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"Description": "LANTHANUM CARBONATE contains lanthanum carbonate with molecular formula La2(CO3)3 xH2O (on average x=4-5 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate is described as white to almost-white powder. Lanthanum carbonate is practically insoluble in water and is insoluble in organic solvents; it dissolves in dilute mineral acids with effervescence. Each LANTHANUM CARBONATE white to off-white, chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: colloidal silicon dioxide, dextrates (hydrated), magnesium stearate."
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"Description": "LANTHANUM CARBONATE contains lanthanum carbonate with molecular formula La2(CO3)3 xH2O (on average x=4-5 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate is described as white to almost-white powder. Lanthanum carbonate is practically insoluble in water and is insoluble in organic solvents; it dissolves in dilute mineral acids with effervescence. Each LANTHANUM CARBONATE white to off-white, chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: colloidal silicon dioxide, dextrates (hydrated), magnesium stearate."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"Description": "Prazosin hydrochloride, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy- 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. It is a white, crystalline substance, slightly soluble in water and isotonic saline, and has a molecular weight of 419.87. Each 1 mg capsule of prazosin hydrochloride for oral use contains drug equivalent to 1 mg free base. Inert ingredients in the formulations are: hard gelatin capsules (which may contain Blue 1, Red 3, Red 28, Red 40, and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose."
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"Description": "Prazosin hydrochloride, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy- 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. It is a white, crystalline substance, slightly soluble in water and isotonic saline, and has a molecular weight of 419.87. Each 1 mg capsule of prazosin hydrochloride for oral use contains drug equivalent to 1 mg free base. Inert ingredients in the formulations are: hard gelatin capsules (which may contain Blue 1, Red 3, Red 28, Red 40, and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose."
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"Description": "Prazosin hydrochloride, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy- 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. It is a white, crystalline substance, slightly soluble in water and isotonic saline, and has a molecular weight of 419.87. Each 1 mg capsule of prazosin hydrochloride for oral use contains drug equivalent to 1 mg free base. Inert ingredients in the formulations are: hard gelatin capsules (which may contain Blue 1, Red 3, Red 28, Red 40, and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose."
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{
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{
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"StartMarketingDate": "20131211",
"EndMarketingDate": "20210228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090778",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131211",
"EndMarketingDatePackage": "20210228",
"SamplePackage": "N"
},
{
"NDCCode": "66993-879-85",
"PackageDescription": "85 g in 1 TUBE (66993-879-85)",
"NDC11Code": "66993-0879-85",
"ProductNDC": "66993-879",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Econazole Nitrate",
"NonProprietaryName": "Econazole Nitrate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070901",
"EndMarketingDate": "20150228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076574",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "ECONAZOLE NITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC],Azoles [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-03-06"
},
{
"NDCCode": "0143-9533-01",
"PackageDescription": "1 VIAL in 1 BOX, UNIT-DOSE (0143-9533-01) > 25 mL in 1 VIAL",
"NDC11Code": "00143-9533-01",
"ProductNDC": "0143-9533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol Sodium",
"NonProprietaryName": "Allopurinol Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20040901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076870",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ALLOPURINOL SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/25mL",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040901",
"SamplePackage": "N",
"IndicationAndUsage": "Allopurinol Sodium for Injection is indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.",
"Description": "Allopurinol Sodium for Injection, a xanthine oxidase inhibitor, is a sterile, white, lyophilized powder or cake, in a single-dose vial for reconstitution. Each vial contains 500 mg of allopurinol equivalent to 580.7 mg of allopurinol sodium and 162.5 mg of sodium hydroxide as a solubilizer. Sodium hydroxide is also used as a pH adjuster. Allopurinol Sodium for Injection contains no preservatives. Allopurinol is a xanthine oxidase inhibitor. The chemical name for allopurinol sodium is 1,5-dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one monosodium salt. It is a white amorphous mass with a molecular weight of 158.09 and molecular formula C5H3N4NaO. The structural formula is. The pKa of allopurinol sodium is 9.31."
