{
"NDC": [
{
"NDCCode": "65483-495-14",
"PackageDescription": "14 BLISTER PACK in 1 CARTON (65483-495-14) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "65483-0495-14",
"ProductNDC": "65483-495",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helidac Therapy",
"NonProprietaryName": "Bismuth Subsalicylate, Metronidazole And Tetracycline Hydrochloride",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "19960815",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050719",
"LabelerName": "Prometheus Laboratories Inc.",
"Status": "Deprecated",
"LastUpdate": "2014-02-19"
},
{
"NDCCode": "36800-495-69",
"PackageDescription": "1 TUBE in 1 CARTON (36800-495-69) / 14.2 g in 1 TUBE",
"NDC11Code": "36800-0495-69",
"ProductNDC": "36800-495",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare",
"ProprietaryNameSuffix": "Antifungal",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19930831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2025-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930831",
"SamplePackage": "N",
"IndicationAndUsage": "cures most athlete's foot, jock itch and ringworm. relieves itching, burning, cracking, scaling and discomfort which accompany these conditions."
},
{
"NDCCode": "63776-495-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-495-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0495-14",
"ProductNDC": "63776-495",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-str Ss",
"NonProprietaryName": "Cobalt, Copper, Gelsemium, Gingko, Ginseng, Gotu Kola, Iodium, Lomatium, Vanadium",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "AMERICAN GINSENG; CENTELLA ASIATICA LEAF; COBALT; COPPER; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; IODINE; LOMATIUM DISSECTUM WHOLE; VANADIUM",
"StrengthNumber": "3; 3; 12; 3; 12; 3; 12; 3; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190705",
"SamplePackage": "N",
"IndicationAndUsage": "To support in times of stress.",
"Description": "Viatrexx-Str ss is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system."
},
{
"NDCCode": "0023-6142-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, UNIT-DOSE (0023-6142-30) ",
"NDC11Code": "00023-6142-30",
"ProductNDC": "0023-6142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapaflo",
"NonProprietaryName": "Silodosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090323",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022206",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "SILODOSIN",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090323",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "RAPAFLO®, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)]. RAPAFLO is not indicated for the treatment of hypertension.",
"Description": "RAPAFLO is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53. The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105 to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each RAPAFLO 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #1 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing FD&C Blue No. 1 Aluminum Lake and yellow iron oxide. Each RAPAFLO 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing yellow iron oxide."
},
{
"NDCCode": "0023-6142-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, UNIT-DOSE (0023-6142-90) ",
"NDC11Code": "00023-6142-90",
"ProductNDC": "0023-6142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapaflo",
"NonProprietaryName": "Silodosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090323",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022206",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "SILODOSIN",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090323",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N",
"IndicationAndUsage": "RAPAFLO®, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)]. RAPAFLO is not indicated for the treatment of hypertension.",
"Description": "RAPAFLO is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53. The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105 to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each RAPAFLO 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #1 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing FD&C Blue No. 1 Aluminum Lake and yellow iron oxide. Each RAPAFLO 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing yellow iron oxide."
},
{
"NDCCode": "0023-6147-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, UNIT-DOSE (0023-6147-30) ",
"NDC11Code": "00023-6147-30",
"ProductNDC": "0023-6147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapaflo",
"NonProprietaryName": "Silodosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090323",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022206",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "SILODOSIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090323",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "RAPAFLO®, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)]. RAPAFLO is not indicated for the treatment of hypertension.",
"Description": "RAPAFLO is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53. The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105 to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each RAPAFLO 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #1 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing FD&C Blue No. 1 Aluminum Lake and yellow iron oxide. Each RAPAFLO 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing yellow iron oxide."
},
{
"NDCCode": "11673-495-71",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (11673-495-71) / 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "11673-0495-71",
"ProductNDC": "11673-495",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Gas Relief",
"NonProprietaryName": "Simethicone",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M002",
"LabelerName": "TARGET CORPORATION",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230701",
"SamplePackage": "N",
"IndicationAndUsage": "Use for the relief of : 1 pressure, bloating and fullness commonly referred to as gas."
