NDC 0338-8402-01 - TISSEEL Fibrin Sealant
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0338-8402
- Requested NDC
- 0338-8402-01
- Package NDCs from labels
- 0338-8402-01, 0338-8402-02, 0338-8402-03, 0338-8402-04, 0338-8402-09, 0338-8402-10
- Manufacturer
- Baxter Healthcare Corporation
- Effective date
- 2025-09-30
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| TISSEEL Fibrin Sealant - Baxter Healthcare Corporation | Baxter Healthcare Corporation | 2025-09-30 | PLASMA DERIVATIVE |
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 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 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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dr. Talbots Daily Allergy Relief | ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM | Talbot's Pharmaceuticals Family Products, LLC. | 91c2795d-4cde-6e2c-e053-2995a90a0096 | 2021-10-05 | Warnings | 451W47IQ8X |
| Solucion InterSol | SOLUCION ADITIVA PARA PLAQUETAS 3 | Fenwal, Inc. | d5eaf5f4-67d3-4475-af9a-f5b0f882f5d1 | 2021-10-04 | Warnings, Adverse reactions | 451W47IQ8X B22547B95K |
| Vitamin B Complex | THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE | Mylan Institutional LLC | 282ccec8-9bcd-4571-9b91-bbb96ef2620d | 2021-09-15 | Warnings, Adverse reactions | 25X51I8RD4 |
| NATRUM MURIATICUM | NATRUM MURIATICUM | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | 520edb18-5f2a-4448-ba53-83408a839e1f | 2021-09-02 | Warnings | 451W47IQ8X |
| Sterile Water | STERILE WATER | B. Braun Medical Inc. | d99f9133-e4d0-4dee-b611-dbc3f918b547 | 2021-08-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Lactated Ringers Irrigation | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE | B. Braun Medical Inc. | 0db56c7a-2b8f-4593-8591-2c481c92b2cf | 2021-08-06 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Sodium Chloride for Irrigation | SODIUM CHLORIDE FOR IRRIGATION | B. Braun Medical Inc. | 5bd9b176-0402-4a3f-a6b4-c3f393fc092a | 2021-08-06 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | B. Braun Medical Inc. | 8924e52e-8622-4ed6-a061-1908183e0a18 | 2021-08-06 | Warnings, Adverse reactions | 059QF0KO0R |
| DERLADIE WITCH HAZEL PERFECT VITAMIN GELCREAM | NIACINAMIDE, ADENOSINE | LAON COMMERCE co ltd | c76c4bc7-1f7b-252e-e053-2a95a90aa215 | 2021-07-18 | Warnings | 25X51I8RD4 |
| DERLADIE WITCH HAZEL PERFECT VITAMIN SERUM | NIACINAMIDE, ADENOSINE | LAON COMMERCE co ltd | c7709e83-3246-d4f8-e053-2a95a90a2bbe | 2021-07-18 | Warnings | 25X51I8RD4 |
| 0.9% SODIUM CHLORIDE | SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | c755e41b-acba-7234-e053-2995a90aff0f | 2021-07-17 | Warnings, Adverse reactions | 451W47IQ8X |
| THE SKINHOUSE VITA SNAIL FIRST ESSENSE | NIACINAMIDE, ADENOSINE | NOKSIBCHO cosmetic Co., Ltd. | 20fcfd5c-7645-453a-a761-d355b0f1efc6 | 2021-07-15 | Warnings | 25X51I8RD4 |
| COXIR INTENSIVE EGF PEPTIDE TONER | NIACINAMIDE, ADENOSINE | NOKSIBCHO cosmetic Co., Ltd. | 847fd2db-7202-4d81-85b7-03a46cfe3e66 | 2021-07-14 | Warnings | 25X51I8RD4 |
| COXIR INTENSIVE EGF PEPTIDE SERUM | NIACINAMIDE, ADENOSINE | NOKSIBCHO cosmetic Co., Ltd. | 03a97ef0-6ad1-47ef-a8f4-fd32fd02a199 | 2021-07-14 | Warnings | 25X51I8RD4 |
| COXIR INTENSIVE EGF PEPTIDE | NIACINAMIDE, ADENOSINE | NOKSIBCHO cosmetic Co., Ltd. | a2caa508-e74b-40d7-8cde-20280731c2a6 | 2021-07-14 | Warnings | 25X51I8RD4 |
| COXIR INTENSIVE EGF PEPTIDE | NIACINAMIDE, ADENOSINE | NOKSIBCHO cosmetic Co., Ltd. | 2f121591-4c13-4824-95d6-bd3ab4ee17c9 | 2021-07-14 | Warnings | 25X51I8RD4 |
| COXIR INTENSIVE EGF PEPTIDE MASK PACK | NIACINAMIDE, ADENOSINE | NOKSIBCHO cosmetic Co., Ltd. | 68542629-f580-46b9-a4b6-efb055b17fc5 | 2021-07-14 | Warnings | 25X51I8RD4 |
| Melange combination | CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA | Seroyal USA | 0a071fbf-0075-4479-e054-00144ff8d46c | 2021-07-14 | Warnings | 451W47IQ8X |
| THE SKINHOUSE ALOE SOOTHING VITAMIN | NIACINAMIDE | NOKSIBCHO cosmetic Co., Ltd. | 516f3790-a127-455c-9eae-d41895fe2411 | 2021-07-14 | Warnings | 25X51I8RD4 |
| Eyewash | EYEWASH | Global Equipment Company | c4f78121-4668-2e0c-e053-2995a90ab6c6 | 2021-06-17 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.