RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>83425-2250-4</NDCCode>
    <PackageDescription>100 kg in 1 DRUM (83425-2250-4) </PackageDescription>
    <NDC11Code>83425-2250-04</NDC11Code>
    <ProductNDC>83425-2250</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>THURS ORGANICS PRIVATE LIMITED</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-11-19</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-MAY-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>83425-1510-4</NDCCode>
    <PackageDescription>100 kg in 1 DRUM (83425-1510-4) </PackageDescription>
    <NDC11Code>83425-1510-04</NDC11Code>
    <ProductNDC>83425-1510</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Simethicone Emulsion 30%</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <StartMarketingDate>20260928</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>THURS ORGANICS PRIVATE LIMITED</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-09-29</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>28-SEP-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>83425-2250-1</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (83425-2250-1) </PackageDescription>
    <NDC11Code>83425-2250-01</NDC11Code>
    <ProductNDC>83425-2250</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>THURS ORGANICS PRIVATE LIMITED</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-11-19</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-MAY-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>83425-2250-2</NDCCode>
    <PackageDescription>30 kg in 1 DRUM (83425-2250-2) </PackageDescription>
    <NDC11Code>83425-2250-02</NDC11Code>
    <ProductNDC>83425-2250</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>THURS ORGANICS PRIVATE LIMITED</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-11-19</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-MAY-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>83425-2250-3</NDCCode>
    <PackageDescription>200 kg in 1 DRUM (83425-2250-3) </PackageDescription>
    <NDC11Code>83425-2250-03</NDC11Code>
    <ProductNDC>83425-2250</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>THURS ORGANICS PRIVATE LIMITED</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-11-19</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-MAY-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0037-2250-04</NDCCode>
    <PackageDescription>4 POUCH in 1 BOX (0037-2250-04)  &gt; 1 TABLET in 1 POUCH</PackageDescription>
    <NDC11Code>00037-2250-04</NDC11Code>
    <ProductNDC>0037-2250</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Soma</ProprietaryName>
    <NonProprietaryName>Carisoprodol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070901</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA011792</ApplicationNumber>
    <LabelerName>Meda Pharmaceuticals</LabelerName>
    <SubstanceName>CARISOPRODOL</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-09-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>36987-2250-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-2250-4)</PackageDescription>
    <NDC11Code>36987-2250-04</NDC11Code>
    <ProductNDC>36987-2250</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Jute</ProprietaryName>
    <NonProprietaryName>Jute</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>CORCORUS CAPSULARIS FIBER</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>37662-2250-4</NDCCode>
    <PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-2250-4) </PackageDescription>
    <NDC11Code>37662-2250-04</NDC11Code>
    <ProductNDC>37662-2250</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ornithogalum Umbellatum</ProprietaryName>
    <NonProprietaryName>Ornithogalum Umbellatum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230104</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>ORNITHOGALUM UMBELLATUM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-01-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>57520-0506-4</NDCCode>
    <PackageDescription>2250 mL in 1 JUG (57520-0506-4)</PackageDescription>
    <NDC11Code>57520-0506-04</NDC11Code>
    <ProductNDC>57520-0506</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Paullinia Sorbilis, Fucus Vesiculosus, Pulsatilla, Anacardium Orientale, Chelidonium Majus,</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20100715</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Apotheca Company</LabelerName>
    <SubstanceName>PAULLINIA CUPANA SEED; FUCUS VESICULOSUS; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; CHELIDONIUM MAJUS; SODIUM SULFATE; IODINE; LYCOPODIUM CLAVATUM SPORE; SULFUR; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; THYROID</SubstanceName>
    <StrengthNumber>3; 6; 30; 6; 6; 6; 12; 12; 30; 12; 12; 4</StrengthNumber>
    <StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0069-2250-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0069-2250-30) </PackageDescription>
    <NDC11Code>00069-2250-30</NDC11Code>
    <ProductNDC>0069-2250</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Caduet</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040130</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021540</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>10; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.</IndicationAndUsage>
    <Description>CADUET (amlodipine and atorvastatin) tablets combine the calcium channel blocker amlodipine besylate with the HMG CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5∙C6H6O3S. Atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Its empirical formula is (C33H34 FN2O5)2Ca∙3H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. CADUET contains amlodipine besylate, a white to off-white crystalline powder, and atorvastatin calcium, also a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. CADUET is available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 3  5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-4210-02</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0338-4210-02)  *  1 mL in 1 VIAL, GLASS (0338-7112-01)  *  1 mL in 1 VIAL, GLASS (0338-7332-01)  *  1 mL in 1 VIAL, GLASS (0338-7201-01)  *  1 mL in 1 VIAL, GLASS (0338-7401-01) </PackageDescription>
    <NDC11Code>00338-4210-02</NDC11Code>
    <ProductNDC>0338-4210</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Tisseel</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19980501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103980</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
    <Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin (Synthetic) solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) Solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1  The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2  Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3  Thrombin Solution, 4  Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5  * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-4211-04</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0338-4211-04)  *  2 mL in 1 VIAL, GLASS (0338-7112-02)  *  2 mL in 1 VIAL, GLASS (0338-7332-02)  *  2 mL in 1 VIAL, GLASS (0338-7201-02)  *  2 mL in 1 VIAL, GLASS (0338-7401-02) </PackageDescription>