},
{
"NDCCode": "14789-101-01",
"PackageDescription": "1 BAG in 1 CARTON (14789-101-01) / 100 mL in 1 BAG",
"NDC11Code": "14789-0101-01",
"ProductNDC": "14789-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirofiban Hydrochloride",
"NonProprietaryName": "Tirofiban Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213947",
"LabelerName": "Nexus Pharmaceuticals LLC",
"SubstanceName": "TIROFIBAN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230925",
"SamplePackage": "N",
"IndicationAndUsage": "Tirofiban Hydrochloride Injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).",
"Description": "Tirofiban Hydrochloride Injection contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)- O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C 22H 36N 2O 5SHClH 2O and its structural formula is:. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. Tirofiban Hydrochloride Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.5 mg citric acid monohydrate. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8.75 mg citric acid monohydrate."
},
{
"NDCCode": "14789-102-02",
"PackageDescription": "1 BAG in 1 CARTON (14789-102-02) / 250 mL in 1 BAG",
"NDC11Code": "14789-0102-02",
"ProductNDC": "14789-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirofiban Hydrochloride",
"NonProprietaryName": "Tirofiban Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213947",
"LabelerName": "Nexus Pharmaceuticals LLC",
"SubstanceName": "TIROFIBAN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230925",
"SamplePackage": "N",
"IndicationAndUsage": "Tirofiban Hydrochloride Injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).",
"Description": "Tirofiban Hydrochloride Injection contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)- O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C 22H 36N 2O 5SHClH 2O and its structural formula is:. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. Tirofiban Hydrochloride Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.5 mg citric acid monohydrate. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8.75 mg citric acid monohydrate."
},
{
"NDCCode": "14789-102-10",
"PackageDescription": "2 BAG in 1 CARTON (14789-102-10) / 250 mL in 1 BAG",
"NDC11Code": "14789-0102-10",
"ProductNDC": "14789-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirofiban Hydrochloride",
"NonProprietaryName": "Tirofiban Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213947",
"LabelerName": "Nexus Pharmaceuticals LLC",
"SubstanceName": "TIROFIBAN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240210",
"SamplePackage": "N",
"IndicationAndUsage": "Tirofiban Hydrochloride Injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).",
"Description": "Tirofiban Hydrochloride Injection contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)- O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C 22H 36N 2O 5SHClH 2O and its structural formula is:. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. Tirofiban Hydrochloride Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.5 mg citric acid monohydrate. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8.75 mg citric acid monohydrate."
},
{
"NDCCode": "25021-417-84",
"PackageDescription": "1 BAG in 1 CARTON (25021-417-84) / 250 mL in 1 BAG",
"NDC11Code": "25021-0417-84",
"ProductNDC": "25021-417",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirofiban Hydrochloride",
"NonProprietaryName": "Tirofiban Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206888",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "TIROFIBAN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241115",
"SamplePackage": "N",
"IndicationAndUsage": "Tirofiban hydrochloride injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).",
"Description": "Tirofiban hydrochloride injection contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is:. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. Tirofiban hydrochloride injection is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg per mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous."
},
{
"NDCCode": "25208-001-04",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (25208-001-04) / 15 mL in 1 VIAL, GLASS",
"NDC11Code": "25208-0001-04",
"ProductNDC": "25208-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aggrastat",
"NonProprietaryName": "Tirofiban",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20161015",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020912",
"LabelerName": "Medicure International Inc",
"SubstanceName": "TIROFIBAN HYDROCHLORIDE",
"StrengthNumber": "3.75",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161015",
"SamplePackage": "N",
"IndicationAndUsage": "AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).",
"Description": "AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection."
