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NDC 00338-8503-02 ARTISS 86.5; 4 mg/mL; [iU]/mL Details
ARTISS 86.5; 4 mg/mL; [iU]/mL
ARTISS 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 | 00338-8503 |
|---|---|
| Product ID | 0338-8503_d49b844c-32d1-4c69-94fd-f4447c4bd409 |
| Associated GPIs | 84209904102000 |
| GCN Sequence Number | 064459 |
| GCN Sequence Number Description | thrombin/fibrinog/aprotin/calc SYRINGE 2 ML TOPICAL |
| HIC3 | L9K |
| HIC3 Description | TISSUE/WOUND ADHESIVES |
| GCN | 14367 |
| HICL Sequence Number | 035889 |
| HICL Sequence Number Description | THROMBIN(HUM PLAS)/FIBRINOGEN/APROTININ,SYN/CALCIUM CHLORIDE |
| Brand/Generic | Brand |
| Proprietary Name | ARTISS |
| Proprietary Name Suffix | Fibrin Sealant |
| Non-Proprietary Name | Fibrinogen Human, Human Thrombin |
| Product Type | PLASMA DERIVATIVE |
| Dosage Form | SOLUTION |
| Route | TOPICAL |
| Active Ingredient Strength | 86.5; 4 |
| 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 | BLA125266 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00338-8503-02 (00338850302)
| NDC Package Code | 0338-8503-02 |
|---|---|
| Billing NDC | 00338850302 |
| Package | 1 SYRINGE, PLASTIC in 1 CARTON (0338-8503-02) / 2 mL in 1 SYRINGE, PLASTIC (0338-8503-01) |
| Marketing Start Date | 2008-03-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |