{
"NDC": [
{
"NDCCode": "66993-086-96",
"PackageDescription": "1 INHALER in 1 CARTON (66993-086-96) / 120 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "66993-0086-96",
"ProductNDC": "66993-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluticasone Propionate And Salmeterol Hfa",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol Xinafoate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20230301",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021254",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "45; 21",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230301",
"SamplePackage": "N",
"IndicationAndUsage": "Fluticasone Propionate and Salmeterol HFA is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. Fluticasone Propionate and Salmeterol HFA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA). Limitations of Use. Fluticasone Propionate and Salmeterol HFA is not indicated for the relief of acute bronchospasm.",
"Description": "Fluticasone Propionate and Salmeterol HFA 45 mcg/21 mcg inhalation aerosol, Fluticasone Propionate and Salmeterol HFA inhalation aerosol 115 mcg/21 mcg, and Fluticasone Propionate and Salmeterol HFA inhalation aerosol 230 mcg/21 mcg are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Fluticasone Propionate and Salmeterol HFA is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-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. The other active component of Fluticasone Propionate and Salmeterol HFA 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-α1-[[[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. Fluticasone Propionate and Salmeterol HFA is a purple plastic inhaler with a light purple cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of micronized fluticasone propionate and micronized salmeterol xinafoate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate and 25 mcg of salmeterol in 75 mg of suspension from the valve. Each actuation delivers 45, 115, or 230 mcg of fluticasone propionate and 21 mcg of salmeterol from the actuator. Twenty-one micrograms (21 mcg) of salmeterol base is equivalent to 30.45 mcg of salmeterol xinafoate. The actual amount of drug delivered to the lung will depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. Prime Fluticasone Propionate and Salmeterol HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 sprays into the air away from the face, shaking well for 5 seconds before each spray. Avoid spraying in eyes."
},
{
"NDCCode": "66993-078-96",
"PackageDescription": "1 INHALER in 1 CARTON (66993-078-96) / 120 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "66993-0078-96",
"ProductNDC": "66993-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluticasone Propionate",
"ProprietaryNameSuffix": "Hfa",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220523",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021433",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "44",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220523",
"SamplePackage": "N",
"IndicationAndUsage": "Fluticasone Propionate HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of Use. Fluticasone Propionate HFA is not indicated for the relief of acute bronchospasm.",
"Description": "Fluticasone Propionate HFA is a pressurized metered dose inhaler for oral inhalation. The active component of Fluticasone Propionate HFA 44 mcg, Fluticasone Propionate HFA 110 mcg, and Fluticasone Propionate HFA 220 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-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. Fluticasone Propionate HFA is a dark orange plastic inhaler with a peach cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of micronized fluticasone propionate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate in 60 mg of suspension (for the 44-mcg product) or in 75 mg of suspension (for the 110- and 220-mcg products) from the valve. Each actuation delivers 44, 110, or 220 mcg of fluticasone propionate from the actuator. The actual amount of drug delivered to the lung will depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. Prime Fluticasone Propionate HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds and releasing 1 spray into the air away from the face. Avoid spraying in eyes."
},
{
"NDCCode": "66993-079-96",
"PackageDescription": "1 INHALER in 1 CARTON (66993-079-96) / 120 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "66993-0079-96",
"ProductNDC": "66993-079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluticasone Propionate",
"ProprietaryNameSuffix": "Hfa",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220523",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021433",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "110",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220523",
"SamplePackage": "N",
"IndicationAndUsage": "Fluticasone Propionate HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of Use. Fluticasone Propionate HFA is not indicated for the relief of acute bronchospasm.",
"Description": "Fluticasone Propionate HFA is a pressurized metered dose inhaler for oral inhalation. The active component of Fluticasone Propionate HFA 44 mcg, Fluticasone Propionate HFA 110 mcg, and Fluticasone Propionate HFA 220 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-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. Fluticasone Propionate HFA is a dark orange plastic inhaler with a peach cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of micronized fluticasone propionate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate in 60 mg of suspension (for the 44-mcg product) or in 75 mg of suspension (for the 110- and 220-mcg products) from the valve. Each actuation delivers 44, 110, or 220 mcg of fluticasone propionate from the actuator. The actual amount of drug delivered to the lung will depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. Prime Fluticasone Propionate HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds and releasing 1 spray into the air away from the face. Avoid spraying in eyes."
},
{
"NDCCode": "66993-080-96",
"PackageDescription": "1 INHALER in 1 CARTON (66993-080-96) / 120 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "66993-0080-96",
"ProductNDC": "66993-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluticasone Propionate",
"ProprietaryNameSuffix": "Hfa",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220523",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021433",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "220",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220523",
"SamplePackage": "N",
"IndicationAndUsage": "Fluticasone Propionate HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of Use. Fluticasone Propionate HFA is not indicated for the relief of acute bronchospasm.",
"Description": "Fluticasone Propionate HFA is a pressurized metered dose inhaler for oral inhalation. The active component of Fluticasone Propionate HFA 44 mcg, Fluticasone Propionate HFA 110 mcg, and Fluticasone Propionate HFA 220 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-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. Fluticasone Propionate HFA is a dark orange plastic inhaler with a peach cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of micronized fluticasone propionate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate in 60 mg of suspension (for the 44-mcg product) or in 75 mg of suspension (for the 110- and 220-mcg products) from the valve. Each actuation delivers 44, 110, or 220 mcg of fluticasone propionate from the actuator. The actual amount of drug delivered to the lung will depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. Prime Fluticasone Propionate HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds and releasing 1 spray into the air away from the face. Avoid spraying in eyes."
},
{
"NDCCode": "66993-087-96",
"PackageDescription": "1 INHALER in 1 CARTON (66993-087-96) / 120 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "66993-0087-96",
"ProductNDC": "66993-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluticasone Propionate And Salmeterol Hfa",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol Xinafoate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20230301",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021254",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "115; 21",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230301",
"SamplePackage": "N",
"IndicationAndUsage": "Fluticasone Propionate and Salmeterol HFA is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. Fluticasone Propionate and Salmeterol HFA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA). Limitations of Use. Fluticasone Propionate and Salmeterol HFA is not indicated for the relief of acute bronchospasm.",
"Description": "Fluticasone Propionate and Salmeterol HFA 45 mcg/21 mcg inhalation aerosol, Fluticasone Propionate and Salmeterol HFA inhalation aerosol 115 mcg/21 mcg, and Fluticasone Propionate and Salmeterol HFA inhalation aerosol 230 mcg/21 mcg are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Fluticasone Propionate and Salmeterol HFA is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-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. The other active component of Fluticasone Propionate and Salmeterol HFA 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-α1-[[[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. Fluticasone Propionate and Salmeterol HFA is a purple plastic inhaler with a light purple cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of micronized fluticasone propionate and micronized salmeterol xinafoate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate and 25 mcg of salmeterol in 75 mg of suspension from the valve. Each actuation delivers 45, 115, or 230 mcg of fluticasone propionate and 21 mcg of salmeterol from the actuator. Twenty-one micrograms (21 mcg) of salmeterol base is equivalent to 30.45 mcg of salmeterol xinafoate. The actual amount of drug delivered to the lung will depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. Prime Fluticasone Propionate and Salmeterol HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 sprays into the air away from the face, shaking well for 5 seconds before each spray. Avoid spraying in eyes."
},
{
"NDCCode": "66993-088-96",
"PackageDescription": "1 INHALER in 1 CARTON (66993-088-96) / 120 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "66993-0088-96",
"ProductNDC": "66993-088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluticasone Propionate And Salmeterol Hfa",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol Xinafoate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20230301",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021254",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "230; 21",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230301",
"SamplePackage": "N",
"IndicationAndUsage": "Fluticasone Propionate and Salmeterol HFA is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. Fluticasone Propionate and Salmeterol HFA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA). Limitations of Use. Fluticasone Propionate and Salmeterol HFA is not indicated for the relief of acute bronchospasm.",
"Description": "Fluticasone Propionate and Salmeterol HFA 45 mcg/21 mcg inhalation aerosol, Fluticasone Propionate and Salmeterol HFA inhalation aerosol 115 mcg/21 mcg, and Fluticasone Propionate and Salmeterol HFA inhalation aerosol 230 mcg/21 mcg are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Fluticasone Propionate and Salmeterol HFA is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-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. The other active component of Fluticasone Propionate and Salmeterol HFA 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-α1-[[[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. Fluticasone Propionate and Salmeterol HFA is a purple plastic inhaler with a light purple cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of micronized fluticasone propionate and micronized salmeterol xinafoate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate and 25 mcg of salmeterol in 75 mg of suspension from the valve. Each actuation delivers 45, 115, or 230 mcg of fluticasone propionate and 21 mcg of salmeterol from the actuator. Twenty-one micrograms (21 mcg) of salmeterol base is equivalent to 30.45 mcg of salmeterol xinafoate. The actual amount of drug delivered to the lung will depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. Prime Fluticasone Propionate and Salmeterol HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 sprays into the air away from the face, shaking well for 5 seconds before each spray. Avoid spraying in eyes."
},
{
"NDCCode": "66993-345-76",
"PackageDescription": "1 BOTTLE in 1 CARTON (66993-345-76) / 96 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "66993-0345-76",
"ProductNDC": "66993-345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lofexidine Hydrochloride",
"NonProprietaryName": "Lofexidine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240829",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA209229",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "LOFEXIDINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240829",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "Lofexidine tablets are indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.",
"Description": "Lofexidine tablets contain lofexidine, a central alpha-2 adrenergic agonist, as the hydrochloride salt. Lofexidine hydrochloride is chemically designated as 2-[1-(2,6-dichlorophenoxy)ethyl]-4,5 dihydro-1H- imidazole monohydrochloride with a molecular formula of C11H12Cl2N2O∙HCl. Its molecular weight is 295.6 g/mole and its structural formula is. Lofexidine hydrochloride is a white to off-white crystalline powder freely soluble in water, methanol, and ethanol. It is slightly soluble in chloroform and practically insoluble in n-hexane and benzene. Lofexidine tablets are available as round, convex-shaped, peach-colored, film-coated tablets for oral administration. Each tablet contains 0.18 lofexidine, equivalent to 0.2 mg of lofexidine hydrochloride, and the following inactive ingredients: 92.6 mg lactose, 12.3 mg citric acid, 1.1 mg povidone, 5.7 mg microcrystalline cellulose, 1.4 mg calcium stearate, 0.7 mg sodium lauryl sulphate, and Opadry OY S 9480 (contains indigo carmine and sunset yellow)."
},
{
"NDCCode": "66993-470-96",
"PackageDescription": "12 POUCH in 1 CARTON (66993-470-96) > 8 AMPULE in 1 POUCH > 5 mL in 1 AMPULE",
"NDC11Code": "66993-0470-96",
"ProductNDC": "66993-470",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cromolyn Sodium",
"NonProprietaryName": "Cromolyn Sodium",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "ORAL",
"StartMarketingDate": "20111212",
"EndMarketingDate": "20180131",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020479",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "CROMOLYN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "66993-135-97",
"PackageDescription": "1 TRAY in 1 CARTON (66993-135-97) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER",
"NDC11Code": "66993-0135-97",
"ProductNDC": "66993-135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluticasone Furoate And Vilanterol",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220523",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA204275",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "100; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220523",
"SamplePackage": "N",
"IndicationAndUsage": "Fluticasone Furoate/Vilanterol ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long‑acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "Fluticasone Furoate/Vilanterol ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. Fluticasone furoate/vilanterol ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100 or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone furoate/vilanterol ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "66993-136-97",
"PackageDescription": "1 TRAY in 1 CARTON (66993-136-97) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER",
"NDC11Code": "66993-0136-97",
"ProductNDC": "66993-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluticasone Furoate And Vilanterol",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220523",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA204275",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "200; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220523",
"SamplePackage": "N",
"IndicationAndUsage": "Fluticasone Furoate/Vilanterol ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long‑acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "Fluticasone Furoate/Vilanterol ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. Fluticasone furoate/vilanterol ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100 or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone furoate/vilanterol ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "42806-086-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42806-086-05) ",
"NDC11Code": "42806-0086-05",
"ProductNDC": "42806-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208972",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2019-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190417",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "42806-086-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42806-086-60) ",
"NDC11Code": "42806-0086-60",
"ProductNDC": "42806-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208972",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2019-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190417",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "75929-086-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (75929-086-03) ",
"NDC11Code": "75929-0086-03",
"ProductNDC": "75929-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aricept",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19961125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020690",
"LabelerName": "Pharma Packaging Solutions, LLC dba Tjoapack LLC",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19961125",
"SamplePackage": "N",
"IndicationAndUsage": "ARICEPT is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.",
"Description": "ARICEPT (donepezil hydrochloride) is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C 24H 29NO 3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. ARICEPT is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, and magnesium stearate. The film coating contains talc, polyethylene glycol, hypromellose, and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent. Inactive ingredients in 23 mg tablets include ethylcellulose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and methacrylic acid copolymer, Type C. The film coating includes ferric oxide, hypromellose 2910, polyethylene glycol 8000, talc, and titanium dioxide. ARICEPT ODT tablets are available for oral administration. Each ARICEPT ODT tablet contains 5 or 10 mg of donepezil hydrochloride. Inactive ingredients are carrageenan, mannitol, colloidal silicon dioxide, and polyvinyl alcohol. Additionally, the 10 mg tablet contains ferric oxide (yellow) as a coloring agent."
},
{
"NDCCode": "66993-002-10",
"PackageDescription": "1 TUBE in 1 CARTON (66993-002-10) / 42.5 g in 1 TUBE",
"NDC11Code": "66993-0002-10",
"ProductNDC": "66993-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol Vaginal Cream",
"NonProprietaryName": "Estradiol",
"DosageFormName": "CREAM",
"RouteName": "VAGINAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212313",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol Vaginal Cream, USP, 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.",
"Description": "Each gram of Estradiol Vaginal Cream, USP, 0.01% contains 0.1 mg of estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate disodium, and tertiary-butylhydroquinone. Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is:."
},
{
"NDCCode": "66993-015-64",
"PackageDescription": "1 CANISTER in 1 CARTON (66993-015-64) > 60 AEROSOL, METERED in 1 CANISTER",
"NDC11Code": "66993-0015-64",
"ProductNDC": "66993-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclesonide",
"NonProprietaryName": "Ciclesonide",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20220423",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA202129",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "CICLESONIDE",
"StrengthNumber": "37",
"StrengthUnit": "ug/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20220423",
"SamplePackage": "N"
},
{
"NDCCode": "66993-019-68",
"PackageDescription": "1 INHALER in 1 CARTON (66993-019-68) / 200 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "66993-0019-68",
"ProductNDC": "66993-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"ProprietaryNameSuffix": "Hfa",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20190115",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020983",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190115",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol Sulfate HFA is a beta2-adrenergic agonist indicated for: 1 Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. (1.1), 2 Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. (1.2).",
"Description": "The active component of Albuterol Sulfate HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α′-diol sulfate (2:1)(salt) and the following chemical structure. Albuterol sulfate is a white crystalline powder with a molecular weight of 576.7, and the empirical formula is (C13H21NO3)2H2SO4. It is soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate HFA is a blue plastic inhaler with a blue cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFA‑134a (1,1,1,2‑tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Prime Albuterol Sulfate HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime Albuterol Sulfate HFA, release 4 sprays into the air away from the face, shaking well before each spray. Avoid spraying in eyes."
},
{
"NDCCode": "66993-021-27",
"PackageDescription": "2 POUCH in 1 CARTON (66993-021-27) > 12 VIAL, SINGLE-DOSE in 1 POUCH (66993-021-35) > 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "66993-0021-27",
"ProductNDC": "66993-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol Hydrochloride",
"NonProprietaryName": "Levalbuterol Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020837",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": ".31",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-02-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150227",
"SamplePackage": "N"
},
{
"NDCCode": "66993-022-27",
"PackageDescription": "2 POUCH in 1 CARTON (66993-022-27) > 12 VIAL, SINGLE-DOSE in 1 POUCH (66993-022-35) > 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "66993-0022-27",
"ProductNDC": "66993-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol Hydrochloride",
"NonProprietaryName": "Levalbuterol Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020837",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": ".63",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-02-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150227",
"SamplePackage": "N"
},
{
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},
{
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{
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"LastUpdate": "2022-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170530",
"EndMarketingDatePackage": "20220331",
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},
{
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{
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{
"NDCCode": "66993-045-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (66993-045-30) ",
"NDC11Code": "66993-0045-30",
"ProductNDC": "66993-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Prasco Laboratories",
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"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
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"LastUpdate": "2022-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170530",
"EndMarketingDatePackage": "20220131",
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},
{
"NDCCode": "66993-046-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (66993-046-30) ",
"NDC11Code": "66993-0046-30",
"ProductNDC": "66993-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>66993-086-96</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (66993-086-96) / 120 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>66993-0086-96</NDC11Code>
<ProductNDC>66993-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate And Salmeterol Hfa</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol Xinafoate</NonProprietaryName>
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<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20230301</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021254</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>45; 21</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluticasone Propionate and Salmeterol HFA is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. Fluticasone Propionate and Salmeterol HFA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA). Limitations of Use. Fluticasone Propionate and Salmeterol HFA is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>Fluticasone Propionate and Salmeterol HFA 45 mcg/21 mcg inhalation aerosol, Fluticasone Propionate and Salmeterol HFA inhalation aerosol 115 mcg/21 mcg, and Fluticasone Propionate and Salmeterol HFA inhalation aerosol 230 mcg/21 mcg are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Fluticasone Propionate and Salmeterol HFA is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-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. The other active component of Fluticasone Propionate and Salmeterol HFA 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-α1-[[[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. Fluticasone Propionate and Salmeterol HFA is a purple plastic inhaler with a light purple cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of micronized fluticasone propionate and micronized salmeterol xinafoate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate and 25 mcg of salmeterol in 75 mg of suspension from the valve. Each actuation delivers 45, 115, or 230 mcg of fluticasone propionate and 21 mcg of salmeterol from the actuator. Twenty-one micrograms (21 mcg) of salmeterol base is equivalent to 30.45 mcg of salmeterol xinafoate. The actual amount of drug delivered to the lung will depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. Prime Fluticasone Propionate and Salmeterol HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 sprays into the air away from the face, shaking well for 5 seconds before each spray. Avoid spraying in eyes.</Description>
</NDC>
<NDC>
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<PackageDescription>1 INHALER in 1 CARTON (66993-078-96) / 120 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>66993-0078-96</NDC11Code>
<ProductNDC>66993-078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate</ProprietaryName>
<ProprietaryNameSuffix>Hfa</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220523</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021433</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>44</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluticasone Propionate HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of Use. Fluticasone Propionate HFA is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>Fluticasone Propionate HFA is a pressurized metered dose inhaler for oral inhalation. The active component of Fluticasone Propionate HFA 44 mcg, Fluticasone Propionate HFA 110 mcg, and Fluticasone Propionate HFA 220 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-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. Fluticasone Propionate HFA is a dark orange plastic inhaler with a peach cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of micronized fluticasone propionate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate in 60 mg of suspension (for the 44-mcg product) or in 75 mg of suspension (for the 110- and 220-mcg products) from the valve. Each actuation delivers 44, 110, or 220 mcg of fluticasone propionate from the actuator. The actual amount of drug delivered to the lung will depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. Prime Fluticasone Propionate HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds and releasing 1 spray into the air away from the face. Avoid spraying in eyes.</Description>
</NDC>
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<NDCCode>66993-079-96</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (66993-079-96) / 120 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>66993-0079-96</NDC11Code>
<ProductNDC>66993-079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate</ProprietaryName>
<ProprietaryNameSuffix>Hfa</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220523</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021433</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>110</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluticasone Propionate HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of Use. Fluticasone Propionate HFA is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>Fluticasone Propionate HFA is a pressurized metered dose inhaler for oral inhalation. The active component of Fluticasone Propionate HFA 44 mcg, Fluticasone Propionate HFA 110 mcg, and Fluticasone Propionate HFA 220 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-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. Fluticasone Propionate HFA is a dark orange plastic inhaler with a peach cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of micronized fluticasone propionate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate in 60 mg of suspension (for the 44-mcg product) or in 75 mg of suspension (for the 110- and 220-mcg products) from the valve. Each actuation delivers 44, 110, or 220 mcg of fluticasone propionate from the actuator. The actual amount of drug delivered to the lung will depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. Prime Fluticasone Propionate HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds and releasing 1 spray into the air away from the face. Avoid spraying in eyes.</Description>
</NDC>
<NDC>
<NDCCode>66993-080-96</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (66993-080-96) / 120 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>66993-0080-96</NDC11Code>
<ProductNDC>66993-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate</ProprietaryName>
<ProprietaryNameSuffix>Hfa</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220523</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021433</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluticasone Propionate HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of Use. Fluticasone Propionate HFA is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>Fluticasone Propionate HFA is a pressurized metered dose inhaler for oral inhalation. The active component of Fluticasone Propionate HFA 44 mcg, Fluticasone Propionate HFA 110 mcg, and Fluticasone Propionate HFA 220 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-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. Fluticasone Propionate HFA is a dark orange plastic inhaler with a peach cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of micronized fluticasone propionate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate in 60 mg of suspension (for the 44-mcg product) or in 75 mg of suspension (for the 110- and 220-mcg products) from the valve. Each actuation delivers 44, 110, or 220 mcg of fluticasone propionate from the actuator. The actual amount of drug delivered to the lung will depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. Prime Fluticasone Propionate HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds and releasing 1 spray into the air away from the face. Avoid spraying in eyes.</Description>
</NDC>
<NDC>
<NDCCode>66993-087-96</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (66993-087-96) / 120 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>66993-0087-96</NDC11Code>
<ProductNDC>66993-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate And Salmeterol Hfa</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol Xinafoate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20230301</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021254</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>115; 21</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluticasone Propionate and Salmeterol HFA is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. Fluticasone Propionate and Salmeterol HFA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA). Limitations of Use. Fluticasone Propionate and Salmeterol HFA is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>Fluticasone Propionate and Salmeterol HFA 45 mcg/21 mcg inhalation aerosol, Fluticasone Propionate and Salmeterol HFA inhalation aerosol 115 mcg/21 mcg, and Fluticasone Propionate and Salmeterol HFA inhalation aerosol 230 mcg/21 mcg are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Fluticasone Propionate and Salmeterol HFA is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-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. The other active component of Fluticasone Propionate and Salmeterol HFA 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-α1-[[[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. Fluticasone Propionate and Salmeterol HFA is a purple plastic inhaler with a light purple cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of micronized fluticasone propionate and micronized salmeterol xinafoate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate and 25 mcg of salmeterol in 75 mg of suspension from the valve. Each actuation delivers 45, 115, or 230 mcg of fluticasone propionate and 21 mcg of salmeterol from the actuator. Twenty-one micrograms (21 mcg) of salmeterol base is equivalent to 30.45 mcg of salmeterol xinafoate. The actual amount of drug delivered to the lung will depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. Prime Fluticasone Propionate and Salmeterol HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 sprays into the air away from the face, shaking well for 5 seconds before each spray. Avoid spraying in eyes.</Description>
</NDC>
<NDC>
<NDCCode>66993-088-96</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (66993-088-96) / 120 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>66993-0088-96</NDC11Code>
<ProductNDC>66993-088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate And Salmeterol Hfa</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol Xinafoate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20230301</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021254</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>230; 21</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluticasone Propionate and Salmeterol HFA is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. Fluticasone Propionate and Salmeterol HFA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA). Limitations of Use. Fluticasone Propionate and Salmeterol HFA is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>Fluticasone Propionate and Salmeterol HFA 45 mcg/21 mcg inhalation aerosol, Fluticasone Propionate and Salmeterol HFA inhalation aerosol 115 mcg/21 mcg, and Fluticasone Propionate and Salmeterol HFA inhalation aerosol 230 mcg/21 mcg are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Fluticasone Propionate and Salmeterol HFA is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-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. The other active component of Fluticasone Propionate and Salmeterol HFA 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-α1-[[[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. Fluticasone Propionate and Salmeterol HFA is a purple plastic inhaler with a light purple cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of micronized fluticasone propionate and micronized salmeterol xinafoate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate and 25 mcg of salmeterol in 75 mg of suspension from the valve. Each actuation delivers 45, 115, or 230 mcg of fluticasone propionate and 21 mcg of salmeterol from the actuator. Twenty-one micrograms (21 mcg) of salmeterol base is equivalent to 30.45 mcg of salmeterol xinafoate. The actual amount of drug delivered to the lung will depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. Prime Fluticasone Propionate and Salmeterol HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 sprays into the air away from the face, shaking well for 5 seconds before each spray. Avoid spraying in eyes.</Description>
</NDC>
<NDC>
<NDCCode>66993-345-76</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (66993-345-76) / 96 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>66993-0345-76</NDC11Code>
<ProductNDC>66993-345</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lofexidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lofexidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240829</StartMarketingDate>
<EndMarketingDate>20270630</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA209229</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>LOFEXIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240829</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lofexidine tablets are indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.</IndicationAndUsage>
<Description>Lofexidine tablets contain lofexidine, a central alpha-2 adrenergic agonist, as the hydrochloride salt. Lofexidine hydrochloride is chemically designated as 2-[1-(2,6-dichlorophenoxy)ethyl]-4,5 dihydro-1H- imidazole monohydrochloride with a molecular formula of C11H12Cl2N2O∙HCl. Its molecular weight is 295.6 g/mole and its structural formula is. Lofexidine hydrochloride is a white to off-white crystalline powder freely soluble in water, methanol, and ethanol. It is slightly soluble in chloroform and practically insoluble in n-hexane and benzene. Lofexidine tablets are available as round, convex-shaped, peach-colored, film-coated tablets for oral administration. Each tablet contains 0.18 lofexidine, equivalent to 0.2 mg of lofexidine hydrochloride, and the following inactive ingredients: 92.6 mg lactose, 12.3 mg citric acid, 1.1 mg povidone, 5.7 mg microcrystalline cellulose, 1.4 mg calcium stearate, 0.7 mg sodium lauryl sulphate, and Opadry OY S 9480 (contains indigo carmine and sunset yellow).</Description>
</NDC>
<NDC>
<NDCCode>66993-470-96</NDCCode>
<PackageDescription>12 POUCH in 1 CARTON (66993-470-96) > 8 AMPULE in 1 POUCH > 5 mL in 1 AMPULE</PackageDescription>
<NDC11Code>66993-0470-96</NDC11Code>
<ProductNDC>66993-470</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cromolyn Sodium</ProprietaryName>
<NonProprietaryName>Cromolyn Sodium</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111212</StartMarketingDate>
<EndMarketingDate>20180131</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020479</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>CROMOLYN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>66993-135-97</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (66993-135-97) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>66993-0135-97</NDC11Code>
<ProductNDC>66993-135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Furoate And Vilanterol</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220523</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>100; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluticasone Furoate/Vilanterol ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long‑acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>Fluticasone Furoate/Vilanterol ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. Fluticasone furoate/vilanterol ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100 or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone furoate/vilanterol ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>66993-136-97</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (66993-136-97) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>66993-0136-97</NDC11Code>
<ProductNDC>66993-136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Furoate And Vilanterol</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220523</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>200; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluticasone Furoate/Vilanterol ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long‑acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>Fluticasone Furoate/Vilanterol ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. Fluticasone furoate/vilanterol ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100 or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone furoate/vilanterol ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>42806-086-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42806-086-05) </PackageDescription>
<NDC11Code>42806-0086-05</NDC11Code>
<ProductNDC>42806-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208972</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2019-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42806-086-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (42806-086-60) </PackageDescription>
<NDC11Code>42806-0086-60</NDC11Code>
<ProductNDC>42806-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208972</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2019-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>75929-086-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (75929-086-03) </PackageDescription>
<NDC11Code>75929-0086-03</NDC11Code>
<ProductNDC>75929-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aricept</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020690</ApplicationNumber>
<LabelerName>Pharma Packaging Solutions, LLC dba Tjoapack LLC</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARICEPT is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.</IndicationAndUsage>
<Description>ARICEPT (donepezil hydrochloride) is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C 24H 29NO 3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. ARICEPT is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, and magnesium stearate. The film coating contains talc, polyethylene glycol, hypromellose, and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent. Inactive ingredients in 23 mg tablets include ethylcellulose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and methacrylic acid copolymer, Type C. The film coating includes ferric oxide, hypromellose 2910, polyethylene glycol 8000, talc, and titanium dioxide. ARICEPT ODT tablets are available for oral administration. Each ARICEPT ODT tablet contains 5 or 10 mg of donepezil hydrochloride. Inactive ingredients are carrageenan, mannitol, colloidal silicon dioxide, and polyvinyl alcohol. Additionally, the 10 mg tablet contains ferric oxide (yellow) as a coloring agent.</Description>
</NDC>
<NDC>
<NDCCode>66993-002-10</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (66993-002-10) / 42.5 g in 1 TUBE</PackageDescription>
<NDC11Code>66993-0002-10</NDC11Code>
<ProductNDC>66993-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol Vaginal Cream</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212313</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol Vaginal Cream, USP, 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.</IndicationAndUsage>
<Description>Each gram of Estradiol Vaginal Cream, USP, 0.01% contains 0.1 mg of estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate disodium, and tertiary-butylhydroquinone. Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>66993-015-64</NDCCode>
<PackageDescription>1 CANISTER in 1 CARTON (66993-015-64) > 60 AEROSOL, METERED in 1 CANISTER</PackageDescription>
<NDC11Code>66993-0015-64</NDC11Code>
<ProductNDC>66993-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclesonide</ProprietaryName>
<NonProprietaryName>Ciclesonide</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220423</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA202129</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>CICLESONIDE</SubstanceName>
<StrengthNumber>37</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66993-019-68</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (66993-019-68) / 200 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>66993-0019-68</NDC11Code>
<ProductNDC>66993-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol Sulfate</ProprietaryName>
<ProprietaryNameSuffix>Hfa</ProprietaryNameSuffix>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20190115</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020983</ApplicationNumber>
<LabelerName>Prasco Laboratories</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>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol Sulfate HFA is a beta2-adrenergic agonist indicated for: 1 Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. (1.1), 2 Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. (1.2).</IndicationAndUsage>
<Description>The active component of Albuterol Sulfate HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α′-diol sulfate (2:1)(salt) and the following chemical structure. Albuterol sulfate is a white crystalline powder with a molecular weight of 576.7, and the empirical formula is (C13H21NO3)2H2SO4. It is soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate HFA is a blue plastic inhaler with a blue cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFA‑134a (1,1,1,2‑tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Prime Albuterol Sulfate HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime Albuterol Sulfate HFA, release 4 sprays into the air away from the face, shaking well before each spray. Avoid spraying in eyes.</Description>
</NDC>
<NDC>
<NDCCode>66993-021-27</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (66993-021-27) > 12 VIAL, SINGLE-DOSE in 1 POUCH (66993-021-35) > 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>66993-0021-27</NDC11Code>
<ProductNDC>66993-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol Hydrochloride</ProprietaryName>
<NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020837</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.31</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-02-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66993-022-27</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (66993-022-27) > 12 VIAL, SINGLE-DOSE in 1 POUCH (66993-022-35) > 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>66993-0022-27</NDC11Code>
<ProductNDC>66993-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol Hydrochloride</ProprietaryName>
<NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020837</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.63</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-02-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66993-023-27</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (66993-023-27) > 12 VIAL, SINGLE-DOSE in 1 POUCH (66993-023-35) > 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>66993-0023-27</NDC11Code>
<ProductNDC>66993-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol Hydrochloride</ProprietaryName>
<NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020837</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-02-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66993-024-52</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (66993-024-52) > 120 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>66993-0024-52</NDC11Code>
<ProductNDC>66993-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20121019</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020121</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-12-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>66993-025-01</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (66993-025-01) > 5 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>66993-0025-01</NDC11Code>
<ProductNDC>66993-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desmopressin Acetate</ProprietaryName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021333</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/.1mL</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66993-038-83</NDCCode>
<PackageDescription>4 CARTON in 1 TRAY (66993-038-83) > 1 VIAL, GLASS in 1 CARTON > 1 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>66993-0038-83</NDC11Code>
<ProductNDC>66993-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyprogesterone Caproate</ProprietaryName>
<NonProprietaryName>Hydroxyprogesterone Caproate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20180702</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021945</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>HYDROXYPROGESTERONE CAPROATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>1 VIAL, GLASS in 1 CARTON (66993-039-01) > 5 mL in 1 VIAL, GLASS</PackageDescription>
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<ProprietaryName>Hydroxyprogesterone Caproate</ProprietaryName>
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<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20180702</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021945</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>HYDROXYPROGESTERONE CAPROATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>66993-040-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (66993-040-30) </PackageDescription>
<NDC11Code>66993-0040-30</NDC11Code>
<ProductNDC>66993-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20220331</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20220331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66993-041-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (66993-041-30) </PackageDescription>
<NDC11Code>66993-0041-30</NDC11Code>
<ProductNDC>66993-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66993-042-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (66993-042-30) </PackageDescription>
<NDC11Code>66993-0042-30</NDC11Code>
<ProductNDC>66993-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20220731</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20220731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66993-043-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (66993-043-30) </PackageDescription>
<NDC11Code>66993-0043-30</NDC11Code>
<ProductNDC>66993-043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20220331</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20220331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66993-044-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (66993-044-30) </PackageDescription>
<NDC11Code>66993-0044-30</NDC11Code>
<ProductNDC>66993-044</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
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<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20220331</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20220331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66993-045-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (66993-045-30) </PackageDescription>
<NDC11Code>66993-0045-30</NDC11Code>
<ProductNDC>66993-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20220131</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20220131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66993-046-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (66993-046-30) </PackageDescription>
<NDC11Code>66993-0046-30</NDC11Code>
<ProductNDC>66993-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20220131</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20220131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>