},
{
"NDCCode": "25208-002-01",
"PackageDescription": "1 BAG in 1 CARTON (25208-002-01) / 100 mL in 1 BAG",
"NDC11Code": "25208-0002-01",
"ProductNDC": "25208-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aggrastat",
"NonProprietaryName": "Tirofiban",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19980514",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020913",
"LabelerName": "Medicure International Inc",
"SubstanceName": "TIROFIBAN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201224",
"SamplePackage": "N",
"IndicationAndUsage": "AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).",
"Description": "AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection."
},
{
"NDCCode": "25208-002-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (25208-002-02) / 250 mL in 1 CONTAINER",
"NDC11Code": "25208-0002-02",
"ProductNDC": "25208-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aggrastat",
"NonProprietaryName": "Tirofiban",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19980514",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020913",
"LabelerName": "Medicure International Inc",
"SubstanceName": "TIROFIBAN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980514",
"SamplePackage": "N",
"IndicationAndUsage": "AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).",
"Description": "AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection."
},
{
"NDCCode": "25208-002-03",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (25208-002-03) / 100 mL in 1 VIAL, GLASS",
"NDC11Code": "25208-0002-03",
"ProductNDC": "25208-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aggrastat",
"NonProprietaryName": "Tirofiban",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19980514",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020913",
"LabelerName": "Medicure International Inc",
"SubstanceName": "TIROFIBAN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161015",
"SamplePackage": "N",
"IndicationAndUsage": "AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).",
"Description": "AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection."
},
{
"NDCCode": "25208-901-04",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (25208-901-04) / 15 mL in 1 VIAL, GLASS",
"NDC11Code": "25208-0901-04",
"ProductNDC": "25208-901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aggrastat",
"NonProprietaryName": "Tirofiban",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20161015",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020912",
"LabelerName": "Medicure International Inc",
"SubstanceName": "TIROFIBAN HYDROCHLORIDE",
"StrengthNumber": "3.75",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161015",
"SamplePackage": "N",
"IndicationAndUsage": "AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).",
"Description": "AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection."
},
{
"NDCCode": "25208-902-01",
"PackageDescription": "1 BAG in 1 CARTON (25208-902-01) / 100 mL in 1 BAG",
"NDC11Code": "25208-0902-01",
"ProductNDC": "25208-902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aggrastat",
"NonProprietaryName": "Tirofiban",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19980514",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020913",
"LabelerName": "Medicure International Inc",
"SubstanceName": "TIROFIBAN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201224",
"SamplePackage": "N",
"IndicationAndUsage": "AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).",
"Description": "AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection."
},
{
"NDCCode": "25208-902-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (25208-902-02) / 250 mL in 1 CONTAINER",
"NDC11Code": "25208-0902-02",
"ProductNDC": "25208-902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aggrastat",
"NonProprietaryName": "Tirofiban",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19980514",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020913",
"LabelerName": "Medicure International Inc",
"SubstanceName": "TIROFIBAN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980514",
"SamplePackage": "N",
"IndicationAndUsage": "AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).",
"Description": "AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection."
