{
"NDC": [
{
"NDCCode": "45802-580-84",
"PackageDescription": "4 POUCH in 1 CARTON (45802-580-84) / 1 PATCH, EXTENDED RELEASE in 1 POUCH",
"NDC11Code": "45802-0580-84",
"ProductNDC": "45802-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scopolamine Transdermal System",
"NonProprietaryName": "Scopolamine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170613",
"EndMarketingDate": "20280630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078830",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170613",
"EndMarketingDatePackage": "20280630",
"SamplePackage": "N",
"IndicationAndUsage": "Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "45802-580-01",
"PackageDescription": "1 PATCH, EXTENDED RELEASE in 1 POUCH (45802-580-01) ",
"NDC11Code": "45802-0580-01",
"ProductNDC": "45802-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scopolamine Transdermal System",
"NonProprietaryName": "Scopolamine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078830",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170613",
"SamplePackage": "N",
"IndicationAndUsage": "Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "45802-580-46",
"PackageDescription": "10 POUCH in 1 CARTON (45802-580-46) / 1 PATCH, EXTENDED RELEASE in 1 POUCH",
"NDC11Code": "45802-0580-46",
"ProductNDC": "45802-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scopolamine Transdermal System",
"NonProprietaryName": "Scopolamine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170613",
"EndMarketingDate": "20280630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078830",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170613",
"EndMarketingDatePackage": "20280630",
"SamplePackage": "N",
"IndicationAndUsage": "Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "45802-580-62",
"PackageDescription": "24 POUCH in 1 CARTON (45802-580-62) / 1 PATCH, EXTENDED RELEASE in 1 POUCH",
"NDC11Code": "45802-0580-62",
"ProductNDC": "45802-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scopolamine Transdermal System",
"NonProprietaryName": "Scopolamine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170613",
"EndMarketingDate": "20280630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078830",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170613",
"EndMarketingDatePackage": "20280630",
"SamplePackage": "N",
"IndicationAndUsage": "Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "45802-102-84",
"PackageDescription": "1 TUBE in 1 CARTON (45802-102-84) / 45 g in 1 TUBE",
"NDC11Code": "45802-0102-84",
"ProductNDC": "45802-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivermectin",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210225",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Antiparasitic [EPC], Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240108",
"SamplePackage": "N",
"IndicationAndUsage": "Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea.",
"Description": "Ivermectin Cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of ivermectin cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0 % and not more than 102.0 % of 5-O-demethyl-22,23-dihydroavermectin A1a plus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b or H2B1a and H2B1b, respectively; and the ratio (calculated by area percentage) of component H2B1a/(H2B1a + H2B1b) is not less than 90.0 %. The respective empirical formulas of H2B1a and H2B1b are C48H74O14 and C47H72O14 with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H2B1a: R = C2H5, Component H2B1b: R = CH3. Ivermectin cream contains the following inactive ingredients: cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol."
},
{
"NDCCode": "45802-453-84",
"PackageDescription": "1 TUBE in 1 CARTON (45802-453-84) / 45 g in 1 TUBE",
"NDC11Code": "45802-0453-84",
"ProductNDC": "45802-453",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene",
"NonProprietaryName": "Adapalene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101026",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020748",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "ADAPALENE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101027",
"SamplePackage": "N",
"IndicationAndUsage": "Adapalene Cream, 0.1% is indicated for the topical treatment of acne vulgaris.",
"Description": "Adapalene Cream, 0.1%, contains adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula."
},
{
"NDCCode": "45802-491-84",
"PackageDescription": "4 BOTTLE, UNIT-DOSE in 1 CARTON (45802-491-84) / 1 SPRAY in 1 BOTTLE, UNIT-DOSE",
"NDC11Code": "45802-0491-84",
"ProductNDC": "45802-491",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyanocobalamin",
"NonProprietaryName": "Cyanocobalamin",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20231228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212458",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CYANOCOBALAMIN",
"StrengthNumber": "500",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Vitamin B 12 [CS], Vitamin B12 [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231228",
"SamplePackage": "N",
"IndicationAndUsage": "Cyanocobalamin Nasal Spray is indicated for: 1 Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement , 2 Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia , 3 Prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normal.",
"Description": "Cyanocobalamin is a synthetic form of vitamin B12. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide. The cobalt content is 4.35%. The molecular formula is C63H88CoN14O14P, which corresponds to a molecular weight of 1355.38 and the following structural formula. Figure 1. Cyanocobalamin Nasal Spray Chemical Structure. Cyanocobalamin occurs as dark red crystals or orthorhombic needles or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly to moderately soluble in water (1:80). Its pharmacologic activity is destroyed by heavy metals (iron) and strong oxidizing or reducing agents (vitamin C), but not by autoclaving for short periods of time (15-20 minutes) at 121°C. The vitamin B12 coenzymes are very unstable in light. Cyanocobalamin Nasal Spray is a solution of cyanocobalamin, USP (vitamin B12) for administration as a spray to the nasal mucosa. Each unit dose device of Cyanocobalamin Nasal Spray contains 0.125 mL of a 500 mcg/0.1 mL solution of cyanocobalamin with benzalkonium chloride in purified water, citric acid, glycerin and sodium citrate. The spray solution has a pH between 4.5 and 5.5. Each spray delivers an average of 500 mcg of cyanocobalamin per actuation."
},
{
"NDCCode": "45802-505-84",
"PackageDescription": "1 TUBE in 1 CARTON (45802-505-84) / 45 g in 1 TUBE",
"NDC11Code": "45802-0505-84",
"ProductNDC": "45802-505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Dipropionate",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215847",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220520",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Betamethasone dipropionate ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21- dipropionate. The structural formula is. Each gram of the 0.05% ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum."
},
{
"NDCCode": "45802-578-84",
"PackageDescription": "2 VIAL, SINGLE-DOSE in 1 CARTON (45802-578-84) / .1 mL in 1 VIAL, SINGLE-DOSE (45802-578-00) ",
"NDC11Code": "45802-0578-84",
"ProductNDC": "45802-578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20230730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211951",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/.1mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230730",
"SamplePackage": "N",
"IndicationAndUsage": " to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin. this medicine can save a life."
},
{
"NDCCode": "45802-736-84",
"PackageDescription": "1 TUBE in 1 CARTON (45802-736-84) / 45 g in 1 TUBE",
"NDC11Code": "45802-0736-84",
"ProductNDC": "45802-736",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate And Benzoyl Peroxide",
"NonProprietaryName": "Clindamycin, Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090979",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE",
"StrengthNumber": "10; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2023-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120626",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris. (1.1). Limitation of Use. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. (1.2).",
"Description": "Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a fixed combination product with two active ingredients in a white, opaque, aqueous gel formulation. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Clindamycin phosphate is C18H34ClN2O8PS. The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio- L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). Benzoyl peroxide is C14H10O4. It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% contains 10 mg (1%) clindamycin, as clindamycin phosphate, and 50 mg (5%) benzoyl peroxide in a base consisting of carbomer homopolymer (type B), hydrochloric acid, methylparaben, dimethicone, propylparaben, purified water and sodium hydroxide."
},
{
"NDCCode": "45802-811-84",
"PackageDescription": "2 VIAL, SINGLE-DOSE in 1 CARTON (45802-811-84) / .1 mL in 1 VIAL, SINGLE-DOSE (45802-811-00) ",
"NDC11Code": "45802-0811-84",
"ProductNDC": "45802-811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20220621",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211951",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/.1mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220621",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "Naloxone HCl Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. Naloxone HCl Nasal Spray is not a substitute for emergency medical care. Limitations of Use. Restrict prescription of naloxone hydrochloride nasal spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.",
"Description": "Naloxone HCl Nasal Spray is a pre-filled, single dose intranasal spray. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride with the following structure. C19H21NO4●HCl. M.W. 363.84. Naloxone hydrochloride, an opioid antagonist, occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform. Each Naloxone HCl Nasal Spray contains a 4 mg single dose of naloxone hydrochloride (equivalent to 3.6 mg of naloxone) in a 0.1 mL (100 microliter) aqueous solution. Inactive ingredients include benzalkonium chloride (preservative), disodium ethylenediaminetetraacetate (chelating agent), sodium chloride, hydrochloric acid to adjust pH, and purified water. The pH range is 3.5 to 5.5."
},
{
"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": "20271231",
"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": "20271231",
"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": "20271231",
"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",
"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) ",
"NDC11Code": "00338-4301-02",
"ProductNDC": "0338-4301",
"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": "0338-4302-04",
"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) ",
"NDC11Code": "00338-4302-04",
"ProductNDC": "0338-4302",
"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": "0338-4303-10",
"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) ",
"NDC11Code": "00338-4303-10",
"ProductNDC": "0338-4303",
"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": "0338-8402-02",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0338-8402-02) / 2 mL in 1 SYRINGE, PLASTIC (0338-8402-01) ",
"NDC11Code": "00338-8402-02",
"ProductNDC": "0338-8402",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Tisseel",
"ProprietaryNameSuffix": "Fibrin Sealant",
"NonProprietaryName": "Fibrinogen Human, Human Thrombin",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19980501",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103980",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "FIBRINOGEN HUMAN; HUMAN THROMBIN",
"StrengthNumber": "90; 500",
"StrengthUnit": "mg/mL; [iU]/mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19980501",
"SamplePackage": "N",
"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.",
"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)."
},
{
"NDCCode": "0338-8402-04",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0338-8402-04) / 4 mL in 1 SYRINGE, PLASTIC (0338-8402-03) ",
"NDC11Code": "00338-8402-04",
"ProductNDC": "0338-8402",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Tisseel",
"ProprietaryNameSuffix": "Fibrin Sealant",
"NonProprietaryName": "Fibrinogen Human, Human Thrombin",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19980501",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103980",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "FIBRINOGEN HUMAN; HUMAN THROMBIN",
"StrengthNumber": "90; 500",
"StrengthUnit": "mg/mL; [iU]/mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19980501",
"SamplePackage": "N",
"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.",
"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)."
},
{
"NDCCode": "0338-8402-10",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0338-8402-10) / 10 mL in 1 SYRINGE, PLASTIC (0338-8402-09) ",
"NDC11Code": "00338-8402-10",
"ProductNDC": "0338-8402",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Tisseel",
"ProprietaryNameSuffix": "Fibrin Sealant",
"NonProprietaryName": "Fibrinogen Human, Human Thrombin",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19980501",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103980",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "FIBRINOGEN HUMAN; HUMAN THROMBIN",
"StrengthNumber": "90; 500",
"StrengthUnit": "mg/mL; [iU]/mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19980501",
"SamplePackage": "N",
"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.",
"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)."
},
{
"NDCCode": "0338-8503-02",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0338-8503-02) / 2 mL in 1 SYRINGE, PLASTIC (0338-8503-01) ",
"NDC11Code": "00338-8503-02",
"ProductNDC": "0338-8503",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Artiss",
"ProprietaryNameSuffix": "Fibrin Sealant",
"NonProprietaryName": "Fibrinogen Human, Human Thrombin",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080319",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125266",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "FIBRINOGEN HUMAN; HUMAN THROMBIN",
"StrengthNumber": "86.5; 4",
"StrengthUnit": "mg/mL; [iU]/mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080319",
"SamplePackage": "N",
"IndicationAndUsage": "ARTISS is a fibrin sealant indicated to: 1 Adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age., 2 Adhere tissue flaps during facial rhytidectomy surgery (face-lift).",
"Description": "ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma. Sealer Protein SolutionTotal protein: 96 -125 mg/mLFibrinogen: 67 - 106 mg/mLFibrinolysis Inhibitor (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL. Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI). Thrombin SolutionThrombin (Human): 2.5 - 6.5 units/mL1Calcium Chloride: 36 - 44 µmol/mLOther ingredients include: Human albumin, sodium chloride and water for injection (WFI). 1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU). Sealer Protein (Human). Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human). Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2). Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at US licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)]. Viral Clearance. The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein Concentrate and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV, HBV, HCV, HAV and Human Parvovirus B19. The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 6 for each of the viruses tested. n.d. = not determined. HIV-1: Human immunodeficiency virus 1; HAV: Hepatitis A virus; BVDV: Bovine viral diarrhea virus, a model for Hepatitis C virus; PRV: Pseudorabies virus, a model for enveloped DNA viruses, among those Hepatitis B virus; MMV: Mice minute virus, a model for B19V. In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and >4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively."
