Home NDC 0338-8503 ARTISS
Product NDC 0338-8503
11-digit product format 003388503
Labeler code 0338
Product ID 0338-8503_fe2e12c8-3210-43c7-844b-b50af32dad87
Type PLASMA DERIVATIVE
Nonproprietary name Fibrinogen Human, Human Thrombin
Dosage form SOLUTION
Route TOPICAL
Labeler Baxter Healthcare Corporation
Application BLA125266
Marketing category BLA
Marketing start 2008-03-19
Marketing end 0000-00-00
Substance FIBRINOGEN HUMAN; HUMAN THROMBIN
Active strength 87 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 0338-8503-02 excluded package package 0338-8503-04 excluded package package 0338-8503-10
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0338-8503-01 ARTISSFibrin Sealant 2 mL in 1 SYRINGE, PLASTIC SOLUTION 2 12 0338-8503-02 ARTISSFibrin Sealant 1 in 1 CARTON SOLUTION 1 12 0338-8503-03 ARTISSFibrin Sealant 4 mL in 1 SYRINGE, PLASTIC SOLUTION 4 12 0338-8503-04 ARTISSFibrin Sealant 1 in 1 CARTON SOLUTION 1 12 0338-8503-09 ARTISSFibrin Sealant 10 mL in 1 SYRINGE, PLASTIC SOLUTION 10 12 0338-8503-10 ARTISSFibrin Sealant 1 in 1 CARTON SOLUTION 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-8503 ARTISS FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) SOLUTION [BAXTER HEALTHCARE CORPORATION] 10 Legacy NDC, 6 package rows 20250209_92fc93e1-9695-4705-90c5-4452a80bb074.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125266 Artiss Fibrin Sealant (Human) 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1305910 ARTISS (Frozen) fibrin sealant (human) topical solution 10 mL Prefilled Syringe PSN 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305892 ARTISS (Frozen) fibrin sealant (human) topical solution 2 mL Prefilled Syringe PSN 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305908 ARTISS (Frozen) fibrin sealant (human) topical solution 4 mL Prefilled Syringe PSN 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305909 fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 10 mL Prefilled Syringe, frozen PSN 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305891 fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 2 mL Prefilled Syringe, frozen PSN 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305907 fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozen PSN 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305910 10 ML fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled Syringe [Artiss] SBD 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305892 2 ML fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled Syringe [Artiss] SBD 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305908 4 ML fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled Syringe [Artiss] SBD 92fc93e1-9695-4705-90c5-4452a80bb074 12 1359489 fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled Syringe [Artiss] SBD 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305909 10 ML fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled Syringe SCD 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305891 2 ML fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled Syringe SCD 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305907 4 ML fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled Syringe SCD 92fc93e1-9695-4705-90c5-4452a80bb074 12 1360136 fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled Syringe SCD 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305910 Artiss (Frozen) fibrin sealant (human) topical solution 10 ML Prefilled Syringe SY 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305892 Artiss (Frozen) fibrin sealant (human) topical solution 2 ML Prefilled Syringe SY 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305908 Artiss (Frozen) fibrin sealant (human) topical solution 4 ML Prefilled Syringe SY 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305909 fibrin sealant (thrombin 6.5 UNT/ML, human) topical solution 10 ML Prefilled Syringe, frozen SY 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305891 fibrin sealant (thrombin 6.5 UNT/ML, human) topical solution 2 ML Prefilled Syringe, frozen SY 92fc93e1-9695-4705-90c5-4452a80bb074 12 1305907 fibrin sealant (thrombin 6.5 UNT/ML, human) topical solution 4 ML Prefilled Syringe, frozen SY 92fc93e1-9695-4705-90c5-4452a80bb074 12
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0338-8503-01 00338850301 2 mL in 1 SYRINGE, PLASTIC 2 ml Historical 0338-8503-02 00338850302 1 SYRINGE, PLASTIC in 1 CARTON (0338-8503-02) > 2 mL in 1 SYRINGE, PLASTIC (0338-8503-01) 2008-03-19 0000-00-00 No No Current 0338-8503-03 00338850303 4 mL in 1 SYRINGE, PLASTIC 4 ml Historical 0338-8503-04 00338850304 1 SYRINGE, PLASTIC in 1 CARTON (0338-8503-04) > 4 mL in 1 SYRINGE, PLASTIC (0338-8503-03) 2008-03-19 0000-00-00 No No Current 0338-8503-09 00338850309 10 mL in 1 SYRINGE, PLASTIC 10 ml Historical 0338-8503-10 00338850310 1 SYRINGE, PLASTIC in 1 CARTON (0338-8503-10) > 10 mL in 1 SYRINGE, PLASTIC (0338-8503-09) 2008-03-19 0000-00-00 No No Current