},
{
"NDCCode": "0173-0922-38",
"PackageDescription": "8 TABLET, FILM COATED in 1 BOTTLE (0173-0922-38) ",
"NDC11Code": "00173-0922-38",
"ProductNDC": "0173-0922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Blujepa",
"NonProprietaryName": "Gepotidacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250325",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218230",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "GEPOTIDACIN MESYLATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Topoisomerase 2 Inhibitors [MoA], Topoisomerase 4 Inhibitors [MoA], Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251211",
"SamplePackage": "N",
"IndicationAndUsage": "BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: 1 Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). (1.1), 2 Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. (1.2, 6.1).",
"Description": "BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is (R)-2-((4-(((3,4-dihydro-2H-pyrano[2,3-c]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3H,8H-2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C24H28N6O3●CH4O3S●2H2O and its molecular mass is 580.66. The structural formula is shown below. *stereogenic center. Each BLUJEPA oral tablet contains gepotidacin 750 mg (equivalent to 910.7 mg of gepotidacin mesylate [anhydrous]). Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "0173-0922-45",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45) ",
"NDC11Code": "00173-0922-45",
"ProductNDC": "0173-0922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Blujepa",
"NonProprietaryName": "Gepotidacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250325",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218230",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "GEPOTIDACIN MESYLATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Topoisomerase 2 Inhibitors [MoA], Topoisomerase 4 Inhibitors [MoA], Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250325",
"SamplePackage": "N",
"IndicationAndUsage": "BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: 1 Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). (1.1), 2 Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. (1.2, 6.1).",
"Description": "BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is (R)-2-((4-(((3,4-dihydro-2H-pyrano[2,3-c]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3H,8H-2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C24H28N6O3●CH4O3S●2H2O and its molecular mass is 580.66. The structural formula is shown below. *stereogenic center. Each BLUJEPA oral tablet contains gepotidacin 750 mg (equivalent to 910.7 mg of gepotidacin mesylate [anhydrous]). Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "0338-0644-03",
"PackageDescription": "500 mL in 1 BAG (0338-0644-03) ",
"NDC11Code": "00338-0644-03",
"ProductNDC": "0338-0644",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Travasol",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19840823",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018931",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE",
"StrengthNumber": "730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19840823",
"SamplePackage": "N",
"IndicationAndUsage": "TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.",
"Description": "TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0644-04",
"PackageDescription": "1000 mL in 1 BAG (0338-0644-04) ",
"NDC11Code": "00338-0644-04",
"ProductNDC": "0338-0644",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Travasol",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19840823",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018931",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE",
"StrengthNumber": "730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19840823",
"SamplePackage": "N",
"IndicationAndUsage": "TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.",
"Description": "TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0644-06",
"PackageDescription": "2000 mL in 1 BAG (0338-0644-06) ",
"NDC11Code": "00338-0644-06",
"ProductNDC": "0338-0644",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Travasol",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19840823",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018931",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE",
"StrengthNumber": "730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19840823",
"SamplePackage": "N",
"IndicationAndUsage": "TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.",
"Description": "TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-4210-02",
"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) ",
"NDC11Code": "00338-4210-02",
"ProductNDC": "0338-4210",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Tisseel",
"ProprietaryNameSuffix": "Fibrin Sealant",
"NonProprietaryName": "Fibrinogen Human, Human Thrombin",
"DosageFormName": "KIT",
"StartMarketingDate": "19980501",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103980",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980501",
"SamplePackage": "N",
"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.",
"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)."
},
{
"NDCCode": "0338-4211-04",
"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) ",
"NDC11Code": "00338-4211-04",
"ProductNDC": "0338-4211",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Tisseel",
"ProprietaryNameSuffix": "Fibrin Sealant",
"NonProprietaryName": "Fibrinogen Human, Human Thrombin",
"DosageFormName": "KIT",
"StartMarketingDate": "19980501",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103980",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980501",
"SamplePackage": "N",
"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.",
"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)."
},
{
"NDCCode": "0338-4212-10",
"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) ",
"NDC11Code": "00338-4212-10",
"ProductNDC": "0338-4212",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Tisseel",
"ProprietaryNameSuffix": "Fibrin Sealant",
"NonProprietaryName": "Fibrinogen Human, Human Thrombin",
"DosageFormName": "KIT",
"StartMarketingDate": "19980501",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103980",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980501",
"SamplePackage": "N",
"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.",
"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)."
},
{
"NDCCode": "0338-4301-02",
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"ProductTypeName": "PLASMA DERIVATIVE",
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"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)."
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{
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"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)."
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{
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"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)."
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"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)."
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"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)."
