RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (34 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "73289-0089-1",
      "PackageDescription": "13 mL in 1 BOTTLE (73289-0089-1) ",
      "NDC11Code": "73289-0089-01",
      "ProductNDC": "73289-0089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pyquvi",
      "NonProprietaryName": "Deflazacort",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219417",
      "LabelerName": "Aucta Pharmaceuticals, Inc.",
      "SubstanceName": "DEFLAZACORT",
      "StrengthNumber": "22.75",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250630",
      "SamplePackage": "N",
      "IndicationAndUsage": "PYQUVI is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza ® (deflazacort) oral suspension. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.",
      "Description": "The active ingredient in PYQUVI is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic.  The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is 16α,17-isoxazole-11β,21-dihydroxypregna-1,4-diene-3,20-dione 21acetate, and the structure is:. Deflazacort is a white or almost white crystalline powder and has a molecular weight of 441.52. Deflazacort is soluble in dichloromethane and chloroform, slightly soluble in ethanol and ethyl acetate, almost insoluble in water. PYQUVI for oral administration is available as an immediate-release oral suspension in a strength of 22.75 mg/mL. The oral suspension contains deflazacort and the following inactive ingredients: Benzyl Alcohol, Carboxymethylcellulose Sodium, Colloidal silicon dioxide, Glacial Acetic Acid, Noncrystallizing Sorbitol Solution, Magnesium Aluminum Silicate, Polysorbate 80, Purified water."
    },
    {
      "NDCCode": "73289-0002-0",
      "PackageDescription": "50 PACKAGE in 1 CARTON (73289-0002-0)  > 10 mL in 1 PACKAGE",
      "NDC11Code": "73289-0002-00",
      "ProductNDC": "73289-0002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vigadrone",
      "NonProprietaryName": "Vigabatrin",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180621",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210196",
      "LabelerName": "Aucta Pharmaceuticals, Inc.",
      "SubstanceName": "VIGABATRIN",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-epileptic Agent [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-02-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20180621",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73289-0003-0",
      "PackageDescription": "50 PACKAGE in 1 CARTON (73289-0003-0)  > 10 mL in 1 PACKAGE",
      "NDC11Code": "73289-0003-00",
      "ProductNDC": "73289-0003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vigadrone",
      "NonProprietaryName": "Vigabatrin",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180621",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210196",
      "LabelerName": "Aucta Pharmaceuticals, Inc.",
      "SubstanceName": "VIGABATRIN",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-epileptic Agent [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-02-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20180621",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73289-0060-1",
      "PackageDescription": "30 POUCH in 1 CARTON (73289-0060-1)  / 2 mL in 1 POUCH (73289-0060-3) ",
      "NDC11Code": "73289-0060-01",
      "ProductNDC": "73289-0060",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Formoterol Fumarate",
      "NonProprietaryName": "Formoterol Fumarate Dihydrate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20221215",
      "EndMarketingDate": "20250331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216486",
      "LabelerName": "Aucta Pharmaceuticals, Inc",
      "SubstanceName": "FORMOTEROL FUMARATE",
      "StrengthNumber": ".02",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20221215",
      "EndMarketingDatePackage": "20250331",
      "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 840.93 and its empirical formula is (C 19H 24N 2O 4) 2C 4H 4O 42H 2O. 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": "73289-0060-2",
      "PackageDescription": "60 POUCH in 1 CARTON (73289-0060-2)  / 2 mL in 1 POUCH (73289-0060-3) ",
      "NDC11Code": "73289-0060-02",
      "ProductNDC": "73289-0060",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Formoterol Fumarate",
      "NonProprietaryName": "Formoterol Fumarate Dihydrate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20221215",
      "EndMarketingDate": "20250331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216486",
      "LabelerName": "Aucta Pharmaceuticals, Inc",
      "SubstanceName": "FORMOTEROL FUMARATE",
      "StrengthNumber": ".02",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20221215",
      "EndMarketingDatePackage": "20250331",
      "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 840.93 and its empirical formula is (C 19H 24N 2O 4) 2C 4H 4O 42H 2O. 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": "73289-0063-1",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (73289-0063-1)  / 14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "73289-0063-01",
      "ProductNDC": "73289-0063",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Motpoly Xr",
      "NonProprietaryName": "Lacosamide",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230505",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216185",
      "LabelerName": "Aucta Pharmaceuticals, Inc.",
      "SubstanceName": "LACOSAMIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2025-07-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230505",
      "SamplePackage": "Y",
      "IndicationAndUsage": "MOTPOLY XR is indicated for: 1 Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg (1.2).",
      "Description": "The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
    },
    {
      "NDCCode": "73289-0063-2",
      "PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (73289-0063-2) ",
      "NDC11Code": "73289-0063-02",
      "ProductNDC": "73289-0063",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Motpoly Xr",
      "NonProprietaryName": "Lacosamide",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230505",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216185",
      "LabelerName": "Aucta Pharmaceuticals, Inc.",
      "SubstanceName": "LACOSAMIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2025-07-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230505",
      "SamplePackage": "N",
      "IndicationAndUsage": "MOTPOLY XR is indicated for: 1 Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg (1.2).",
      "Description": "The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
    },
    {
      "NDCCode": "73289-0064-2",
      "PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (73289-0064-2) ",
      "NDC11Code": "73289-0064-02",
      "ProductNDC": "73289-0064",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Motpoly Xr",
      "NonProprietaryName": "Lacosamide",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230505",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216185",
      "LabelerName": "Aucta Pharmaceuticals, Inc.",
      "SubstanceName": "LACOSAMIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2025-07-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230505",
      "SamplePackage": "N",
      "IndicationAndUsage": "MOTPOLY XR is indicated for: 1 Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg (1.2).",
      "Description": "The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
    },
    {
      "NDCCode": "73289-0065-2",
      "PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (73289-0065-2) ",
      "NDC11Code": "73289-0065-02",
      "ProductNDC": "73289-0065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Motpoly Xr",
      "NonProprietaryName": "Lacosamide",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230505",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216185",
      "LabelerName": "Aucta Pharmaceuticals, Inc.",
      "SubstanceName": "LACOSAMIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2025-07-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230505",
      "SamplePackage": "N",
      "IndicationAndUsage": "MOTPOLY XR is indicated for: 1 Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg (1.2).",
      "Description": "The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
    },
    {
      "NDCCode": "73289-0067-1",
      "PackageDescription": "1 GRANULE, FOR SOLUTION in 1 PACKET (73289-0067-1) ",
      "NDC11Code": "73289-0067-01",
      "ProductNDC": "73289-0067",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fosfomycin Tromethamine",
      "NonProprietaryName": "Fosfomycin Tromethamine",
      "DosageFormName": "GRANULE, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260409",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217772",
      "LabelerName": "Aucta Pharmaceuticals, Inc.",
      "SubstanceName": "FOSFOMYCIN TROMETHAMINE",
      "StrengthNumber": "3",
      "StrengthUnit": "g/1",
      "Status": "Active",
      "LastUpdate": "2026-04-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260409",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of  Escherichia coli and Enterococcus faecalis. Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONSand  CLINICAL STUDIESsections.).",
      "Description": "Fosfomycin tromethamine granules for oral solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single­ dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredient:sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (lR,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C3H7O4PC4H11NO3, and its chemical structure is as follows."
    },
    {
      "NDCCode": "73289-0067-2",
      "PackageDescription": "1 DOSE PACK in 1 CARTON (73289-0067-2)  / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK",
      "NDC11Code": "73289-0067-02",
      "ProductNDC": "73289-0067",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fosfomycin Tromethamine",
      "NonProprietaryName": "Fosfomycin Tromethamine",
      "DosageFormName": "GRANULE, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260409",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217772",
      "LabelerName": "Aucta Pharmaceuticals, Inc.",
      "SubstanceName": "FOSFOMYCIN TROMETHAMINE",
      "StrengthNumber": "3",
      "StrengthUnit": "g/1",
      "Status": "Active",
      "LastUpdate": "2026-04-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260409",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of  Escherichia coli and Enterococcus faecalis. Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONSand  CLINICAL STUDIESsections.).",
      "Description": "Fosfomycin tromethamine granules for oral solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single­ dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredient:sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (lR,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C3H7O4PC4H11NO3, and its chemical structure is as follows."
    },
    {
      "NDCCode": "73289-0070-2",
      "PackageDescription": "30 PACKET in 1 CARTON (73289-0070-2)  / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0070-1) ",
      "NDC11Code": "73289-0070-02",
      "ProductNDC": "73289-0070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zelvysia",
      "NonProprietaryName": "Sapropterin Dihydrochloride",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250429",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218645",
      "LabelerName": "Aucta Pharmaceuticals, Inc.",
      "SubstanceName": "SAPROPTERIN DIHYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250429",
      "SamplePackage": "N",
      "IndicationAndUsage": "Zelvysia is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Zelvysia is to be used in conjunction with a Phe-restricted diet.",
      "Description": "Zelvysia (sapropterin dihydrochloride) is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in Zelvysia , is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is an off-white to pale yellow powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C 9H 15N 5O 3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. Zelvysia is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Zelvysia is also supplied as powder for oral solution containing 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base). Zelvysia powder for oral solution is off-white to yellow in color. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol (USP) and potassium citrate (USP)."
    },
    {
      "NDCCode": "73289-0071-2",
      "PackageDescription": "30 PACKET in 1 CARTON (73289-0071-2)  / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0071-1) ",
      "NDC11Code": "73289-0071-02",
      "ProductNDC": "73289-0071",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zelvysia",
      "NonProprietaryName": "Sapropterin Dihydrochloride",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250429",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218645",
      "LabelerName": "Aucta Pharmaceuticals, Inc.",
      "SubstanceName": "SAPROPTERIN DIHYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250429",
      "SamplePackage": "N",
      "IndicationAndUsage": "Zelvysia is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Zelvysia is to be used in conjunction with a Phe-restricted diet.",
      "Description": "Zelvysia (sapropterin dihydrochloride) is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in Zelvysia , is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is an off-white to pale yellow powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C 9H 15N 5O 3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. Zelvysia is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Zelvysia is also supplied as powder for oral solution containing 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base). Zelvysia powder for oral solution is off-white to yellow in color. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol (USP) and potassium citrate (USP)."
    },
    {
      "NDCCode": "73289-0072-3",
      "PackageDescription": "30 POUCH in 1 CARTON (73289-0072-3)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (73289-0072-1)  / 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "73289-0072-03",
      "ProductNDC": "73289-0072",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Arformoterol Tartrate Inhalation Solution",
      "NonProprietaryName": "Arformoterol Tartrate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250211",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218380",
      "LabelerName": "Aucta Pharmaceuticals, Inc.",
      "SubstanceName": "ARFORMOTEROL TARTRATE",
      "StrengthNumber": "15",
      "StrengthUnit": "ug/2mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250211",
      "SamplePackage": "N",
      "IndicationAndUsage": "Arformoterol Tartrate Inhalation Solution is a long-acting beta 2-adrenergic agonist (beta 2-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 beta 2-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 tartrateis 494.5 g/mol, and its empirical formula is C 19H 24N 2O 4C 4H 6O 6(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 NEB 3000 compressor under in vitroconditions, 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": "73289-0072-4",
      "PackageDescription": "15 POUCH in 1 CARTON (73289-0072-4)  / 4 VIAL, SINGLE-DOSE in 1 POUCH (73289-0072-2)  / 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "73289-0072-04",
      "ProductNDC": "73289-0072",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Arformoterol Tartrate Inhalation Solution",
      "NonProprietaryName": "Arformoterol Tartrate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250211",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218380",
      "LabelerName": "Aucta Pharmaceuticals, Inc.",
      "SubstanceName": "ARFORMOTEROL TARTRATE",
      "StrengthNumber": "15",
      "StrengthUnit": "ug/2mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250211",
      "SamplePackage": "N",
      "IndicationAndUsage": "Arformoterol Tartrate Inhalation Solution is a long-acting beta 2-adrenergic agonist (beta 2-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 beta 2-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 tartrateis 494.5 g/mol, and its empirical formula is C 19H 24N 2O 4C 4H 6O 6(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 NEB 3000 compressor under in vitroconditions, 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": "0089-0175-40",
      "PackageDescription": "120 AEROSOL, METERED in 1 CANISTER (0089-0175-40)",
      "NDC11Code": "00089-0175-40",
      "ProductNDC": "0089-0175",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Beclomethasone Dipropionate",
      "DosageFormName": "AEROSOL, METERED",
      "StartMarketingDate": "20140915",
      "EndMarketingDate": "20191031",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "3M Company",
      "SubstanceName": "BECLOMETHASONE DIPROPIONATE",
      "StrengthNumber": "40",
      "StrengthUnit": "ug/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04"
    },
    {
      "NDCCode": "0089-0177-80",
      "PackageDescription": "120 AEROSOL, METERED in 1 CANISTER (0089-0177-80)",
      "NDC11Code": "00089-0177-80",
      "ProductNDC": "0089-0177",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Beclomethasone Dipropionate",
      "DosageFormName": "AEROSOL, METERED",
      "StartMarketingDate": "20140915",
      "EndMarketingDate": "20191130",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "3M Company",
      "SubstanceName": "BECLOMETHASONE DIPROPIONATE",
      "StrengthNumber": "80",
      "StrengthUnit": "ug/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04"
    },
    {
      "NDCCode": "0089-0231-10",
      "PackageDescription": "100 TABLET, MULTILAYER in 1 BOTTLE (0089-0231-10)",
      "NDC11Code": "00089-0231-10",
      "ProductNDC": "0089-0231",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Norgesic",
      "NonProprietaryName": "Orphenadrine Citrate, Aspirin And Caffeine",
      "DosageFormName": "TABLET, MULTILAYER",
      "RouteName": "ORAL",
      "StartMarketingDate": "19640304",
      "EndMarketingDate": "20151231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA013416",
      "LabelerName": "3M Pharmaceuticals",
      "SubstanceName": "ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE",
      "StrengthNumber": "25; 385; 30",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-01-01"
    },
    {
      "NDCCode": "0089-0231-50",
      "PackageDescription": "500 TABLET, MULTILAYER in 1 BOTTLE (0089-0231-50)",
      "NDC11Code": "00089-0231-50",
      "ProductNDC": "0089-0231",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Norgesic",
      "NonProprietaryName": "Orphenadrine Citrate, Aspirin And Caffeine",
      "DosageFormName": "TABLET, MULTILAYER",
      "RouteName": "ORAL",
      "StartMarketingDate": "19640304",
      "EndMarketingDate": "20151231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA013416",
      "LabelerName": "3M Pharmaceuticals",
      "SubstanceName": "ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE",
      "StrengthNumber": "25; 385; 30",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-01-01"
    },
    {
      "NDCCode": "0089-0233-10",
      "PackageDescription": "100 TABLET, MULTILAYER in 1 BOTTLE (0089-0233-10)",
      "NDC11Code": "00089-0233-10",
      "ProductNDC": "0089-0233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Norgesic Forte",
      "NonProprietaryName": "Orphenadrine Citrate, Aspirin And Caffeine",
      "DosageFormName": "TABLET, MULTILAYER",
      "RouteName": "ORAL",
      "StartMarketingDate": "19640304",
      "EndMarketingDate": "20151231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA013416",
      "LabelerName": "3M Pharmaceuticals",
      "SubstanceName": "ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE",
      "StrengthNumber": "50; 770; 60",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-01-01"
    },
    {
      "NDCCode": "0089-0233-50",
      "PackageDescription": "500 TABLET, MULTILAYER in 1 BOTTLE (0089-0233-50)",
      "NDC11Code": "00089-0233-50",
      "ProductNDC": "0089-0233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Norgesic Forte",
      "NonProprietaryName": "Orphenadrine Citrate, Aspirin And Caffeine",
      "DosageFormName": "TABLET, MULTILAYER",
      "RouteName": "ORAL",
      "StartMarketingDate": "19640304",
      "EndMarketingDate": "20151231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA013416",
      "LabelerName": "3M Pharmaceuticals",
      "SubstanceName": "ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE",
      "StrengthNumber": "50; 770; 60",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-01-01"
    },
    {
      "NDCCode": "0089-0510-06",
      "PackageDescription": "6 AMPULE in 1 BOX (0089-0510-06)  > 5 mL in 1 AMPULE",
      "NDC11Code": "00089-0510-06",
      "ProductNDC": "0089-0510",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcium Disodium Versenate",
      "NonProprietaryName": "Edetate Calcium Disodium",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20090709",
      "EndMarketingDate": "20151231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA008922",
      "LabelerName": "3M Pharmaceuticals",
      "SubstanceName": "EDETATE CALCIUM DISODIUM",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Lead Chelating Activity [MoA],Lead Chelator [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-01-01"
    },
    {
      "NDCCode": "0089-0610-12",
      "PackageDescription": "12 PACKET in 1 BOX (0089-0610-12)  > 250 mg in 1 PACKET",
      "NDC11Code": "00089-0610-12",
      "ProductNDC": "0089-0610",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aldara",
      "NonProprietaryName": "Imiquimod",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110624",
      "EndMarketingDate": "20150131",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020723",
      "LabelerName": "3M Pharmaceuticals",
      "SubstanceName": "IMIQUIMOD",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1000mg",
      "Pharm_Classes": "Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2015-02-06"
    },
    {
      "NDCCode": "0089-1206-06",
      "PackageDescription": "1 INHALER in 1 CARTON (0089-1206-06)  > 60 AEROSOL, METERED in 1 INHALER",
      "NDC11Code": "00089-1206-06",
      "ProductNDC": "0089-1206",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Beclomethasone Dipropionate",
      "DosageFormName": "AEROSOL, METERED",
      "StartMarketingDate": "20150201",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "3M Company",
      "SubstanceName": "BECLOMETHASONE DIPROPIONATE",
      "StrengthNumber": "40",
      "StrengthUnit": "ug/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "0089-1210-12",
      "PackageDescription": "120 AEROSOL, METERED in 1 INHALER (0089-1210-12)",
      "NDC11Code": "00089-1210-12",
      "ProductNDC": "0089-1210",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Beclomethasone Dipropionate",
      "DosageFormName": "AEROSOL, METERED",
      "StartMarketingDate": "20120413",
      "EndMarketingDate": "20200212",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "3M Company",
      "SubstanceName": "BECLOMETHASONE DIPROPIONATE",
      "StrengthNumber": "80",
      "StrengthUnit": "ug/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04"
    },
    {
      "NDCCode": "0089-1210-50",
      "PackageDescription": "50 AEROSOL, METERED in 1 PACKAGE (0089-1210-50)",
      "NDC11Code": "00089-1210-50",
      "ProductNDC": "0089-1210",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Beclomethasone Dipropionate",
      "DosageFormName": "AEROSOL, METERED",
      "StartMarketingDate": "20120413",
      "EndMarketingDate": "20200212",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "3M Company",
      "SubstanceName": "BECLOMETHASONE DIPROPIONATE",
      "StrengthNumber": "80",
