RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "65597-504-28",
      "PackageDescription": "1 BOTTLE in 1 CARTON (65597-504-28)  / 28 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "65597-0504-28",
      "ProductNDC": "65597-504",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vanflyta",
      "NonProprietaryName": "Quizartinib",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230720",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216993",
      "LabelerName": "Daiichi Sankyo Inc.",
      "SubstanceName": "QUIZARTINIB DIHYDROCHLORIDE",
      "StrengthNumber": "17.7",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "FMS-like Receptor Tyrosine Kinase 3 (FLT3) Inhibitors [MoA], Kinase Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230720",
      "SamplePackage": "N",
      "IndicationAndUsage": "VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1) and Clinical Studies (14)].",
      "Description": "VANFLYTA (quizartinib) is a kinase inhibitor for oral use. The chemical name of quizartinib dihydrochloride is N-(5-tert-butyl-isoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-ylethoxy)imidazo[2,1- b][1,3]benzothiazol-2-yl]phenyl}urea dihydrochloride. Quizartinib dihydrochloride is a white to off-white solid with a molecular formula of C29H32N6O4S∙2 HCl and a molecular weight of 633.6 for the salt and 560.7 for the free base. The aqueous solubility of quizartinib dihydrochloride (pKa 4.75 and 3.16) decreases with increasing pH. It is very slightly soluble in aqueous media at pH 1 and practically insoluble or insoluble at pH 2 and higher. Quizartinib dihydrochloride is very slightly soluble in ethanol. The chemical structure of quizartinib dihydrochloride is. VANFLYTA is supplied as film-coated tablets containing 20 mg and 30 mg quizartinib dihydrochloride equivalent to 17.7 mg or 26.5 mg of quizartinib, respectively. The inactive ingredients in the tablet core are hydroxypropyl betadex, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of hypromellose, talc, titanium dioxide, and triacetin. The 26.5 mg tablet coating also contains ferric oxide."
    },
    {
      "NDCCode": "65597-504-04",
      "PackageDescription": "1 BOTTLE in 1 CARTON (65597-504-04)  / 14 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "65597-0504-04",
      "ProductNDC": "65597-504",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vanflyta",
      "NonProprietaryName": "Quizartinib",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230720",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216993",
      "LabelerName": "Daiichi Sankyo Inc.",
      "SubstanceName": "QUIZARTINIB DIHYDROCHLORIDE",
      "StrengthNumber": "17.7",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "FMS-like Receptor Tyrosine Kinase 3 (FLT3) Inhibitors [MoA], Kinase Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230720",
      "SamplePackage": "N",
      "IndicationAndUsage": "VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1) and Clinical Studies (14)].",
      "Description": "VANFLYTA (quizartinib) is a kinase inhibitor for oral use. The chemical name of quizartinib dihydrochloride is N-(5-tert-butyl-isoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-ylethoxy)imidazo[2,1- b][1,3]benzothiazol-2-yl]phenyl}urea dihydrochloride. Quizartinib dihydrochloride is a white to off-white solid with a molecular formula of C29H32N6O4S∙2 HCl and a molecular weight of 633.6 for the salt and 560.7 for the free base. The aqueous solubility of quizartinib dihydrochloride (pKa 4.75 and 3.16) decreases with increasing pH. It is very slightly soluble in aqueous media at pH 1 and practically insoluble or insoluble at pH 2 and higher. Quizartinib dihydrochloride is very slightly soluble in ethanol. The chemical structure of quizartinib dihydrochloride is. VANFLYTA is supplied as film-coated tablets containing 20 mg and 30 mg quizartinib dihydrochloride equivalent to 17.7 mg or 26.5 mg of quizartinib, respectively. The inactive ingredients in the tablet core are hydroxypropyl betadex, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of hypromellose, talc, titanium dioxide, and triacetin. The 26.5 mg tablet coating also contains ferric oxide."
