Home NDC 83078-702 TachoSil
Product NDC 83078-702
11-digit product format 830780702
Labeler code 83078
Product ID 83078-702_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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base TachoSil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HUMAN THROMBIN 5.5 mg/1 FIBRINOGEN HUMAN 2 [USP'U]/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 83078-702-00 TachoSil 1 in 1 POUCH PATCH 1 7 83078-702-02 TachoSil 2 in 1 CARTON PATCH 2 7 83078-702-99 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 83078-702 TACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [CORZA MEDICAL GMBH] 5 Current NDC, 3 package rows 20250216_0c324332-290f-413f-820c-8c9a971a2766.zip
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 2026-06-01
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 83078-702-00 83078070200 1 in 1 POUCH Historical 83078-702-02 83078070202 2 POUCH in 1 CARTON (83078-702-02) / 1 BLISTER PACK in 1 POUCH (83078-702-00) / 1 PATCH in 1 BLISTER PACK (83078-702-99) 2 pouch 2025-08-29 No No Current 83078-702-99 83078070299 1 in 1 BLISTER PACK Historical