RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "69097-840-87",
      "PackageDescription": "1 POUCH in 1 CARTON (69097-840-87)  / 30 VIAL in 1 POUCH / 3 mL in 1 VIAL",
      "NDC11Code": "69097-0840-87",
      "ProductNDC": "69097-840",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
      "NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20200601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202496",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "IPRATROPIUM BROMIDE; ALBUTEROL SULFATE",
      "StrengthNumber": ".5; 2.5",
      "StrengthUnit": "mg/3mL; mg/3mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-01-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.",
      "Description": "The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α.  1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C13H 21NO3)2H2SO4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Figure 3.1-1. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C20H30BrNO3H2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Figure 3.1-2. Chemical structure of ipratropium bromide. Each 3 mL Sterile Unit-dose Vial contains 0.5 mg of ipratropium bromide (0.017%) and 3 mg Equivalent to 2.5 mg albuterol base albuterol sulfate (0.083%) in an isotonic, sterile, aqueous solution containing sodium chloride and 1 N hydrochloric acid to adjust to pH 4. *Equivalent to 2.5 mg albuterol base. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus® nebulizer (with face mask or mouthpiece) connected to a PRONEB® compressor system, under  in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see.    DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "69097-840-53",
      "PackageDescription": "30 POUCH in 1 CARTON (69097-840-53)  / 1 VIAL in 1 POUCH (69097-840-34)  / 3 mL in 1 VIAL",
      "NDC11Code": "69097-0840-53",
      "ProductNDC": "69097-840",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
      "NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20200601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202496",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "IPRATROPIUM BROMIDE; ALBUTEROL SULFATE",
      "StrengthNumber": ".5; 2.5",
      "StrengthUnit": "mg/3mL; mg/3mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-01-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.",
      "Description": "The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α.  1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C13H 21NO3)2H2SO4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Figure 3.1-1. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C20H30BrNO3H2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Figure 3.1-2. Chemical structure of ipratropium bromide. Each 3 mL Sterile Unit-dose Vial contains 0.5 mg of ipratropium bromide (0.017%) and 3 mg Equivalent to 2.5 mg albuterol base albuterol sulfate (0.083%) in an isotonic, sterile, aqueous solution containing sodium chloride and 1 N hydrochloric acid to adjust to pH 4. *Equivalent to 2.5 mg albuterol base. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus® nebulizer (with face mask or mouthpiece) connected to a PRONEB® compressor system, under  in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see.    DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "69097-840-64",
      "PackageDescription": "2 POUCH in 1 CARTON (69097-840-64)  / 30 VIAL in 1 POUCH / 3 mL in 1 VIAL",
      "NDC11Code": "69097-0840-64",
      "ProductNDC": "69097-840",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
      "NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20200601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202496",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "IPRATROPIUM BROMIDE; ALBUTEROL SULFATE",
      "StrengthNumber": ".5; 2.5",
      "StrengthUnit": "mg/3mL; mg/3mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-01-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.",
      "Description": "The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α.  1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C13H 21NO3)2H2SO4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Figure 3.1-1. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C20H30BrNO3H2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Figure 3.1-2. Chemical structure of ipratropium bromide. Each 3 mL Sterile Unit-dose Vial contains 0.5 mg of ipratropium bromide (0.017%) and 3 mg Equivalent to 2.5 mg albuterol base albuterol sulfate (0.083%) in an isotonic, sterile, aqueous solution containing sodium chloride and 1 N hydrochloric acid to adjust to pH 4. *Equivalent to 2.5 mg albuterol base. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus® nebulizer (with face mask or mouthpiece) connected to a PRONEB® compressor system, under  in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see.    DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "69097-168-87",
      "PackageDescription": "6 POUCH in 1 CARTON (69097-168-87)  / 5 VIAL, SINGLE-DOSE in 1 POUCH (69097-168-48)  / 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "69097-0168-87",
      "ProductNDC": "69097-168",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Arformoterol Tartrate",
      "NonProprietaryName": "Arformoterol Tartrate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20210622",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207306",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "ARFORMOTEROL TARTRATE",
      "StrengthNumber": "15",
      "StrengthUnit": "ug/2mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-08-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210622",
      "SamplePackage": "N",
      "IndicationAndUsage": "Arformoterol tartrate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1   Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).",
      "Description": "Arformoterol tartrate inhalation solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-, (2R,3R)-2,3-dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows. The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C19H24N2O4C4H6O6 (1:1 salt). It is a white to off-white solid that is slightly soluble in water. Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-tartrate. Arformoterol tartrate inhalation solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. Arformoterol tartrate inhalation solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC®Plus nebulizer (with mouthpiece) connected to a PARI DURA NEBTM3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. Arformoterol tartrate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece. Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Patient Information)."
    },
    {
      "NDCCode": "69097-318-87",
      "PackageDescription": "6 POUCH in 1 CARTON (69097-318-87)  / 5 AMPULE in 1 POUCH (69097-318-86)  / 2 mL in 1 AMPULE",
      "NDC11Code": "69097-0318-87",
      "ProductNDC": "69097-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Budesonide",
      "ProprietaryNameSuffix": "Inhalation Suspension",
      "NonProprietaryName": "Budesonide",
      "DosageFormName": "INHALANT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171116",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205710",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "BUDESONIDE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20171116",
      "SamplePackage": "N",
      "IndicationAndUsage": "Budesonide inhalation suspension is an inhaled corticosteroid indicated for:.   Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (1). Limitations of Use:. Not indicated for the relief of acute bronchospasm (1).",
      "Description": "Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients disodium edetate, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 80, and Water for Injection. Three dose strengths are available in single-dose ampules (ampules): 0.25 mg, 0.5 mg, and 1 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration (2)]."
