TachoSil

Product NDC: 0944-8701
11-digit product format: 009448701
Labeler code: 0944
Product ID: 0944-8701_e7ac607f-3b8c-4e7f-aaec-e9421b020e62
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: THROMBIN HUMAN and FIBRINOGEN
Dosage form: PATCH
Route: TOPICAL
Labeler: Baxalta US Inc.
Application: BLA125351
Marketing category: BLA
Marketing start: 2010-04-05
Marketing end: 2020-05-31
Substance: HUMAN THROMBIN; FIBRINOGEN HUMAN
Active strength: 2 [USP'U]/1; mg/1
Pharmacologic classes: Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [CS],Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0944-8701		D	Discontinued by firm		2026-09-14
excluded package	package	0944-8701	0944-8701-01	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 · 24 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	0944-8701-01	`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	0944-8701-01	`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	0944-8701-01	`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	0944-8701-01	`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	0944-8701-01	`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	0944-8701-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0944-8701-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0944-8701-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0944-8701-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0944-8701-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0944-8701-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0944-8701-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0944-8701-01	EA - Each	0944-8701	ae964b07-4e29-4624-b8e3-c5980230918c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FIBRINOGEN HUMAN	ACTIVE INGREDIENT	N94833051K	TACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]	6
HUMAN THROMBIN	ACTIVE INGREDIENT	6K15ABL77G	TACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]	6
FIBRINOGEN HUMAN	ACTIVE MOIETY	N94833051K	TACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]	6
HUMAN THROMBIN	ACTIVE MOIETY	6K15ABL77G	TACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]	6
ALBUMIN HUMAN	INACTIVE INGREDIENT	ZIF514RVZR	TACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]	6
ARGININE HYDROCHLORIDE	INACTIVE INGREDIENT	F7LTH1E20Y	TACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]	6
EQUINE COLLAGEN	INACTIVE INGREDIENT	3221SCV0LS	TACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]	6
RIBOFLAVIN	INACTIVE INGREDIENT	TLM2976OFR	TACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	TACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]	6
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	TACHOSIL (THROMBIN HUMAN AND FIBRINOGEN) PATCH [BAXTER HEALTHCARE CORPORATION]	6

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
6K15ABL77G	HUMAN THROMBIN	9002-04-4	HUMAN THROMBIN
N94833051K	FIBRINOGEN HUMAN	9001-32-5	FIBRINOGEN HUMAN