{
"NDC": [
{
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"PackageDescription": "96 TABLET, CHEWABLE in 1 BOTTLE (21130-184-22) ",
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"ProprietaryName": "Antacid Extra Strength Assorted Berry",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
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"LabelerName": "Safeway",
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"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
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"LastUpdate": "2024-01-02",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150808",
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"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn."
},
{
"NDCCode": "21130-184-66",
"PackageDescription": "200 TABLET, CHEWABLE in 1 BOTTLE (21130-184-66) ",
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"ProductTypeName": "HUMAN OTC DRUG",
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"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150808",
"SamplePackage": "N",
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},
{
"NDCCode": "37835-184-22",
"PackageDescription": "96 TABLET, CHEWABLE in 1 BOTTLE (37835-184-22) ",
"NDC11Code": "37835-0184-22",
"ProductNDC": "37835-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bi-mart Extra Strength Antacid Assorted Berry",
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"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20180926",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Bi-Mart",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180926",
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"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn."
},
{
"NDCCode": "53041-184-22",
"PackageDescription": "96 TABLET, CHEWABLE in 1 BOTTLE (53041-184-22) ",
"NDC11Code": "53041-0184-22",
"ProductNDC": "53041-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guardian Extra Strength Assorted Berry Antacid",
"ProprietaryNameSuffix": "Extra Strength Assorted Berry Antacid",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20231205",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part331",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231205",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn."
},
{
"NDCCode": "69842-184-22",
"PackageDescription": "96 TABLET, CHEWABLE in 1 BOTTLE (69842-184-22)",
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"ProductNDC": "69842-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antacid Extra Strength Assorted Berry",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "CVS",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2017-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150401",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn."
},
{
"NDCCode": "21130-109-22",
"PackageDescription": "15 BLISTER PACK in 1 CARTON (21130-109-22) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "21130-0109-22",
"ProductNDC": "21130-109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Allergy Relief",
"NonProprietaryName": "Fexofenadine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076447",
"LabelerName": "Safeway",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150811",
"SamplePackage": "N"
},
{
"NDCCode": "21130-127-22",
"PackageDescription": "96 TABLET, CHEWABLE in 1 BOTTLE (21130-127-22) ",
"NDC11Code": "21130-0127-22",
"ProductNDC": "21130-127",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antacid Relief Extra Strength Assorted Fruit",
"NonProprietaryName": "Calcium Antacid",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150808",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Safeway",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150808",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn."
},
{
"NDCCode": "21130-130-22",
"PackageDescription": "96 TABLET, CHEWABLE in 1 BOTTLE (21130-130-22) ",
"NDC11Code": "21130-0130-22",
"ProductNDC": "21130-130",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antacid Relief Extra Strength",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150808",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Safeway",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150808",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn."
},
{
"NDCCode": "21130-190-22",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (21130-190-22) > 12 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "21130-0190-22",
"ProductNDC": "21130-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900315",
"EndMarketingDate": "20181113",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Better Living Brands, LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "21130-202-22",
"PackageDescription": "96 TABLET, CHEWABLE in 1 BOTTLE (21130-202-22) ",
"NDC11Code": "21130-0202-22",
"ProductNDC": "21130-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antacid Relief Extra Strength Tropical Fruit",
"NonProprietaryName": "Calcium Antacid",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150808",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Safeway",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150808",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn."
},
{
"NDCCode": "21130-329-22",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (21130-329-22) / 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "21130-0329-22",
"ProductNDC": "21130-329",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19900302",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Better Living Brands, LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900302",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throat. temporarily relieves these symptoms due to the common cold:runny nosesneezing."
},
{
"NDCCode": "21130-375-22",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-375-22) > 48 TABLET in 1 BOTTLE",
"NDC11Code": "21130-0375-22",
"ProductNDC": "21130-375",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-diarrheal",
"NonProprietaryName": "Loperamide Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076497",
"LabelerName": "Better Living Brands, LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20050503",
"EndMarketingDatePackage": "20211024",
"SamplePackage": "N"
},
{
"NDCCode": "21130-386-22",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (21130-386-22) > 16 TABLET in 1 BLISTER PACK",
"NDC11Code": "21130-0386-22",
"ProductNDC": "21130-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Sleep Aid",
"NonProprietaryName": "Doxylamine Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020411",
"EndMarketingDate": "20220801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040564",
"LabelerName": "Better Living Brands, LLC",
"SubstanceName": "DOXYLAMINE SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20020411",
"EndMarketingDatePackage": "20220801",
"SamplePackage": "N"
},
{
"NDCCode": "21130-571-22",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (21130-571-22) > 5 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "21130-0571-22",
"ProductNDC": "21130-571",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexofenadine Hydrochloride",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076447",
"LabelerName": "Safeway",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "21130-616-22",
"PackageDescription": "15 BLISTER PACK in 1 CARTON (21130-616-22) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "21130-0616-22",
"ProductNDC": "21130-616",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Fexofenadine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076447",
"LabelerName": "Safeway",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "21130-654-22",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (21130-654-22) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "21130-0654-22",
"ProductNDC": "21130-654",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Sleep Aid",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20190524",
"EndMarketingDate": "20221022",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part338",
"LabelerName": "Better Living Brands, LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190524",
"EndMarketingDatePackage": "20221022",
"SamplePackage": "N"
},
{
"NDCCode": "21130-778-22",
"PackageDescription": "4 BLISTER PACK in 1 PACKAGE (21130-778-22) > 8 TABLET in 1 BLISTER PACK",
"NDC11Code": "21130-0778-22",
"ProductNDC": "21130-778",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motion Sickness Relief",
"ProprietaryNameSuffix": "Less Drowsy",
"NonProprietaryName": "Meclizine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020624",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part336",
"LabelerName": "Better Living Brands, LLC",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-09-26"
},
{
"NDCCode": "0173-0859-10",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0859-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER",
"NDC11Code": "00173-0859-10",
"ProductNDC": "0173-0859",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breo Ellipta",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130826",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204275",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "100; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130826",
"SamplePackage": "N",
"IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0859-14",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0859-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0859-14",
"ProductNDC": "0173-0859",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breo Ellipta",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130826",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204275",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "100; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130826",
"SamplePackage": "N",
"IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0859-61",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0859-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0859-61",
"ProductNDC": "0173-0859",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breo Ellipta",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130826",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204275",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "100; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0882-10",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0882-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER",
"NDC11Code": "00173-0882-10",
"ProductNDC": "0173-0882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breo Ellipta",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204275",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "200; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0882-14",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0882-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0882-14",
"ProductNDC": "0173-0882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breo Ellipta",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204275",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "200; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0882-61",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0882-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0882-61",
"ProductNDC": "0173-0882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breo Ellipta",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204275",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "200; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0916-10",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0916-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER",
"NDC11Code": "00173-0916-10",
"ProductNDC": "0173-0916",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breo Ellipta",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20230512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204275",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "50; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20230512",
"SamplePackage": "N",
"IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0941-0465-01",
"PackageDescription": "5000 mL in 1 BAG (0941-0465-01)",
"NDC11Code": "00941-0465-01",
"ProductNDC": "0941-0465",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dianeal For Peritoneal Dialysis",
"NonProprietaryName": "Anhydrous Dextrose, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20141027",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "ANHYDROUS DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "22.7; 5.38; 4.48; .184; .051",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-02-15",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "16714-184-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16714-184-01) ",
"NDC11Code": "16714-0184-01",
"ProductNDC": "16714-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078406",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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},
{
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"Description": "Paroxetine tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively.Inactive ingredients consist of dibasic calcium phosphate dihydrate, lactose monohydrate, sodium starch glycolate, dibasic calcium phosphate anhydrous, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition to this, 10 mg tablet contains D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake. 20 mg and 40 mg tablets contain D&C Red #30 Aluminum Lake. 30 mg tablet contains FD&C Blue #2 Aluminum Lake."