},
{
"NDCCode": "27241-144-01",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (27241-144-01) ",
"NDC11Code": "27241-0144-01",
"ProductNDC": "27241-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silodosin",
"NonProprietaryName": "Silodosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211060",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "SILODOSIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181203",
"SamplePackage": "N",
"IndicationAndUsage": "Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Silodosin capsules are not indicated for the treatment of hypertension.",
"Description": "Silodosin capsules, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2 (2,2,2-trifluoroethoxy) phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53. The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105 to 109°C. It is freely soluble in acetic acid and in absolute alcohol, and insoluble in water. Each silodosin 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: mannitol, pregelatinized starch, sodium lauryl sulfate and sodium stearyl fumarate. The size #1 hard gelatin capsules contain FD & C Blue 1, FD & C Red 3, FD & C Red 40, gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Each silodosin 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: mannitol, pregelatinized starch, sodium lauryl sulfate and sodium stearyl fumarate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "27241-145-01",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (27241-145-01) ",
"NDC11Code": "27241-0145-01",
"ProductNDC": "27241-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silodosin",
"NonProprietaryName": "Silodosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211060",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "SILODOSIN",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181203",
"SamplePackage": "N",
"IndicationAndUsage": "Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Silodosin capsules are not indicated for the treatment of hypertension.",
"Description": "Silodosin capsules, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2 (2,2,2-trifluoroethoxy) phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53. The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105 to 109°C. It is freely soluble in acetic acid and in absolute alcohol, and insoluble in water. Each silodosin 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: mannitol, pregelatinized starch, sodium lauryl sulfate and sodium stearyl fumarate. The size #1 hard gelatin capsules contain FD & C Blue 1, FD & C Red 3, FD & C Red 40, gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Each silodosin 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: mannitol, pregelatinized starch, sodium lauryl sulfate and sodium stearyl fumarate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "27241-145-03",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (27241-145-03) ",
"NDC11Code": "27241-0145-03",
"ProductNDC": "27241-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silodosin",
"NonProprietaryName": "Silodosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211060",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "SILODOSIN",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181203",
"SamplePackage": "N",
"IndicationAndUsage": "Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Silodosin capsules are not indicated for the treatment of hypertension.",
"Description": "Silodosin capsules, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2 (2,2,2-trifluoroethoxy) phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53. The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105 to 109°C. It is freely soluble in acetic acid and in absolute alcohol, and insoluble in water. Each silodosin 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: mannitol, pregelatinized starch, sodium lauryl sulfate and sodium stearyl fumarate. The size #1 hard gelatin capsules contain FD & C Blue 1, FD & C Red 3, FD & C Red 40, gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Each silodosin 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: mannitol, pregelatinized starch, sodium lauryl sulfate and sodium stearyl fumarate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "31722-635-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (31722-635-30) ",
"NDC11Code": "31722-0635-30",
"ProductNDC": "31722-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silodosin",
"NonProprietaryName": "Silodosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204793",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "SILODOSIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200214",
"SamplePackage": "N",
"IndicationAndUsage": "Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.",
"Description": "Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
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"IndicationAndUsage": "Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.",
"Description": "Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
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"IndicationAndUsage": "Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.",
"Description": "Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Camber Pharmaceuticals, Inc.",
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"IndicationAndUsage": "Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.",
"Description": "Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Camber Pharmaceuticals, Inc.",
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"IndicationAndUsage": "Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.",
"Description": "Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
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{
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"PackageDescription": "30 CAPSULE in 1 BOTTLE (31722-636-31) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Camber Pharmaceuticals, Inc.",
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"IndicationAndUsage": "Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.",
"Description": "Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.",
"Description": "Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silodosin",
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"LabelerName": "Camber Pharmaceuticals, Inc.",
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"IndicationAndUsage": "Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.",
"Description": "Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
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"PackageDescription": "30 CAPSULE in 1 BOTTLE (33342-384-07) ",
"NDC11Code": "33342-0384-07",
"ProductNDC": "33342-384",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silodosin",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211166",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "SILODOSIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
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"IndicationAndUsage": "Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)]. Silodosin is not indicated for the treatment of hypertension.",
"Description": "Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is (R)-1-(3-hydroxypropyl)-5-(2-(2-(2-(2,2,2-trifluoroethoxy)phenoxy)ethylamino)propyl) indoline-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53. The structural formula of silodosin is. Silodosin is a white to pale yellowish colour powder that melts at approximately 105 to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each silodosin 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: mannitol, magnesium stearate, pregelatinized starch (maize), and sodium lauryl sulfate. The size #1 hard gelatin capsules contain gelatin, titanium dioxide and sodium lauryl sulfate. The capsules are printed with edible ink containing shellac, propylene glycol, FD&C Blue No. 1 Aluminum Lake and yellow iron oxide. Each silodosin 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: mannitol, magnesium stearate, pregelatinized starch (maize), and sodium lauryl sulfate. The size #3 hard gelatin capsules contain gelatin, titanium dioxide and sodium lauryl sulfate. The capsules are printed with edible ink containing shellac, propylene glycol and yellow iron oxide."
