FDA.reportPublic FDA data

EVICEL Fibrin Sealant (Human)

Product NDC
63713-390
Requested package NDC
63713-390-22
11-digit product format
637130390
Labeler code
63713
Product ID
63713-390_5e56f7f0-fdfd-4c76-835e-ab31d22b08e9
Type
PLASMA DERIVATIVE
Nonproprietary name
Fibrinogen Human and Thrombin Human
Dosage form
KIT
Labeler
Ethicon Inc
Application
BLA125010
Marketing category
BLA
Marketing start
2013-03-21
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63713-39063713-390-22DDiscontinued by firm2026-08-11

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
63713-390-112024-12-19f386c64a-3609-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EVICEL ® safely and effectively. See full prescribing information for EVICEL ® . EVICEL ® (Fibrin Sealant [Human]) frozen solutions, for topical use only Initial U.S. approval: 2003
63713-390-222024-12-19f386c64a-4498-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EVICEL ® safely and effectively. See full prescribing information for EVICEL ® . EVICEL ® Fibrin Sealant (Human) For Topical Use Only Frozen solutions of BAC2 (Fibrinogen) and Thrombin Initial U.S. approval: 2003
63713-390-552024-12-19f386c649-ec5c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EVICEL ® safely and effectively. See full prescribing information for EVICEL ® . EVICEL ® Fibrin Sealant (Human) For Topical Use only Frozen solutions of BAC2 (Fibrinogen) and Thrombin Initial U.S. approval: 2003
63713-390-112023-01-30f386c64a-3609-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EVICEL ® safely and effectively. See full prescribing information for EVICEL ® . EVICEL ® (Fibrin Sealant [Human]) frozen solutions, for topical use only Initial U.S. approval: 2003
63713-390-222023-01-30f386c64a-4498-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EVICEL ® safely and effectively. See full prescribing information for EVICEL ® . EVICEL ® Fibrin Sealant (Human) For Topical Use Only Frozen solutions of BAC2 (Fibrinogen) and Thrombin Initial U.S. approval: 2003
63713-390-552023-01-30f386c649-ec5c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EVICEL ® safely and effectively. See full prescribing information for EVICEL ® . EVICEL ® Fibrin Sealant (Human) For Topical Use only Frozen solutions of BAC2 (Fibrinogen) and Thrombin Initial U.S. approval: 2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63713-390-11ML - Milliliter63713-39004e32fb1-9adf-4c87-bdc5-a823b87959fd12020-08-06
63713-390-22ML - Milliliter63713-39025a46423-710a-43ad-9693-127455d0413f12017-04-05
63713-390-55ML - Milliliter63713-3903b13f94c-7934-4531-b6e7-75ccfc6ad95b12016-04-04

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125010Crosseal, EvicelFibrin Sealant (Human)351(a)Disc2026-07-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63713-390-22637130390221 KIT in 1 PACKAGE, COMBINATION (63713-390-22) * 2 mL in 1 VIAL, GLASS * 2 mL in 1 VIAL, GLASS1 kit2013-03-210000-00-00NoNoCurrent