},
{
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"Description": "Paroxetine tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively.Inactive ingredients consist of dibasic calcium phosphate dihydrate, lactose monohydrate, sodium starch glycolate, dibasic calcium phosphate anhydrous, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition to this, 10 mg tablet contains D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake. 20 mg and 40 mg tablets contain D&C Red #30 Aluminum Lake. 30 mg tablet contains FD&C Blue #2 Aluminum Lake."
},
{
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},
{
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"Description": "Paroxetine tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively.Inactive ingredients consist of dibasic calcium phosphate dihydrate, lactose monohydrate, sodium starch glycolate, dibasic calcium phosphate anhydrous, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition to this, 10 mg tablet contains D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake. 20 mg and 40 mg tablets contain D&C Red #30 Aluminum Lake. 30 mg tablet contains FD&C Blue #2 Aluminum Lake."
}
]
}
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<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150808</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 acid indigestion, 2 heartburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21130-329-22</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (21130-329-22) / 12 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21130-0329-22</NDC11Code>
<ProductNDC>21130-329</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900302</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Better Living Brands, LLC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throat. temporarily relieves these symptoms due to the common cold:runny nosesneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21130-375-22</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (21130-375-22) > 48 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>21130-0375-22</NDC11Code>
<ProductNDC>21130-375</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076497</ApplicationNumber>
<LabelerName>Better Living Brands, LLC</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050503</StartMarketingDatePackage>
<EndMarketingDatePackage>20211024</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>21130-386-22</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (21130-386-22) > 16 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21130-0386-22</NDC11Code>
<ProductNDC>21130-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Sleep Aid</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020411</StartMarketingDate>
<EndMarketingDate>20220801</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040564</ApplicationNumber>
<LabelerName>Better Living Brands, LLC</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20020411</StartMarketingDatePackage>
<EndMarketingDatePackage>20220801</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>21130-571-22</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (21130-571-22) > 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21130-0571-22</NDC11Code>
<ProductNDC>21130-571</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076447</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>21130-616-22</NDCCode>
<PackageDescription>15 BLISTER PACK in 1 CARTON (21130-616-22) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21130-0616-22</NDC11Code>
<ProductNDC>21130-616</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Fexofenadine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076447</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>21130-654-22</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (21130-654-22) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21130-0654-22</NDC11Code>
<ProductNDC>21130-654</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Sleep Aid</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190524</StartMarketingDate>
<EndMarketingDate>20221022</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part338</ApplicationNumber>
<LabelerName>Better Living Brands, LLC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190524</StartMarketingDatePackage>
<EndMarketingDatePackage>20221022</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>21130-778-22</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 PACKAGE (21130-778-22) > 8 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21130-0778-22</NDC11Code>
<ProductNDC>21130-778</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motion Sickness Relief</ProprietaryName>
<ProprietaryNameSuffix>Less Drowsy</ProprietaryNameSuffix>
<NonProprietaryName>Meclizine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020624</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part336</ApplicationNumber>
<LabelerName>Better Living Brands, LLC</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-09-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>0173-0859-10</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0859-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0859-10</NDC11Code>
<ProductNDC>0173-0859</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breo Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130826</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>100; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0859-14</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0859-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0859-14</NDC11Code>
<ProductNDC>0173-0859</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breo Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130826</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>100; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0859-61</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0859-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0859-61</NDC11Code>
<ProductNDC>0173-0859</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breo Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130826</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>100; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130826</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0882-10</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0882-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0882-10</NDC11Code>