    },
    {
      "NDCCode": "69097-319-87",
      "PackageDescription": "6 POUCH in 1 CARTON (69097-319-87)  / 5 AMPULE in 1 POUCH (69097-319-86)  / 2 mL in 1 AMPULE",
      "NDC11Code": "69097-0319-87",
      "ProductNDC": "69097-319",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Budesonide",
      "ProprietaryNameSuffix": "Inhalation Suspension",
      "NonProprietaryName": "Budesonide",
      "DosageFormName": "INHALANT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171116",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205710",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "BUDESONIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20171116",
      "SamplePackage": "N",
      "IndicationAndUsage": "Budesonide inhalation suspension is an inhaled corticosteroid indicated for:.   Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (1). Limitations of Use:. Not indicated for the relief of acute bronchospasm (1).",
      "Description": "Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients disodium edetate, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 80, and Water for Injection. Three dose strengths are available in single-dose ampules (ampules): 0.25 mg, 0.5 mg, and 1 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration (2)]."
    },
    {
      "NDCCode": "69097-321-87",
      "PackageDescription": "6 POUCH in 1 CARTON (69097-321-87)  / 5 AMPULE in 1 POUCH (69097-321-86)  / 2 mL in 1 AMPULE",
      "NDC11Code": "69097-0321-87",
      "ProductNDC": "69097-321",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Budesonide",
      "ProprietaryNameSuffix": "Inhalation Suspension",
      "NonProprietaryName": "Budesonide",
      "DosageFormName": "INHALANT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171116",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205710",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "BUDESONIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20171116",
      "SamplePackage": "N",
      "IndicationAndUsage": "Budesonide inhalation suspension is an inhaled corticosteroid indicated for:.   Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (1). Limitations of Use:. Not indicated for the relief of acute bronchospasm (1).",
      "Description": "Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients disodium edetate, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 80, and Water for Injection. Three dose strengths are available in single-dose ampules (ampules): 0.25 mg, 0.5 mg, and 1 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration (2)]."
    },
    {
      "NDCCode": "69097-439-35",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (69097-439-35)  / 5 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "69097-0439-35",
      "ProductNDC": "69097-439",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Palonosetron Hydrochloride",
      "NonProprietaryName": "Palonsetron Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20211010",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206396",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "PALONOSETRON HYDROCHLORIDE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-03-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20211010",
      "SamplePackage": "N",
      "IndicationAndUsage": "Palonosetron hydrochloride injection is indicated in adults for prevention of.      ●      acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).      ●      acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC).      ●      postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride is recommended even where the incidence of postoperative nausea and/or vomiting is low. Palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of.      ●      acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer. chemotherapy, including highly emetogenic cancer chemotherapy.",
      "Description": "Palonosetron hydrochloride is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2 [(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo 1Hbenz[de]isoquinoline hydrochloride. The empirical formula is C19H24         N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is a white to pale yellow crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron hydrochloride injection is a sterile, clear, colorless, non pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron hydrochloride injection is available as 5 mL single-dose vial. Each 5 mL vial contains 0.25 mg palonosetron (equivalent to 0.28 mg palonosetron hydrochloride), 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration. The pH of the solution in the 5 mL vials is 4.5 to 5.5."
    },
    {
      "NDCCode": "69097-927-35",
      "PackageDescription": "1 VIAL in 1 CARTON (69097-927-35)  > 5 mL in 1 VIAL",
      "NDC11Code": "69097-0927-35",
      "ProductNDC": "69097-927",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Palonosetron Hydrochloride",
      "NonProprietaryName": "Palonosetron Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180323",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA021372",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "PALONOSETRON HYDROCHLORIDE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-01-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180323",
      "SamplePackage": "N",
      "IndicationAndUsage": "Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT3) receptor antagonist indicated in adults for: 1   Moderately emetogenic cancer chemotherapy - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses (1.1), 2   Highly emetogenic cancer chemotherapy - prevention of acute nausea and vomiting associated with initial and repeat courses (1.1), 3   Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.  Efficacy beyond 24 hours has not been demonstrated (1.3).",
      "Description": "Palonosetron Hydrochloride Injection is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is a white to off-white crystalline powder.  It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron Hydrochloride Injection is a sterile, clear, colorless, non pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron Hydrochloride Injection is available as 5 mL single use vial. Each 5 mL vial contains 0.25 mg palonosetron base as 0.28 mg palonosetron hydrochloride, 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration. The pH of the solution in the 5 mL vials is 4.5 to 5.5."
    },
    {
      "NDCCode": "0093-4061-06",
      "PackageDescription": "60 POUCH in 1 CARTON (0093-4061-06)  > 1 VIAL in 1 POUCH > 2 mL in 1 VIAL",
      "NDC11Code": "00093-4061-06",
      "ProductNDC": "0093-4061",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Formoterol Fumarate",
      "NonProprietaryName": "Formoterol Fumarate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20210622",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091141",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "FORMOTEROL FUMARATE",
      "StrengthNumber": "20",
      "StrengthUnit": "ug/2mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210622",
      "SamplePackage": "N",
      "IndicationAndUsage": "Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1)Important limitations of use:, 2 Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. (1.2, 5.2), 3 Formoterol fumarate inhalation solution is not indicated to treat asthma. (1.2).",
      "Description": "Formoterol fumarate inhalation solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 3 mL single-dose low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, water, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of formoterol fumarate inhalation solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate, USP is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2´-Hydroxy-5´-[(R*)-1-hydroxy-2-[[(R*)-p-methoxy-α-methylphenethyl]amino]ethyl]formanilide fumarate (2:1) (salt), dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.91 and its molecular formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. Formoterol fumarate inhalation solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. Formoterol fumarate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece."
    },
    {
      "NDCCode": "0093-4061-30",
      "PackageDescription": "30 POUCH in 1 CARTON (0093-4061-30)  > 1 VIAL in 1 POUCH (0093-4061-19)  > 2 mL in 1 VIAL",
      "NDC11Code": "00093-4061-30",
      "ProductNDC": "0093-4061",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Formoterol Fumarate",
      "NonProprietaryName": "Formoterol Fumarate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20210622",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091141",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "FORMOTEROL FUMARATE",
      "StrengthNumber": "20",
      "StrengthUnit": "ug/2mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210622",
      "SamplePackage": "N",
      "IndicationAndUsage": "Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1)Important limitations of use:, 2 Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. (1.2, 5.2), 3 Formoterol fumarate inhalation solution is not indicated to treat asthma. (1.2).",
      "Description": "Formoterol fumarate inhalation solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 3 mL single-dose low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, water, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of formoterol fumarate inhalation solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate, USP is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2´-Hydroxy-5´-[(R*)-1-hydroxy-2-[[(R*)-p-methoxy-α-methylphenethyl]amino]ethyl]formanilide fumarate (2:1) (salt), dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.91 and its molecular formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. Formoterol fumarate inhalation solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. Formoterol fumarate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece."
