FDA.reportPublic FDA data

VISTASEAL

Product NDC
61953-0012
11-digit product format
619530012
Labeler code
61953
Product ID
61953-0012_54f6ba29-974e-400a-80d4-13c351229916
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
2027-03-18
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VISTASEAL

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
61953-0012-1VISTASEAL1 in 1 PACKAGE, COMBINATIONKIT114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61953-0012-1ML - Milliliter61953-0012bcdb727d-c01a-4f29-bd18-d3bc0a69d51d12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61953-0012VISTASEAL (HUMAN FIBRINOGEN, HUMAN THROMBIN) KIT [GRIFOLS USA, LLC]13Current NDC, Legacy NDC, 1 package rows20241010_a8708417-2f74-4dfa-b6f9-ef88f902e0fc.zip

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
61953-0012-1619530012011 KIT in 1 PACKAGE, COMBINATION (61953-0012-1) * 2 mL in 1 SYRINGE, GLASS * 2 mL in 1 SYRINGE, GLASS1 kit2019-11-012027-03-18NoNoCurrent