}
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<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
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<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>LANTHANUM CARBONATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LANTHANUM CARBONATE is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.</IndicationAndUsage>
<Description>LANTHANUM CARBONATE contains lanthanum carbonate with molecular formula La2(CO3)3 xH2O (on average x=4-5 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate is described as white to almost-white powder. Lanthanum carbonate is practically insoluble in water and is insoluble in organic solvents; it dissolves in dilute mineral acids with effervescence. Each LANTHANUM CARBONATE white to off-white, chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: colloidal silicon dioxide, dextrates (hydrated), magnesium stearate.</Description>
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<LabelerName>Prasco Laboratories</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LANTHANUM CARBONATE is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.</IndicationAndUsage>
<Description>LANTHANUM CARBONATE contains lanthanum carbonate with molecular formula La2(CO3)3 xH2O (on average x=4-5 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate is described as white to almost-white powder. Lanthanum carbonate is practically insoluble in water and is insoluble in organic solvents; it dissolves in dilute mineral acids with effervescence. Each LANTHANUM CARBONATE white to off-white, chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: colloidal silicon dioxide, dextrates (hydrated), magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>66993-424-85</NDCCode>
<PackageDescription>9 BOTTLE in 1 PACKAGE (66993-424-85) / 10 TABLET, CHEWABLE in 1 BOTTLE (66993-424-75) </PackageDescription>
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<LabelerName>Prasco Laboratories</LabelerName>
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<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LANTHANUM CARBONATE is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.</IndicationAndUsage>
<Description>LANTHANUM CARBONATE contains lanthanum carbonate with molecular formula La2(CO3)3 xH2O (on average x=4-5 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate is described as white to almost-white powder. Lanthanum carbonate is practically insoluble in water and is insoluble in organic solvents; it dissolves in dilute mineral acids with effervescence. Each LANTHANUM CARBONATE white to off-white, chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: colloidal silicon dioxide, dextrates (hydrated), magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>66993-431-85</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (66993-431-85) </PackageDescription>
<NDC11Code>66993-0431-85</NDC11Code>
<ProductNDC>66993-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210825</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA017442</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy- 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. It is a white, crystalline substance, slightly soluble in water and isotonic saline, and has a molecular weight of 419.87. Each 1 mg capsule of prazosin hydrochloride for oral use contains drug equivalent to 1 mg free base. Inert ingredients in the formulations are: hard gelatin capsules (which may contain Blue 1, Red 3, Red 28, Red 40, and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose.</Description>
</NDC>
<NDC>
<NDCCode>66993-432-85</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (66993-432-85) </PackageDescription>
<NDC11Code>66993-0432-85</NDC11Code>
<ProductNDC>66993-432</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220311</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA017442</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy- 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. It is a white, crystalline substance, slightly soluble in water and isotonic saline, and has a molecular weight of 419.87. Each 1 mg capsule of prazosin hydrochloride for oral use contains drug equivalent to 1 mg free base. Inert ingredients in the formulations are: hard gelatin capsules (which may contain Blue 1, Red 3, Red 28, Red 40, and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose.</Description>
</NDC>
<NDC>
<NDCCode>66993-433-85</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (66993-433-85) </PackageDescription>
<NDC11Code>66993-0433-85</NDC11Code>
<ProductNDC>66993-433</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220311</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA017442</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy- 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. It is a white, crystalline substance, slightly soluble in water and isotonic saline, and has a molecular weight of 419.87. Each 1 mg capsule of prazosin hydrochloride for oral use contains drug equivalent to 1 mg free base. Inert ingredients in the formulations are: hard gelatin capsules (which may contain Blue 1, Red 3, Red 28, Red 40, and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose.</Description>
</NDC>
<NDC>
<NDCCode>66993-483-85</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (66993-483-85)</PackageDescription>
<NDC11Code>66993-0483-85</NDC11Code>
<ProductNDC>66993-483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe</ProprietaryName>
<NonProprietaryName>Ezetimibe</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170522</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021445</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>EZETIMIBE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>66993-663-85</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (66993-663-85) </PackageDescription>
<NDC11Code>66993-0663-85</NDC11Code>
<ProductNDC>66993-663</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<EndMarketingDate>20210228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090778</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<EndMarketingDatePackage>20210228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66993-664-85</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (66993-664-85) </PackageDescription>
<NDC11Code>66993-0664-85</NDC11Code>
<ProductNDC>66993-664</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<EndMarketingDate>20210228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090778</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<EndMarketingDatePackage>20210228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66993-879-85</NDCCode>