    <NDC11Code>00338-4211-04</NDC11Code>
    <ProductNDC>0338-4211</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Tisseel</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19980501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103980</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
    <Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin (Synthetic) solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) Solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1  The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2  Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3  Thrombin Solution, 4  Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5  * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-4212-10</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0338-4212-10)  *  5 mL in 1 VIAL, GLASS (0338-7332-05)  *  5 mL in 1 VIAL, GLASS (0338-7201-05)  *  5 mL in 1 VIAL, GLASS (0338-7401-05)  *  5 mL in 1 VIAL, GLASS (0338-7112-05) </PackageDescription>
    <NDC11Code>00338-4212-10</NDC11Code>
    <ProductNDC>0338-4212</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Tisseel</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19980501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103980</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
    <Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin (Synthetic) solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) Solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1  The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2  Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3  Thrombin Solution, 4  Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5  * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-4301-02</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0338-4301-02)  *  1 mL in 1 VIAL, GLASS (0338-7332-01)  *  1 mL in 1 VIAL, GLASS (0338-7201-01)  *  1 mL in 1 VIAL, GLASS (0338-7401-01)  *  1 mL in 1 VIAL, GLASS (0338-7112-01) </PackageDescription>
    <NDC11Code>00338-4301-02</NDC11Code>
    <ProductNDC>0338-4301</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Tisseel</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19980501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103980</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
    <Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin (Synthetic) solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) Solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1  The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2  Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3  Thrombin Solution, 4  Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5  * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-4302-04</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0338-4302-04)  *  2 mL in 1 VIAL, GLASS (0338-7332-02)  *  2 mL in 1 VIAL, GLASS (0338-7201-02)  *  2 mL in 1 VIAL, GLASS (0338-7401-02)  *  2 mL in 1 VIAL, GLASS (0338-7112-02) </PackageDescription>
    <NDC11Code>00338-4302-04</NDC11Code>
    <ProductNDC>0338-4302</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Tisseel</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19980501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103980</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
    <Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin (Synthetic) solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) Solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1  The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2  Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3  Thrombin Solution, 4  Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5  * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-4303-10</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0338-4303-10)  *  5 mL in 1 VIAL, GLASS (0338-7332-05)  *  5 mL in 1 VIAL, GLASS (0338-7201-05)  *  5 mL in 1 VIAL, GLASS (0338-7401-05)  *  5 mL in 1 VIAL, GLASS (0338-7112-05) </PackageDescription>
    <NDC11Code>00338-4303-10</NDC11Code>
    <ProductNDC>0338-4303</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Tisseel</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19980501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103980</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
    <Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin (Synthetic) solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) Solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1  The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2  Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3  Thrombin Solution, 4  Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5  * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-8402-02</NDCCode>
    <PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0338-8402-02)  / 2 mL in 1 SYRINGE, PLASTIC (0338-8402-01) </PackageDescription>
    <NDC11Code>00338-8402-02</NDC11Code>
    <ProductNDC>0338-8402</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Tisseel</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19980501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103980</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
    <StrengthNumber>90; 500</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
    <Pharm_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]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (&gt;1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
    <Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1  The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2  Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3  Thrombin Solution, 4  Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5  * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-8402-04</NDCCode>
    <PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0338-8402-04)  / 4 mL in 1 SYRINGE, PLASTIC (0338-8402-03) </PackageDescription>
    <NDC11Code>00338-8402-04</NDC11Code>
    <ProductNDC>0338-8402</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Tisseel</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19980501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103980</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
    <StrengthNumber>90; 500</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
    <Pharm_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]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (&gt;1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
