RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "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": "65597-511-04",
      "PackageDescription": "1 BOTTLE in 1 CARTON (65597-511-04)  / 14 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "65597-0511-04",
      "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": "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": "30400-504-04",
      "PackageDescription": "296 mL in 1 BOTTLE, PLASTIC (30400-504-04) ",
      "NDC11Code": "30400-0504-04",
      "ProductNDC": "30400-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Isopropyl Rubbing Alcohol 70%",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120315",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Jell Pharmaceuticals Pvt. Ltd.",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2025-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120315",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 first aid to help prevent the risk of infection in minor cuts, scrapes and burns."
    },
    {
      "NDCCode": "61924-504-04",
      "PackageDescription": "113 g in 1 TUBE (61924-504-04) ",
      "NDC11Code": "61924-0504-04",
      "ProductNDC": "61924-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lantiseptic By Dermarite Dry Skin Therapy",
      "NonProprietaryName": "Lanolin",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181225",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Dermarite Industries LLC",
      "SubstanceName": "LANOLIN",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20181225",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily protects minor cuts, scrapes, and burns. Helps prevent and temporarily protects chafed, chapped or cracked skin."
    },
    {
      "NDCCode": "63545-504-04",
      "PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (63545-504-04) ",
      "NDC11Code": "63545-0504-04",
      "ProductNDC": "63545-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Blatta Orientalis",
      "NonProprietaryName": "Blatta Orientalis",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220503",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "BLATTA ORIENTALIS",
      "StrengthNumber": "500",
      "StrengthUnit": "[hp_C]/1",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Non-Standardized Insect Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-05-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220503",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70994-504-04",
      "PackageDescription": "17 g in 1 TUBE (70994-504-04) ",
      "NDC11Code": "70994-0504-04",
      "ProductNDC": "70994-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Childrens First Aid",
      "NonProprietaryName": "Calendula Officials, Stellaria Media, St. Johns Wort, Rosemary Oil, Plantago Major, Commiphora Myrrha, Comfrey Leaf, Salvia Officinalis, Sunflower Oil",
      "DosageFormName": "SALVE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160401",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Spry Life LLC",
      "SubstanceName": "ACHILLEA MILLEFOLIUM FLOWER; ST. JOHN'S WORT; STELLARIA MEDIA; CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; COMMIPHORA MYRRHA WHOLE; SALVIA OFFICINALIS WHOLE; COMFREY LEAF",
      "StrengthNumber": "1; 1; 1; 1; 1; 1; 1; 1",
      "StrengthUnit": "[hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160401",
      "SamplePackage": "N",
      "IndicationAndUsage": " temporarily protects minor  cuts  scrapes  abrasions  blisters  burns.  helps prevent and temporarily protects and helps relieve  chapped or cracked skin  helps protect from the drying effects of wind and cold weather.  temporarily protects and helps relieve minor skin irritation and itching due to  poison ivy  insect bites  rashes caused by soaps, detergents, cosmetics, or jewelry.  temporarily protects and helps relieve minor pain associated with  scrapes  bisters  abrasions  bruises  cuts  minor burns  cold sores."
    },
    {
      "NDCCode": "70994-504-11",
      "PackageDescription": "1 TUBE in 1 BOX (70994-504-11)  > 17 g in 1 TUBE (70994-504-04)",
      "NDC11Code": "70994-0504-11",
      "ProductNDC": "70994-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Childrens First Aid",
      "NonProprietaryName": "Calendula Officials, Stellaria Media, St. Johns Wort, Rosemary Oil, Plantago Major, Commiphora Myrrha, Comfrey Leaf, Salvia Officinalis, Sunflower Oil",
      "DosageFormName": "SALVE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160401",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Sierra Sage Herbs LLC",
      "SubstanceName": "ACHILLEA MILLEFOLIUM FLOWER; ST. JOHN'S WORT; STELLARIA MEDIA; CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; COMMIPHORA MYRRHA WHOLE; SALVIA OFFICINALIS WHOLE; COMFREY LEAF",
      "StrengthNumber": "1; 1; 1; 1; 1; 1; 1; 1",
      "StrengthUnit": "[hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g",
      "Status": "Deprecated",
      "LastUpdate": "2019-02-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "75109-504-04",
      "PackageDescription": "50 POUCH in 1 PACKAGE (75109-504-04)  > 270 g in 1 POUCH",
      "NDC11Code": "75109-0504-04",
      "ProductNDC": "75109-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200621",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Kangna (Zhejiang) Medical Supplies Co., Ltd.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".3",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200621",
      "SamplePackage": "N",
      "IndicationAndUsage": "●For hand sanitizing to decrease bacteria on the skin. ●Apply topically to the skin to help prevent cross contamination. ●Recommended for repeated use. ●Dries in seconds."
    },
    {
      "NDCCode": "76309-504-11",
      "PackageDescription": "1 TUBE in 1 BOX (76309-504-11)  > 17 g in 1 TUBE (76309-504-04)",
      "NDC11Code": "76309-0504-11",
      "ProductNDC": "76309-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Childrens First Aid",
      "NonProprietaryName": "Calendula Officials, Salvia Officinalis, Stellaria Media, St. Johns Wort, Rosemary Oil, Plantago Major, Commiphora Myrrha, Comfrey Leaf, Salvia Officinalis, Sunflower Oil",
      "DosageFormName": "SALVE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160401",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "SnugsZ USA",
      "SubstanceName": "ACHILLEA MILLEFOLIUM FLOWER; ROSEMARY OIL; ST. JOHN'S WORT; STELLARIA MEDIA; CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; COMMIPHORA MYRRHA WHOLE; SALVIA OFFICINALIS WHOLE; COMFREY LEAF",
      "StrengthNumber": ".113; .034; .168; .113; .224; .168; .205; .075; .074",
      "StrengthUnit": "g/17g; g/17g; g/17g; g/17g; g/17g; g/17g; g/17g; g/17g; g/17g",
      "Status": "Deprecated",
      "LastUpdate": "2017-02-13"
    },
    {
      "NDCCode": "78975-504-04",
      "PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (78975-504-04) ",
      "NDC11Code": "78975-0504-04",
      "ProductNDC": "78975-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Care 1",
      "NonProprietaryName": "Hand Sanitizer",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "LAUREE LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "80",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "82429-504-04",
      "PackageDescription": "50 g in 1 CONTAINER (82429-504-04) ",
      "NDC11Code": "82429-0504-04",
      "ProductNDC": "82429-504",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Tirzepatide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20240402",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Gabar Health Sciences Corp.",
      "SubstanceName": "TIRZEPATIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "01-AUG-24"
    },
    {
      "NDCCode": "84522-504-04",
      "PackageDescription": "50 g in 1 BOX (84522-504-04) ",
      "NDC11Code": "84522-0504-04",
      "ProductNDC": "84522-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Retinol 24night Cream",
      "NonProprietaryName": "Retinol 24night Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241213",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
      "SubstanceName": "NIACINAMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241213",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "84756-504-04",
      "PackageDescription": "50 g in 1 BOX (84756-504-04) ",
      "NDC11Code": "84756-0504-04",
      "ProductNDC": "84756-504",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Retinol Moisturizing Cream",
      "NonProprietaryName": "Retinol Moisturizing Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241127",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Yiwu Luoxin E �Commerce Co Ltd",
      "SubstanceName": "NIACINAMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241127",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "65597-103-03",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (65597-103-03) ",
      "NDC11Code": "65597-0103-03",
      "ProductNDC": "65597-103",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benicar",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020425",
      "EndMarketingDate": "20240331",
      "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": "2024-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20140403",
      "EndMarketingDatePackage": "20240331",
      "SamplePackage": "N",
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      "EndMarketingDatePackage": "20240331",
      "SamplePackage": "N",
      "IndicationAndUsage": "Benicar is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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 Benicar. 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. It may be used alone or in combination with other antihypertensive agents.",
      "Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically 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 and its structural formula is. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Benicar is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide."
    },
    {
      "NDCCode": "65597-104-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-104-30) ",
      "NDC11Code": "65597-0104-30",
      "ProductNDC": "65597-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benicar",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020425",
      "EndMarketingDate": "20240331",
      "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": "2024-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20020425",
      "EndMarketingDatePackage": "20240331",
      "SamplePackage": "N",
      "IndicationAndUsage": "Benicar is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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 Benicar. 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. It may be used alone or in combination with other antihypertensive agents.",
      "Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically 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 and its structural formula is. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Benicar is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide."
