Home NDC 83078-704 TachoSil
Product NDC 83078-704
11-digit product format 830780704
Labeler code 83078
Product ID 83078-704_a6dcd8af-ccd7-4b27-880a-c7da5c7e6efc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name THROMBIN HUMAN and FIBRINOGEN
Dosage form PATCH
Route TOPICAL
Labeler Corza Medical GmbH
Application BLA125351
Marketing category BLA
Marketing start 2025-08-29
Substance FIBRINOGEN HUMAN; HUMAN THROMBIN
Active strength 5.5; 2 mg/1; [USP'U]/1
Pharmacologic classes Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base TachoSil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HUMAN THROMBIN 2 [USP'U]/1 FIBRINOGEN HUMAN 5.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N94833051K Internal UNII lookup 6K15ABL77G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1001591 Internal RxNorm lookup 1001593 Internal RxNorm lookup 1014303 Internal RxNorm lookup 1014305 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83078-704-00 TachoSil 1 in 1 POUCH PATCH 1 7 83078-704-01 TachoSil 1 in 1 CARTON PATCH 1 7 83078-704-99 TachoSil 1 in 1 BLISTER PACK PATCH 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83078-704 TACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [CORZA MEDICAL GMBH] 5 Current NDC, 3 package rows 20250216_0c324332-290f-413f-820c-8c9a971a2766.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125351 Tachosil Fibrin Sealant Patch 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1014303 fibrinogen / thrombin (human) 1.9 inch x 1.9 inch Patch PSN 0c324332-290f-413f-820c-8c9a971a2766 7 1001591 fibrinogen / thrombin (human) 3.7 inch x 1.9 inch Medicated Patch PSN 0c324332-290f-413f-820c-8c9a971a2766 7 1014305 TachoSil 1.9 inch x 1.9 inch Patch PSN 0c324332-290f-413f-820c-8c9a971a2766 7 1001593 TachoSil 3.7 inch x 1.9 inch Medicated Patch PSN 0c324332-290f-413f-820c-8c9a971a2766 7 1014305 fibrinogen, human 171 MG / thrombin, human 62.2 UNT Medicated Patch [TachoSil] SBD 0c324332-290f-413f-820c-8c9a971a2766 7 1001593 fibrinogen, human 337 MG / thrombin, human 123 UNT Medicated Patch [TachoSil] SBD 0c324332-290f-413f-820c-8c9a971a2766 7 1014303 fibrinogen, human 171 MG / thrombin, human 62.2 UNT Medicated Patch SCD 0c324332-290f-413f-820c-8c9a971a2766 7 1001591 fibrinogen, human 337 MG / thrombin, human 123 UNT Medicated Patch SCD 0c324332-290f-413f-820c-8c9a971a2766 7 1014303 fibrinogen, human / thrombin, human 1.9 inch x 1.9 inch Patch SY 0c324332-290f-413f-820c-8c9a971a2766 7 1001591 fibrinogen, human / thrombin, human 3.7 inch x 1.9 inch Medicated Patch SY 0c324332-290f-413f-820c-8c9a971a2766 7 1014305 TachoSil (fibrinogen, human 170.5 MG / thrombin, human 62.2 UNT) Medicated Patch SY 0c324332-290f-413f-820c-8c9a971a2766 7 1001593 TachoSil (fibrinogen, human 337.4 MG / thrombin, human 123.1 UNT) Medicated Patch SY 0c324332-290f-413f-820c-8c9a971a2766 7
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83078-704-00 83078070400 1 in 1 POUCH Historical 83078-704-01 83078070401 1 POUCH in 1 CARTON (83078-704-01) / 1 BLISTER PACK in 1 POUCH (83078-704-00) / 1 PATCH in 1 BLISTER PACK (83078-704-99) 1 pouch 2025-08-29 Yes No Current 83078-704-99 83078070499 1 in 1 BLISTER PACK Historical