    },
    {
      "NDCCode": "0186-0370-20",
      "PackageDescription": "1 POUCH in 1 CARTON (0186-0370-20)  / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER",
      "NDC11Code": "00186-0370-20",
      "ProductNDC": "0186-0370",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Symbicort",
      "NonProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
      "DosageFormName": "AEROSOL",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20070529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021929",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
      "StrengthNumber": "160; 4.5",
      "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": "2024-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20070529",
      "SamplePackage": "N",
      "IndicationAndUsage": "SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
      "Description": "SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each SYMBICORT 80/4.5 and SYMBICORT 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. SYMBICORT should be primed before using for the first time by releasing two test 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 before each spray and releasing two test sprays into the air away from the face. One active component of SYMBICORT is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of SYMBICORT is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
    },
    {
      "NDCCode": "0186-0370-28",
      "PackageDescription": "1 POUCH in 1 CARTON (0186-0370-28)  / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER",
      "NDC11Code": "00186-0370-28",
      "ProductNDC": "0186-0370",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Symbicort",
      "NonProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
      "DosageFormName": "AEROSOL",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20070529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021929",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
      "StrengthNumber": "160; 4.5",
      "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": "2024-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20070906",
      "SamplePackage": "N",
      "IndicationAndUsage": "SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
      "Description": "SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each SYMBICORT 80/4.5 and SYMBICORT 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. SYMBICORT should be primed before using for the first time by releasing two test 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 before each spray and releasing two test sprays into the air away from the face. One active component of SYMBICORT is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of SYMBICORT is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
    },
    {
      "NDCCode": "0186-0372-20",
      "PackageDescription": "1 POUCH in 1 CARTON (0186-0372-20)  / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER",
      "NDC11Code": "00186-0372-20",
      "ProductNDC": "0186-0372",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Symbicort",
      "NonProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
      "DosageFormName": "AEROSOL",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20070529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021929",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
      "StrengthNumber": "80; 4.5",
      "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": "2024-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20070529",
      "SamplePackage": "N",
      "IndicationAndUsage": "SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
      "Description": "SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each SYMBICORT 80/4.5 and SYMBICORT 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. SYMBICORT should be primed before using for the first time by releasing two test 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 before each spray and releasing two test sprays into the air away from the face. One active component of SYMBICORT is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of SYMBICORT is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
    },
    {
      "NDCCode": "0186-0372-28",
      "PackageDescription": "1 POUCH in 1 CARTON (0186-0372-28)  / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER",
      "NDC11Code": "00186-0372-28",
      "ProductNDC": "0186-0372",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Symbicort",
      "NonProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
      "DosageFormName": "AEROSOL",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20070529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021929",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
      "StrengthNumber": "80; 4.5",
      "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": "2024-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20070906",
      "SamplePackage": "N",
      "IndicationAndUsage": "SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
      "Description": "SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each SYMBICORT 80/4.5 and SYMBICORT 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. SYMBICORT should be primed before using for the first time by releasing two test 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 before each spray and releasing two test sprays into the air away from the face. One active component of SYMBICORT is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of SYMBICORT is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
    },
    {
      "NDCCode": "0310-0900-30",
      "PackageDescription": "1 POUCH in 1 CARTON (0310-0900-30)  / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER",
      "NDC11Code": "00310-0900-30",
      "ProductNDC": "0310-0900",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duaklir Pressair",
      "NonProprietaryName": "Aclidinium Bromide And Formoterol Fumarate",
      "DosageFormName": "POWDER, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20220817",
      "EndMarketingDate": "20250430",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210595",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE",
      "StrengthNumber": "400; 12",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20220817",
      "EndMarketingDatePackage": "20240930",
      "SamplePackage": "N",
      "IndicationAndUsage": "DUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.4)].",
      "Description": "DUAKLIR PRESSAIR consists of a dry powder formulation of aclidinium bromide and formoterol fumarate for oral inhalation only. Aclidinium bromide, is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30 NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. Formoterol fumarate, a racemate, is a selective beta2-adrenergic agonist. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1methylethyl]-amino]ethyl]formanilide fumarate dihydrate. The structural formula is. Formoterol fumarate (as a dihydrate) has a molecular weight of 840.91, and its molecular formula is (C19H24N2O4)2 C4H4O42H2O. Formoterol fumarate is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. DUAKLIR PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of DUAKLIR PRESSAIR provides a metered dose of 12 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier, 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium), and 12.0 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.5 mcg of formoterol fumarate anhydrous and 9.8 mcg of formoterol). This results in delivery of 396 mcg of aclidinium bromide (equivalent to 340 mcg of aclidinium) and 11.8 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.3 mcg of formoterol fumarate anhydrous and 9.7 mcg of formoterol) from the mouthpiece, based on in vitro testing at an average flow rate of approximately 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time."
