VISTASEAL
- Product NDC
- 61953-0020
- 11-digit product format
- 619530020
- Labeler code
- 61953
- Product ID
- 61953-0020_28f64c1d-b52d-4df0-b976-fe9c0cdd4170
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Human fibrinogen, human thrombin
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- GRIFOLS USA, LLC
- Application
- BLA125640
- Marketing category
- BLA
- Marketing start
- 2019-11-01
- Substance
- FIBRINOGEN HUMAN; HUMAN THROMBIN
- Active strength
- 80; 500 mg/mL; [iU]/mL
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VISTASEAL
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FIBRINOGEN HUMAN | 80 mg/mL |
| HUMAN THROMBIN | 500 [iU]/mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2 | Product name | 5 | 20250304 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 1681bc73-b05f-12c3-1075-382ae39f449c | Product name | 1 | 20140508 |
| 87711080-88eb-65c5-b2dd-bf99e700a372 | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61953-0020-1 | VISTASEAL | 1 in 1 PACKAGE, COMBINATION | SOLUTION | 1 | 2 | |
| 61953-0020-2 | VISTASEAL | 2 mL in 1 SYRINGE, GLASS | SOLUTION | 2 | 2 | |
| 61953-0020-3 | VISTASEAL | 1 in 1 PACKAGE, COMBINATION | SOLUTION | 1 | 2 | |
| 61953-0020-4 | VISTASEAL | 4 mL in 1 SYRINGE, GLASS | SOLUTION | 4 | 2 | |
| 61953-0020-5 | VISTASEAL | 1 in 1 PACKAGE, COMBINATION | SOLUTION | 1 | 2 | |
| 61953-0020-6 | VISTASEAL | 6 mL in 1 SYRINGE, GLASS | SOLUTION | 6 | 2 | |
| 61953-0020-7 | VISTASEAL | 1 in 1 PACKAGE, COMBINATION | SOLUTION | 1 | 2 | |
| 61953-0020-8 | VISTASEAL | 10 mL in 1 SYRINGE, GLASS | SOLUTION | 10 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61953-0020 | VISTASEAL (HUMAN FIBRINOGEN, HUMAN THROMBIN) SOLUTION [GRIFOLS USA, LLC] | 2 | Current NDC, 8 package rows | 20241228_e832dbe8-ff52-4656-a61d-3140731aa123.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2264608 | fibrin sealant (thrombin 500 UNT/mL, human) topical solution 10 mL Prefilled Syringe, frozen | PSN | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264366 | fibrin sealant (thrombin 500 UNT/mL, human) topical solution 2 mL Prefilled Syringe, frozen | PSN | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264603 | fibrin sealant (thrombin 500 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozen | PSN | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264606 | fibrin sealant (thrombin 500 UNT/mL, human) topical solution 6 mL Prefilled Syringe, frozen | PSN | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264609 | VistaSeal (Frozen) fibrin sealant (human) topical solution 10 mL Prefilled Syringe | PSN | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264371 | VistaSeal (Frozen) fibrin sealant (human) topical solution 2 mL Prefilled Syringe | PSN | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264604 | VistaSeal (Frozen) fibrin sealant (human) topical solution 4 mL Prefilled Syringe | PSN | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264607 | VistaSeal (frozen) fibrin sealant (human) topical solution 6 mL Prefilled Syringe | PSN | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264609 | 10 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal] | SBD | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264371 | 2 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal] | SBD | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264604 | 4 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal] | SBD | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264607 | 6 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal] | SBD | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264608 | 10 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe | SCD | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264366 | 2 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe | SCD | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264603 | 4 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe | SCD | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264606 | 6 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe | SCD | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264608 | fibrin sealant (thrombin 500 UNT/ML, human) topical solution 10 ML Prefilled Syringe, frozen | SY | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264366 | fibrin sealant (thrombin 500 UNT/ML, human) topical solution 2 ML Prefilled Syringe, frozen | SY | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264603 | fibrin sealant (thrombin 500 UNT/ML, human) topical solution 4 ML Prefilled Syringe, frozen | SY | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264606 | fibrin sealant (thrombin 500 UNT/ML, human) topical solution 6 ML Prefilled Syringe, frozen | SY | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264609 | VistaSeal (Frozen) fibrin sealant (human) topical solution 10 ML Prefilled Syringe | SY | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264371 | VistaSeal (Frozen) fibrin sealant (human) topical solution 2 ML Prefilled Syringe | SY | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264604 | VistaSeal (Frozen) fibrin sealant (human) topical solution 4 ML Prefilled Syringe | SY | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
| 2264607 | VistaSeal (frozen) fibrin sealant (human) topical solution 6 ML Prefilled Syringe | SY | e832dbe8-ff52-4656-a61d-3140731aa123 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61953-0020-1 | 61953002001 | 1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-1) / 2 mL in 1 SYRINGE, GLASS (61953-0020-2) | 2019-11-01 | No | No | Historical | |
| 61953-0020-2 | 61953002002 | 2 mL in 1 SYRINGE, GLASS | 2 ml | Historical | |||
| 61953-0020-3 | 61953002003 | 1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-3) / 4 mL in 1 SYRINGE, GLASS (61953-0020-4) | 2019-11-01 | No | No | Historical | |
| 61953-0020-4 | 61953002004 | 4 mL in 1 SYRINGE, GLASS | 4 ml | Historical | |||
| 61953-0020-5 | 61953002005 | 1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-5) / 6 mL in 1 SYRINGE, GLASS (61953-0020-6) | 2019-11-01 | No | No | Historical | |
| 61953-0020-6 | 61953002006 | 6 mL in 1 SYRINGE, GLASS | 6 ml | Historical | |||
| 61953-0020-7 | 61953002007 | 1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-7) / 10 mL in 1 SYRINGE, GLASS (61953-0020-8) | 2019-11-01 | No | No | Historical | |
| 61953-0020-8 | 61953002008 | 10 mL in 1 SYRINGE, GLASS | 10 ml | Historical |