    <Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1  The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2  Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3  Thrombin Solution, 4  Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5  * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-8402-10</NDCCode>
    <PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0338-8402-10)  / 10 mL in 1 SYRINGE, PLASTIC (0338-8402-09) </PackageDescription>
    <NDC11Code>00338-8402-10</NDC11Code>
    <ProductNDC>0338-8402</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Tisseel</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19980501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103980</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
    <StrengthNumber>90; 500</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
    <Pharm_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]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (&gt;1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
    <Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1  The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2  Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3  Thrombin Solution, 4  Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5  * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-8503-02</NDCCode>
    <PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0338-8503-02)  / 2 mL in 1 SYRINGE, PLASTIC (0338-8503-01) </PackageDescription>
    <NDC11Code>00338-8503-02</NDC11Code>
    <ProductNDC>0338-8503</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Artiss</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20080319</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125266</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
    <StrengthNumber>86.5; 4</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
    <Pharm_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]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ARTISS is a fibrin sealant indicated to: 1 Adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age., 2 Adhere tissue flaps during facial rhytidectomy surgery (face-lift).</IndicationAndUsage>
    <Description>ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma. Sealer Protein SolutionTotal protein: 96 -125 mg/mLFibrinogen: 67 - 106 mg/mLFibrinolysis Inhibitor (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL. Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI). Thrombin SolutionThrombin (Human): 2.5 - 6.5 units/mL1Calcium Chloride: 36 - 44 µmol/mLOther ingredients include: Human albumin, sodium chloride and water for injection (WFI). 1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU). Sealer Protein (Human). Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human). Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2). Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at US licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)]. Viral Clearance. The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein Concentrate and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV, HBV, HCV, HAV and Human Parvovirus B19. The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 6 for each of the viruses tested. n.d. = not determined. HIV-1: Human immunodeficiency virus 1; HAV: Hepatitis A virus; BVDV: Bovine viral diarrhea virus, a model for Hepatitis C virus; PRV: Pseudorabies virus, a model for enveloped DNA viruses, among those Hepatitis B virus; MMV: Mice minute virus, a model for B19V. In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and &gt;4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-8503-04</NDCCode>
    <PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0338-8503-04)  / 4 mL in 1 SYRINGE, PLASTIC (0338-8503-03) </PackageDescription>
    <NDC11Code>00338-8503-04</NDC11Code>
    <ProductNDC>0338-8503</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Artiss</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20080319</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125266</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
    <StrengthNumber>86.5; 4</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
    <Pharm_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]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ARTISS is a fibrin sealant indicated to: 1 Adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age., 2 Adhere tissue flaps during facial rhytidectomy surgery (face-lift).</IndicationAndUsage>
    <Description>ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma. Sealer Protein SolutionTotal protein: 96 -125 mg/mLFibrinogen: 67 - 106 mg/mLFibrinolysis Inhibitor (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL. Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI). Thrombin SolutionThrombin (Human): 2.5 - 6.5 units/mL1Calcium Chloride: 36 - 44 µmol/mLOther ingredients include: Human albumin, sodium chloride and water for injection (WFI). 1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU). Sealer Protein (Human). Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human). Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2). Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at US licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)]. Viral Clearance. The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein Concentrate and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV, HBV, HCV, HAV and Human Parvovirus B19. The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 6 for each of the viruses tested. n.d. = not determined. HIV-1: Human immunodeficiency virus 1; HAV: Hepatitis A virus; BVDV: Bovine viral diarrhea virus, a model for Hepatitis C virus; PRV: Pseudorabies virus, a model for enveloped DNA viruses, among those Hepatitis B virus; MMV: Mice minute virus, a model for B19V. In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and &gt;4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-8503-10</NDCCode>
    <PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0338-8503-10)  / 10 mL in 1 SYRINGE, PLASTIC (0338-8503-09) </PackageDescription>
    <NDC11Code>00338-8503-10</NDC11Code>
    <ProductNDC>0338-8503</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Artiss</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20080319</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125266</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
    <StrengthNumber>86.5; 4</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
    <Pharm_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]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ARTISS is a fibrin sealant indicated to: 1 Adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age., 2 Adhere tissue flaps during facial rhytidectomy surgery (face-lift).</IndicationAndUsage>