},
{
"NDCCode": "0338-8503-04",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0338-8503-04) / 4 mL in 1 SYRINGE, PLASTIC (0338-8503-03) ",
"NDC11Code": "00338-8503-04",
"ProductNDC": "0338-8503",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Artiss",
"ProprietaryNameSuffix": "Fibrin Sealant",
"NonProprietaryName": "Fibrinogen Human, Human Thrombin",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080319",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125266",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "FIBRINOGEN HUMAN; HUMAN THROMBIN",
"StrengthNumber": "86.5; 4",
"StrengthUnit": "mg/mL; [iU]/mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080319",
"SamplePackage": "N",
"IndicationAndUsage": "ARTISS is a fibrin sealant indicated to: 1 Adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age., 2 Adhere tissue flaps during facial rhytidectomy surgery (face-lift).",
"Description": "ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma. Sealer Protein SolutionTotal protein: 96 -125 mg/mLFibrinogen: 67 - 106 mg/mLFibrinolysis Inhibitor (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL. Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI). Thrombin SolutionThrombin (Human): 2.5 - 6.5 units/mL1Calcium Chloride: 36 - 44 µmol/mLOther ingredients include: Human albumin, sodium chloride and water for injection (WFI). 1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU). Sealer Protein (Human). Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human). Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2). Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at US licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)]. Viral Clearance. The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein Concentrate and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV, HBV, HCV, HAV and Human Parvovirus B19. The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 6 for each of the viruses tested. n.d. = not determined. HIV-1: Human immunodeficiency virus 1; HAV: Hepatitis A virus; BVDV: Bovine viral diarrhea virus, a model for Hepatitis C virus; PRV: Pseudorabies virus, a model for enveloped DNA viruses, among those Hepatitis B virus; MMV: Mice minute virus, a model for B19V. In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and >4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively."
},
{
"NDCCode": "0338-8503-10",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0338-8503-10) / 10 mL in 1 SYRINGE, PLASTIC (0338-8503-09) ",
"NDC11Code": "00338-8503-10",
"ProductNDC": "0338-8503",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Artiss",
"ProprietaryNameSuffix": "Fibrin Sealant",
"NonProprietaryName": "Fibrinogen Human, Human Thrombin",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080319",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125266",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "FIBRINOGEN HUMAN; HUMAN THROMBIN",
"StrengthNumber": "86.5; 4",
"StrengthUnit": "mg/mL; [iU]/mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2025-10-13",
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"IndicationAndUsage": "ARTISS is a fibrin sealant indicated to: 1 Adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age., 2 Adhere tissue flaps during facial rhytidectomy surgery (face-lift).",
"Description": "ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma. Sealer Protein SolutionTotal protein: 96 -125 mg/mLFibrinogen: 67 - 106 mg/mLFibrinolysis Inhibitor (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL. Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI). Thrombin SolutionThrombin (Human): 2.5 - 6.5 units/mL1Calcium Chloride: 36 - 44 µmol/mLOther ingredients include: Human albumin, sodium chloride and water for injection (WFI). 1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU). Sealer Protein (Human). Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human). Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2). Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at US licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)]. Viral Clearance. The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein Concentrate and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV, HBV, HCV, HAV and Human Parvovirus B19. The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 6 for each of the viruses tested. n.d. = not determined. HIV-1: Human immunodeficiency virus 1; HAV: Hepatitis A virus; BVDV: Bovine viral diarrhea virus, a model for Hepatitis C virus; PRV: Pseudorabies virus, a model for enveloped DNA viruses, among those Hepatitis B virus; MMV: Mice minute virus, a model for B19V. In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and >4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively."
},
{
"NDCCode": "0338-9560-01",
"PackageDescription": "2 mL in 1 SYRINGE, PLASTIC (0338-9560-01) ",
"NDC11Code": "00338-9560-01",
"ProductNDC": "0338-9560",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Tisseel",
"ProprietaryNameSuffix": "Fibrin Sealant",
"NonProprietaryName": "Fibrinogen Human, Human Thrombin",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19980501",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103980",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "FIBRINOGEN HUMAN; HUMAN THROMBIN",
"StrengthNumber": "86.5; 500",
"StrengthUnit": "mg/mL; [iU]/mL",
"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]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
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"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)."
}
]
}
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<PackageDescription>4 POUCH in 1 CARTON (45802-580-84) / 1 PATCH, EXTENDED RELEASE in 1 POUCH</PackageDescription>
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<Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
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<Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
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<Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
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<Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
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<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
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<LastUpdate>2025-05-17</LastUpdate>
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<IndicationAndUsage>Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea.</IndicationAndUsage>
<Description>Ivermectin Cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of ivermectin cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0 % and not more than 102.0 % of 5-O-demethyl-22,23-dihydroavermectin A1a plus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b or H2B1a and H2B1b, respectively; and the ratio (calculated by area percentage) of component H2B1a/(H2B1a + H2B1b) is not less than 90.0 %. The respective empirical formulas of H2B1a and H2B1b are C48H74O14 and C47H72O14 with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H2B1a: R = C2H5, Component H2B1b: R = CH3. Ivermectin cream contains the following inactive ingredients: cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol.</Description>
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<PackageDescription>1 TUBE in 1 CARTON (45802-453-84) / 45 g in 1 TUBE</PackageDescription>
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<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101026</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
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<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
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<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
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<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adapalene Cream, 0.1% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Adapalene Cream, 0.1%, contains adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>45802-491-84</NDCCode>
<PackageDescription>4 BOTTLE, UNIT-DOSE in 1 CARTON (45802-491-84) / 1 SPRAY in 1 BOTTLE, UNIT-DOSE</PackageDescription>
<NDC11Code>45802-0491-84</NDC11Code>
<ProductNDC>45802-491</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyanocobalamin</ProprietaryName>
<NonProprietaryName>Cyanocobalamin</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20231228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212458</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Vitamin B 12 [CS], Vitamin B12 [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyanocobalamin Nasal Spray is indicated for: 1 Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement , 2 Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia , 3 Prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normal.</IndicationAndUsage>
<Description>Cyanocobalamin is a synthetic form of vitamin B12. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide. The cobalt content is 4.35%. The molecular formula is C63H88CoN14O14P, which corresponds to a molecular weight of 1355.38 and the following structural formula. Figure 1. Cyanocobalamin Nasal Spray Chemical Structure. Cyanocobalamin occurs as dark red crystals or orthorhombic needles or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly to moderately soluble in water (1:80). Its pharmacologic activity is destroyed by heavy metals (iron) and strong oxidizing or reducing agents (vitamin C), but not by autoclaving for short periods of time (15-20 minutes) at 121°C. The vitamin B12 coenzymes are very unstable in light. Cyanocobalamin Nasal Spray is a solution of cyanocobalamin, USP (vitamin B12) for administration as a spray to the nasal mucosa. Each unit dose device of Cyanocobalamin Nasal Spray contains 0.125 mL of a 500 mcg/0.1 mL solution of cyanocobalamin with benzalkonium chloride in purified water, citric acid, glycerin and sodium citrate. The spray solution has a pH between 4.5 and 5.5. Each spray delivers an average of 500 mcg of cyanocobalamin per actuation.</Description>
</NDC>
<NDC>
<NDCCode>45802-505-84</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-505-84) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0505-84</NDC11Code>
<ProductNDC>45802-505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215847</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone dipropionate ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21- dipropionate. The structural formula is. Each gram of the 0.05% ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>45802-578-84</NDCCode>
<PackageDescription>2 VIAL, SINGLE-DOSE in 1 CARTON (45802-578-84) / .1 mL in 1 VIAL, SINGLE-DOSE (45802-578-00) </PackageDescription>
<NDC11Code>45802-0578-84</NDC11Code>