<PackageDescription>85 g in 1 TUBE (66993-879-85)</PackageDescription>
<NDC11Code>66993-0879-85</NDC11Code>
<ProductNDC>66993-879</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Econazole Nitrate</ProprietaryName>
<NonProprietaryName>Econazole Nitrate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20070901</StartMarketingDate>
<EndMarketingDate>20150228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076574</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>ECONAZOLE NITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC],Azoles [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-03-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>0143-9533-01</NDCCode>
<PackageDescription>1 VIAL in 1 BOX, UNIT-DOSE (0143-9533-01) > 25 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9533-01</NDC11Code>
<ProductNDC>0143-9533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol Sodium</ProprietaryName>
<NonProprietaryName>Allopurinol Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20040901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076870</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ALLOPURINOL SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/25mL</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allopurinol Sodium for Injection is indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.</IndicationAndUsage>
<Description>Allopurinol Sodium for Injection, a xanthine oxidase inhibitor, is a sterile, white, lyophilized powder or cake, in a single-dose vial for reconstitution. Each vial contains 500 mg of allopurinol equivalent to 580.7 mg of allopurinol sodium and 162.5 mg of sodium hydroxide as a solubilizer. Sodium hydroxide is also used as a pH adjuster. Allopurinol Sodium for Injection contains no preservatives. Allopurinol is a xanthine oxidase inhibitor. The chemical name for allopurinol sodium is 1,5-dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one monosodium salt. It is a white amorphous mass with a molecular weight of 158.09 and molecular formula C5H3N4NaO. The structural formula is. The pKa of allopurinol sodium is 9.31.</Description>
</NDC>
<NDC>
<NDCCode>0173-0922-38</NDCCode>
<PackageDescription>8 TABLET, FILM COATED in 1 BOTTLE (0173-0922-38) </PackageDescription>
<NDC11Code>00173-0922-38</NDC11Code>
<ProductNDC>0173-0922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Blujepa</ProprietaryName>
<NonProprietaryName>Gepotidacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250325</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218230</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>GEPOTIDACIN MESYLATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Topoisomerase 2 Inhibitors [MoA], Topoisomerase 4 Inhibitors [MoA], Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: 1 Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). (1.1), 2 Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. (1.2, 6.1).</IndicationAndUsage>
<Description>BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is (R)-2-((4-(((3,4-dihydro-2H-pyrano[2,3-c]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3H,8H-2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C24H28N6O3●CH4O3S●2H2O and its molecular mass is 580.66. The structural formula is shown below. *stereogenic center. Each BLUJEPA oral tablet contains gepotidacin 750 mg (equivalent to 910.7 mg of gepotidacin mesylate [anhydrous]). Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0173-0922-45</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45) </PackageDescription>
<NDC11Code>00173-0922-45</NDC11Code>
<ProductNDC>0173-0922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Blujepa</ProprietaryName>
<NonProprietaryName>Gepotidacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250325</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218230</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>GEPOTIDACIN MESYLATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Topoisomerase 2 Inhibitors [MoA], Topoisomerase 4 Inhibitors [MoA], Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: 1 Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). (1.1), 2 Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. (1.2, 6.1).</IndicationAndUsage>
<Description>BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is (R)-2-((4-(((3,4-dihydro-2H-pyrano[2,3-c]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3H,8H-2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C24H28N6O3●CH4O3S●2H2O and its molecular mass is 580.66. The structural formula is shown below. *stereogenic center. Each BLUJEPA oral tablet contains gepotidacin 750 mg (equivalent to 910.7 mg of gepotidacin mesylate [anhydrous]). Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0338-0644-03</NDCCode>
<PackageDescription>500 mL in 1 BAG (0338-0644-03) </PackageDescription>
<NDC11Code>00338-0644-03</NDC11Code>
<ProductNDC>0338-0644</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Travasol</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19840823</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018931</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE</SubstanceName>
<StrengthNumber>730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0644-04</NDCCode>
<PackageDescription>1000 mL in 1 BAG (0338-0644-04) </PackageDescription>
<NDC11Code>00338-0644-04</NDC11Code>
<ProductNDC>0338-0644</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Travasol</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19840823</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018931</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE</SubstanceName>
<StrengthNumber>730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0644-06</NDCCode>
<PackageDescription>2000 mL in 1 BAG (0338-0644-06) </PackageDescription>
<NDC11Code>00338-0644-06</NDC11Code>
<ProductNDC>0338-0644</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Travasol</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19840823</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018931</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE</SubstanceName>
<StrengthNumber>730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum.</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 (>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 (>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>
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