    <Description>ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma. Sealer Protein SolutionTotal protein: 96 -125 mg/mLFibrinogen: 67 - 106 mg/mLFibrinolysis Inhibitor (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL. Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI). Thrombin SolutionThrombin (Human): 2.5 - 6.5 units/mL1Calcium Chloride: 36 - 44 µmol/mLOther ingredients include: Human albumin, sodium chloride and water for injection (WFI). 1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU). Sealer Protein (Human). Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human). Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2). Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at US licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)]. Viral Clearance. The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein Concentrate and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV, HBV, HCV, HAV and Human Parvovirus B19. The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 6 for each of the viruses tested. n.d. = not determined. HIV-1: Human immunodeficiency virus 1; HAV: Hepatitis A virus; BVDV: Bovine viral diarrhea virus, a model for Hepatitis C virus; PRV: Pseudorabies virus, a model for enveloped DNA viruses, among those Hepatitis B virus; MMV: Mice minute virus, a model for B19V. In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and &gt;4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-9560-01</NDCCode>
    <PackageDescription>2 mL in 1 SYRINGE, PLASTIC (0338-9560-01) </PackageDescription>
    <NDC11Code>00338-9560-01</NDC11Code>
    <ProductNDC>0338-9560</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Tisseel</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19980501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103980</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
    <StrengthNumber>86.5; 500</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
    <Pharm_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]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
    <Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin (Synthetic) solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) Solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1  The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2  Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3  Thrombin Solution, 4  Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5  * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-9564-01</NDCCode>
    <PackageDescription>4 mL in 1 SYRINGE, PLASTIC (0338-9564-01) </PackageDescription>
    <NDC11Code>00338-9564-01</NDC11Code>
    <ProductNDC>0338-9564</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Tisseel</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19980501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103980</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
    <StrengthNumber>86.5; 500</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
    <Pharm_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]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
    <Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin (Synthetic) solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) Solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1  The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2  Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3  Thrombin Solution, 4  Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5  * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-9568-01</NDCCode>
    <PackageDescription>10 mL in 1 SYRINGE, PLASTIC (0338-9568-01) </PackageDescription>
    <NDC11Code>00338-9568-01</NDC11Code>
    <ProductNDC>0338-9568</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Tisseel</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19980501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103980</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
    <StrengthNumber>86.5; 500</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
    <Pharm_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]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
    <Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin (Synthetic) solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) Solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1  The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2  Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3  Thrombin Solution, 4  Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5  * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-9637-01</NDCCode>
    <PackageDescription>2 mL in 1 SYRINGE, PLASTIC (0338-9637-01) </PackageDescription>
    <NDC11Code>00338-9637-01</NDC11Code>
    <ProductNDC>0338-9637</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Artiss</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20080319</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125266</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
    <StrengthNumber>86.5; 4</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
    <Pharm_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]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ARTISS is a fibrin sealant indicated in adult and pediatric patients to: 1 Adhere autologous skin grafts to surgically prepared wound beds resulting from burns., 2 Adhere tissue flaps during facial rhytidectomy surgery.</IndicationAndUsage>
    <Description>ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma. Sealer Protein SolutionTotal protein: 96 -125 mg/mLFibrinogen: 67 - 106 mg/mLFibrinolysis Inhibitor, Aprotinin (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL. Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI). Thrombin SolutionThrombin (Human): 2.5 - 6.5 units/mL1Calcium Chloride: 36 - 44 µmol/mLOther ingredients include: Human albumin, sodium chloride and water for injection (WFI). 1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU). Sealer Protein (Human). Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human). Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2). Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at U.S. licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)]. Viral Clearance. The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV-1, BVDV, PRV, HAV and MMV (Human Parvovirus B19). The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 5 for each of the viruses tested. Table 5: Mean Reduction Factors [log10] for Virus Removal and/or Inactivation. Sealer Protein Component. Thrombin Component. In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and &gt;4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-9639-01</NDCCode>
    <PackageDescription>4 mL in 1 SYRINGE, PLASTIC (0338-9639-01) </PackageDescription>
    <NDC11Code>00338-9639-01</NDC11Code>
    <ProductNDC>0338-9639</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Artiss</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20080319</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125266</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
