FDA.reportPublic FDA data

TachoSil

Product NDC
0944-8701
11-digit product format
009448701
Labeler code
0944
Product ID
0944-8701_e7ac607f-3b8c-4e7f-aaec-e9421b020e62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
THROMBIN HUMAN and FIBRINOGEN
Dosage form
PATCH
Route
TOPICAL
Labeler
Baxalta US Inc.
Application
BLA125351
Marketing category
BLA
Marketing start
2010-04-05
Marketing end
2020-05-31
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
0000-00-00
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0944-8701DDiscontinued by firm2026-07-31
excluded packagepackage0944-87010944-8701-01DDiscontinued by firm2026-07-31

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TachoSilTHROMBIN HUMAN AND FIBRINOGENCorza Medical GmbH0c324332-290f-413f-820c-8c9a971a27662025-10-08Warnings, Adverse reactionsExact identifier
application number: BLA125351

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0944-8701-01EA - Each0944-8701ae964b07-4e29-4624-b8e3-c5980230918c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FIBRINOGEN HUMANACTIVE INGREDIENTN94833051KTACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]6
HUMAN THROMBINACTIVE INGREDIENT6K15ABL77GTACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]6
FIBRINOGEN HUMANACTIVE MOIETYN94833051KTACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]6
HUMAN THROMBINACTIVE MOIETY6K15ABL77GTACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]6
ALBUMIN HUMANINACTIVE INGREDIENTZIF514RVZRTACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]6
ARGININE HYDROCHLORIDEINACTIVE INGREDIENTF7LTH1E20YTACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]6
EQUINE COLLAGENINACTIVE INGREDIENT3221SCV0LSTACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]6
RIBOFLAVININACTIVE INGREDIENTTLM2976OFRTACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]6
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]6

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125351TachosilFibrin Sealant Patch351(a)Rx2026-06-01