    },
    {
      "NDCCode": "65597-402-28",
      "PackageDescription": "1 BOTTLE in 1 CARTON (65597-402-28)  / 28 CAPSULE in 1 BOTTLE",
      "NDC11Code": "65597-0402-28",
      "ProductNDC": "65597-402",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Turalio",
      "NonProprietaryName": "Pexidartinib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190802",
      "EndMarketingDate": "20240131",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA211810",
      "LabelerName": "Daiichi Sankyo Inc.",
      "SubstanceName": "PEXIDARTINIB HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], Tyrosine Kinase Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-02-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190802",
      "EndMarketingDatePackage": "20240131",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65597-407-28",
      "PackageDescription": "1 BOTTLE in 1 CARTON (65597-407-28)  / 28 CAPSULE in 1 BOTTLE",
      "NDC11Code": "65597-0407-28",
      "ProductNDC": "65597-407",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Turalio",
      "NonProprietaryName": "Pexidartinib Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230201",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA211810",
      "LabelerName": "Daiichi Sankyo Inc.",
      "SubstanceName": "PEXIDARTINIB HYDROCHLORIDE",
      "StrengthNumber": "125",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], Tyrosine Kinase Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-01-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230201",
      "SamplePackage": "N",
      "IndicationAndUsage": "TURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.",
      "Description": "Pexidartinib is a kinase inhibitor. The chemical name of pexidartinib hydrochloride is 5-[(5-Chloro-1H-pyrrolo[2,3-b]pyridin-3-yl)methyl]-N-{[6-(trifluoromethyl)pyridin-3-yl]methyl}pyridin-2-amine monohydrochloride. Pexidartinib hydrochloride is an off-white to white solid. The molecular formula for pexidartinib hydrochloride is C20H15ClF3N5∙HCl. The molecular weight is 454.28 for the hydrochloride salt and 417.81 for the free base. The chemical structure is. The solubility of pexidartinib hydrochloride in aqueous solutions decreases with increasing pH. The pKa1 and pKa2 were determined to be 2.6 and 5.4 respectively for the conjugate acids. Pexidartinib hydrochloride is soluble in methanol, slightly soluble in water and ethanol, and practically insoluble in heptane. TURALIO (pexidartinib) capsules are for oral use. Each capsule contains 125 mg pexidartinib which is equivalent to 135.9 mg pexidartinib hydrochloride. The capsule contains the following inactive ingredients: poloxamer 407, mannitol, crospovidone, and magnesium stearate. The hypromellose capsule shell contains hypromellose, titanium dioxide and FD&C Blue No. 1."
    },
    {
      "NDCCode": "65597-511-28",
      "PackageDescription": "1 BOTTLE in 1 CARTON (65597-511-28)  / 28 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "65597-0511-28",
      "ProductNDC": "65597-511",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vanflyta",
      "NonProprietaryName": "Quizartinib",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230720",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216993",
      "LabelerName": "Daiichi Sankyo Inc.",
      "SubstanceName": "QUIZARTINIB DIHYDROCHLORIDE",
      "StrengthNumber": "26.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "FMS-like Receptor Tyrosine Kinase 3 (FLT3) Inhibitors [MoA], Kinase Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230720",
      "SamplePackage": "N",
      "IndicationAndUsage": "VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1) and Clinical Studies (14)].",
      "Description": "VANFLYTA (quizartinib) is a kinase inhibitor for oral use. The chemical name of quizartinib dihydrochloride is N-(5-tert-butyl-isoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-ylethoxy)imidazo[2,1- b][1,3]benzothiazol-2-yl]phenyl}urea dihydrochloride. Quizartinib dihydrochloride is a white to off-white solid with a molecular formula of C29H32N6O4S∙2 HCl and a molecular weight of 633.6 for the salt and 560.7 for the free base. The aqueous solubility of quizartinib dihydrochloride (pKa 4.75 and 3.16) decreases with increasing pH. It is very slightly soluble in aqueous media at pH 1 and practically insoluble or insoluble at pH 2 and higher. Quizartinib dihydrochloride is very slightly soluble in ethanol. The chemical structure of quizartinib dihydrochloride is. VANFLYTA is supplied as film-coated tablets containing 20 mg and 30 mg quizartinib dihydrochloride equivalent to 17.7 mg or 26.5 mg of quizartinib, respectively. The inactive ingredients in the tablet core are hydroxypropyl betadex, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of hypromellose, talc, titanium dioxide, and triacetin. The 26.5 mg tablet coating also contains ferric oxide."
    },
    {
      "NDCCode": "17224-504-28",
      "PackageDescription": "28 TABLET in 1 BOTTLE (17224-504-28) ",
      "NDC11Code": "17224-0504-28",
      "ProductNDC": "17224-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Np Thyroid",
      "NonProprietaryName": "Thyroid Tablets",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250801",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Calvin Scott & Co Inc.",
      "SubstanceName": "LIOTHYRONINE; LEVOTHYROXINE",
      "StrengthNumber": "13.5; 57",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Used as a thyroid hormone replacement for hypothyroidism."
    },
    {
      "NDCCode": "41250-504-02",
      "PackageDescription": "1 TUBE in 1 CARTON (41250-504-02)  > 28.4 g in 1 TUBE",
      "NDC11Code": "41250-0504-02",
      "ProductNDC": "41250-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Meijer",
      "ProprietaryNameSuffix": "Triple Antibiotic Plus Pain Relief",
      "NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120331",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333B",
      "LabelerName": "Meijer Distribution Inc",
      "SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE",
      "StrengthNumber": "500; 3.5; 10000; 10",
      "StrengthUnit": "[iU]/g; mg/g; [iU]/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "first aid to help prevent infection and for the temporary relief of pain or discomfort in minor: 1 cuts, 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "55312-504-02",
      "PackageDescription": "1 TUBE in 1 CARTON (55312-504-02)  > 28 g in 1 TUBE",
      "NDC11Code": "55312-0504-02",
      "ProductNDC": "55312-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Western Family",
      "ProprietaryNameSuffix": "Triple Antibiotic Plus Pain Relief",
      "NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120331",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333B",
      "LabelerName": "Western Family Foods Inc",
      "SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE",
      "StrengthNumber": "500; 3.5; 10000; 10",
      "StrengthUnit": "[iU]/g; mg/g; [iU]/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "first aid to help prevent infection and for the temporary relief of pain or discomfort in: 1 minor cuts, 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "63187-504-01",
      "PackageDescription": "1 TUBE in 1 CARTON (63187-504-01)  / 28.4 g in 1 TUBE",
      "NDC11Code": "63187-0504-01",
      "ProductNDC": "63187-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hydrocortisone",
      "ProprietaryNameSuffix": "With Aloe",
      "NonProprietaryName": "Hydrocortisone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19950823",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "HYDROCORTISONE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150202",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporary relief of itching associated with minor skin irritations and rashes due tooeczemaoinsect bitesopoison ivy, poison oak, or poison sumacosoapsodetergentsocosmeticsojewelryoseborrheic dermatitisopsoriasisoexternal genital and anal itching. other uses of this product should be only under the advice and supervision of a doctor."
    },
    {
      "NDCCode": "63304-504-28",
      "PackageDescription": "180 TABLET in 1 BOTTLE (63304-504-28)",
      "NDC11Code": "63304-0504-28",
      "ProductNDC": "63304-504",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acyclovir",
      "NonProprietaryName": "Acyclovir",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19990208",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074980",
      "LabelerName": "Ranbaxy Laboratories Ltd.",
      "SubstanceName": "ACYCLOVIR",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "72705-504-01",
      "PackageDescription": "1 TUBE in 1 BLISTER PACK (72705-504-01)  / 28 g in 1 TUBE",
      "NDC11Code": "72705-0504-01",
      "ProductNDC": "72705-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Frida Fluoride Strawberry Toothbrush Set",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20260801",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "Fridababy, LLC",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "2.2",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2026-08-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Aids in the prevention of dental cavities."
    },
    {
      "NDCCode": "65597-103-77",
      "PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-103-77)",
      "NDC11Code": "65597-0103-77",
      "ProductNDC": "65597-103",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benicar",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020425",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021286",
      "LabelerName": "Daiichi Sankyo, Inc",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2014-05-28"
    },
    {
      "NDCCode": "65597-104-77",
      "PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-104-77)",
      "NDC11Code": "65597-0104-77",
      "ProductNDC": "65597-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benicar",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020425",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021286",
      "LabelerName": "Daiichi Sankyo, Inc",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2014-05-28"
    },
    {
      "NDCCode": "65597-113-07",
      "PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-113-07) ",
      "NDC11Code": "65597-0113-07",
      "ProductNDC": "65597-113",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azor",
      "NonProprietaryName": "Amlodipine Besylate And Olmesartan Medoxomil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070926",
      "EndMarketingDate": "20250228",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022100",
      "LabelerName": "Daiichi Sankyo Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "10; 40",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20070926",
      "EndMarketingDatePackage": "20250228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Azor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Azor may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with Azor compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with Azor 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Azor 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on Azor 5/20 mg, and to 68% (systolic) and 85% (diastolic) on Azor 10/40 mg.",
      "Description": "Azor provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of Azor is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of Azor is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The structural formula for amlodipine besylate is. The structural formula for olmesartan medoxomil is. Azor contains amlodipine besylate, a white to off-white crystalline powder, and olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Each tablet of Azor also contains the following inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg tablets)."
    },
    {
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      "ProductNDC": "65597-113",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azor",
      "NonProprietaryName": "Amlodipine Besylate And Olmesartan Medoxomil",
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      "LabelerName": "Daiichi Sankyo Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "10; 40",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
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      "IndicationAndUsage": "Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Azor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Azor may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with Azor compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with Azor 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Azor 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on Azor 5/20 mg, and to 68% (systolic) and 85% (diastolic) on Azor 10/40 mg.",
      "Description": "Azor provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of Azor is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of Azor is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The structural formula for amlodipine besylate is. The structural formula for olmesartan medoxomil is. Azor contains amlodipine besylate, a white to off-white crystalline powder, and olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Each tablet of Azor also contains the following inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg tablets)."
