TachoSil
- Product NDC
- 83078-702
- 11-digit product format
- 830780702
- Labeler code
- 83078
- Product ID
- 83078-702_a6dcd8af-ccd7-4b27-880a-c7da5c7e6efc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- THROMBIN HUMAN and FIBRINOGEN
- Dosage form
- PATCH
- Route
- TOPICAL
- Labeler
- Corza Medical GmbH
- Application
- BLA125351
- Marketing category
- BLA
- Marketing start
- 2025-08-29
- Substance
- FIBRINOGEN HUMAN; HUMAN THROMBIN
- Active strength
- 5.5; 2 mg/1; [USP'U]/1
- Pharmacologic classes
- Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| N94833051K | FIBRINOGEN HUMAN | 9001-32-5 | FIBRINOGEN HUMAN |
| 6K15ABL77G | HUMAN THROMBIN | 9002-04-4 | HUMAN THROMBIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83078-702-02 | 83078070202 | 2 POUCH in 1 CARTON (83078-702-02) / 1 BLISTER PACK in 1 POUCH (83078-702-00) / 1 PATCH in 1 BLISTER PACK (83078-702-99) | 2 pouch | 2025-08-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TachoSil | Corza Medical GmbH | 2025-10-08 | HUMAN PRESCRIPTION DRUG LABEL | 7 |
| TachoSil | Corza Medical GmbH | 2025-08-29 | HUMAN PRESCRIPTION DRUG LABEL | 6 |