      "StrengthUnit": "ug/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04"
    },
    {
      "NDCCode": "0089-5870-24",
      "PackageDescription": "450 cm2 in 1 CARTON (0089-5870-24)",
      "NDC11Code": "00089-5870-24",
      "ProductNDC": "0089-5870",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Flurandrenolide",
      "DosageFormName": "TAPE",
      "StartMarketingDate": "20160815",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "3m Company",
      "SubstanceName": "FLURANDRENOLIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "ug/cm2",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "0093-0089-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0093-0089-01)",
      "NDC11Code": "00093-0089-01",
      "ProductNDC": "0093-0089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "ProprietaryNameSuffix": "(double Strength)",
      "NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19900930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070037",
      "LabelerName": "Teva Pharmaceuticals USA Inc",
      "SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
      "StrengthNumber": "800; 160",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-02-03"
    },
    {
      "NDCCode": "0093-0089-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (0093-0089-05)",
      "NDC11Code": "00093-0089-05",
      "ProductNDC": "0093-0089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "ProprietaryNameSuffix": "(double Strength)",
      "NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19900930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070037",
      "LabelerName": "Teva Pharmaceuticals USA Inc",
      "SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
      "StrengthNumber": "800; 160",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-02-03"
    },
    {
      "NDCCode": "0095-0089-21",
      "PackageDescription": "21 TABLET in 1 BLISTER PACK (0095-0089-21) ",
      "NDC11Code": "00095-0089-21",
      "ProductNDC": "0095-0089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexamethasone",
      "NonProprietaryName": "Dexamethasone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040700",
      "LabelerName": "Bausch Health US LLC",
      "SubstanceName": "DEXAMETHASONE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20090401",
      "SamplePackage": "N"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"73289-0089-1","ProprietaryName":"Pyquvi","NonProprietaryName":"Deflazacort"},{"NDCCode":"73289-0002-0","ProprietaryName":"Vigadrone","NonProprietaryName":"Vigabatrin"},{"NDCCode":"73289-0003-0","ProprietaryName":"Vigadrone","NonProprietaryName":"Vigabatrin"},{"NDCCode":"73289-0060-1","ProprietaryName":"Formoterol Fumarate","NonProprietaryName":"Formoterol Fumarate Dihydrate"},{"NDCCode":"73289-0060-2","ProprietaryName":"Formoterol Fumarate","NonProprietaryName":"Formoterol Fumarate Dihydrate"},{"NDCCode":"73289-0063-1","ProprietaryName":"Motpoly Xr","NonProprietaryName":"Lacosamide"},{"NDCCode":"73289-0063-2","ProprietaryName":"Motpoly Xr","NonProprietaryName":"Lacosamide"},{"NDCCode":"73289-0064-2","ProprietaryName":"Motpoly Xr","NonProprietaryName":"Lacosamide"},{"NDCCode":"73289-0065-2","ProprietaryName":"Motpoly Xr","NonProprietaryName":"Lacosamide"},{"NDCCode":"73289-0067-1","ProprietaryName":"Fosfomycin Tromethamine","NonProprietaryName":"Fosfomycin Tromethamine"},{"NDCCode":"73289-0067-2","ProprietaryName":"Fosfomycin Tromethamine","NonProprietaryName":"Fosfomycin Tromethamine"},{"NDCCode":"73289-0070-2","ProprietaryName":"Zelvysia","NonProprietaryName":"Sapropterin Dihydrochloride"},{"NDCCode":"73289-0071-2","ProprietaryName":"Zelvysia","NonProprietaryName":"Sapropterin Dihydrochloride"},{"NDCCode":"73289-0072-3","ProprietaryName":"Arformoterol Tartrate Inhalation Solution","NonProprietaryName":"Arformoterol Tartrate"},{"NDCCode":"73289-0072-4","ProprietaryName":"Arformoterol Tartrate Inhalation Solution","NonProprietaryName":"Arformoterol Tartrate"},{"NDCCode":"0089-0175-40","NonProprietaryName":"Beclomethasone Dipropionate"},{"NDCCode":"0089-0177-80","NonProprietaryName":"Beclomethasone Dipropionate"},{"NDCCode":"0089-0231-10","ProprietaryName":"Norgesic","NonProprietaryName":"Orphenadrine Citrate, Aspirin And Caffeine"},{"NDCCode":"0089-0231-50","ProprietaryName":"Norgesic","NonProprietaryName":"Orphenadrine Citrate, Aspirin And Caffeine"},{"NDCCode":"0089-0233-10","ProprietaryName":"Norgesic Forte","NonProprietaryName":"Orphenadrine Citrate, Aspirin And Caffeine"},{"NDCCode":"0089-0233-50","ProprietaryName":"Norgesic Forte","NonProprietaryName":"Orphenadrine Citrate, Aspirin And Caffeine"},{"NDCCode":"0089-0510-06","ProprietaryName":"Calcium Disodium Versenate","NonProprietaryName":"Edetate Calcium Disodium"},{"NDCCode":"0089-0610-12","ProprietaryName":"Aldara","NonProprietaryName":"Imiquimod"},{"NDCCode":"0089-1206-06","NonProprietaryName":"Beclomethasone Dipropionate"},{"NDCCode":"0089-1210-12","NonProprietaryName":"Beclomethasone Dipropionate"},{"NDCCode":"0089-1210-50","NonProprietaryName":"Beclomethasone Dipropionate"},{"NDCCode":"0089-5870-24","NonProprietaryName":"Flurandrenolide"},{"NDCCode":"0093-0089-01","ProprietaryName":"Sulfamethoxazole And Trimethoprim","NonProprietaryName":"Sulfamethoxazole And Trimethoprim"},{"NDCCode":"0093-0089-05","ProprietaryName":"Sulfamethoxazole And Trimethoprim","NonProprietaryName":"Sulfamethoxazole And Trimethoprim"},{"NDCCode":"0095-0089-21","ProprietaryName":"Dexamethasone","NonProprietaryName":"Dexamethasone"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>73289-0089-1</NDCCode>
    <PackageDescription>13 mL in 1 BOTTLE (73289-0089-1) </PackageDescription>
    <NDC11Code>73289-0089-01</NDC11Code>
    <ProductNDC>73289-0089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pyquvi</ProprietaryName>
    <NonProprietaryName>Deflazacort</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219417</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DEFLAZACORT</SubstanceName>
    <StrengthNumber>22.75</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PYQUVI is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza ® (deflazacort) oral suspension. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>The active ingredient in PYQUVI is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic.  The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is 16α,17-isoxazole-11β,21-dihydroxypregna-1,4-diene-3,20-dione 21acetate, and the structure is:. Deflazacort is a white or almost white crystalline powder and has a molecular weight of 441.52. Deflazacort is soluble in dichloromethane and chloroform, slightly soluble in ethanol and ethyl acetate, almost insoluble in water. PYQUVI for oral administration is available as an immediate-release oral suspension in a strength of 22.75 mg/mL. The oral suspension contains deflazacort and the following inactive ingredients: Benzyl Alcohol, Carboxymethylcellulose Sodium, Colloidal silicon dioxide, Glacial Acetic Acid, Noncrystallizing Sorbitol Solution, Magnesium Aluminum Silicate, Polysorbate 80, Purified water.</Description>
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  <NDC>
    <NDCCode>73289-0002-0</NDCCode>