    },
    {
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      "ProductNDC": "65597-113",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azor",
      "NonProprietaryName": "Amlodipine Besylate And Olmesartan Medoxomil",
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      "LabelerName": "Daiichi Sankyo Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "10; 40",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
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      "IndicationAndUsage": "Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Azor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Azor may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with Azor compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with Azor 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Azor 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on Azor 5/20 mg, and to 68% (systolic) and 85% (diastolic) on Azor 10/40 mg.",
      "Description": "Azor provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of Azor is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of Azor is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The structural formula for amlodipine besylate is. The structural formula for olmesartan medoxomil is. Azor contains amlodipine besylate, a white to off-white crystalline powder, and olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Each tablet of Azor also contains the following inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg tablets)."
    },
    {
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      "LabelerName": "Daiichi Sankyo Inc.",
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      "IndicationAndUsage": "Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Azor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Azor may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with Azor compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with Azor 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Azor 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on Azor 5/20 mg, and to 68% (systolic) and 85% (diastolic) on Azor 10/40 mg.",
      "Description": "Azor provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of Azor is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of Azor is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The structural formula for amlodipine besylate is. The structural formula for olmesartan medoxomil is. Azor contains amlodipine besylate, a white to off-white crystalline powder, and olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Each tablet of Azor also contains the following inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg tablets)."
    },
    {
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      "SamplePackage": "N",
      "IndicationAndUsage": "Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Azor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Azor may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with Azor compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with Azor 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Azor 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on Azor 5/20 mg, and to 68% (systolic) and 85% (diastolic) on Azor 10/40 mg.",
      "Description": "Azor provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of Azor is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of Azor is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The structural formula for amlodipine besylate is. The structural formula for olmesartan medoxomil is. Azor contains amlodipine besylate, a white to off-white crystalline powder, and olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Each tablet of Azor also contains the following inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg tablets)."
    },
    {
      "NDCCode": "65597-407-20",
      "PackageDescription": "1 BOTTLE in 1 CARTON (65597-407-20)  / 120 CAPSULE in 1 BOTTLE",
      "NDC11Code": "65597-0407-20",
      "ProductNDC": "65597-407",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Turalio",
      "NonProprietaryName": "Pexidartinib Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230201",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA211810",
      "LabelerName": "Daiichi Sankyo Inc.",
      "SubstanceName": "PEXIDARTINIB HYDROCHLORIDE",
      "StrengthNumber": "125",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], Tyrosine Kinase Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-01-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230201",
      "SamplePackage": "N",
      "IndicationAndUsage": "TURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.",
      "Description": "Pexidartinib is a kinase inhibitor. The chemical name of pexidartinib hydrochloride is 5-[(5-Chloro-1H-pyrrolo[2,3-b]pyridin-3-yl)methyl]-N-{[6-(trifluoromethyl)pyridin-3-yl]methyl}pyridin-2-amine monohydrochloride. Pexidartinib hydrochloride is an off-white to white solid. The molecular formula for pexidartinib hydrochloride is C20H15ClF3N5∙HCl. The molecular weight is 454.28 for the hydrochloride salt and 417.81 for the free base. The chemical structure is. The solubility of pexidartinib hydrochloride in aqueous solutions decreases with increasing pH. The pKa1 and pKa2 were determined to be 2.6 and 5.4 respectively for the conjugate acids. Pexidartinib hydrochloride is soluble in methanol, slightly soluble in water and ethanol, and practically insoluble in heptane. TURALIO (pexidartinib) capsules are for oral use. Each capsule contains 125 mg pexidartinib which is equivalent to 135.9 mg pexidartinib hydrochloride. The capsule contains the following inactive ingredients: poloxamer 407, mannitol, crospovidone, and magnesium stearate. The hypromellose capsule shell contains hypromellose, titanium dioxide and FD&C Blue No. 1."
    },
    {
      "NDCCode": "0472-0381-15",
      "PackageDescription": "1 TUBE in 1 CARTON (0472-0381-15)  / 15 g in 1 TUBE",
      "NDC11Code": "00472-0381-15",
      "ProductNDC": "0472-0381",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Betamethasone Dipropionate",
      "NonProprietaryName": "Betamethasone Dipropionate",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19970201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071012",
      "LabelerName": "Actavis Pharma, Inc.",
      "SubstanceName": "BETAMETHASONE DIPROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19970201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Betamethasone dipropionate ointment is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.",
      "Description": "Betamethasone dipropionate ointment contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-Fluoro-11 β, 17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of betamethasone dipropionate ointment 0.05% contains: 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in an ointment base consisting of mineral oil and white petrolatum."
