FDA.reportPublic FDA data

TachoSil

Product NDC
0338-8701
Requested package NDC
0338-8701-01
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0338-87010338-8701-01DDiscontinued by firm2026-07-31

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TachoSilTHROMBIN HUMAN AND FIBRINOGENCorza Medical GmbH0c324332-290f-413f-820c-8c9a971a27662025-10-08Warnings, Adverse reactionsExact identifier
application number: BLA125351

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-8701-01EA - Each0338-87017a5928e5-c12a-4396-94cb-0231bb148c6412018-01-12

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125351TachosilFibrin Sealant Patch351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-8701-01003388701011 POUCH in 1 CARTON (0338-8701-01) > 1 BLISTER PACK in 1 POUCH (0338-8701-00) > 1 PATCH in 1 BLISTER PACK1 pouch2010-04-050000-00-00NoNoCurrent