<ProductNDC>0173-0882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breo Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>200; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0882-14</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0882-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0882-14</NDC11Code>
<ProductNDC>0173-0882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breo Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>200; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0882-61</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0882-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0882-61</NDC11Code>
<ProductNDC>0173-0882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breo Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>200; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0916-10</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0916-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0916-10</NDC11Code>
<ProductNDC>0173-0916</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breo Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20230512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>50; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0941-0465-01</NDCCode>
<PackageDescription>5000 mL in 1 BAG (0941-0465-01)</PackageDescription>
<NDC11Code>00941-0465-01</NDC11Code>
<ProductNDC>0941-0465</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dianeal For Peritoneal Dialysis</ProprietaryName>
<NonProprietaryName>Anhydrous Dextrose, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>20141027</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>ANHYDROUS DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>22.7; 5.38; 4.48; .184; .051</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-15</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16714-184-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16714-184-01) </PackageDescription>
<NDC11Code>16714-0184-01</NDC11Code>
<ProductNDC>16714-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078406</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: : 1 Major depressive disorder (MDD) , 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD) , 4 Social anxiety disorder (SAD) , 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively.Inactive ingredients consist of dibasic calcium phosphate dihydrate, lactose monohydrate, sodium starch glycolate, dibasic calcium phosphate anhydrous, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition to this, 10 mg tablet contains D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake. 20 mg and 40 mg tablets contain D&C Red #30 Aluminum Lake. 30 mg tablet contains FD&C Blue #2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>16714-184-02</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (16714-184-02) </PackageDescription>
<NDC11Code>16714-0184-02</NDC11Code>
<ProductNDC>16714-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078406</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: : 1 Major depressive disorder (MDD) , 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD) , 4 Social anxiety disorder (SAD) , 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively.Inactive ingredients consist of dibasic calcium phosphate dihydrate, lactose monohydrate, sodium starch glycolate, dibasic calcium phosphate anhydrous, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition to this, 10 mg tablet contains D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake. 20 mg and 40 mg tablets contain D&C Red #30 Aluminum Lake. 30 mg tablet contains FD&C Blue #2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>16714-184-03</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (16714-184-03) </PackageDescription>
<NDC11Code>16714-0184-03</NDC11Code>
<ProductNDC>16714-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078406</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070725</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: : 1 Major depressive disorder (MDD) , 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD) , 4 Social anxiety disorder (SAD) , 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively.Inactive ingredients consist of dibasic calcium phosphate dihydrate, lactose monohydrate, sodium starch glycolate, dibasic calcium phosphate anhydrous, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition to this, 10 mg tablet contains D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake. 20 mg and 40 mg tablets contain D&C Red #30 Aluminum Lake. 30 mg tablet contains FD&C Blue #2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>16714-184-04</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (16714-184-04) </PackageDescription>
<NDC11Code>16714-0184-04</NDC11Code>
<ProductNDC>16714-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078406</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: : 1 Major depressive disorder (MDD) , 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD) , 4 Social anxiety disorder (SAD) , 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively.Inactive ingredients consist of dibasic calcium phosphate dihydrate, lactose monohydrate, sodium starch glycolate, dibasic calcium phosphate anhydrous, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition to this, 10 mg tablet contains D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake. 20 mg and 40 mg tablets contain D&C Red #30 Aluminum Lake. 30 mg tablet contains FD&C Blue #2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>16714-184-05</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (16714-184-05) </PackageDescription>
<NDC11Code>16714-0184-05</NDC11Code>
<ProductNDC>16714-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078406</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: : 1 Major depressive disorder (MDD) , 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD) , 4 Social anxiety disorder (SAD) , 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively.Inactive ingredients consist of dibasic calcium phosphate dihydrate, lactose monohydrate, sodium starch glycolate, dibasic calcium phosphate anhydrous, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition to this, 10 mg tablet contains D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake. 20 mg and 40 mg tablets contain D&C Red #30 Aluminum Lake. 30 mg tablet contains FD&C Blue #2 Aluminum Lake.</Description>
</NDC>
</NDCList>