NDC 0338-8702

TachoSil

Thrombin Human And Fibrinogen

TachoSil is a Topical Patch in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Human Thrombin; Fibrinogen Human.

Product ID0338-8702_14c30095-725e-4957-9c9a-81ea6c6d4c7a
NDC0338-8702
Product TypeHuman Prescription Drug
Proprietary NameTachoSil
Generic NameThrombin Human And Fibrinogen
Dosage FormPatch
Route of AdministrationTOPICAL
Marketing Start Date2010-04-05
Marketing CategoryBLA / BLA
Application NumberBLA125351
Labeler NameBaxter Healthcare Corporation
Substance NameHUMAN THROMBIN; FIBRINOGEN HUMAN
Active Ingredient Strength2 [USP'U]/1; mg/1
Pharm ClassesHuman 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 FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0338-8702-02

2 POUCH in 1 CARTON (0338-8702-02) > 1 BLISTER PACK in 1 POUCH (0338-8702-00) > 1 PATCH in 1 BLISTER PACK
Marketing Start Date2010-04-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0338-8702-02 [00338870202]

TachoSil PATCH
Marketing CategoryBLA
Application NumberBLA125351
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-05

NDC 0338-8702-00 [00338870200]

TachoSil PATCH
Marketing CategoryBLA
Application NumberBLA125351
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-02

Drug Details

Active Ingredients

IngredientStrength
HUMAN THROMBIN2 [USP'U]/1

OpenFDA Data

SPL SET ID:69e05cbe-615e-45af-ad7e-92e3650cafc8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1001593
  • 1001591
  • 1014303
  • 1001603
  • 1014305
  • 1001601
  • Pharmacological Class

    • 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 Crossover Matching brand name "TachoSil" or generic name "Thrombin Human And Fibrinogen"

    NDCBrand NameGeneric Name
    0338-8701TachoSilTHROMBIN HUMAN and FIBRINOGEN
    0338-8702TachoSilTHROMBIN HUMAN and FIBRINOGEN
    0338-8703TachoSilTHROMBIN HUMAN and FIBRINOGEN
    0944-8701TachoSilTHROMBIN HUMAN and FIBRINOGEN
    0944-8702TachoSilTHROMBIN HUMAN and FIBRINOGEN
    0944-8703TachoSilTHROMBIN HUMAN and FIBRINOGEN

    Trademark Results [TachoSil]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TACHOSIL
    TACHOSIL
    78284603 2951400 Live/Registered
    TAKEDA AS
    2003-08-07
    TACHOSIL
    TACHOSIL
    77870559 3878803 Live/Registered
    TAKEDA AS
    2009-11-11

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