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NDC 00338-8402-02 TISSEEL 90; 500 mg/mL; [iU]/mL Details
TISSEEL 90; 500 mg/mL; [iU]/mL
TISSEEL is a TOPICAL SOLUTION in the PLASMA DERIVATIVE category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is FIBRINOGEN HUMAN; HUMAN THROMBIN.
Product Information
| NDC | 00338-8402 |
|---|---|
| Product ID | 0338-8402_ab3c245f-c0ae-42fb-97ac-5c0dd0f49879 |
| Associated GPIs | 84209904102000 |
| GCN Sequence Number | 078212 |
| GCN Sequence Number Description | thrombin/fibrinog/aprotin/calc SYRINGE 2 ML TOPICAL |
| HIC3 | L9K |
| HIC3 Description | TISSUE/WOUND ADHESIVES |
| GCN | 44497 |
| HICL Sequence Number | 035889 |
| HICL Sequence Number Description | THROMBIN(HUM PLAS)/FIBRINOGEN/APROTININ,SYN/CALCIUM CHLORIDE |
| Brand/Generic | Brand |
| Proprietary Name | TISSEEL |
| Proprietary Name Suffix | Fibrin Sealant |
| Non-Proprietary Name | fibrinogen human, human thrombin |
| Product Type | PLASMA DERIVATIVE |
| Dosage Form | SOLUTION |
| Route | TOPICAL |
| Active Ingredient Strength | 90; 500 |
| Active Ingredient Units | mg/mL; [iU]/mL |
| Substance Name | FIBRINOGEN HUMAN; HUMAN THROMBIN |
| Labeler Name | Baxter Healthcare Corporation |
| Pharmaceutical Class | 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] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA103980 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00338-8402-02 (00338840202)
| NDC Package Code | 0338-8402-02 |
|---|---|
| Billing NDC | 00338840202 |
| Package | 1 SYRINGE, PLASTIC in 1 CARTON (0338-8402-02) / 2 mL in 1 SYRINGE, PLASTIC (0338-8402-01) |
| Marketing Start Date | 1998-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |