TISSEEL
- Product NDC
- 0338-8402
- 11-digit product format
- 003388402
- Labeler code
- 0338
- Product ID
- 0338-8402_92e85779-aead-491b-bbd5-e17bbb517580
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- fibrinogen human, human thrombin
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Baxter Healthcare Corporation
- Application
- BLA103980
- Marketing category
- BLA
- Marketing start
- 1998-05-01
- Marketing end
- 0000-00-00
- Substance
- FIBRINOGEN HUMAN; HUMAN THROMBIN
- Active strength
- 90 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
| 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 |
|---|---|---|---|---|---|---|
| 0338-8402-01 | TISSEELFibrin Sealant | 2 mL in 1 SYRINGE, PLASTIC | SOLUTION | 2 | 9 | |
| 0338-8402-02 | TISSEELFibrin Sealant | 1 in 1 CARTON | SOLUTION | 1 | 9 | |
| 0338-8402-03 | TISSEELFibrin Sealant | 4 mL in 1 SYRINGE, PLASTIC | SOLUTION | 4 | 9 | |
| 0338-8402-04 | TISSEELFibrin Sealant | 1 in 1 CARTON | SOLUTION | 1 | 9 | |
| 0338-8402-09 | TISSEELFibrin Sealant | 10 mL in 1 SYRINGE, PLASTIC | SOLUTION | 10 | 9 | |
| 0338-8402-10 | TISSEELFibrin Sealant | 1 in 1 CARTON | SOLUTION | 1 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-8402-01 | ML - Milliliter | 0338-8402 | cbf2520f-e91d-44fa-a468-64bd4e21cbe3 | 1 | 2022-06-06 |
| 0338-8402-02 | ML - Milliliter | 0338-8402 | 95155609-93b5-4cc5-9907-8c99429aef28 | 1 | 2018-01-12 |
| 0338-8402-03 | ML - Milliliter | 0338-8402 | 53cca17c-cdbe-42fb-a3c0-cd18878c3fbe | 1 | 2022-06-06 |
| 0338-8402-04 | ML - Milliliter | 0338-8402 | 18b1ebf7-b9ce-41a9-8593-0bdaefd9efd9 | 1 | 2018-01-12 |
| 0338-8402-09 | ML - Milliliter | 0338-8402 | b6027cf3-c779-4169-8fce-e438b0ba32e6 | 1 | 2022-06-06 |
| 0338-8402-10 | ML - Milliliter | 0338-8402 | ab4c2acb-d2d6-406f-bd13-b1e43ce263ca | 1 | 2018-01-12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0338-8402 | TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) KIT TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) SOLUTION [BAXTER HEALTHCARE CORPORATION] | 8 | Legacy NDC, 6 package rows | 20240802_b3f69e25-1b87-4507-81fa-582ea084673d.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2003660 | fibrin sealant (thrombin 625 UNT/ML, human) Topical Solution | PSN | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003669 | fibrin sealant (thrombin 625 UNT/mL, human) topical solution 10 mL Prefilled Syringe, frozen | PSN | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003663 | fibrin sealant (thrombin 625 UNT/mL, human) topical solution 2 mL Prefilled Syringe, frozen | PSN | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003667 | fibrin sealant (thrombin 625 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozen | PSN | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003670 | TISSEEL (frozen) fibrin sealant (human) topical solution 10 mL Prefilled Syringe | PSN | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003664 | TISSEEL (frozen) fibrin sealant (human) topical solution 2 mL Prefilled Syringe | PSN | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003668 | TISSEEL (frozen) fibrin sealant (human) topical solution 4 mL Prefilled Syringe | PSN | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003662 | TISSEEL, fibrin sealant (human) Topical Solution | PSN | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003670 | 10 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel] | SBD | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003664 | 2 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel] | SBD | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003668 | 4 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel] | SBD | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003666 | fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel] | SBD | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003662 | fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Topical Solution [Tisseel] | SBD | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003669 | 10 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe | SCD | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003663 | 2 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe | SCD | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003667 | 4 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe | SCD | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003665 | fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe | SCD | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003660 | fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Topical Solution | SCD | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003660 | fibrin sealant (thrombin 625 UNT/ML, human) Topical Solution | SY | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003669 | fibrin sealant (thrombin 625 UNT/ML, human) topical solution 10 ML Prefilled Syringe, frozen | SY | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003663 | fibrin sealant (thrombin 625 UNT/ML, human) topical solution 2 ML Prefilled Syringe, frozen | SY | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003667 | fibrin sealant (thrombin 625 UNT/ML, human) topical solution 4 ML Prefilled Syringe, frozen | SY | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003670 | Tisseel (frozen) fibrin sealant (human) topical solution 10 ML Prefilled Syringe | SY | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003664 | Tisseel (frozen) fibrin sealant (human) topical solution 2 ML Prefilled Syringe | SY | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003668 | Tisseel (frozen) fibrin sealant (human) topical solution 4 ML Prefilled Syringe | SY | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003666 | Tisseel (frozen) fibrin sealant (human) topical solution Prefilled Syringe | SY | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
| 2003662 | TISSEEL, fibrin sealant (human) Topical Solution | SY | b3f69e25-1b87-4507-81fa-582ea084673d | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0338-8402-01 | 00338840201 | 2 mL in 1 SYRINGE, PLASTIC | 2 ml | Historical | ||||
| 0338-8402-02 | 00338840202 | 1 SYRINGE, PLASTIC in 1 CARTON (0338-8402-02) > 2 mL in 1 SYRINGE, PLASTIC (0338-8402-01) | 1998-05-01 | 0000-00-00 | No | No | Current | |
| 0338-8402-03 | 00338840203 | 4 mL in 1 SYRINGE, PLASTIC | 4 ml | Historical | ||||
| 0338-8402-04 | 00338840204 | 1 SYRINGE, PLASTIC in 1 CARTON (0338-8402-04) > 4 mL in 1 SYRINGE, PLASTIC (0338-8402-03) | 1998-05-01 | 0000-00-00 | No | No | Current | |
| 0338-8402-09 | 00338840209 | 10 mL in 1 SYRINGE, PLASTIC | 10 ml | Historical | ||||
| 0338-8402-10 | 00338840210 | 1 SYRINGE, PLASTIC in 1 CARTON (0338-8402-10) > 10 mL in 1 SYRINGE, PLASTIC (0338-8402-09) | 1998-05-01 | 0000-00-00 | No | No | Current |