    },
    {
      "NDCCode": "0472-0381-45",
      "PackageDescription": "1 TUBE in 1 CARTON (0472-0381-45)  / 45 g in 1 TUBE",
      "NDC11Code": "00472-0381-45",
      "ProductNDC": "0472-0381",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Betamethasone Dipropionate",
      "NonProprietaryName": "Betamethasone Dipropionate",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19970201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071012",
      "LabelerName": "Actavis Pharma, Inc.",
      "SubstanceName": "BETAMETHASONE DIPROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19970201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Betamethasone dipropionate ointment is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.",
      "Description": "Betamethasone dipropionate ointment contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-Fluoro-11 β, 17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of betamethasone dipropionate ointment 0.05% contains: 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in an ointment base consisting of mineral oil and white petrolatum."
    },
    {
      "NDCCode": "0781-3288-09",
      "PackageDescription": "24 BAG in 1 CARTON (0781-3288-09)  / 50 mL in 1 BAG (0781-3288-91) ",
      "NDC11Code": "00781-3288-09",
      "ProductNDC": "0781-3288",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin In 5 Percent Dextrose",
      "NonProprietaryName": "Clindamycin In 5 Percent Dextrose",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20130207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201692",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "CLINDAMYCIN",
      "StrengthNumber": "6",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin in 5% Dextrose Injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin in 5% Dextrose Injection is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibacterial drug-associated pseudomembranous colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction with antibacterial drug therapy. Clindamycin in 5% Dextrose Injection is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus. Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes. Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes. Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms. Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes. Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin in 5% Dextrose Injection and other antibacterial drugs, Clindamycin in 5% Dextrose Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Clindamycin in 5% Dextrose Injection in the Cryovac plastic container for intravenous use is composed of clindamycin phosphate equivalent to 300, 600 and 900 mg of clindamycin premixed with 5% dextrose as a sterile solution. Disodium edetate has been added at a concentration of 0.04 mg/mL. The pH has been adjusted with sodium hydroxide and/or hydrochloric acid. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name of clindamycin phosphate is L-threo-α-D-galacto- Octopyranoside, methyl-7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2- pyrrolidinyl) carbonyl] amino]-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-. The molecular formula is C18H34CIN208PS and the molecular weight is 504.97. The structural formula is represented below. The plastic container is fabricated from a specially designed multilayer plastic, M312A material. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "0781-3289-09",
      "PackageDescription": "24 BAG in 1 CARTON (0781-3289-09)  / 50 mL in 1 BAG (0781-3289-91) ",
      "NDC11Code": "00781-3289-09",
      "ProductNDC": "0781-3289",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin In 5 Percent Dextrose",
      "NonProprietaryName": "Clindamycin In 5 Percent Dextrose",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20130207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201692",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "CLINDAMYCIN",
      "StrengthNumber": "12",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin in 5% Dextrose Injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin in 5% Dextrose Injection is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibacterial drug-associated pseudomembranous colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction with antibacterial drug therapy. Clindamycin in 5% Dextrose Injection is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus. Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes. Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes. Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms. Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes. Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin in 5% Dextrose Injection and other antibacterial drugs, Clindamycin in 5% Dextrose Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Clindamycin in 5% Dextrose Injection in the Cryovac plastic container for intravenous use is composed of clindamycin phosphate equivalent to 300, 600 and 900 mg of clindamycin premixed with 5% dextrose as a sterile solution. Disodium edetate has been added at a concentration of 0.04 mg/mL. The pH has been adjusted with sodium hydroxide and/or hydrochloric acid. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name of clindamycin phosphate is L-threo-α-D-galacto- Octopyranoside, methyl-7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2- pyrrolidinyl) carbonyl] amino]-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-. The molecular formula is C18H34CIN208PS and the molecular weight is 504.97. The structural formula is represented below. The plastic container is fabricated from a specially designed multilayer plastic, M312A material. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "0781-3290-09",
      "PackageDescription": "24 BAG in 1 CARTON (0781-3290-09)  / 50 mL in 1 BAG (0781-3290-91) ",
      "NDC11Code": "00781-3290-09",
      "ProductNDC": "0781-3290",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin In 5 Percent Dextrose",
      "NonProprietaryName": "Clindamycin In 5 Percent Dextrose",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20130207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201692",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "CLINDAMYCIN",
      "StrengthNumber": "18",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin in 5% Dextrose Injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin in 5% Dextrose Injection is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibacterial drug-associated pseudomembranous colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction with antibacterial drug therapy. Clindamycin in 5% Dextrose Injection is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus. Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes. Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes. Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms. Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes. Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin in 5% Dextrose Injection and other antibacterial drugs, Clindamycin in 5% Dextrose Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Clindamycin in 5% Dextrose Injection in the Cryovac plastic container for intravenous use is composed of clindamycin phosphate equivalent to 300, 600 and 900 mg of clindamycin premixed with 5% dextrose as a sterile solution. Disodium edetate has been added at a concentration of 0.04 mg/mL. The pH has been adjusted with sodium hydroxide and/or hydrochloric acid. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name of clindamycin phosphate is L-threo-α-D-galacto- Octopyranoside, methyl-7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2- pyrrolidinyl) carbonyl] amino]-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-. The molecular formula is C18H34CIN208PS and the molecular weight is 504.97. The structural formula is represented below. The plastic container is fabricated from a specially designed multilayer plastic, M312A material. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "0781-7275-43",
      "PackageDescription": "1 KIT in 1 CARTON (0781-7275-43)  *  7 g in 1 BOTTLE (0781-6525-17)  *  20 g in 1 BOTTLE, PUMP (0781-7274-28) ",
      "NDC11Code": "00781-7275-43",
      "ProductNDC": "0781-7275",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin And Benzoyl Peroxide",
      "NonProprietaryName": "Clindamycin And Benzoyl Peroxide",
      "DosageFormName": "KIT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170815",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204087",
      "LabelerName": "Sandoz Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20170815",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.",
      "Description": "For Dermatological Use Only - Not for Ophthalmic Use. *Reconstitute Before Dispensing*. Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below.  clindamycin phosphate. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl Peroxide. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide."
