
| Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic | Anticoagulant Citrate Phosphate Dextrose (CPD) | solution, intravenous | 0942-9202NDA |
| CPD/ADSOL | anticoagulant citrate phosphate dextrose (cpd) and adsol preservation | kit | 0942-6505NDA |
| CPDA-1 | Anticoagulant Citrate Phosphate Dextrose Adenine | solution, intravenous | 0942-6305NDA |
| CPDA-1 | Anticoagulant Citrate Phosphate Dextrose Adenine | solution, intravenous | 0942-6307NDA |
| CPDA-1 | Anticoagulant Citrate Phosphate Dextrose Adenine | solution, intravenous | 0942-6308NDA |
| CPDA-1 | Anticoagulant Citrate Phosphate Dextrose Adenine | solution, intravenous | 0942-6312NDA |
| CPDA-1 | Anticoagulant Citrate Phosphate Dextrose Adenine | solution, intravenous | 0942-6316NDA |
| CPDA-1 | Anticoagulant Citrate Phosphate Dextrose Adenine | solution, intravenous | 0942-6320NDA |
| CPDA-1 | Anticoagulant Citrate Phosphate Dextrose Adenine | solution, intravenous | 0942-6322NDA |
| CPDA-1 | Anticoagulant Citrate Phosphate Dextrose Adenine | solution, intravenous | 0942-6326NDA |
| CPDA-1 | Anticoagulant Citrate Phosphate Dextrose Adenine | solution, intravenous | 0942-9393NDA |
| CPDA-1 | Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Solution | solution, intravenous | 0942-9394NDA |
| CPDA-1 | Anticoagulant Citrate Phosphate Dextrose Adenine | solution, intravenous | 0942-9398NDA |
| InterSol | Platelet Additive 3 | solution, intravenous | 0942-9601NDA |
| InterSol | Platelet Additive 3 | solution, intravenous | 0942-9602NDA |
| InterSol | Platelet Additive 3 | solution, intravenous | 0942-9605NDA |
| Sodium Citrate Blood-Pack Units, (PL 146 Plastic) | Anticoagulant Sodium Citrate Solution | solution, intravenous | 0942-9504NDA |
| Sodium Citrate Blood-Pack Units, (PL 146 Plastic) | Anticoagulant Sodium Citrate Solution | solution, intravenous | 0942-9505NDA |
| Sodium Citrate Blood-Pack Units, (PL 146 Plastic) | Anticoagulant Sodium Citrate Solution | solution, intravenous | 0942-9506NDA |
| Solucion InterSol | Solucion aditiva para plaquetas 3 | solution, intravenous | 0942-9603NDA |
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Enquiry
Common questions
- Is Fenwal, Inc. FDA approved?
- Fenwal, Inc. holds 3 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Fenwal, Inc.'s drugs manufactured?
- At registered sites in Czechia, the United States. The FDA register lists Hor�tev; Maricao, PR; San German, PR. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.
- What drugs does Fenwal, Inc. make?
- 41 products are listed under Fenwal, Inc. in the openFDA NDC Directory, most often as solution; kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.