    },
    {
      "NDCCode": "0310-0900-60",
      "PackageDescription": "1 POUCH in 1 CARTON (0310-0900-60)  / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER",
      "NDC11Code": "00310-0900-60",
      "ProductNDC": "0310-0900",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duaklir Pressair",
      "NonProprietaryName": "Aclidinium Bromide And Formoterol Fumarate",
      "DosageFormName": "POWDER, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20220817",
      "EndMarketingDate": "20250430",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210595",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE",
      "StrengthNumber": "400; 12",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20220817",
      "EndMarketingDatePackage": "20250430",
      "SamplePackage": "N",
      "IndicationAndUsage": "DUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.4)].",
      "Description": "DUAKLIR PRESSAIR consists of a dry powder formulation of aclidinium bromide and formoterol fumarate for oral inhalation only. Aclidinium bromide, is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30 NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. Formoterol fumarate, a racemate, is a selective beta2-adrenergic agonist. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1methylethyl]-amino]ethyl]formanilide fumarate dihydrate. The structural formula is. Formoterol fumarate (as a dihydrate) has a molecular weight of 840.91, and its molecular formula is (C19H24N2O4)2 C4H4O42H2O. Formoterol fumarate is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. DUAKLIR PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of DUAKLIR PRESSAIR provides a metered dose of 12 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier, 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium), and 12.0 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.5 mcg of formoterol fumarate anhydrous and 9.8 mcg of formoterol). This results in delivery of 396 mcg of aclidinium bromide (equivalent to 340 mcg of aclidinium) and 11.8 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.3 mcg of formoterol fumarate anhydrous and 9.7 mcg of formoterol) from the mouthpiece, based on in vitro testing at an average flow rate of approximately 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time."
    },
    {
      "NDCCode": "0310-4600-12",
      "PackageDescription": "120 AEROSOL, METERED in 1 INHALER (0310-4600-12) ",
      "NDC11Code": "00310-4600-12",
      "ProductNDC": "0310-4600",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bevespi Aerosphere",
      "NonProprietaryName": "Glycopyrrolate And Formoterol Fumarate",
      "DosageFormName": "AEROSOL, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20161003",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA208294",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "GLYCOPYRROLATE; FORMOTEROL FUMARATE",
      "StrengthNumber": "9; 4.8",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161003",
      "SamplePackage": "N",
      "IndicationAndUsage": "BEVESPI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use:. BEVESPI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.2)].",
      "Description": "BEVESPI AEROSPHERE (glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that contains a combination of micronized glycopyrrolate, an anticholinergic, and micronized formoterol fumarate, a long-acting beta2-adrenergic agonist, for oral inhalation. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows. Glycopyrrolate contains two chiral centers (denoted by * in structure above) and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1- methylethyl]-amino] ethyl]phenyl] formamide, €-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2.C4H4O4.2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers (denoted by * in structure above), and consists of a single enantiomeric pair (a racemate of R,R and S,S). BEVESPI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 120 inhalations. The canister has an attached dose indicator and is supplied with a white plastic actuator body and mouthpiece with an orange dust cap. After priming each actuation of the inhaler meters 10.4 mcg of glycopyrrolate (equivalent to 8.3 mcg of glycopyrronium) and 5.5 mcg of formoterol fumarate from the valve which delivers 9 mcg of glycopyrrolate (equivalent to 7.2 mcg of glycopyrronium) and 4.8 mcg of formoterol fumarate from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BEVESPI AEROSPHERE also contains porous particles that form a cosuspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation."
    },
    {
      "NDCCode": "0310-4616-12",
      "PackageDescription": "120 AEROSOL, METERED in 1 INHALER (0310-4616-12) ",
      "NDC11Code": "00310-4616-12",
      "ProductNDC": "0310-4616",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Breztri",
      "NonProprietaryName": "Budesonide, Glycopyrrolate, And Formoterol Fumarate",
      "DosageFormName": "AEROSOL, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20200723",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212122",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL",
      "StrengthNumber": "160; 9; 4.8",
      "StrengthUnit": "ug/1; ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200723",
      "SamplePackage": "N",
      "IndicationAndUsage": "BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. (1.1), 2 the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. (1.2).",
      "Description": "BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] for oral inhalation. Budesonide is a corticosteroid with the following chemical name: (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a white to off-white, powder which is practically insoluble in water. The molecular formula is C25H34O6 and the molecular weight is 430.54. The structural formula is as follows:. Budesonide contains nine chiral centers and is a mixture of the two epimers (22R and 22S). Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows:. Glycopyrrolate contains two chiral centers and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino] ethyl]phenyl] formamide, (E)-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2·C4H4O4·2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S). BREZTRI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a yellow plastic actuator and white mouthpiece with a grey dust cap. After priming, each actuation of the inhaler meters 170 mcg of budesonide, 9.6 or 19.1 mcg of glycopyrrolate (equivalent to 7.7 or 15.3 mcg of glycopyrronium), and 5.1 mcg of formoterol fumarate (equivalent to 4.4 mcg of formoterol) from the valve which delivers 160 mcg of budesonide, 9.0 or 18 mcg of glycopyrrolate (equivalent to 7.2 or 14.4 mcg of glycopyrronium), and 4.8 mcg of formoterol fumarate (equivalent to 4.1 mcg of formoterol) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREZTRI AEROSPHERE also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation."
    },
    {
      "NDCCode": "0310-4616-28",
      "PackageDescription": "28 AEROSOL, METERED in 1 INHALER (0310-4616-28) ",
      "NDC11Code": "00310-4616-28",
      "ProductNDC": "0310-4616",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Breztri",
      "NonProprietaryName": "Budesonide, Glycopyrrolate, And Formoterol Fumarate",
      "DosageFormName": "AEROSOL, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20200723",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212122",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL",
      "StrengthNumber": "160; 9; 4.8",
      "StrengthUnit": "ug/1; ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200723",
      "SamplePackage": "Y",
      "IndicationAndUsage": "BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. (1.1), 2 the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. (1.2).",
      "Description": "BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] for oral inhalation. Budesonide is a corticosteroid with the following chemical name: (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a white to off-white, powder which is practically insoluble in water. The molecular formula is C25H34O6 and the molecular weight is 430.54. The structural formula is as follows:. Budesonide contains nine chiral centers and is a mixture of the two epimers (22R and 22S). Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows:. Glycopyrrolate contains two chiral centers and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino] ethyl]phenyl] formamide, (E)-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2·C4H4O4·2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S). BREZTRI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a yellow plastic actuator and white mouthpiece with a grey dust cap. After priming, each actuation of the inhaler meters 170 mcg of budesonide, 9.6 or 19.1 mcg of glycopyrrolate (equivalent to 7.7 or 15.3 mcg of glycopyrronium), and 5.1 mcg of formoterol fumarate (equivalent to 4.4 mcg of formoterol) from the valve which delivers 160 mcg of budesonide, 9.0 or 18 mcg of glycopyrrolate (equivalent to 7.2 or 14.4 mcg of glycopyrronium), and 4.8 mcg of formoterol fumarate (equivalent to 4.1 mcg of formoterol) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREZTRI AEROSPHERE also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation."
    },
    {
      "NDCCode": "0310-4616-39",
      "PackageDescription": "28 AEROSOL, METERED in 1 INHALER (0310-4616-39) ",
      "NDC11Code": "00310-4616-39",
      "ProductNDC": "0310-4616",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Breztri",
      "NonProprietaryName": "Budesonide, Glycopyrrolate, And Formoterol Fumarate",
      "DosageFormName": "AEROSOL, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20200723",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212122",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL",
      "StrengthNumber": "160; 9; 4.8",
      "StrengthUnit": "ug/1; ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200723",
      "SamplePackage": "N",
      "IndicationAndUsage": "BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. (1.1), 2 the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. (1.2).",
      "Description": "BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] for oral inhalation. Budesonide is a corticosteroid with the following chemical name: (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a white to off-white, powder which is practically insoluble in water. The molecular formula is C25H34O6 and the molecular weight is 430.54. The structural formula is as follows:. Budesonide contains nine chiral centers and is a mixture of the two epimers (22R and 22S). Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows:. Glycopyrrolate contains two chiral centers and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino] ethyl]phenyl] formamide, (E)-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2·C4H4O4·2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S). BREZTRI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a yellow plastic actuator and white mouthpiece with a grey dust cap. After priming, each actuation of the inhaler meters 170 mcg of budesonide, 9.6 or 19.1 mcg of glycopyrrolate (equivalent to 7.7 or 15.3 mcg of glycopyrronium), and 5.1 mcg of formoterol fumarate (equivalent to 4.4 mcg of formoterol) from the valve which delivers 160 mcg of budesonide, 9.0 or 18 mcg of glycopyrrolate (equivalent to 7.2 or 14.4 mcg of glycopyrronium), and 4.8 mcg of formoterol fumarate (equivalent to 4.1 mcg of formoterol) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREZTRI AEROSPHERE also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation."
    },
    {
      "NDCCode": "0310-6616-01",
      "PackageDescription": "120 AEROSOL, METERED in 1 INHALER (0310-6616-01) ",
      "NDC11Code": "00310-6616-01",
      "ProductNDC": "0310-6616",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Breztri",
      "NonProprietaryName": "Budesonide, Glycopyrrolate, And Formoterol Fumarate",
      "DosageFormName": "AEROSOL, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20260427",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212122",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL",
      "StrengthNumber": "160; 18; 4.8",
      "StrengthUnit": "ug/1; ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260427",
      "SamplePackage": "N",
      "IndicationAndUsage": "BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. (1.1), 2 the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. (1.2).",
      "Description": "BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] for oral inhalation. Budesonide is a corticosteroid with the following chemical name: (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a white to off-white, powder which is practically insoluble in water. The molecular formula is C25H34O6 and the molecular weight is 430.54. The structural formula is as follows:. Budesonide contains nine chiral centers and is a mixture of the two epimers (22R and 22S). Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows:. Glycopyrrolate contains two chiral centers and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino] ethyl]phenyl] formamide, (E)-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2·C4H4O4·2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S). BREZTRI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a yellow plastic actuator and white mouthpiece with a grey dust cap. After priming, each actuation of the inhaler meters 170 mcg of budesonide, 9.6 or 19.1 mcg of glycopyrrolate (equivalent to 7.7 or 15.3 mcg of glycopyrronium), and 5.1 mcg of formoterol fumarate (equivalent to 4.4 mcg of formoterol) from the valve which delivers 160 mcg of budesonide, 9.0 or 18 mcg of glycopyrrolate (equivalent to 7.2 or 14.4 mcg of glycopyrronium), and 4.8 mcg of formoterol fumarate (equivalent to 4.1 mcg of formoterol) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREZTRI AEROSPHERE also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation."
    },
    {
      "NDCCode": "0310-6616-39",
      "PackageDescription": "28 AEROSOL, METERED in 1 INHALER (0310-6616-39) ",
      "NDC11Code": "00310-6616-39",
      "ProductNDC": "0310-6616",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Breztri",
      "NonProprietaryName": "Budesonide, Glycopyrrolate, And Formoterol Fumarate",
      "DosageFormName": "AEROSOL, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20260427",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212122",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL",
      "StrengthNumber": "160; 18; 4.8",
      "StrengthUnit": "ug/1; ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260427",
      "SamplePackage": "N",
      "IndicationAndUsage": "BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. (1.1), 2 the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. (1.2).",
      "Description": "BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] for oral inhalation. Budesonide is a corticosteroid with the following chemical name: (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a white to off-white, powder which is practically insoluble in water. The molecular formula is C25H34O6 and the molecular weight is 430.54. The structural formula is as follows:. Budesonide contains nine chiral centers and is a mixture of the two epimers (22R and 22S). Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows:. Glycopyrrolate contains two chiral centers and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino] ethyl]phenyl] formamide, (E)-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2·C4H4O4·2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S). BREZTRI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a yellow plastic actuator and white mouthpiece with a grey dust cap. After priming, each actuation of the inhaler meters 170 mcg of budesonide, 9.6 or 19.1 mcg of glycopyrrolate (equivalent to 7.7 or 15.3 mcg of glycopyrronium), and 5.1 mcg of formoterol fumarate (equivalent to 4.4 mcg of formoterol) from the valve which delivers 160 mcg of budesonide, 9.0 or 18 mcg of glycopyrrolate (equivalent to 7.2 or 14.4 mcg of glycopyrronium), and 4.8 mcg of formoterol fumarate (equivalent to 4.1 mcg of formoterol) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREZTRI AEROSPHERE also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation."
    },
    {
      "NDCCode": "0310-6616-95",
      "PackageDescription": "28 AEROSOL, METERED in 1 INHALER (0310-6616-95) ",
      "NDC11Code": "00310-6616-95",
      "ProductNDC": "0310-6616",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Breztri",
      "NonProprietaryName": "Budesonide, Glycopyrrolate, And Formoterol Fumarate",
      "DosageFormName": "AEROSOL, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20260427",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212122",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL",
      "StrengthNumber": "160; 18; 4.8",
      "StrengthUnit": "ug/1; ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260427",
      "SamplePackage": "Y",
      "IndicationAndUsage": "BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. (1.1), 2 the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. (1.2).",
      "Description": "BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] for oral inhalation. Budesonide is a corticosteroid with the following chemical name: (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a white to off-white, powder which is practically insoluble in water. The molecular formula is C25H34O6 and the molecular weight is 430.54. The structural formula is as follows:. Budesonide contains nine chiral centers and is a mixture of the two epimers (22R and 22S). Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows:. Glycopyrrolate contains two chiral centers and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino] ethyl]phenyl] formamide, (E)-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2·C4H4O4·2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S). BREZTRI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a yellow plastic actuator and white mouthpiece with a grey dust cap. After priming, each actuation of the inhaler meters 170 mcg of budesonide, 9.6 or 19.1 mcg of glycopyrrolate (equivalent to 7.7 or 15.3 mcg of glycopyrronium), and 5.1 mcg of formoterol fumarate (equivalent to 4.4 mcg of formoterol) from the valve which delivers 160 mcg of budesonide, 9.0 or 18 mcg of glycopyrrolate (equivalent to 7.2 or 14.4 mcg of glycopyrronium), and 4.8 mcg of formoterol fumarate (equivalent to 4.1 mcg of formoterol) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREZTRI AEROSPHERE also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation."
    },
    {
      "NDCCode": "0310-7370-20",
      "PackageDescription": "1 POUCH in 1 CARTON (0310-7370-20)  / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER",
      "NDC11Code": "00310-7370-20",
      "ProductNDC": "0310-7370",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
      "NonProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
      "DosageFormName": "AEROSOL",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20200103",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA021929",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
      "StrengthNumber": "160; 4.5",
      "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": "2025-12-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200103",
      "SamplePackage": "N",
      "IndicationAndUsage": "BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
      "Description": "BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 and BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 and BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL should be primed before using for the first time by releasing two test 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 before each spray and releasing two test sprays into the air away from the face. One active component of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
    },
    {
      "NDCCode": "0310-7372-20",
      "PackageDescription": "1 POUCH in 1 CARTON (0310-7372-20)  / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER",
      "NDC11Code": "00310-7372-20",
      "ProductNDC": "0310-7372",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
      "NonProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
      "DosageFormName": "AEROSOL",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20200103",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA021929",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
      "StrengthNumber": "80; 4.5",
      "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": "2025-12-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200103",
      "SamplePackage": "N",
      "IndicationAndUsage": "BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
      "Description": "BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 and BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 and BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL should be primed before using for the first time by releasing two test 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 before each spray and releasing two test sprays into the air away from the face. One active component of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
    },
    {
      "NDCCode": "0338-0341-04",
      "PackageDescription": "14 BAG in 1 CARTON (0338-0341-04)  / 1000 mL in 1 BAG",
      "NDC11Code": "00338-0341-04",
      "ProductNDC": "0338-0341",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cardioplegic",
      "NonProprietaryName": "Calcium Chloride, Magnesium Chloride, Potassium Chloride And Sodium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRA-ARTERIAL",
      "StartMarketingDate": "20000421",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075323",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE",
      "StrengthNumber": "17.6; 325.3; 119.3; 643",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20000421",
      "SamplePackage": "N",
      "IndicationAndUsage": "Baxter Cardioplegic Solution when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.",
      "Description": "Baxter Cardioplegic Solution is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in Water for Injection, USP. It is a “core solution” intended for use only after addition of sodium bicarbonate to adjust pH prior to administration. After buffering with sodium bicarbonate it is suitable for cardiac instillation (usually with hypothermia) to induce arrest during open heart surgery. Other agents may be added to the solution prior to instillation (See INSTRUCTIONS FOR USE). Each 100 mL of solution contains Calcium Chloride Dihydrate USP 17.6 mg, Magnesium Chloride, Hexahydrate USP 325.3 mg, Potassium Chloride USP 119.3 mg and Sodium Chloride USP 643 mg in Water for Injection, USP. May contain HCl and/or NaOH for pH adjustment. Electrolyte content per liter (not including ions for pH adjustment): Calcium (Ca++) 2.4 mEq; Magnesium (Mg++) 32 mEq; Potassium (K+) 16 mEq; Sodium (Na+) 110 mEq; Chloride (Cl-) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH 3.8 (3.5 to 3.9) prior to sodium bicarbonate addition. It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of cardioplegic solution to adjust pH. Use 10 mL of Hospira1 List 4900, 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH’s of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be stored under refrigeration and be used within 24 hours. The buffered admixture contains the following electrolytes (per liter): Ca++ 2.4 mEq, Mg++ 32 mEq, K+ 16 mEq, Na+ 120 mEq, Cl- 160 mEq and bicarbonate (HCO3-) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these values may be altered. The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded. Cardioplegic Solution with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2  2 H2O), white fragments or granules freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl2  6 H2O), deliquescent flakes or crystals very soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0378-1631-91",
      "PackageDescription": "60 POUCH in 1 CARTON (0378-1631-91)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL",
      "NDC11Code": "00378-1631-91",
      "ProductNDC": "0378-1631",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Formoterol Fumarate",
      "NonProprietaryName": "Formoterol Fumarate Dihydrate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20210622",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA022007",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "FORMOTEROL FUMARATE",
      "StrengthNumber": "20",
      "StrengthUnit": "ug/2mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210622",
      "SamplePackage": "N",
      "IndicationAndUsage": "Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).",
      "Description": "Formoterol fumarate inhalation solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of formoterol fumarate inhalation solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. Formoterol fumarate inhalation solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. Formoterol fumarate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece."
    },
    {
      "NDCCode": "0378-1631-93",
      "PackageDescription": "30 POUCH in 1 CARTON (0378-1631-93)  / 1 VIAL in 1 POUCH (0378-1631-32)  / 2 mL in 1 VIAL",
      "NDC11Code": "00378-1631-93",
      "ProductNDC": "0378-1631",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Formoterol Fumarate",
      "NonProprietaryName": "Formoterol Fumarate Dihydrate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20210622",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA022007",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "FORMOTEROL FUMARATE",
      "StrengthNumber": "20",
      "StrengthUnit": "ug/2mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210622",
      "SamplePackage": "N",
      "IndicationAndUsage": "Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).",
      "Description": "Formoterol fumarate inhalation solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of formoterol fumarate inhalation solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. Formoterol fumarate inhalation solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. Formoterol fumarate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece."
    },
    {
      "NDCCode": "0378-7502-32",
      "PackageDescription": "1 POUCH in 1 CARTON (0378-7502-32)  / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER",
      "NDC11Code": "00378-7502-32",
      "ProductNDC": "0378-7502",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Breyna",
      "NonProprietaryName": "Budesonide And Formoterol Fumarate",
      "DosageFormName": "AEROSOL, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20230731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211699",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
      "StrengthNumber": "80; 4.5",
      "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": "20230731",
      "SamplePackage": "N",
      "IndicationAndUsage": "BREYNA is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
      "Description": "BREYNA 80 mcg/4.5 mcg and BREYNA 160 mcg/4.5 mcg each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each BREYNA 80 mcg/4.5 mcg and BREYNA 160 mcg/4.5 mcg canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREYNA also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. BREYNA should be primed before using for the first time by releasing two test 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 before each spray and releasing two test sprays into the air away from the face. One active component of BREYNA is budesonide, a corticosteroid designated chemically as (RS)‑11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of BREYNA is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"69097-840-87","ProprietaryName":"Ipratropium Bromide And Albuterol Sulfate","NonProprietaryName":"Ipratropium Bromide And Albuterol Sulfate"},{"NDCCode":"69097-840-53","ProprietaryName":"Ipratropium Bromide And Albuterol Sulfate","NonProprietaryName":"Ipratropium Bromide And Albuterol Sulfate"},{"NDCCode":"69097-840-64","ProprietaryName":"Ipratropium Bromide And Albuterol Sulfate","NonProprietaryName":"Ipratropium Bromide And Albuterol Sulfate"},{"NDCCode":"69097-168-87","ProprietaryName":"Arformoterol Tartrate","NonProprietaryName":"Arformoterol Tartrate"},{"NDCCode":"69097-318-87","ProprietaryName":"Budesonide","NonProprietaryName":"Budesonide"},{"NDCCode":"69097-319-87","ProprietaryName":"Budesonide","NonProprietaryName":"Budesonide"},{"NDCCode":"69097-321-87","ProprietaryName":"Budesonide","NonProprietaryName":"Budesonide"},{"NDCCode":"69097-439-35","ProprietaryName":"Palonosetron Hydrochloride","NonProprietaryName":"Palonsetron Hydrochloride"},{"NDCCode":"69097-927-35","ProprietaryName":"Palonosetron Hydrochloride","NonProprietaryName":"Palonosetron Hydrochloride"},{"NDCCode":"0093-4061-06","ProprietaryName":"Formoterol Fumarate","NonProprietaryName":"Formoterol Fumarate"},{"NDCCode":"0093-4061-30","ProprietaryName":"Formoterol Fumarate","NonProprietaryName":"Formoterol Fumarate"},{"NDCCode":"0186-0370-20","ProprietaryName":"Symbicort","NonProprietaryName":"Budesonide And Formoterol Fumarate Dihydrate"},{"NDCCode":"0186-0370-28","ProprietaryName":"Symbicort","NonProprietaryName":"Budesonide And Formoterol Fumarate Dihydrate"},{"NDCCode":"0186-0372-20","ProprietaryName":"Symbicort","NonProprietaryName":"Budesonide And Formoterol Fumarate Dihydrate"},{"NDCCode":"0186-0372-28","ProprietaryName":"Symbicort","NonProprietaryName":"Budesonide And Formoterol Fumarate Dihydrate"},{"NDCCode":"0310-0900-30","ProprietaryName":"Duaklir Pressair","NonProprietaryName":"Aclidinium Bromide And Formoterol Fumarate"},{"NDCCode":"0310-0900-60","ProprietaryName":"Duaklir Pressair","NonProprietaryName":"Aclidinium Bromide And Formoterol Fumarate"},{"NDCCode":"0310-4600-12","ProprietaryName":"Bevespi Aerosphere","NonProprietaryName":"Glycopyrrolate And Formoterol Fumarate"},{"NDCCode":"0310-4616-12","ProprietaryName":"Breztri","NonProprietaryName":"Budesonide, Glycopyrrolate, And Formoterol Fumarate"},{"NDCCode":"0310-4616-28","ProprietaryName":"Breztri","NonProprietaryName":"Budesonide, Glycopyrrolate, And Formoterol Fumarate"},{"NDCCode":"0310-4616-39","ProprietaryName":"Breztri","NonProprietaryName":"Budesonide, Glycopyrrolate, And Formoterol Fumarate"},{"NDCCode":"0310-6616-01","ProprietaryName":"Breztri","NonProprietaryName":"Budesonide, Glycopyrrolate, And Formoterol Fumarate"},{"NDCCode":"0310-6616-39","ProprietaryName":"Breztri","NonProprietaryName":"Budesonide, Glycopyrrolate, And Formoterol Fumarate"},{"NDCCode":"0310-6616-95","ProprietaryName":"Breztri","NonProprietaryName":"Budesonide, Glycopyrrolate, And Formoterol Fumarate"},{"NDCCode":"0310-7370-20","ProprietaryName":"Budesonide And Formoterol Fumarate Dihydrate","NonProprietaryName":"Budesonide And Formoterol Fumarate Dihydrate"},{"NDCCode":"0310-7372-20","ProprietaryName":"Budesonide And Formoterol Fumarate Dihydrate","NonProprietaryName":"Budesonide And Formoterol Fumarate Dihydrate"},{"NDCCode":"0338-0341-04","ProprietaryName":"Cardioplegic","NonProprietaryName":"Calcium Chloride, Magnesium Chloride, Potassium Chloride And Sodium Chloride"},{"NDCCode":"0378-1631-91","ProprietaryName":"Formoterol Fumarate","NonProprietaryName":"Formoterol Fumarate Dihydrate"},{"NDCCode":"0378-1631-93","ProprietaryName":"Formoterol Fumarate","NonProprietaryName":"Formoterol Fumarate Dihydrate"},{"NDCCode":"0378-7502-32","ProprietaryName":"Breyna","NonProprietaryName":"Budesonide And Formoterol Fumarate"}]}
                    

