{
"NDC": [
{
"NDCCode": "59310-579-22",
"PackageDescription": "1 INHALER in 1 CARTON (59310-579-22) / 200 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "59310-0579-22",
"ProductNDC": "59310-579",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proair",
"ProprietaryNameSuffix": "Hfa",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20121203",
"EndMarketingDate": "20240621",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021457",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121203",
"EndMarketingDatePackage": "20240621",
"SamplePackage": "N",
"IndicationAndUsage": "PROAIR HFA Inhalation Aerosol is a beta2-adrenergic agonist indicated for: 1 Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1), 2 Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2).",
"Description": "The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name α1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and has the following chemical structure. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official generic name in the United States, and salbutamol sulfate is the World Health Organization recommended generic name. PROAIR HFA Inhalation Aerosol is a pressurized metered-dose aerosol unit with a dose counter. PROAIR HFA is for oral inhalation only. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1, 1, 1, 2-tetrafluoroethane) and ethanol. Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face. After priming, each actuation delivers 108 mcg albuterol sulfate, from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Each canister provides 200 actuations (inhalations). This product does not contain chlorofluorocarbons (CFCs) as the propellant."
},
{
"NDCCode": "59310-579-20",
"PackageDescription": "200 AEROSOL, METERED in 1 INHALER (59310-579-20)",
"NDC11Code": "59310-0579-20",
"ProductNDC": "59310-579",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proair",
"ProprietaryNameSuffix": "Hfa",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20041227",
"EndMarketingDate": "20140731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021457",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-08-08"
},
{
"NDCCode": "59310-579-21",
"PackageDescription": "200 AEROSOL, METERED in 1 INHALER (59310-579-21)",
"NDC11Code": "59310-0579-21",
"ProductNDC": "59310-579",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proair",
"ProprietaryNameSuffix": "Hfa",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20041227",
"EndMarketingDate": "20140731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021457",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-08-08"
},
{
"NDCCode": "59310-579-23",
"PackageDescription": "1 INHALER in 1 CARTON (59310-579-23) > 200 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "59310-0579-23",
"ProductNDC": "59310-579",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proair",
"ProprietaryNameSuffix": "Hfa",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20121203",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021457",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-06-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20121203",
"SamplePackage": "N"
},
{
"NDCCode": "59310-206-08",
"PackageDescription": "1 INHALER in 1 CARTON (59310-206-08) > 60 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "59310-0206-08",
"ProductNDC": "59310-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qnasl",
"NonProprietaryName": "Beclomethasone Dipropionate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20150201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202813",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "BECLOMETHASONE DIPROPIONATE",
"StrengthNumber": "40",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150201",
"EndMarketingDatePackage": "20190122",
"SamplePackage": "N"
},
{
"NDCCode": "50458-579-99",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (50458-579-99) ",
"NDC11Code": "50458-0579-99",
"ProductNDC": "50458-579",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xarelto",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111105",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022406",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20111105",
"SamplePackage": "N"
},
{
"NDCCode": "68001-492-36",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 PACKAGE (68001-492-36) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "68001-0492-36",
"ProductNDC": "68001-492",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxorubicin Hydrochloride",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTABLE, LIPOSOMAL",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203263",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210531",
"SamplePackage": "N",
"IndicationAndUsage": "Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor indicated for: 1 Ovarian cancer:After failure of platinum-based chemotherapy ( 1.1). , 2 AIDS-related Kaposi’s Sarcoma:After failure of prior systemic chemotherapy or intolerance to such therapy ( 1.2). , 3 Multiple Myeloma:In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy ( 1.3). .",
"Description": "The active ingredient in doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in pegylated liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C 27H 29NO 11 HCl and the molecular weight is 579.99. The structural formula is:. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion. Each single-dose vial contains 20 mg or 50 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The pegylated liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine, 1.50 mg as a buffer; hydrochloric acid and/or sodium hydroxide for pH control; and sucrose, 100 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the pegylated liposomes."
},
{
"NDCCode": "68001-493-26",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 PACKAGE (68001-493-26) / 25 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "68001-0493-26",
"ProductNDC": "68001-493",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxorubicin Hydrochloride",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTABLE, LIPOSOMAL",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203263",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210531",
"SamplePackage": "N",
"IndicationAndUsage": "Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor indicated for: 1 Ovarian cancer:After failure of platinum-based chemotherapy ( 1.1). , 2 AIDS-related Kaposi’s Sarcoma:After failure of prior systemic chemotherapy or intolerance to such therapy ( 1.2). , 3 Multiple Myeloma:In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy ( 1.3). .",
"Description": "The active ingredient in doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in pegylated liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C 27H 29NO 11 HCl and the molecular weight is 579.99. The structural formula is:. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion. Each single-dose vial contains 20 mg or 50 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The pegylated liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine, 1.50 mg as a buffer; hydrochloric acid and/or sodium hydroxide for pH control; and sucrose, 100 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the pegylated liposomes."
},
{
"NDCCode": "71335-2493-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (71335-2493-1) ",
"NDC11Code": "71335-2493-01",
"ProductNDC": "71335-2493",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214344",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240910",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending."
},
{
"NDCCode": "71335-2493-2",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (71335-2493-2) ",
"NDC11Code": "71335-2493-02",
"ProductNDC": "71335-2493",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214344",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending."
},
{
"NDCCode": "71335-2493-3",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71335-2493-3) ",
"NDC11Code": "71335-2493-03",
"ProductNDC": "71335-2493",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214344",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240909",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending."
},
{
"NDCCode": "71335-2493-4",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71335-2493-4) ",
"NDC11Code": "71335-2493-04",
"ProductNDC": "71335-2493",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214344",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending."
},
{
"NDCCode": "71335-2493-5",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (71335-2493-5) ",
"NDC11Code": "71335-2493-05",
"ProductNDC": "71335-2493",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214344",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending."
},
{
"NDCCode": "71335-2493-6",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (71335-2493-6) ",
"NDC11Code": "71335-2493-06",
"ProductNDC": "71335-2493",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214344",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending."
},
{
"NDCCode": "71335-2493-7",
"PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE (71335-2493-7) ",
"NDC11Code": "71335-2493-07",
"ProductNDC": "71335-2493",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214344",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending."
},
{
"NDCCode": "59310-111-06",
"PackageDescription": "1 POUCH in 1 CARTON (59310-111-06) / 1 INHALER in 1 POUCH / 1 POWDER, METERED in 1 INHALER",
"NDC11Code": "59310-0111-06",
"ProductNDC": "59310-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Airduo Digihaler",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200915",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208799",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "55; 14",
"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": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200915",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "AirDuo® Digihaler® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AirDuo Digihaler is not indicated for the relief of acute bronchospasm.",
"Description": "AirDuo Digihaler 55/14 mcg, AirDuo Digihaler 113/14 mcg and AirDuo Digihaler 232/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AirDuo Digihaler is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AirDuo Digihaler is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AirDuo Digihaler. AirDuo Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AirDuo Digihaler inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 106.72 L/min (range: 73.64 to 125.51 L/min). AirDuo Digihaler includes a QR code (on the top of the inhaler), and contains a built-in electronic module which automatically detects, records and stores data on inhaler events, including peak inspiratory flow rate (L/min). AirDuo Digihaler may pair with and transmit data to the mobile App where inhaler events are categorized."
},
{
"NDCCode": "59310-114-06",
"PackageDescription": "1 POUCH in 1 CARTON (59310-114-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER",
"NDC11Code": "59310-0114-06",
"ProductNDC": "59310-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armonair Digihaler",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200915",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208798",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "55",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200915",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "ArmonAir® Digihaler® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use. ArmonAir Digihaler is not indicated for the relief of acute bronchospasm.",
"Description": "The active component of ArmonAir Digihaler 30 mcg, 55 mcg, ArmonAir Digihaler 113 mcg, and ArmonAir Digihaler 232 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. ArmonAir Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains a formulation blend of fluticasone propionate and alpha lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters the formulation from the device reservoir as follows: 1 5.5 mg of formulation, which contains 30 mcg of fluticasone propionate, 2 11.5 mg of formulation, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate. ."
},
{
"NDCCode": "59310-117-20",
"PackageDescription": "1 INHALER in 1 BOX (59310-117-20) / 200 INHALANT in 1 INHALER",
"NDC11Code": "59310-0117-20",
"ProductNDC": "59310-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proair Digihaler",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20191004",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205636",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191004",
"SamplePackage": "N",
"Description": "The active ingredient of ProAir Digihaler inhalation powder is albuterol sulfate, a racemic salt of albuterol. Albuterol sulfate is a beta2-adrenergic agonist. It has the chemical name α1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following chemical structure. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official U.S. Adopted Name in the United States, and salbutamol sulfate is the recommended World Health Organization international nonproprietary name. ProAir Digihaler is inhalation-driven, multi-dose inhalation powder (dry powder inhaler) for oral inhalation only. It contains a formulation blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation provides a metered dose of 2.6 mg of the formulation containing 117 mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) and lactose from the device reservoir. Under standardized in vitro test conditions with fixed flow rates ranging from 58 to 71 L/min, and with a total air volume of 2 L, ProAir Digihaler inhaler delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) with lactose from the mouthpiece. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. In a study that investigated the peak inspiratory flow rate (PIFR) in asthma (n=27, ages 12 to 17 years old and n=50, ages 18 to 45 years old) and COPD (n=50, over 50 years old) patients, the mean PIFR achieved by subjects was >60 L/min (range = 31 to 110 L/min.), indicating that patients would be able to achieve the required inspiratory flow to operate the MDPI device correctly. The inhaler is provided for 200 or 30 actuations (inhalations). ProAir Digihaler contains a QR code on the electronic module which is built-in to the top of the inhaler and automatically detects, records and stores data on inhaler events, including peak inspiratory flow rate (L/min). ProAir Digihaler may pair with and transmit data to the mobile App where inhaler events are categorized."
},
{
"NDCCode": "59310-117-21",
"PackageDescription": "1 INHALER in 1 BOX (59310-117-21) > 200 INHALANT in 1 INHALER",
"NDC11Code": "59310-0117-21",
"ProductNDC": "59310-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proair Digihaler",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20191004",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205636",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20191004",
"SamplePackage": "N"
},
{
"NDCCode": "59310-129-06",
"PackageDescription": "1 POUCH in 1 CARTON (59310-129-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER",
"NDC11Code": "59310-0129-06",
"ProductNDC": "59310-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Airduo Digihaler",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200915",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208799",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "113; 14",
"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": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200915",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "AirDuo® Digihaler® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AirDuo Digihaler is not indicated for the relief of acute bronchospasm.",
"Description": "AirDuo Digihaler 55/14 mcg, AirDuo Digihaler 113/14 mcg and AirDuo Digihaler 232/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AirDuo Digihaler is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AirDuo Digihaler is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AirDuo Digihaler. AirDuo Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AirDuo Digihaler inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 106.72 L/min (range: 73.64 to 125.51 L/min). AirDuo Digihaler includes a QR code (on the top of the inhaler), and contains a built-in electronic module which automatically detects, records and stores data on inhaler events, including peak inspiratory flow rate (L/min). AirDuo Digihaler may pair with and transmit data to the mobile App where inhaler events are categorized."
},
{
"NDCCode": "59310-136-06",
"PackageDescription": "1 POUCH in 1 CARTON (59310-136-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER",
"NDC11Code": "59310-0136-06",
"ProductNDC": "59310-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Airduo Digihaler",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200915",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208799",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "232; 14",
"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": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200915",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "AirDuo® Digihaler® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AirDuo Digihaler is not indicated for the relief of acute bronchospasm.",
"Description": "AirDuo Digihaler 55/14 mcg, AirDuo Digihaler 113/14 mcg and AirDuo Digihaler 232/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AirDuo Digihaler is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AirDuo Digihaler is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AirDuo Digihaler. AirDuo Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AirDuo Digihaler inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 106.72 L/min (range: 73.64 to 125.51 L/min). AirDuo Digihaler includes a QR code (on the top of the inhaler), and contains a built-in electronic module which automatically detects, records and stores data on inhaler events, including peak inspiratory flow rate (L/min). AirDuo Digihaler may pair with and transmit data to the mobile App where inhaler events are categorized."
},
{
"NDCCode": "59310-175-41",
"PackageDescription": "1 CANISTER in 1 BOX (59310-175-41) > 100 AEROSOL, METERED in 1 CANISTER",
"NDC11Code": "59310-0175-41",
"ProductNDC": "59310-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qvar",
"NonProprietaryName": "Beclomethasone Dipropionate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20001006",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020911",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "BECLOMETHASONE DIPROPIONATE",
"StrengthNumber": "40",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "59310-200-06",
"PackageDescription": "1 POUCH in 1 CARTON (59310-200-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER",
"NDC11Code": "59310-0200-06",
"ProductNDC": "59310-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armonair Digihaler",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200915",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208798",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "113",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200915",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "ArmonAir® Digihaler® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use. ArmonAir Digihaler is not indicated for the relief of acute bronchospasm.",
"Description": "The active component of ArmonAir Digihaler 30 mcg, 55 mcg, ArmonAir Digihaler 113 mcg, and ArmonAir Digihaler 232 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. ArmonAir Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains a formulation blend of fluticasone propionate and alpha lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters the formulation from the device reservoir as follows: 1 5.5 mg of formulation, which contains 30 mcg of fluticasone propionate, 2 11.5 mg of formulation, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate. ."
},
{
"NDCCode": "59310-202-12",
"PackageDescription": "1 CANISTER in 1 BOX (59310-202-12) > 120 AEROSOL, METERED in 1 CANISTER",
"NDC11Code": "59310-0202-12",
"ProductNDC": "59310-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qvar",
"NonProprietaryName": "Beclomethasone Dipropionate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140915",
"EndMarketingDate": "20191031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020911",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "BECLOMETHASONE DIPROPIONATE",
"StrengthNumber": "40",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140915",
"EndMarketingDatePackage": "20191031",
"SamplePackage": "N"
},
{
"NDCCode": "59310-202-14",
"PackageDescription": "1 CANISTER in 1 BOX (59310-202-14) > 120 AEROSOL, METERED in 1 CANISTER",
"NDC11Code": "59310-0202-14",
"ProductNDC": "59310-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qvar",
"NonProprietaryName": "Beclomethasone Dipropionate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020911",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "BECLOMETHASONE DIPROPIONATE",
"StrengthNumber": "40",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140915",
"EndMarketingDatePackage": "20180831",
"SamplePackage": "N"
},
{
"NDCCode": "59310-202-40",
"PackageDescription": "1 CANISTER in 1 BOX (59310-202-40) > 120 AEROSOL, METERED in 1 CANISTER",
"NDC11Code": "59310-0202-40",
"ProductNDC": "59310-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qvar",
"NonProprietaryName": "Beclomethasone Dipropionate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20110119",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020911",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "BECLOMETHASONE DIPROPIONATE",
"StrengthNumber": "40",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "59310-204-12",
"PackageDescription": "1 CANISTER in 1 BOX (59310-204-12) > 120 AEROSOL, METERED in 1 CANISTER",
"NDC11Code": "59310-0204-12",
"ProductNDC": "59310-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qvar",
"NonProprietaryName": "Beclomethasone Dipropionate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140915",
"EndMarketingDate": "20191130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020911",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "BECLOMETHASONE DIPROPIONATE",
"StrengthNumber": "80",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140915",
"EndMarketingDatePackage": "20191130",
"SamplePackage": "N"
},
{
"NDCCode": "59310-204-14",
"PackageDescription": "1 CANISTER in 1 BOX (59310-204-14) > 120 AEROSOL, METERED in 1 CANISTER",
"NDC11Code": "59310-0204-14",
"ProductNDC": "59310-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qvar",
"NonProprietaryName": "Beclomethasone Dipropionate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020911",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "BECLOMETHASONE DIPROPIONATE",
"StrengthNumber": "80",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140915",
"EndMarketingDatePackage": "20190228",
"SamplePackage": "N"
},
{
"NDCCode": "59310-204-50",
"PackageDescription": "1 CANISTER in 1 BOX (59310-204-50) > 50 AEROSOL, METERED in 1 CANISTER",
"NDC11Code": "59310-0204-50",
"ProductNDC": "59310-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qvar",
"NonProprietaryName": "Beclomethasone Dipropionate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20110121",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020911",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "BECLOMETHASONE DIPROPIONATE",
"StrengthNumber": "80",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "59310-204-80",
"PackageDescription": "1 CANISTER in 1 BOX (59310-204-80) > 120 AEROSOL, METERED in 1 CANISTER",
"NDC11Code": "59310-0204-80",
"ProductNDC": "59310-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qvar",
"NonProprietaryName": "Beclomethasone Dipropionate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20110121",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020911",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "BECLOMETHASONE DIPROPIONATE",
"StrengthNumber": "80",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>59310-579-22</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (59310-579-22) / 200 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0579-22</NDC11Code>
<ProductNDC>59310-579</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proair</ProprietaryName>
<ProprietaryNameSuffix>Hfa</ProprietaryNameSuffix>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20121203</StartMarketingDate>
<EndMarketingDate>20240621</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021457</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20121203</StartMarketingDatePackage>
<EndMarketingDatePackage>20240621</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROAIR HFA Inhalation Aerosol is a beta2-adrenergic agonist indicated for: 1 Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1), 2 Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2).</IndicationAndUsage>
<Description>The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name α1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and has the following chemical structure. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official generic name in the United States, and salbutamol sulfate is the World Health Organization recommended generic name. PROAIR HFA Inhalation Aerosol is a pressurized metered-dose aerosol unit with a dose counter. PROAIR HFA is for oral inhalation only. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1, 1, 1, 2-tetrafluoroethane) and ethanol. Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face. After priming, each actuation delivers 108 mcg albuterol sulfate, from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Each canister provides 200 actuations (inhalations). This product does not contain chlorofluorocarbons (CFCs) as the propellant.</Description>
</NDC>
<NDC>
<NDCCode>59310-579-20</NDCCode>
<PackageDescription>200 AEROSOL, METERED in 1 INHALER (59310-579-20)</PackageDescription>
<NDC11Code>59310-0579-20</NDC11Code>
<ProductNDC>59310-579</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proair</ProprietaryName>
<ProprietaryNameSuffix>Hfa</ProprietaryNameSuffix>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20041227</StartMarketingDate>
<EndMarketingDate>20140731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021457</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-08-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>59310-579-21</NDCCode>
<PackageDescription>200 AEROSOL, METERED in 1 INHALER (59310-579-21)</PackageDescription>
<NDC11Code>59310-0579-21</NDC11Code>
<ProductNDC>59310-579</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proair</ProprietaryName>
<ProprietaryNameSuffix>Hfa</ProprietaryNameSuffix>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20041227</StartMarketingDate>
<EndMarketingDate>20140731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021457</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-08-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>59310-579-23</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (59310-579-23) > 200 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0579-23</NDC11Code>
<ProductNDC>59310-579</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proair</ProprietaryName>
<ProprietaryNameSuffix>Hfa</ProprietaryNameSuffix>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20121203</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
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<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
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<LabelerName>Teva Respiratory, LLC</LabelerName>
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<ProprietaryName>Xarelto</ProprietaryName>
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<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2023-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<LabelerName>BluePoint Laboratories</LabelerName>
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<LastUpdate>2026-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor indicated for: 1 Ovarian cancer:After failure of platinum-based chemotherapy ( 1.1). , 2 AIDS-related Kaposi’s Sarcoma:After failure of prior systemic chemotherapy or intolerance to such therapy ( 1.2). , 3 Multiple Myeloma:In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy ( 1.3). .</IndicationAndUsage>
<Description>The active ingredient in doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in pegylated liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C 27H 29NO 11 HCl and the molecular weight is 579.99. The structural formula is:. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion. Each single-dose vial contains 20 mg or 50 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The pegylated liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine, 1.50 mg as a buffer; hydrochloric acid and/or sodium hydroxide for pH control; and sucrose, 100 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the pegylated liposomes.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<Status>Active</Status>
<LastUpdate>2026-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor indicated for: 1 Ovarian cancer:After failure of platinum-based chemotherapy ( 1.1). , 2 AIDS-related Kaposi’s Sarcoma:After failure of prior systemic chemotherapy or intolerance to such therapy ( 1.2). , 3 Multiple Myeloma:In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy ( 1.3). .</IndicationAndUsage>
<Description>The active ingredient in doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in pegylated liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C 27H 29NO 11 HCl and the molecular weight is 579.99. The structural formula is:. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion. Each single-dose vial contains 20 mg or 50 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The pegylated liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine, 1.50 mg as a buffer; hydrochloric acid and/or sodium hydroxide for pH control; and sucrose, 100 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the pegylated liposomes.</Description>
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<ProductNDC>71335-2493</ProductNDC>
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<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214344</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending.</Description>
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<NDC>
<NDCCode>71335-2493-2</NDCCode>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214344</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending.</Description>
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<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214344</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending.</Description>
</NDC>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Bryant Ranch Prepack</LabelerName>
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<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending.</Description>
</NDC>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214344</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>71335-2493-6</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (71335-2493-6) </PackageDescription>
<NDC11Code>71335-2493-06</NDC11Code>
<ProductNDC>71335-2493</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214344</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>71335-2493-7</NDCCode>
<PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE (71335-2493-7) </PackageDescription>
<NDC11Code>71335-2493-07</NDC11Code>
<ProductNDC>71335-2493</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214344</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>59310-111-06</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (59310-111-06) / 1 INHALER in 1 POUCH / 1 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0111-06</NDC11Code>
<ProductNDC>59310-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Airduo Digihaler</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208799</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>55; 14</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>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AirDuo® Digihaler® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AirDuo Digihaler is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>AirDuo Digihaler 55/14 mcg, AirDuo Digihaler 113/14 mcg and AirDuo Digihaler 232/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AirDuo Digihaler is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AirDuo Digihaler is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AirDuo Digihaler. AirDuo Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AirDuo Digihaler inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 106.72 L/min (range: 73.64 to 125.51 L/min). AirDuo Digihaler includes a QR code (on the top of the inhaler), and contains a built-in electronic module which automatically detects, records and stores data on inhaler events, including peak inspiratory flow rate (L/min). AirDuo Digihaler may pair with and transmit data to the mobile App where inhaler events are categorized.</Description>
</NDC>
<NDC>
<NDCCode>59310-114-06</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (59310-114-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0114-06</NDC11Code>
<ProductNDC>59310-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armonair Digihaler</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208798</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>55</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ArmonAir® Digihaler® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use. ArmonAir Digihaler is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>The active component of ArmonAir Digihaler 30 mcg, 55 mcg, ArmonAir Digihaler 113 mcg, and ArmonAir Digihaler 232 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. ArmonAir Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains a formulation blend of fluticasone propionate and alpha lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters the formulation from the device reservoir as follows: 1 5.5 mg of formulation, which contains 30 mcg of fluticasone propionate, 2 11.5 mg of formulation, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate. .</Description>
</NDC>
<NDC>
<NDCCode>59310-117-20</NDCCode>
<PackageDescription>1 INHALER in 1 BOX (59310-117-20) / 200 INHALANT in 1 INHALER</PackageDescription>
<NDC11Code>59310-0117-20</NDC11Code>
<ProductNDC>59310-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proair Digihaler</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20191004</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205636</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The active ingredient of ProAir Digihaler inhalation powder is albuterol sulfate, a racemic salt of albuterol. Albuterol sulfate is a beta2-adrenergic agonist. It has the chemical name α1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following chemical structure. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official U.S. Adopted Name in the United States, and salbutamol sulfate is the recommended World Health Organization international nonproprietary name. ProAir Digihaler is inhalation-driven, multi-dose inhalation powder (dry powder inhaler) for oral inhalation only. It contains a formulation blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation provides a metered dose of 2.6 mg of the formulation containing 117 mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) and lactose from the device reservoir. Under standardized in vitro test conditions with fixed flow rates ranging from 58 to 71 L/min, and with a total air volume of 2 L, ProAir Digihaler inhaler delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) with lactose from the mouthpiece. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. In a study that investigated the peak inspiratory flow rate (PIFR) in asthma (n=27, ages 12 to 17 years old and n=50, ages 18 to 45 years old) and COPD (n=50, over 50 years old) patients, the mean PIFR achieved by subjects was >60 L/min (range = 31 to 110 L/min.), indicating that patients would be able to achieve the required inspiratory flow to operate the MDPI device correctly. The inhaler is provided for 200 or 30 actuations (inhalations). ProAir Digihaler contains a QR code on the electronic module which is built-in to the top of the inhaler and automatically detects, records and stores data on inhaler events, including peak inspiratory flow rate (L/min). ProAir Digihaler may pair with and transmit data to the mobile App where inhaler events are categorized.</Description>
</NDC>
<NDC>
<NDCCode>59310-117-21</NDCCode>
<PackageDescription>1 INHALER in 1 BOX (59310-117-21) > 200 INHALANT in 1 INHALER</PackageDescription>
<NDC11Code>59310-0117-21</NDC11Code>
<ProductNDC>59310-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proair Digihaler</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20191004</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205636</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59310-129-06</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (59310-129-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0129-06</NDC11Code>
<ProductNDC>59310-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Airduo Digihaler</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208799</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>113; 14</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>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AirDuo® Digihaler® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AirDuo Digihaler is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>AirDuo Digihaler 55/14 mcg, AirDuo Digihaler 113/14 mcg and AirDuo Digihaler 232/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AirDuo Digihaler is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AirDuo Digihaler is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AirDuo Digihaler. AirDuo Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AirDuo Digihaler inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 106.72 L/min (range: 73.64 to 125.51 L/min). AirDuo Digihaler includes a QR code (on the top of the inhaler), and contains a built-in electronic module which automatically detects, records and stores data on inhaler events, including peak inspiratory flow rate (L/min). AirDuo Digihaler may pair with and transmit data to the mobile App where inhaler events are categorized.</Description>
</NDC>
<NDC>
<NDCCode>59310-136-06</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (59310-136-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0136-06</NDC11Code>
<ProductNDC>59310-136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Airduo Digihaler</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208799</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>232; 14</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>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AirDuo® Digihaler® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AirDuo Digihaler is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>AirDuo Digihaler 55/14 mcg, AirDuo Digihaler 113/14 mcg and AirDuo Digihaler 232/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AirDuo Digihaler is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AirDuo Digihaler is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AirDuo Digihaler. AirDuo Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AirDuo Digihaler inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 106.72 L/min (range: 73.64 to 125.51 L/min). AirDuo Digihaler includes a QR code (on the top of the inhaler), and contains a built-in electronic module which automatically detects, records and stores data on inhaler events, including peak inspiratory flow rate (L/min). AirDuo Digihaler may pair with and transmit data to the mobile App where inhaler events are categorized.</Description>
</NDC>
<NDC>
<NDCCode>59310-175-41</NDCCode>
<PackageDescription>1 CANISTER in 1 BOX (59310-175-41) > 100 AEROSOL, METERED in 1 CANISTER</PackageDescription>
<NDC11Code>59310-0175-41</NDC11Code>
<ProductNDC>59310-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qvar</ProprietaryName>
<NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20001006</StartMarketingDate>
<EndMarketingDate>20151130</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020911</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>59310-200-06</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (59310-200-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0200-06</NDC11Code>
<ProductNDC>59310-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armonair Digihaler</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208798</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>113</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ArmonAir® Digihaler® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use. ArmonAir Digihaler is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>The active component of ArmonAir Digihaler 30 mcg, 55 mcg, ArmonAir Digihaler 113 mcg, and ArmonAir Digihaler 232 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. ArmonAir Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains a formulation blend of fluticasone propionate and alpha lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters the formulation from the device reservoir as follows: 1 5.5 mg of formulation, which contains 30 mcg of fluticasone propionate, 2 11.5 mg of formulation, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate. .</Description>
</NDC>
<NDC>
<NDCCode>59310-202-12</NDCCode>
<PackageDescription>1 CANISTER in 1 BOX (59310-202-12) > 120 AEROSOL, METERED in 1 CANISTER</PackageDescription>
<NDC11Code>59310-0202-12</NDC11Code>
<ProductNDC>59310-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qvar</ProprietaryName>
<NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140915</StartMarketingDate>
<EndMarketingDate>20191031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020911</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140915</StartMarketingDatePackage>
<EndMarketingDatePackage>20191031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59310-202-14</NDCCode>
<PackageDescription>1 CANISTER in 1 BOX (59310-202-14) > 120 AEROSOL, METERED in 1 CANISTER</PackageDescription>
<NDC11Code>59310-0202-14</NDC11Code>
<ProductNDC>59310-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qvar</ProprietaryName>
<NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020911</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140915</StartMarketingDatePackage>
<EndMarketingDatePackage>20180831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59310-202-40</NDCCode>
<PackageDescription>1 CANISTER in 1 BOX (59310-202-40) > 120 AEROSOL, METERED in 1 CANISTER</PackageDescription>
<NDC11Code>59310-0202-40</NDC11Code>
<ProductNDC>59310-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qvar</ProprietaryName>
<NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20110119</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020911</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>59310-204-12</NDCCode>
<PackageDescription>1 CANISTER in 1 BOX (59310-204-12) > 120 AEROSOL, METERED in 1 CANISTER</PackageDescription>
<NDC11Code>59310-0204-12</NDC11Code>
<ProductNDC>59310-204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qvar</ProprietaryName>
<NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140915</StartMarketingDate>
<EndMarketingDate>20191130</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020911</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140915</StartMarketingDatePackage>
<EndMarketingDatePackage>20191130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59310-204-14</NDCCode>
<PackageDescription>1 CANISTER in 1 BOX (59310-204-14) > 120 AEROSOL, METERED in 1 CANISTER</PackageDescription>
<NDC11Code>59310-0204-14</NDC11Code>
<ProductNDC>59310-204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qvar</ProprietaryName>
<NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020911</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140915</StartMarketingDatePackage>
<EndMarketingDatePackage>20190228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59310-204-50</NDCCode>
<PackageDescription>1 CANISTER in 1 BOX (59310-204-50) > 50 AEROSOL, METERED in 1 CANISTER</PackageDescription>
<NDC11Code>59310-0204-50</NDC11Code>
<ProductNDC>59310-204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qvar</ProprietaryName>
<NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20110121</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020911</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>59310-204-80</NDCCode>
<PackageDescription>1 CANISTER in 1 BOX (59310-204-80) > 120 AEROSOL, METERED in 1 CANISTER</PackageDescription>
<NDC11Code>59310-0204-80</NDC11Code>
<ProductNDC>59310-204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qvar</ProprietaryName>
<NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20110121</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020911</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
</NDCList>