    <PackageDescription>50 PACKAGE in 1 CARTON (73289-0002-0)  &gt; 10 mL in 1 PACKAGE</PackageDescription>
    <NDC11Code>73289-0002-00</NDC11Code>
    <ProductNDC>73289-0002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vigadrone</ProprietaryName>
    <NonProprietaryName>Vigabatrin</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180621</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210196</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>VIGABATRIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-02-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180621</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>73289-0003-0</NDCCode>
    <PackageDescription>50 PACKAGE in 1 CARTON (73289-0003-0)  &gt; 10 mL in 1 PACKAGE</PackageDescription>
    <NDC11Code>73289-0003-00</NDC11Code>
    <ProductNDC>73289-0003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vigadrone</ProprietaryName>
    <NonProprietaryName>Vigabatrin</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180621</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210196</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>VIGABATRIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-02-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180621</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>73289-0060-1</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (73289-0060-1)  / 2 mL in 1 POUCH (73289-0060-3) </PackageDescription>
    <NDC11Code>73289-0060-01</NDC11Code>
    <ProductNDC>73289-0060</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Formoterol Fumarate</ProprietaryName>
    <NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20221215</StartMarketingDate>
    <EndMarketingDate>20250331</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216486</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>FORMOTEROL FUMARATE</SubstanceName>
    <StrengthNumber>.02</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20221215</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <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) .</IndicationAndUsage>
    <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 840.93 and its empirical formula is (C 19H 24N 2O 4) 2C 4H 4O 42H 2O. 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.</Description>
  </NDC>
  <NDC>
    <NDCCode>73289-0060-2</NDCCode>
    <PackageDescription>60 POUCH in 1 CARTON (73289-0060-2)  / 2 mL in 1 POUCH (73289-0060-3) </PackageDescription>
    <NDC11Code>73289-0060-02</NDC11Code>
    <ProductNDC>73289-0060</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Formoterol Fumarate</ProprietaryName>
    <NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20221215</StartMarketingDate>
    <EndMarketingDate>20250331</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216486</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>FORMOTEROL FUMARATE</SubstanceName>
    <StrengthNumber>.02</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20221215</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <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) .</IndicationAndUsage>
    <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 840.93 and its empirical formula is (C 19H 24N 2O 4) 2C 4H 4O 42H 2O. 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.</Description>
  </NDC>
  <NDC>
    <NDCCode>73289-0063-1</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (73289-0063-1)  / 14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>73289-0063-01</NDC11Code>
    <ProductNDC>73289-0063</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Motpoly Xr</ProprietaryName>
    <NonProprietaryName>Lacosamide</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230505</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216185</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LACOSAMIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-07-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230505</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>MOTPOLY XR is indicated for: 1 Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg (1.2).</IndicationAndUsage>
    <Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>73289-0063-2</NDCCode>
    <PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (73289-0063-2) </PackageDescription>
    <NDC11Code>73289-0063-02</NDC11Code>
    <ProductNDC>73289-0063</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Motpoly Xr</ProprietaryName>
    <NonProprietaryName>Lacosamide</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230505</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216185</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LACOSAMIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-07-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>MOTPOLY XR is indicated for: 1 Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg (1.2).</IndicationAndUsage>
    <Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>73289-0064-2</NDCCode>
    <PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (73289-0064-2) </PackageDescription>
    <NDC11Code>73289-0064-02</NDC11Code>
    <ProductNDC>73289-0064</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Motpoly Xr</ProprietaryName>
    <NonProprietaryName>Lacosamide</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230505</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216185</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LACOSAMIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-07-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>MOTPOLY XR is indicated for: 1 Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg (1.2).</IndicationAndUsage>
    <Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>73289-0065-2</NDCCode>
    <PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (73289-0065-2) </PackageDescription>
    <NDC11Code>73289-0065-02</NDC11Code>
    <ProductNDC>73289-0065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Motpoly Xr</ProprietaryName>
    <NonProprietaryName>Lacosamide</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230505</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216185</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LACOSAMIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-07-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>MOTPOLY XR is indicated for: 1 Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg (1.2).</IndicationAndUsage>
    <Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>73289-0067-1</NDCCode>
    <PackageDescription>1 GRANULE, FOR SOLUTION in 1 PACKET (73289-0067-1) </PackageDescription>
    <NDC11Code>73289-0067-01</NDC11Code>
    <ProductNDC>73289-0067</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fosfomycin Tromethamine</ProprietaryName>
    <NonProprietaryName>Fosfomycin Tromethamine</NonProprietaryName>
    <DosageFormName>GRANULE, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260409</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217772</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FOSFOMYCIN TROMETHAMINE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of  Escherichia coli and Enterococcus faecalis. Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONSand  CLINICAL STUDIESsections.).</IndicationAndUsage>