    },
    {
      "NDCCode": "21922-068-43",
      "PackageDescription": "1 KIT in 1 CARTON (21922-068-43)  *  20 g in 1 JAR (21922-067-62)  *  40 g in 1 JAR (21922-067-41)  *  28 g in 1 BOTTLE, PUMP (21922-067-39)  *  40 g in 1 BOTTLE, PUMP (21922-067-42)  *  10 g in 1 BOTTLE (21922-066-12)  *  7 g in 1 BOTTLE (21922-066-37)  *  5 g in 1 BOTTLE (21922-066-36) ",
      "NDC11Code": "21922-0068-43",
      "ProductNDC": "21922-068",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin And Benzoyl Peroxide",
      "NonProprietaryName": "Clindamycin And Benzoyl Peroxide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20251007",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204087",
      "LabelerName": "Encube Ethicals, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251007",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.",
      "Description": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide."
    },
    {
      "NDCCode": "21922-068-44",
      "PackageDescription": "1 KIT in 1 CARTON (21922-068-44)  *  20 g in 1 JAR (21922-067-62)  *  40 g in 1 JAR (21922-067-41)  *  28 g in 1 BOTTLE, PUMP (21922-067-39)  *  40 g in 1 BOTTLE, PUMP (21922-067-42)  *  10 g in 1 BOTTLE (21922-066-12)  *  7 g in 1 BOTTLE (21922-066-37)  *  5 g in 1 BOTTLE (21922-066-36) ",
      "NDC11Code": "21922-0068-44",
      "ProductNDC": "21922-068",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin And Benzoyl Peroxide",
      "NonProprietaryName": "Clindamycin And Benzoyl Peroxide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20251007",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204087",
      "LabelerName": "Encube Ethicals, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251007",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.",
      "Description": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide."
    },
    {
      "NDCCode": "21922-068-45",
      "PackageDescription": "1 KIT in 1 CARTON (21922-068-45)  *  20 g in 1 JAR (21922-067-62)  *  40 g in 1 JAR (21922-067-41)  *  28 g in 1 BOTTLE, PUMP (21922-067-39)  *  40 g in 1 BOTTLE, PUMP (21922-067-42)  *  10 g in 1 BOTTLE (21922-066-12)  *  7 g in 1 BOTTLE (21922-066-37)  *  5 g in 1 BOTTLE (21922-066-36) ",
      "NDC11Code": "21922-0068-45",
      "ProductNDC": "21922-068",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin And Benzoyl Peroxide",
      "NonProprietaryName": "Clindamycin And Benzoyl Peroxide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20251007",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204087",
      "LabelerName": "Encube Ethicals, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251007",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.",
      "Description": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide."
    },
    {
      "NDCCode": "21922-068-46",
      "PackageDescription": "1 KIT in 1 CARTON (21922-068-46)  *  20 g in 1 JAR (21922-067-62)  *  40 g in 1 JAR (21922-067-41)  *  28 g in 1 BOTTLE, PUMP (21922-067-39)  *  40 g in 1 BOTTLE, PUMP (21922-067-42)  *  10 g in 1 BOTTLE (21922-066-12)  *  7 g in 1 BOTTLE (21922-066-37)  *  5 g in 1 BOTTLE (21922-066-36) ",
      "NDC11Code": "21922-0068-46",
      "ProductNDC": "21922-068",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin And Benzoyl Peroxide",
      "NonProprietaryName": "Clindamycin And Benzoyl Peroxide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20251007",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204087",
      "LabelerName": "Encube Ethicals, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251007",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.",
      "Description": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide."