<ProductNDC>45802-578</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20230730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211951</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/.1mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin. this medicine can save a life.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45802-736-84</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-736-84) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0736-84</NDC11Code>
<ProductNDC>45802-736</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Clindamycin, Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090979</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>10; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris. (1.1). Limitation of Use. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. (1.2).</IndicationAndUsage>
<Description>Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a fixed combination product with two active ingredients in a white, opaque, aqueous gel formulation. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Clindamycin phosphate is C18H34ClN2O8PS. The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio- L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). Benzoyl peroxide is C14H10O4. It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% contains 10 mg (1%) clindamycin, as clindamycin phosphate, and 50 mg (5%) benzoyl peroxide in a base consisting of carbomer homopolymer (type B), hydrochloric acid, methylparaben, dimethicone, propylparaben, purified water and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>45802-811-84</NDCCode>
<PackageDescription>2 VIAL, SINGLE-DOSE in 1 CARTON (45802-811-84) / .1 mL in 1 VIAL, SINGLE-DOSE (45802-811-00) </PackageDescription>
<NDC11Code>45802-0811-84</NDC11Code>
<ProductNDC>45802-811</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220621</StartMarketingDate>
<EndMarketingDate>20250930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211951</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/.1mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220621</StartMarketingDatePackage>
<EndMarketingDatePackage>20250930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naloxone HCl Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. Naloxone HCl Nasal Spray is not a substitute for emergency medical care. Limitations of Use. Restrict prescription of naloxone hydrochloride nasal spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.</IndicationAndUsage>
<Description>Naloxone HCl Nasal Spray is a pre-filled, single dose intranasal spray. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride with the following structure. C19H21NO4●HCl. M.W. 363.84. Naloxone hydrochloride, an opioid antagonist, occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform. Each Naloxone HCl Nasal Spray contains a 4 mg single dose of naloxone hydrochloride (equivalent to 3.6 mg of naloxone) in a 0.1 mL (100 microliter) aqueous solution. Inactive ingredients include benzalkonium chloride (preservative), disodium ethylenediaminetetraacetate (chelating agent), sodium chloride, hydrochloric acid to adjust pH, and purified water. The pH range is 3.5 to 5.5.</Description>
</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>20271231</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>20271231</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>20271231</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>
<NDC>
<NDCCode>0338-8402-10</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0338-8402-10) / 10 mL in 1 SYRINGE, PLASTIC (0338-8402-09) </PackageDescription>
<NDC11Code>00338-8402-10</NDC11Code>
<ProductNDC>0338-8402</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Tisseel</ProprietaryName>
<ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
<NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19980501</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103980</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
<StrengthNumber>90; 500</StrengthNumber>
<StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
<Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1 The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2 Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3 Thrombin Solution, 4 Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5 * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
</NDC>
<NDC>
<NDCCode>0338-8503-02</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0338-8503-02) / 2 mL in 1 SYRINGE, PLASTIC (0338-8503-01) </PackageDescription>
<NDC11Code>00338-8503-02</NDC11Code>
<ProductNDC>0338-8503</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Artiss</ProprietaryName>
<ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
<NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080319</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125266</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
<StrengthNumber>86.5; 4</StrengthNumber>
<StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARTISS is a fibrin sealant indicated to: 1 Adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age., 2 Adhere tissue flaps during facial rhytidectomy surgery (face-lift).</IndicationAndUsage>
<Description>ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma. Sealer Protein SolutionTotal protein: 96 -125 mg/mLFibrinogen: 67 - 106 mg/mLFibrinolysis Inhibitor (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL. Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI). Thrombin SolutionThrombin (Human): 2.5 - 6.5 units/mL1Calcium Chloride: 36 - 44 µmol/mLOther ingredients include: Human albumin, sodium chloride and water for injection (WFI). 1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU). Sealer Protein (Human). Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human). Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2). Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at US licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)]. Viral Clearance. The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein Concentrate and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV, HBV, HCV, HAV and Human Parvovirus B19. The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 6 for each of the viruses tested. n.d. = not determined. HIV-1: Human immunodeficiency virus 1; HAV: Hepatitis A virus; BVDV: Bovine viral diarrhea virus, a model for Hepatitis C virus; PRV: Pseudorabies virus, a model for enveloped DNA viruses, among those Hepatitis B virus; MMV: Mice minute virus, a model for B19V. In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and >4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively.</Description>