    <Description>Fosfomycin tromethamine granules for oral solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single­ dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredient:sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (lR,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C3H7O4PC4H11NO3, and its chemical structure is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>73289-0067-2</NDCCode>
    <PackageDescription>1 DOSE PACK in 1 CARTON (73289-0067-2)  / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK</PackageDescription>
    <NDC11Code>73289-0067-02</NDC11Code>
    <ProductNDC>73289-0067</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fosfomycin Tromethamine</ProprietaryName>
    <NonProprietaryName>Fosfomycin Tromethamine</NonProprietaryName>
    <DosageFormName>GRANULE, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260409</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217772</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FOSFOMYCIN TROMETHAMINE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of  Escherichia coli and Enterococcus faecalis. Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONSand  CLINICAL STUDIESsections.).</IndicationAndUsage>
    <Description>Fosfomycin tromethamine granules for oral solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single­ dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredient:sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (lR,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C3H7O4PC4H11NO3, and its chemical structure is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>73289-0070-2</NDCCode>
    <PackageDescription>30 PACKET in 1 CARTON (73289-0070-2)  / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0070-1) </PackageDescription>
    <NDC11Code>73289-0070-02</NDC11Code>
    <ProductNDC>73289-0070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zelvysia</ProprietaryName>
    <NonProprietaryName>Sapropterin Dihydrochloride</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250429</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218645</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SAPROPTERIN DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zelvysia is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Zelvysia is to be used in conjunction with a Phe-restricted diet.</IndicationAndUsage>
    <Description>Zelvysia (sapropterin dihydrochloride) is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in Zelvysia , is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is an off-white to pale yellow powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C 9H 15N 5O 3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. Zelvysia is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Zelvysia is also supplied as powder for oral solution containing 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base). Zelvysia powder for oral solution is off-white to yellow in color. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol (USP) and potassium citrate (USP).</Description>
  </NDC>
  <NDC>
    <NDCCode>73289-0071-2</NDCCode>
    <PackageDescription>30 PACKET in 1 CARTON (73289-0071-2)  / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0071-1) </PackageDescription>
    <NDC11Code>73289-0071-02</NDC11Code>
    <ProductNDC>73289-0071</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zelvysia</ProprietaryName>
    <NonProprietaryName>Sapropterin Dihydrochloride</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250429</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218645</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SAPROPTERIN DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zelvysia is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Zelvysia is to be used in conjunction with a Phe-restricted diet.</IndicationAndUsage>
    <Description>Zelvysia (sapropterin dihydrochloride) is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in Zelvysia , is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is an off-white to pale yellow powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C 9H 15N 5O 3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. Zelvysia is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Zelvysia is also supplied as powder for oral solution containing 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base). Zelvysia powder for oral solution is off-white to yellow in color. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol (USP) and potassium citrate (USP).</Description>
  </NDC>
  <NDC>
    <NDCCode>73289-0072-3</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (73289-0072-3)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (73289-0072-1)  / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>73289-0072-03</NDC11Code>
    <ProductNDC>73289-0072</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Arformoterol Tartrate Inhalation Solution</ProprietaryName>
    <NonProprietaryName>Arformoterol Tartrate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20250211</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218380</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ARFORMOTEROL TARTRATE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>ug/2mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Arformoterol Tartrate Inhalation Solution is a long-acting beta 2-adrenergic agonist (beta 2-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) .</IndicationAndUsage>
    <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 beta 2-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 tartrateis 494.5 g/mol, and its empirical formula is C 19H 24N 2O 4C 4H 6O 6(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 NEB 3000 compressor under in vitroconditions, 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).</Description>
  </NDC>
  <NDC>
    <NDCCode>73289-0072-4</NDCCode>
    <PackageDescription>15 POUCH in 1 CARTON (73289-0072-4)  / 4 VIAL, SINGLE-DOSE in 1 POUCH (73289-0072-2)  / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>73289-0072-04</NDC11Code>
    <ProductNDC>73289-0072</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Arformoterol Tartrate Inhalation Solution</ProprietaryName>
    <NonProprietaryName>Arformoterol Tartrate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20250211</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218380</ApplicationNumber>
    <LabelerName>Aucta Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ARFORMOTEROL TARTRATE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>ug/2mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Arformoterol Tartrate Inhalation Solution is a long-acting beta 2-adrenergic agonist (beta 2-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) .</IndicationAndUsage>
    <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 beta 2-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 tartrateis 494.5 g/mol, and its empirical formula is C 19H 24N 2O 4C 4H 6O 6(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 NEB 3000 compressor under in vitroconditions, 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).</Description>
