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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0338-8701	0338-8701-01	D	Discontinued by firm		2026-09-14

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-8701-01	EA - Each	0338-8701	7a5928e5-c12a-4396-94cb-0231bb148c64	1	2018-01-12

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N94833051K	FIBRINOGEN HUMAN	9001-32-5	FIBRINOGEN HUMAN
6K15ABL77G	HUMAN THROMBIN	9002-04-4	HUMAN THROMBIN

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