}
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<IndicationAndUsage>RAPAFLO®, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)]. RAPAFLO is not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>RAPAFLO is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53. The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105 to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each RAPAFLO 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #1 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing FD&C Blue No. 1 Aluminum Lake and yellow iron oxide. Each RAPAFLO 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing yellow iron oxide.</Description>
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<StartMarketingDate>20090323</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022206</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>SILODOSIN</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090323</StartMarketingDatePackage>
<EndMarketingDatePackage>20221231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RAPAFLO®, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)]. RAPAFLO is not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>RAPAFLO is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53. The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105 to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each RAPAFLO 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #1 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing FD&C Blue No. 1 Aluminum Lake and yellow iron oxide. Each RAPAFLO 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0023-6147-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, UNIT-DOSE (0023-6147-30) </PackageDescription>
<NDC11Code>00023-6147-30</NDC11Code>
<ProductNDC>0023-6147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rapaflo</ProprietaryName>
<NonProprietaryName>Silodosin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090323</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022206</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>SILODOSIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090323</StartMarketingDatePackage>
<EndMarketingDatePackage>20260331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RAPAFLO®, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)]. RAPAFLO is not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>RAPAFLO is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53. The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105 to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each RAPAFLO 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #1 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing FD&C Blue No. 1 Aluminum Lake and yellow iron oxide. Each RAPAFLO 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>11673-495-71</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (11673-495-71) / 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11673-0495-71</NDC11Code>
<ProductNDC>11673-495</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Gas Relief</ProprietaryName>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M002</ApplicationNumber>
<LabelerName>TARGET CORPORATION</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use for the relief of : 1 pressure, bloating and fullness commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14789-101-01</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (14789-101-01) / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>14789-0101-01</NDC11Code>
<ProductNDC>14789-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirofiban Hydrochloride</ProprietaryName>
<NonProprietaryName>Tirofiban Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213947</ApplicationNumber>
<LabelerName>Nexus Pharmaceuticals LLC</LabelerName>
<SubstanceName>TIROFIBAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tirofiban Hydrochloride Injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).</IndicationAndUsage>
<Description>Tirofiban Hydrochloride Injection contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)- O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C 22H 36N 2O 5SHClH 2O and its structural formula is:. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. Tirofiban Hydrochloride Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.5 mg citric acid monohydrate. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8.75 mg citric acid monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>14789-102-02</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (14789-102-02) / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>14789-0102-02</NDC11Code>
<ProductNDC>14789-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirofiban Hydrochloride</ProprietaryName>
<NonProprietaryName>Tirofiban Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213947</ApplicationNumber>
<LabelerName>Nexus Pharmaceuticals LLC</LabelerName>
<SubstanceName>TIROFIBAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tirofiban Hydrochloride Injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).</IndicationAndUsage>
<Description>Tirofiban Hydrochloride Injection contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)- O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C 22H 36N 2O 5SHClH 2O and its structural formula is:. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. Tirofiban Hydrochloride Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.5 mg citric acid monohydrate. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8.75 mg citric acid monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>14789-102-10</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (14789-102-10) / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>14789-0102-10</NDC11Code>
<ProductNDC>14789-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirofiban Hydrochloride</ProprietaryName>
<NonProprietaryName>Tirofiban Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213947</ApplicationNumber>
<LabelerName>Nexus Pharmaceuticals LLC</LabelerName>
<SubstanceName>TIROFIBAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tirofiban Hydrochloride Injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).</IndicationAndUsage>
