FDA.reportPublic FDA data

VISTASEAL

Product NDC
61953-0013
11-digit product format
619530013
Labeler code
61953
Product ID
61953-0013_3d6c2bfa-ee7e-480a-8472-6681ab2b7574
Type
PLASMA DERIVATIVE
Nonproprietary name
human fibrinogen, human thrombin
Dosage form
KIT
Labeler
GRIFOLS USA, LLC
Application
BLA125640
Marketing category
BLA
Marketing start
2019-11-01
Marketing end
0000-00-00
Active strength
0
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61953-0013DDiscontinued by firm2026-09-14
excluded packagepackage61953-001361953-0013-1DDiscontinued by firm2026-09-14

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct61953-0013DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61953-001361953-0013-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61953-0013-1VISTASEAL1 in 1 PACKAGE, COMBINATIONKIT114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61953-0013VISTASEAL (HUMAN FIBRINOGEN, HUMAN THROMBIN) KIT [GRIFOLS USA, LLC]13Legacy NDC, 1 package rows20241010_a8708417-2f74-4dfa-b6f9-ef88f902e0fc.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125640VistasealFibrin Sealant (Human)351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2264608fibrin sealant (thrombin 500 UNT/mL, human) topical solution 10 mL Prefilled Syringe, frozenPSNa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264366fibrin sealant (thrombin 500 UNT/mL, human) topical solution 2 mL Prefilled Syringe, frozenPSNa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264603fibrin sealant (thrombin 500 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozenPSNa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264606fibrin sealant (thrombin 500 UNT/mL, human) topical solution 6 mL Prefilled Syringe, frozenPSNa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264609VistaSeal (Frozen) fibrin sealant (human) topical solution 10 mL Prefilled SyringePSNa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264371VistaSeal (Frozen) fibrin sealant (human) topical solution 2 mL Prefilled SyringePSNa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264604VistaSeal (Frozen) fibrin sealant (human) topical solution 4 mL Prefilled SyringePSNa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264607VistaSeal (frozen) fibrin sealant (human) topical solution 6 mL Prefilled SyringePSNa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
226460910 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal]SBDa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
22643712 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal]SBDa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
22646044 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal]SBDa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
22646076 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal]SBDa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
226460810 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled SyringeSCDa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
22643662 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled SyringeSCDa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
22646034 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled SyringeSCDa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
22646066 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled SyringeSCDa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264608fibrin sealant (thrombin 500 UNT/ML, human) topical solution 10 ML Prefilled Syringe, frozenSYa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264366fibrin sealant (thrombin 500 UNT/ML, human) topical solution 2 ML Prefilled Syringe, frozenSYa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264603fibrin sealant (thrombin 500 UNT/ML, human) topical solution 4 ML Prefilled Syringe, frozenSYa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264606fibrin sealant (thrombin 500 UNT/ML, human) topical solution 6 ML Prefilled Syringe, frozenSYa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264609VistaSeal (Frozen) fibrin sealant (human) topical solution 10 ML Prefilled SyringeSYa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264371VistaSeal (Frozen) fibrin sealant (human) topical solution 2 ML Prefilled SyringeSYa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264604VistaSeal (Frozen) fibrin sealant (human) topical solution 4 ML Prefilled SyringeSYa8708417-2f74-4dfa-b6f9-ef88f902e0fc14
2264607VistaSeal (frozen) fibrin sealant (human) topical solution 6 ML Prefilled SyringeSYa8708417-2f74-4dfa-b6f9-ef88f902e0fc14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61953-0013-1619530013011 KIT in 1 PACKAGE, COMBINATION (61953-0013-1) * 3 mL in 1 SYRINGE, GLASS * 3 mL in 1 SYRINGE, GLASS1 kit2019-11-010000-00-00NoNoCurrent