</NDC>
<NDC>
<NDCCode>0338-8503-04</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0338-8503-04) / 4 mL in 1 SYRINGE, PLASTIC (0338-8503-03) </PackageDescription>
<NDC11Code>00338-8503-04</NDC11Code>
<ProductNDC>0338-8503</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Artiss</ProprietaryName>
<ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
<NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080319</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125266</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
<StrengthNumber>86.5; 4</StrengthNumber>
<StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARTISS is a fibrin sealant indicated to: 1 Adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age., 2 Adhere tissue flaps during facial rhytidectomy surgery (face-lift).</IndicationAndUsage>
<Description>ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma. Sealer Protein SolutionTotal protein: 96 -125 mg/mLFibrinogen: 67 - 106 mg/mLFibrinolysis Inhibitor (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL. Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI). Thrombin SolutionThrombin (Human): 2.5 - 6.5 units/mL1Calcium Chloride: 36 - 44 µmol/mLOther ingredients include: Human albumin, sodium chloride and water for injection (WFI). 1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU). Sealer Protein (Human). Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human). Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2). Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at US licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)]. Viral Clearance. The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein Concentrate and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV, HBV, HCV, HAV and Human Parvovirus B19. The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 6 for each of the viruses tested. n.d. = not determined. HIV-1: Human immunodeficiency virus 1; HAV: Hepatitis A virus; BVDV: Bovine viral diarrhea virus, a model for Hepatitis C virus; PRV: Pseudorabies virus, a model for enveloped DNA viruses, among those Hepatitis B virus; MMV: Mice minute virus, a model for B19V. In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and >4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively.</Description>
</NDC>
<NDC>
<NDCCode>0338-8503-10</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0338-8503-10) / 10 mL in 1 SYRINGE, PLASTIC (0338-8503-09) </PackageDescription>
<NDC11Code>00338-8503-10</NDC11Code>
<ProductNDC>0338-8503</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Artiss</ProprietaryName>
<ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
<NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080319</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125266</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
<StrengthNumber>86.5; 4</StrengthNumber>
<StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARTISS is a fibrin sealant indicated to: 1 Adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age., 2 Adhere tissue flaps during facial rhytidectomy surgery (face-lift).</IndicationAndUsage>
<Description>ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma. Sealer Protein SolutionTotal protein: 96 -125 mg/mLFibrinogen: 67 - 106 mg/mLFibrinolysis Inhibitor (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL. Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI). Thrombin SolutionThrombin (Human): 2.5 - 6.5 units/mL1Calcium Chloride: 36 - 44 µmol/mLOther ingredients include: Human albumin, sodium chloride and water for injection (WFI). 1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU). Sealer Protein (Human). Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human). Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2). Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at US licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)]. Viral Clearance. The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein Concentrate and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV, HBV, HCV, HAV and Human Parvovirus B19. The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 6 for each of the viruses tested. n.d. = not determined. HIV-1: Human immunodeficiency virus 1; HAV: Hepatitis A virus; BVDV: Bovine viral diarrhea virus, a model for Hepatitis C virus; PRV: Pseudorabies virus, a model for enveloped DNA viruses, among those Hepatitis B virus; MMV: Mice minute virus, a model for B19V. In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and >4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively.</Description>
</NDC>
<NDC>
<NDCCode>0338-9560-01</NDCCode>
<PackageDescription>2 mL in 1 SYRINGE, PLASTIC (0338-9560-01) </PackageDescription>
<NDC11Code>00338-9560-01</NDC11Code>
<ProductNDC>0338-9560</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Tisseel</ProprietaryName>
<ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
<NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19980501</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103980</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
<StrengthNumber>86.5; 500</StrengthNumber>
<StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
<Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin (Synthetic) solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) Solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1 The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2 Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3 Thrombin Solution, 4 Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5 * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
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