TachoSil
- Product NDC
- 0338-8703
- 11-digit product format
- 003388703
- Labeler code
- 0338
- Product ID
- 0338-8703_c2c158b5-9f2d-4082-8aed-55f4cde7be59
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- THROMBIN HUMAN and FIBRINOGEN
- Dosage form
- PATCH
- Route
- TOPICAL
- Labeler
- Baxter Healthcare Corporation
- Application
- BLA125351
- Marketing category
- BLA
- Marketing start
- 2010-04-05
- Marketing end
- 0000-00-00
- Substance
- HUMAN THROMBIN; FIBRINOGEN HUMAN
- Active strength
- 2 [USP'U]/1; mg/1
- Pharmacologic classes
- Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [CS],Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0338-8703 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 0338-8703 | 0338-8703-01 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0338-8703 | 0338-8703-05 | D | Discontinued by firm | 2026-07-31 |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TachoSil | THROMBIN HUMAN AND FIBRINOGEN | Corza Medical GmbH | 0c324332-290f-413f-820c-8c9a971a2766 | 2025-10-08 | Warnings, Adverse reactions | BLA125351 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125351 | Tachosil | Fibrin Sealant Patch | 351(a) | Rx | 2026-06-01 |