<NDCList><NDC><NDCCode>69097-840-87</NDCCode><ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName><NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName></NDC><NDC><NDCCode>69097-840-53</NDCCode><ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName><NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName></NDC><NDC><NDCCode>69097-840-64</NDCCode><ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName><NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName></NDC><NDC><NDCCode>69097-168-87</NDCCode><ProprietaryName>Arformoterol Tartrate</ProprietaryName><NonProprietaryName>Arformoterol Tartrate</NonProprietaryName></NDC><NDC><NDCCode>69097-318-87</NDCCode><ProprietaryName>Budesonide</ProprietaryName><NonProprietaryName>Budesonide</NonProprietaryName></NDC><NDC><NDCCode>69097-319-87</NDCCode><ProprietaryName>Budesonide</ProprietaryName><NonProprietaryName>Budesonide</NonProprietaryName></NDC><NDC><NDCCode>69097-321-87</NDCCode><ProprietaryName>Budesonide</ProprietaryName><NonProprietaryName>Budesonide</NonProprietaryName></NDC><NDC><NDCCode>69097-439-35</NDCCode><ProprietaryName>Palonosetron Hydrochloride</ProprietaryName><NonProprietaryName>Palonsetron Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69097-927-35</NDCCode><ProprietaryName>Palonosetron Hydrochloride</ProprietaryName><NonProprietaryName>Palonosetron Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0093-4061-06</NDCCode><ProprietaryName>Formoterol Fumarate</ProprietaryName><NonProprietaryName>Formoterol Fumarate</NonProprietaryName></NDC><NDC><NDCCode>0093-4061-30</NDCCode><ProprietaryName>Formoterol Fumarate</ProprietaryName><NonProprietaryName>Formoterol Fumarate</NonProprietaryName></NDC><NDC><NDCCode>0186-0370-20</NDCCode><ProprietaryName>Symbicort</ProprietaryName><NonProprietaryName>Budesonide And Formoterol Fumarate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>0186-0370-28</NDCCode><ProprietaryName>Symbicort</ProprietaryName><NonProprietaryName>Budesonide And Formoterol Fumarate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>0186-0372-20</NDCCode><ProprietaryName>Symbicort</ProprietaryName><NonProprietaryName>Budesonide And Formoterol Fumarate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>0186-0372-28</NDCCode><ProprietaryName>Symbicort</ProprietaryName><NonProprietaryName>Budesonide And Formoterol Fumarate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>0310-0900-30</NDCCode><ProprietaryName>Duaklir Pressair</ProprietaryName><NonProprietaryName>Aclidinium Bromide And Formoterol Fumarate</NonProprietaryName></NDC><NDC><NDCCode>0310-0900-60</NDCCode><ProprietaryName>Duaklir Pressair</ProprietaryName><NonProprietaryName>Aclidinium Bromide And Formoterol Fumarate</NonProprietaryName></NDC><NDC><NDCCode>0310-4600-12</NDCCode><ProprietaryName>Bevespi Aerosphere</ProprietaryName><NonProprietaryName>Glycopyrrolate And Formoterol Fumarate</NonProprietaryName></NDC><NDC><NDCCode>0310-4616-12</NDCCode><ProprietaryName>Breztri</ProprietaryName><NonProprietaryName>Budesonide, Glycopyrrolate, And Formoterol Fumarate</NonProprietaryName></NDC><NDC><NDCCode>0310-4616-28</NDCCode><ProprietaryName>Breztri</ProprietaryName><NonProprietaryName>Budesonide, Glycopyrrolate, And Formoterol Fumarate</NonProprietaryName></NDC><NDC><NDCCode>0310-4616-39</NDCCode><ProprietaryName>Breztri</ProprietaryName><NonProprietaryName>Budesonide, Glycopyrrolate, And Formoterol Fumarate</NonProprietaryName></NDC><NDC><NDCCode>0310-6616-01</NDCCode><ProprietaryName>Breztri</ProprietaryName><NonProprietaryName>Budesonide, Glycopyrrolate, And Formoterol Fumarate</NonProprietaryName></NDC><NDC><NDCCode>0310-6616-39</NDCCode><ProprietaryName>Breztri</ProprietaryName><NonProprietaryName>Budesonide, Glycopyrrolate, And Formoterol Fumarate</NonProprietaryName></NDC><NDC><NDCCode>0310-6616-95</NDCCode><ProprietaryName>Breztri</ProprietaryName><NonProprietaryName>Budesonide, Glycopyrrolate, And Formoterol Fumarate</NonProprietaryName></NDC><NDC><NDCCode>0310-7370-20</NDCCode><ProprietaryName>Budesonide And Formoterol Fumarate Dihydrate</ProprietaryName><NonProprietaryName>Budesonide And Formoterol Fumarate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>0310-7372-20</NDCCode><ProprietaryName>Budesonide And Formoterol Fumarate Dihydrate</ProprietaryName><NonProprietaryName>Budesonide And Formoterol Fumarate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>0338-0341-04</NDCCode><ProprietaryName>Cardioplegic</ProprietaryName><NonProprietaryName>Calcium Chloride, Magnesium Chloride, Potassium Chloride And Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0378-1631-91</NDCCode><ProprietaryName>Formoterol Fumarate</ProprietaryName><NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>0378-1631-93</NDCCode><ProprietaryName>Formoterol Fumarate</ProprietaryName><NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>0378-7502-32</NDCCode><ProprietaryName>Breyna</ProprietaryName><NonProprietaryName>Budesonide And Formoterol Fumarate</NonProprietaryName></NDC></NDCList>