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
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 |
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 |