Home NDC 0338-8701 TachoSil
Product NDC 0338-8701
11-digit product format 003388701
Labeler code 0338
Product ID 0338-8701_6491373f-21e0-47c5-9245-c0244b4daf9c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name THROMBIN HUMAN and FIBRINOGEN
Dosage form PATCH
Route TOPICAL
Labeler Baxter Healthcare Corporation
Application BLA125351
Marketing category BLA
Marketing start 2010-04-05
Marketing end 0000-00-00
Substance FIBRINOGEN HUMAN; HUMAN THROMBIN
Active strength 6 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 2023-12-31
Current FDA listing Historical FDA.report record 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TachoSil THROMBIN HUMAN AND FIBRINOGEN Corza Medical GmbH 0c324332-290f-413f-820c-8c9a971a2766 2025-10-08 Warnings, Adverse reactions Exact identifier application number: BLA125351
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0338-8701-01 00338870101 1 POUCH in 1 CARTON (0338-8701-01) > 1 BLISTER PACK in 1 POUCH (0338-8701-00) > 1 PATCH in 1 BLISTER PACK 1 pouch 2010-04-05 0000-00-00 No No Current