    <StrengthNumber>86.5; 4</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
    <Pharm_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]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ARTISS is a fibrin sealant indicated in adult and pediatric patients to: 1 Adhere autologous skin grafts to surgically prepared wound beds resulting from burns., 2 Adhere tissue flaps during facial rhytidectomy surgery.</IndicationAndUsage>
    <Description>ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma. Sealer Protein SolutionTotal protein: 96 -125 mg/mLFibrinogen: 67 - 106 mg/mLFibrinolysis Inhibitor, Aprotinin (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL. Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI). Thrombin SolutionThrombin (Human): 2.5 - 6.5 units/mL1Calcium Chloride: 36 - 44 µmol/mLOther ingredients include: Human albumin, sodium chloride and water for injection (WFI). 1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU). Sealer Protein (Human). Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human). Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2). Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at U.S. licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)]. Viral Clearance. The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV-1, BVDV, PRV, HAV and MMV (Human Parvovirus B19). The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 5 for each of the viruses tested. Table 5: Mean Reduction Factors [log10] for Virus Removal and/or Inactivation. Sealer Protein Component. Thrombin Component. In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and &gt;4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-9641-01</NDCCode>
    <PackageDescription>10 mL in 1 SYRINGE, PLASTIC (0338-9641-01) </PackageDescription>
    <NDC11Code>00338-9641-01</NDC11Code>
    <ProductNDC>0338-9641</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Artiss</ProprietaryName>
    <ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
    <NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20080319</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125266</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
    <StrengthNumber>86.5; 4</StrengthNumber>
    <StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
    <Pharm_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]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ARTISS is a fibrin sealant indicated in adult and pediatric patients to: 1 Adhere autologous skin grafts to surgically prepared wound beds resulting from burns., 2 Adhere tissue flaps during facial rhytidectomy surgery.</IndicationAndUsage>
    <Description>ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma. Sealer Protein SolutionTotal protein: 96 -125 mg/mLFibrinogen: 67 - 106 mg/mLFibrinolysis Inhibitor, Aprotinin (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL. Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI). Thrombin SolutionThrombin (Human): 2.5 - 6.5 units/mL1Calcium Chloride: 36 - 44 µmol/mLOther ingredients include: Human albumin, sodium chloride and water for injection (WFI). 1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU). Sealer Protein (Human). Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human). Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2). Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at U.S. licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)]. Viral Clearance. The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV-1, BVDV, PRV, HAV and MMV (Human Parvovirus B19). The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 5 for each of the viruses tested. Table 5: Mean Reduction Factors [log10] for Virus Removal and/or Inactivation. Sealer Protein Component. Thrombin Component. In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and &gt;4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-2250-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2250-01) </PackageDescription>
    <NDC11Code>00378-2250-01</NDC11Code>
    <ProductNDC>0378-2250</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
    <NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090504</StartMarketingDate>
    <EndMarketingDate>20260430</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065520</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20090504</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
    <Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-Morpholinoethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate. It has a molecular formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. Mycophenolate mofetil, USP is a white to almost white crystalline powder. It is practically insoluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of mycophenolate mofetil and tablets containing 500 mg of mycophenolate mofetil. Inactive ingredients in mycophenolate mofetil 250 mg capsules include black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&amp;C Blue No. 2, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), red iron oxide, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. In addition, the imprinting ink contains the following: ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Inactive ingredients in mycophenolate mofetil 500 mg tablets include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch (corn), red iron oxide, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-2250-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (0378-2250-05) </PackageDescription>
    <NDC11Code>00378-2250-05</NDC11Code>
    <ProductNDC>0378-2250</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
    <NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090504</StartMarketingDate>
    <EndMarketingDate>20260430</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065520</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20090504</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
    <Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-Morpholinoethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. Mycophenolate mofetil, USP is a white or almost white crystalline powder. It is practically insoluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of mycophenolate mofetil and tablets containing 500 mg of mycophenolate mofetil. Inactive ingredients in mycophenolate mofetil 250 mg capsules include black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&amp;C Blue No. 2, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), red iron oxide, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. In addition, the imprinting ink contains the following: ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Inactive ingredients in mycophenolate mofetil 500 mg tablets include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch (corn), red iron oxide, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide.</Description>
  </NDC>
</NDCList>