NDC 0338-8701

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 ID: 0338-8701_14c30095-725e-4957-9c9a-81ea6c6d4c7a
• NDC: 0338-8701
• Product Type: Human Prescription Drug
• Proprietary Name: TachoSil
• Generic Name: Thrombin Human And Fibrinogen
• Dosage Form: Patch
• Route of Administration: TOPICAL
• Marketing Start Date: 2010-04-05
• Marketing Category: BLA / BLA
• Application Number: BLA125351
• Labeler Name: Baxter Healthcare Corporation
• Substance Name: HUMAN THROMBIN; FIBRINOGEN HUMAN
• Active Ingredient Strength: 2 [USP'U]/1; mg/1
• Pharm 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: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0338-8701-01

1 POUCH in 1 CARTON (0338-8701-01) > 1 BLISTER PACK in 1 POUCH (0338-8701-00) > 1 PATCH in 1 BLISTER PACK

• Marketing Start Date: 2010-04-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0338-8701-01 [00338870101]

TachoSil PATCH

• Marketing Category: BLA
• Application Number: BLA125351
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-04-05

NDC 0338-8701-00 [00338870100]

TachoSil PATCH

• Marketing Category: BLA
• Application Number: BLA125351
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-03-02

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN THROMBIN	2 [USP'U]/1

OpenFDA Data

• SPL SET ID: 69e05cbe-615e-45af-ad7e-92e3650cafc8
• Manufacturer:
  • Baxter Healthcare Corporation
• UNII:
  • 6K15ABL77G
  • N94833051K
• 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"

NDC	Brand Name	Generic Name
0338-8701	TachoSil	THROMBIN HUMAN and FIBRINOGEN
0338-8702	TachoSil	THROMBIN HUMAN and FIBRINOGEN
0338-8703	TachoSil	THROMBIN HUMAN and FIBRINOGEN
0944-8701	TachoSil	THROMBIN HUMAN and FIBRINOGEN
0944-8702	TachoSil	THROMBIN HUMAN and FIBRINOGEN
0944-8703	TachoSil	THROMBIN HUMAN and FIBRINOGEN