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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0338-8701-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0338-8701-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0338-8701-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0338-8701-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0338-8701-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0338-8701-01 cdf11ea48f46…ba0047e9e063…
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.
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 2026-08-01
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