<Description>Tirofiban Hydrochloride Injection contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)- O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C 22H 36N 2O 5SHClH 2O and its structural formula is:. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. Tirofiban Hydrochloride Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.5 mg citric acid monohydrate. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8.75 mg citric acid monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>25021-417-84</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (25021-417-84) / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>25021-0417-84</NDC11Code>
<ProductNDC>25021-417</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirofiban Hydrochloride</ProprietaryName>
<NonProprietaryName>Tirofiban Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20241115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206888</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>TIROFIBAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tirofiban hydrochloride injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).</IndicationAndUsage>
<Description>Tirofiban hydrochloride injection contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is:. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. Tirofiban hydrochloride injection is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg per mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous.</Description>
</NDC>
<NDC>
<NDCCode>25208-001-04</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (25208-001-04) / 15 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>25208-0001-04</NDC11Code>
<ProductNDC>25208-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aggrastat</ProprietaryName>
<NonProprietaryName>Tirofiban</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20161015</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020912</ApplicationNumber>
<LabelerName>Medicure International Inc</LabelerName>
<SubstanceName>TIROFIBAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3.75</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).</IndicationAndUsage>
<Description>AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>25208-002-01</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (25208-002-01) / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>25208-0002-01</NDC11Code>
<ProductNDC>25208-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aggrastat</ProprietaryName>
<NonProprietaryName>Tirofiban</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19980514</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020913</ApplicationNumber>
<LabelerName>Medicure International Inc</LabelerName>
<SubstanceName>TIROFIBAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).</IndicationAndUsage>
<Description>AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>25208-002-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (25208-002-02) / 250 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>25208-0002-02</NDC11Code>
<ProductNDC>25208-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aggrastat</ProprietaryName>
<NonProprietaryName>Tirofiban</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19980514</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020913</ApplicationNumber>
<LabelerName>Medicure International Inc</LabelerName>
<SubstanceName>TIROFIBAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).</IndicationAndUsage>
<Description>AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>25208-002-03</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (25208-002-03) / 100 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>25208-0002-03</NDC11Code>
<ProductNDC>25208-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aggrastat</ProprietaryName>
<NonProprietaryName>Tirofiban</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19980514</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020913</ApplicationNumber>
<LabelerName>Medicure International Inc</LabelerName>
<SubstanceName>TIROFIBAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).</IndicationAndUsage>
<Description>AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection.</Description>
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<NDC>
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<PackageDescription>1 VIAL, GLASS in 1 CARTON (25208-901-04) / 15 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>25208-0901-04</NDC11Code>
<ProductNDC>25208-901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aggrastat</ProprietaryName>
<NonProprietaryName>Tirofiban</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20161015</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020912</ApplicationNumber>
<LabelerName>Medicure International Inc</LabelerName>
<SubstanceName>TIROFIBAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3.75</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).</IndicationAndUsage>
<Description>AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>25208-902-01</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (25208-902-01) / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>25208-0902-01</NDC11Code>
<ProductNDC>25208-902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aggrastat</ProprietaryName>
<NonProprietaryName>Tirofiban</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19980514</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020913</ApplicationNumber>
<LabelerName>Medicure International Inc</LabelerName>
<SubstanceName>TIROFIBAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).</IndicationAndUsage>
<Description>AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>25208-902-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (25208-902-02) / 250 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>25208-0902-02</NDC11Code>
<ProductNDC>25208-902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aggrastat</ProprietaryName>
<NonProprietaryName>Tirofiban</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19980514</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020913</ApplicationNumber>
<LabelerName>Medicure International Inc</LabelerName>
<SubstanceName>TIROFIBAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).</IndicationAndUsage>
<Description>AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C22H36N2O5SHClH2O and its structural formula is. Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>27241-144-01</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (27241-144-01) </PackageDescription>
<NDC11Code>27241-0144-01</NDC11Code>
<ProductNDC>27241-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Silodosin</ProprietaryName>