    },
    {
      "NDCCode": "24208-504-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (24208-504-01)  / 2.5 mL in 1 BOTTLE",
      "NDC11Code": "24208-0504-01",
      "ProductNDC": "24208-504",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vyzulta",
      "NonProprietaryName": "Latanoprostene Bunod",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20171102",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA207795",
      "LabelerName": "Bausch & Lomb Incorporated",
      "SubstanceName": "LATANOPROSTENE BUNOD",
      "StrengthNumber": ".24",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-02-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180611",
      "SamplePackage": "Y",
      "IndicationAndUsage": "VYZULTA ®(latanoprostene bunod ophthalmic solution) 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.",
      "Description": "VYZULTA ®(latanoprostene bunod ophthalmic solution), 0.024% is a prostaglandin analog formulated as a sterile topical ophthalmic solution. VYZULTA contains the active ingredient latanoprostene bunod 0.24 mg/mL, the preservative benzalkonium chloride 0.2 mg/mL, and the following inactive ingredients: polysorbate 80, glycerin, EDTA, and water. The formulation is buffered to pH 5.5 with citric acid/sodium citrate. Its chemical name is 4-(Nitrooxy)butyl (5Z)-7-{(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl}hept-5-enoate. Its molecular formula is C 27H 41NO 8. Molecular weight: 507.62. Its chemical structure is. Figure 1. Latanoprostene bunod is a colorless to yellow oil."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"65597-504-28","ProprietaryName":"Vanflyta","NonProprietaryName":"Quizartinib"},{"NDCCode":"65597-504-04","ProprietaryName":"Vanflyta","NonProprietaryName":"Quizartinib"},{"NDCCode":"65597-402-28","ProprietaryName":"Turalio","NonProprietaryName":"Pexidartinib"},{"NDCCode":"65597-407-28","ProprietaryName":"Turalio","NonProprietaryName":"Pexidartinib Hydrochloride"},{"NDCCode":"65597-511-28","ProprietaryName":"Vanflyta","NonProprietaryName":"Quizartinib"},{"NDCCode":"17224-504-28","ProprietaryName":"Np Thyroid","NonProprietaryName":"Thyroid Tablets"},{"NDCCode":"41250-504-02","ProprietaryName":"Meijer","NonProprietaryName":"Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride"},{"NDCCode":"55312-504-02","ProprietaryName":"Western Family","NonProprietaryName":"Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride"},{"NDCCode":"63187-504-01","ProprietaryName":"Hydrocortisone","NonProprietaryName":"Hydrocortisone"},{"NDCCode":"63304-504-28","ProprietaryName":"Acyclovir","NonProprietaryName":"Acyclovir"},{"NDCCode":"72705-504-01","ProprietaryName":"Frida Fluoride Strawberry Toothbrush Set","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"65597-103-77","ProprietaryName":"Benicar","NonProprietaryName":"Olmesartan Medoxomil"},{"NDCCode":"65597-104-77","ProprietaryName":"Benicar","NonProprietaryName":"Olmesartan Medoxomil"},{"NDCCode":"65597-113-07","ProprietaryName":"Azor","NonProprietaryName":"Amlodipine Besylate And Olmesartan Medoxomil"},{"NDCCode":"65597-113-10","ProprietaryName":"Azor","NonProprietaryName":"Amlodipine Besylate And Olmesartan Medoxomil"},{"NDCCode":"65597-113-11","ProprietaryName":"Azor","NonProprietaryName":"Amlodipine Besylate And Olmesartan Medoxomil"},{"NDCCode":"65597-113-30","ProprietaryName":"Azor","NonProprietaryName":"Amlodipine Besylate And Olmesartan Medoxomil"},{"NDCCode":"65597-113-90","ProprietaryName":"Azor","NonProprietaryName":"Amlodipine Besylate And Olmesartan Medoxomil"},{"NDCCode":"65597-407-20","ProprietaryName":"Turalio","NonProprietaryName":"Pexidartinib Hydrochloride"},{"NDCCode":"0472-0381-15","ProprietaryName":"Betamethasone Dipropionate","NonProprietaryName":"Betamethasone Dipropionate"},{"NDCCode":"0472-0381-45","ProprietaryName":"Betamethasone Dipropionate","NonProprietaryName":"Betamethasone Dipropionate"},{"NDCCode":"0781-3288-09","ProprietaryName":"Clindamycin In 5 Percent Dextrose","NonProprietaryName":"Clindamycin In 5 Percent Dextrose"},{"NDCCode":"0781-3289-09","ProprietaryName":"Clindamycin In 5 Percent Dextrose","NonProprietaryName":"Clindamycin In 5 Percent Dextrose"},{"NDCCode":"0781-3290-09","ProprietaryName":"Clindamycin In 5 Percent Dextrose","NonProprietaryName":"Clindamycin In 5 Percent Dextrose"},{"NDCCode":"0781-7275-43","ProprietaryName":"Clindamycin And Benzoyl Peroxide","NonProprietaryName":"Clindamycin And Benzoyl Peroxide"},{"NDCCode":"21922-068-43","ProprietaryName":"Clindamycin And Benzoyl Peroxide","NonProprietaryName":"Clindamycin And Benzoyl Peroxide"},{"NDCCode":"21922-068-44","ProprietaryName":"Clindamycin And Benzoyl Peroxide","NonProprietaryName":"Clindamycin And Benzoyl Peroxide"},{"NDCCode":"21922-068-45","ProprietaryName":"Clindamycin And Benzoyl Peroxide","NonProprietaryName":"Clindamycin And Benzoyl Peroxide"},{"NDCCode":"21922-068-46","ProprietaryName":"Clindamycin And Benzoyl Peroxide","NonProprietaryName":"Clindamycin And Benzoyl Peroxide"},{"NDCCode":"24208-504-01","ProprietaryName":"Vyzulta","NonProprietaryName":"Latanoprostene Bunod"}]}
                    

