TachoSil
These highlights do not include all the information needed to use TACHOSIL safely and effectively. See full prescribing information for TACHOSIL. TACHOSIL Fibrin Sealant PatchAbsorbable Patch for Topical UseInitial U.S. Approval: 2010
Approved
Approval ID
69e05cbe-615e-45af-ad7e-92e3650cafc8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 29, 2022
Manufacturers
FDA
Baxter Healthcare Corporation
DUNS: 005083209
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
THROMBIN HUMAN and FIBRINOGEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-8704
Application NumberBLA125351
Product Classification
M
Marketing Category
C73585
G
Generic Name
THROMBIN HUMAN and FIBRINOGEN
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 13, 2022
FDA Product Classification
INGREDIENTS (8)
HUMAN THROMBINActive
Quantity: 2.0 [USP'U] in 1 1
Code: 6K15ABL77G
Classification: ACTIB
FIBRINOGEN HUMANActive
Quantity: 5.5 mg in 1 1
Code: N94833051K
Classification: ACTIB
EQUINE COLLAGENInactive
Code: 3221SCV0LS
Classification: IACT
ALBUMIN HUMANInactive
Code: ZIF514RVZR
Classification: IACT
RIBOFLAVINInactive
Code: TLM2976OFR
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ARGININE HYDROCHLORIDEInactive
Code: F7LTH1E20Y
Classification: IACT
THROMBIN HUMAN and FIBRINOGEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-8701
Application NumberBLA125351
Product Classification
M
Marketing Category
C73585
G
Generic Name
THROMBIN HUMAN and FIBRINOGEN
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 13, 2022
FDA Product Classification
INGREDIENTS (8)
FIBRINOGEN HUMANActive
Quantity: 5.5 mg in 1 1
Code: N94833051K
Classification: ACTIB
HUMAN THROMBINActive
Quantity: 2.0 [USP'U] in 1 1
Code: 6K15ABL77G
Classification: ACTIB
ALBUMIN HUMANInactive
Code: ZIF514RVZR
Classification: IACT
RIBOFLAVINInactive
Code: TLM2976OFR
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
ARGININE HYDROCHLORIDEInactive
Code: F7LTH1E20Y
Classification: IACT
EQUINE COLLAGENInactive
Code: 3221SCV0LS
Classification: IACT
THROMBIN HUMAN and FIBRINOGEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-8702
Application NumberBLA125351
Product Classification
M
Marketing Category
C73585
G
Generic Name
THROMBIN HUMAN and FIBRINOGEN
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 13, 2022
FDA Product Classification
INGREDIENTS (8)
HUMAN THROMBINActive
Quantity: 2.0 [USP'U] in 1 1
Code: 6K15ABL77G
Classification: ACTIB
ALBUMIN HUMANInactive
Code: ZIF514RVZR
Classification: IACT
FIBRINOGEN HUMANActive
Quantity: 5.5 mg in 1 1
Code: N94833051K
Classification: ACTIB
EQUINE COLLAGENInactive
Code: 3221SCV0LS
Classification: IACT
RIBOFLAVINInactive
Code: TLM2976OFR
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ARGININE HYDROCHLORIDEInactive
Code: F7LTH1E20Y
Classification: IACT