<NonProprietaryName>Silodosin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211060</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>SILODOSIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin capsules, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2 (2,2,2-trifluoroethoxy) phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53. The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105 to 109°C. It is freely soluble in acetic acid and in absolute alcohol, and insoluble in water. Each silodosin 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: mannitol, pregelatinized starch, sodium lauryl sulfate and sodium stearyl fumarate. The size #1 hard gelatin capsules contain FD & C Blue 1, FD & C Red 3, FD & C Red 40, gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Each silodosin 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: mannitol, pregelatinized starch, sodium lauryl sulfate and sodium stearyl fumarate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>27241-145-01</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (27241-145-01) </PackageDescription>
<NDC11Code>27241-0145-01</NDC11Code>
<ProductNDC>27241-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Silodosin</ProprietaryName>
<NonProprietaryName>Silodosin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211060</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>SILODOSIN</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin capsules, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2 (2,2,2-trifluoroethoxy) phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53. The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105 to 109°C. It is freely soluble in acetic acid and in absolute alcohol, and insoluble in water. Each silodosin 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: mannitol, pregelatinized starch, sodium lauryl sulfate and sodium stearyl fumarate. The size #1 hard gelatin capsules contain FD & C Blue 1, FD & C Red 3, FD & C Red 40, gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Each silodosin 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: mannitol, pregelatinized starch, sodium lauryl sulfate and sodium stearyl fumarate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>27241-145-03</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (27241-145-03) </PackageDescription>
<NDC11Code>27241-0145-03</NDC11Code>
<ProductNDC>27241-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Silodosin</ProprietaryName>
<NonProprietaryName>Silodosin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211060</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>SILODOSIN</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin capsules, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2 (2,2,2-trifluoroethoxy) phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53. The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105 to 109°C. It is freely soluble in acetic acid and in absolute alcohol, and insoluble in water. Each silodosin 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: mannitol, pregelatinized starch, sodium lauryl sulfate and sodium stearyl fumarate. The size #1 hard gelatin capsules contain FD & C Blue 1, FD & C Red 3, FD & C Red 40, gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Each silodosin 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: mannitol, pregelatinized starch, sodium lauryl sulfate and sodium stearyl fumarate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-635-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (31722-635-30) </PackageDescription>
<NDC11Code>31722-0635-30</NDC11Code>
<ProductNDC>31722-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Silodosin</ProprietaryName>
<NonProprietaryName>Silodosin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204793</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SILODOSIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>31722-635-31</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (31722-635-31) </PackageDescription>
<NDC11Code>31722-0635-31</NDC11Code>
<ProductNDC>31722-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Silodosin</ProprietaryName>
<NonProprietaryName>Silodosin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204793</ApplicationNumber>
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<IndicationAndUsage>Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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<IndicationAndUsage>Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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<IndicationAndUsage>Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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<IndicationAndUsage>Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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<IndicationAndUsage>Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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<NDC>
<NDCCode>33342-384-07</NDCCode>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211166</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>SILODOSIN</SubstanceName>
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<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
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<LastUpdate>2022-07-02</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)]. Silodosin is not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is (R)-1-(3-hydroxypropyl)-5-(2-(2-(2-(2,2,2-trifluoroethoxy)phenoxy)ethylamino)propyl) indoline-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53. The structural formula of silodosin is. Silodosin is a white to pale yellowish colour powder that melts at approximately 105 to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each silodosin 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: mannitol, magnesium stearate, pregelatinized starch (maize), and sodium lauryl sulfate. The size #1 hard gelatin capsules contain gelatin, titanium dioxide and sodium lauryl sulfate. The capsules are printed with edible ink containing shellac, propylene glycol, FD&C Blue No. 1 Aluminum Lake and yellow iron oxide. Each silodosin 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: mannitol, magnesium stearate, pregelatinized starch (maize), and sodium lauryl sulfate. The size #3 hard gelatin capsules contain gelatin, titanium dioxide and sodium lauryl sulfate. The capsules are printed with edible ink containing shellac, propylene glycol and yellow iron oxide.</Description>
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