<NDCList><NDC><NDCCode>65597-504-28</NDCCode><ProprietaryName>Vanflyta</ProprietaryName><NonProprietaryName>Quizartinib</NonProprietaryName></NDC><NDC><NDCCode>65597-504-04</NDCCode><ProprietaryName>Vanflyta</ProprietaryName><NonProprietaryName>Quizartinib</NonProprietaryName></NDC><NDC><NDCCode>65597-402-28</NDCCode><ProprietaryName>Turalio</ProprietaryName><NonProprietaryName>Pexidartinib</NonProprietaryName></NDC><NDC><NDCCode>65597-407-28</NDCCode><ProprietaryName>Turalio</ProprietaryName><NonProprietaryName>Pexidartinib Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>65597-511-28</NDCCode><ProprietaryName>Vanflyta</ProprietaryName><NonProprietaryName>Quizartinib</NonProprietaryName></NDC><NDC><NDCCode>17224-504-28</NDCCode><ProprietaryName>Np Thyroid</ProprietaryName><NonProprietaryName>Thyroid Tablets</NonProprietaryName></NDC><NDC><NDCCode>41250-504-02</NDCCode><ProprietaryName>Meijer</ProprietaryName><NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55312-504-02</NDCCode><ProprietaryName>Western Family</ProprietaryName><NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>63187-504-01</NDCCode><ProprietaryName>Hydrocortisone</ProprietaryName><NonProprietaryName>Hydrocortisone</NonProprietaryName></NDC><NDC><NDCCode>63304-504-28</NDCCode><ProprietaryName>Acyclovir</ProprietaryName><NonProprietaryName>Acyclovir</NonProprietaryName></NDC><NDC><NDCCode>72705-504-01</NDCCode><ProprietaryName>Frida Fluoride Strawberry Toothbrush Set</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>65597-103-77</NDCCode><ProprietaryName>Benicar</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>65597-104-77</NDCCode><ProprietaryName>Benicar</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>65597-113-07</NDCCode><ProprietaryName>Azor</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>65597-113-10</NDCCode><ProprietaryName>Azor</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>65597-113-11</NDCCode><ProprietaryName>Azor</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>65597-113-30</NDCCode><ProprietaryName>Azor</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>65597-113-90</NDCCode><ProprietaryName>Azor</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>65597-407-20</NDCCode><ProprietaryName>Turalio</ProprietaryName><NonProprietaryName>Pexidartinib Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0472-0381-15</NDCCode><ProprietaryName>Betamethasone Dipropionate</ProprietaryName><NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName></NDC><NDC><NDCCode>0472-0381-45</NDCCode><ProprietaryName>Betamethasone Dipropionate</ProprietaryName><NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName></NDC><NDC><NDCCode>0781-3288-09</NDCCode><ProprietaryName>Clindamycin In 5 Percent Dextrose</ProprietaryName><NonProprietaryName>Clindamycin In 5 Percent Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0781-3289-09</NDCCode><ProprietaryName>Clindamycin In 5 Percent Dextrose</ProprietaryName><NonProprietaryName>Clindamycin In 5 Percent Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0781-3290-09</NDCCode><ProprietaryName>Clindamycin In 5 Percent Dextrose</ProprietaryName><NonProprietaryName>Clindamycin In 5 Percent Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0781-7275-43</NDCCode><ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName><NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>21922-068-43</NDCCode><ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName><NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>21922-068-44</NDCCode><ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName><NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>21922-068-45</NDCCode><ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName><NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>21922-068-46</NDCCode><ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName><NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>24208-504-01</NDCCode><ProprietaryName>Vyzulta</ProprietaryName><NonProprietaryName>Latanoprostene Bunod</NonProprietaryName></NDC></NDCList>