  </NDC>
  <NDC>
    <NDCCode>0089-0175-40</NDCCode>
    <PackageDescription>120 AEROSOL, METERED in 1 CANISTER (0089-0175-40)</PackageDescription>
    <NDC11Code>00089-0175-40</NDC11Code>
    <ProductNDC>0089-0175</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
    <DosageFormName>AEROSOL, METERED</DosageFormName>
    <StartMarketingDate>20140915</StartMarketingDate>
    <EndMarketingDate>20191031</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>3M Company</LabelerName>
    <SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0089-0177-80</NDCCode>
    <PackageDescription>120 AEROSOL, METERED in 1 CANISTER (0089-0177-80)</PackageDescription>
    <NDC11Code>00089-0177-80</NDC11Code>
    <ProductNDC>0089-0177</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
    <DosageFormName>AEROSOL, METERED</DosageFormName>
    <StartMarketingDate>20140915</StartMarketingDate>
    <EndMarketingDate>20191130</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>3M Company</LabelerName>
    <SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0089-0231-10</NDCCode>
    <PackageDescription>100 TABLET, MULTILAYER in 1 BOTTLE (0089-0231-10)</PackageDescription>
    <NDC11Code>00089-0231-10</NDC11Code>
    <ProductNDC>0089-0231</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norgesic</ProprietaryName>
    <NonProprietaryName>Orphenadrine Citrate, Aspirin And Caffeine</NonProprietaryName>
    <DosageFormName>TABLET, MULTILAYER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19640304</StartMarketingDate>
    <EndMarketingDate>20151231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA013416</ApplicationNumber>
    <LabelerName>3M Pharmaceuticals</LabelerName>
    <SubstanceName>ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE</SubstanceName>
    <StrengthNumber>25; 385; 30</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-01-01</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0089-0231-50</NDCCode>
    <PackageDescription>500 TABLET, MULTILAYER in 1 BOTTLE (0089-0231-50)</PackageDescription>
    <NDC11Code>00089-0231-50</NDC11Code>
    <ProductNDC>0089-0231</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norgesic</ProprietaryName>
    <NonProprietaryName>Orphenadrine Citrate, Aspirin And Caffeine</NonProprietaryName>
    <DosageFormName>TABLET, MULTILAYER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19640304</StartMarketingDate>
    <EndMarketingDate>20151231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA013416</ApplicationNumber>
    <LabelerName>3M Pharmaceuticals</LabelerName>
    <SubstanceName>ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE</SubstanceName>
    <StrengthNumber>25; 385; 30</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-01-01</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0089-0233-10</NDCCode>
    <PackageDescription>100 TABLET, MULTILAYER in 1 BOTTLE (0089-0233-10)</PackageDescription>
    <NDC11Code>00089-0233-10</NDC11Code>
    <ProductNDC>0089-0233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norgesic Forte</ProprietaryName>
    <NonProprietaryName>Orphenadrine Citrate, Aspirin And Caffeine</NonProprietaryName>
    <DosageFormName>TABLET, MULTILAYER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19640304</StartMarketingDate>
    <EndMarketingDate>20151231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA013416</ApplicationNumber>
    <LabelerName>3M Pharmaceuticals</LabelerName>
    <SubstanceName>ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE</SubstanceName>
    <StrengthNumber>50; 770; 60</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-01-01</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0089-0233-50</NDCCode>
    <PackageDescription>500 TABLET, MULTILAYER in 1 BOTTLE (0089-0233-50)</PackageDescription>
    <NDC11Code>00089-0233-50</NDC11Code>
    <ProductNDC>0089-0233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norgesic Forte</ProprietaryName>
    <NonProprietaryName>Orphenadrine Citrate, Aspirin And Caffeine</NonProprietaryName>
    <DosageFormName>TABLET, MULTILAYER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19640304</StartMarketingDate>
    <EndMarketingDate>20151231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA013416</ApplicationNumber>
    <LabelerName>3M Pharmaceuticals</LabelerName>
    <SubstanceName>ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE</SubstanceName>
    <StrengthNumber>50; 770; 60</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-01-01</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0089-0510-06</NDCCode>
    <PackageDescription>6 AMPULE in 1 BOX (0089-0510-06)  &gt; 5 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>00089-0510-06</NDC11Code>
    <ProductNDC>0089-0510</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcium Disodium Versenate</ProprietaryName>
    <NonProprietaryName>Edetate Calcium Disodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20090709</StartMarketingDate>
    <EndMarketingDate>20151231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA008922</ApplicationNumber>
    <LabelerName>3M Pharmaceuticals</LabelerName>
    <SubstanceName>EDETATE CALCIUM DISODIUM</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Lead Chelating Activity [MoA],Lead Chelator [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-01-01</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0089-0610-12</NDCCode>
    <PackageDescription>12 PACKET in 1 BOX (0089-0610-12)  &gt; 250 mg in 1 PACKET</PackageDescription>
    <NDC11Code>00089-0610-12</NDC11Code>
    <ProductNDC>0089-0610</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aldara</ProprietaryName>
    <NonProprietaryName>Imiquimod</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110624</StartMarketingDate>
    <EndMarketingDate>20150131</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020723</ApplicationNumber>
    <LabelerName>3M Pharmaceuticals</LabelerName>
    <SubstanceName>IMIQUIMOD</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1000mg</StrengthUnit>
    <Pharm_Classes>Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-02-06</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0089-1206-06</NDCCode>
    <PackageDescription>1 INHALER in 1 CARTON (0089-1206-06)  &gt; 60 AEROSOL, METERED in 1 INHALER</PackageDescription>
    <NDC11Code>00089-1206-06</NDC11Code>
    <ProductNDC>0089-1206</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
    <DosageFormName>AEROSOL, METERED</DosageFormName>
    <StartMarketingDate>20150201</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>3M Company</LabelerName>
    <SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0089-1210-12</NDCCode>
    <PackageDescription>120 AEROSOL, METERED in 1 INHALER (0089-1210-12)</PackageDescription>
    <NDC11Code>00089-1210-12</NDC11Code>
    <ProductNDC>0089-1210</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
    <DosageFormName>AEROSOL, METERED</DosageFormName>
    <StartMarketingDate>20120413</StartMarketingDate>
    <EndMarketingDate>20200212</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>3M Company</LabelerName>
