NDC 63713-460

EVITHROM

Human Thrombin

EVITHROM is a Topical Liquid in the Plasma Derivative category. It is labeled and distributed by Ethicon Inc. The primary component is Human Thrombin.

• Product ID: 63713-460_24247ecb-3e09-4939-80ca-e8f2e42081c3
• NDC: 63713-460
• Product Type: Plasma Derivative
• Proprietary Name: EVITHROM
• Generic Name: Human Thrombin
• Dosage Form: Liquid
• Route of Administration: TOPICAL
• Marketing Start Date: 2007-10-27
• Marketing Category: BLA / BLA
• Application Number: BLA125247
• Labeler Name: Ethicon Inc
• Substance Name: HUMAN THROMBIN
• Active Ingredient Strength: 1000 [iU]/mL
• Pharm Classes: Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 63713-460-02

2 mL in 1 VIAL, GLASS (63713-460-02)

• Marketing Start Date: 2007-10-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63713-460-05 [63713046005]

EVITHROM LIQUID

• Marketing Category: BLA
• Application Number: BLA125247
• Product Type: PLASMA DERIVATIVE
• Marketing Start Date: 2019-02-13

NDC 63713-460-02 [63713046002]

EVITHROM LIQUID

• Marketing Category: BLA
• Application Number: BLA125247
• Product Type: PLASMA DERIVATIVE
• Marketing Start Date: 2007-10-27

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN THROMBIN	1000 [iU]/mL

Pharmacological Class

• Human Blood Coagulation Factor [EPC]
• Increased Coagulation Factor Activity [PE]
• Blood Coagulation Factors [CS]
• Human Blood Coagulation Factor [EPC]
• Increased Coagulation Factor Activity [PE]
• Blood Coagulation Factors [CS]