    <SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0089-1210-50</NDCCode>
    <PackageDescription>50 AEROSOL, METERED in 1 PACKAGE (0089-1210-50)</PackageDescription>
    <NDC11Code>00089-1210-50</NDC11Code>
    <ProductNDC>0089-1210</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
    <DosageFormName>AEROSOL, METERED</DosageFormName>
    <StartMarketingDate>20120413</StartMarketingDate>
    <EndMarketingDate>20200212</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>3M Company</LabelerName>
    <SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0089-5870-24</NDCCode>
    <PackageDescription>450 cm2 in 1 CARTON (0089-5870-24)</PackageDescription>
    <NDC11Code>00089-5870-24</NDC11Code>
    <ProductNDC>0089-5870</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Flurandrenolide</NonProprietaryName>
    <DosageFormName>TAPE</DosageFormName>
    <StartMarketingDate>20160815</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>3m Company</LabelerName>
    <SubstanceName>FLURANDRENOLIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/cm2</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0093-0089-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0093-0089-01)</PackageDescription>
    <NDC11Code>00093-0089-01</NDC11Code>
    <ProductNDC>0093-0089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
    <ProprietaryNameSuffix>(double Strength)</ProprietaryNameSuffix>
    <NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070037</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA Inc</LabelerName>
    <SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
    <StrengthNumber>800; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-02-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0093-0089-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (0093-0089-05)</PackageDescription>
    <NDC11Code>00093-0089-05</NDC11Code>
    <ProductNDC>0093-0089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
    <ProprietaryNameSuffix>(double Strength)</ProprietaryNameSuffix>
    <NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070037</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA Inc</LabelerName>
    <SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
    <StrengthNumber>800; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-02-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0095-0089-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BLISTER PACK (0095-0089-21) </PackageDescription>
    <NDC11Code>00095-0089-21</NDC11Code>
    <ProductNDC>0095-0089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040700</ApplicationNumber>
    <LabelerName>Bausch Health US LLC</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>73289-0089-1</NDCCode><ProprietaryName>Pyquvi</ProprietaryName><NonProprietaryName>Deflazacort</NonProprietaryName></NDC><NDC><NDCCode>73289-0002-0</NDCCode><ProprietaryName>Vigadrone</ProprietaryName><NonProprietaryName>Vigabatrin</NonProprietaryName></NDC><NDC><NDCCode>73289-0003-0</NDCCode><ProprietaryName>Vigadrone</ProprietaryName><NonProprietaryName>Vigabatrin</NonProprietaryName></NDC><NDC><NDCCode>73289-0060-1</NDCCode><ProprietaryName>Formoterol Fumarate</ProprietaryName><NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>73289-0060-2</NDCCode><ProprietaryName>Formoterol Fumarate</ProprietaryName><NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>73289-0063-1</NDCCode><ProprietaryName>Motpoly Xr</ProprietaryName><NonProprietaryName>Lacosamide</NonProprietaryName></NDC><NDC><NDCCode>73289-0063-2</NDCCode><ProprietaryName>Motpoly Xr</ProprietaryName><NonProprietaryName>Lacosamide</NonProprietaryName></NDC><NDC><NDCCode>73289-0064-2</NDCCode><ProprietaryName>Motpoly Xr</ProprietaryName><NonProprietaryName>Lacosamide</NonProprietaryName></NDC><NDC><NDCCode>73289-0065-2</NDCCode><ProprietaryName>Motpoly Xr</ProprietaryName><NonProprietaryName>Lacosamide</NonProprietaryName></NDC><NDC><NDCCode>73289-0067-1</NDCCode><ProprietaryName>Fosfomycin Tromethamine</ProprietaryName><NonProprietaryName>Fosfomycin Tromethamine</NonProprietaryName></NDC><NDC><NDCCode>73289-0067-2</NDCCode><ProprietaryName>Fosfomycin Tromethamine</ProprietaryName><NonProprietaryName>Fosfomycin Tromethamine</NonProprietaryName></NDC><NDC><NDCCode>73289-0070-2</NDCCode><ProprietaryName>Zelvysia</ProprietaryName><NonProprietaryName>Sapropterin Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>73289-0071-2</NDCCode><ProprietaryName>Zelvysia</ProprietaryName><NonProprietaryName>Sapropterin Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>73289-0072-3</NDCCode><ProprietaryName>Arformoterol Tartrate Inhalation Solution</ProprietaryName><NonProprietaryName>Arformoterol Tartrate</NonProprietaryName></NDC><NDC><NDCCode>73289-0072-4</NDCCode><ProprietaryName>Arformoterol Tartrate Inhalation Solution</ProprietaryName><NonProprietaryName>Arformoterol Tartrate</NonProprietaryName></NDC><NDC><NDCCode>0089-0175-40</NDCCode><NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName></NDC><NDC><NDCCode>0089-0177-80</NDCCode><NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName></NDC><NDC><NDCCode>0089-0231-10</NDCCode><ProprietaryName>Norgesic</ProprietaryName><NonProprietaryName>Orphenadrine Citrate, Aspirin And Caffeine</NonProprietaryName></NDC><NDC><NDCCode>0089-0231-50</NDCCode><ProprietaryName>Norgesic</ProprietaryName><NonProprietaryName>Orphenadrine Citrate, Aspirin And Caffeine</NonProprietaryName></NDC><NDC><NDCCode>0089-0233-10</NDCCode><ProprietaryName>Norgesic Forte</ProprietaryName><NonProprietaryName>Orphenadrine Citrate, Aspirin And Caffeine</NonProprietaryName></NDC><NDC><NDCCode>0089-0233-50</NDCCode><ProprietaryName>Norgesic Forte</ProprietaryName><NonProprietaryName>Orphenadrine Citrate, Aspirin And Caffeine</NonProprietaryName></NDC><NDC><NDCCode>0089-0510-06</NDCCode><ProprietaryName>Calcium Disodium Versenate</ProprietaryName><NonProprietaryName>Edetate Calcium Disodium</NonProprietaryName></NDC><NDC><NDCCode>0089-0610-12</NDCCode><ProprietaryName>Aldara</ProprietaryName><NonProprietaryName>Imiquimod</NonProprietaryName></NDC><NDC><NDCCode>0089-1206-06</NDCCode><NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName></NDC><NDC><NDCCode>0089-1210-12</NDCCode><NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName></NDC><NDC><NDCCode>0089-1210-50</NDCCode><NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName></NDC><NDC><NDCCode>0089-5870-24</NDCCode><NonProprietaryName>Flurandrenolide</NonProprietaryName></NDC><NDC><NDCCode>0093-0089-01</NDCCode><ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName><NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName></NDC><NDC><NDCCode>0093-0089-05</NDCCode><ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName><NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName></NDC><NDC><NDCCode>0095-0089-21</NDCCode><ProprietaryName>Dexamethasone</ProprietaryName><NonProprietaryName>Dexamethasone</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
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      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
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}
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