    },
    {
      "NDCCode": "65597-104-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-104-90) ",
      "NDC11Code": "65597-0104-90",
      "ProductNDC": "65597-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benicar",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020425",
      "EndMarketingDate": "20240331",
      "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": "2024-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20020425",
      "EndMarketingDatePackage": "20240331",
      "SamplePackage": "N",
      "IndicationAndUsage": "Benicar is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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 Benicar. 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. It may be used alone or in combination with other antihypertensive agents.",
      "Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically 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 and its structural formula is. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Benicar is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide."
    },
    {
      "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": "0009-0728-09",
      "PackageDescription": "5 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0009-0728-09)  / 60 mL in 1 VIAL, PHARMACY BULK PACKAGE (0009-0728-05) ",
      "NDC11Code": "00009-0728-09",
      "ProductNDC": "0009-0728",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cleocin Phosphate",
      "NonProprietaryName": "Clindamycin Phosphate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19721002",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050441",
      "LabelerName": "Pharmacia & Upjohn Company LLC",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19721002",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. CLEOCIN PHOSPHATE products are 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. CLEOCIN PHOSPHATE 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 CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE 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": "CLEOCIN PHOSPHATE Sterile Solution in vials contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. 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 C18H34ClN2O8PS and the molecular weight is 504.96. The structural formula is represented below. CLEOCIN PHOSPHATE in the ADD-Vantage Vial is intended for intravenous use only after further dilution with appropriate volume of ADD-Vantage diluent base solution (see Directions for Use). CLEOCIN PHOSPHATE IV Solution in the GALAXY 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. The plastic container is fabricated from a specially designed multilayer plastic, PL 2501. 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": "0009-0775-26",
      "PackageDescription": "25 VIAL in 1 CARTON (0009-0775-26)  / 4 mL in 1 VIAL (0009-0775-20) ",
      "NDC11Code": "00009-0775-26",
      "ProductNDC": "0009-0775",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cleocin Phosphate",
      "NonProprietaryName": "Clindamycin Phosphate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19721002",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050441",
      "LabelerName": "Pharmacia & Upjohn Company LLC",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19721002",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. CLEOCIN PHOSPHATE products are 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. CLEOCIN PHOSPHATE 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 CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE 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": "CLEOCIN PHOSPHATE Sterile Solution in vials contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. 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 C18H34ClN2O8PS and the molecular weight is 504.96. The structural formula is represented below. CLEOCIN PHOSPHATE in the ADD-Vantage Vial is intended for intravenous use only after further dilution with appropriate volume of ADD-Vantage diluent base solution (see Directions for Use). CLEOCIN PHOSPHATE IV Solution in the GALAXY 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. The plastic container is fabricated from a specially designed multilayer plastic, PL 2501. 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": "0009-0870-26",
      "PackageDescription": "25 VIAL in 1 CARTON (0009-0870-26)  / 2 mL in 1 VIAL (0009-0870-21) ",
      "NDC11Code": "00009-0870-26",
      "ProductNDC": "0009-0870",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cleocin Phosphate",
      "NonProprietaryName": "Clindamycin Phosphate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19721002",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050441",
      "LabelerName": "Pharmacia & Upjohn Company LLC",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19721002",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. CLEOCIN PHOSPHATE products are 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. CLEOCIN PHOSPHATE 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 CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE 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": "CLEOCIN PHOSPHATE Sterile Solution in vials contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. 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 C18H34ClN2O8PS and the molecular weight is 504.96. The structural formula is represented below. CLEOCIN PHOSPHATE in the ADD-Vantage Vial is intended for intravenous use only after further dilution with appropriate volume of ADD-Vantage diluent base solution (see Directions for Use). CLEOCIN PHOSPHATE IV Solution in the GALAXY 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. The plastic container is fabricated from a specially designed multilayer plastic, PL 2501. 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": "0009-0902-18",
      "PackageDescription": "25 VIAL in 1 CARTON (0009-0902-18)  / 6 mL in 1 VIAL (0009-0902-11) ",
      "NDC11Code": "00009-0902-18",
      "ProductNDC": "0009-0902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cleocin Phosphate",
      "NonProprietaryName": "Clindamycin Phosphate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19721002",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050441",
      "LabelerName": "Pharmacia & Upjohn Company LLC",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19721002",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. CLEOCIN PHOSPHATE products are 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. CLEOCIN PHOSPHATE 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 CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE 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": "CLEOCIN PHOSPHATE Sterile Solution in vials contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. 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 C18H34ClN2O8PS and the molecular weight is 504.96. The structural formula is represented below. CLEOCIN PHOSPHATE in the ADD-Vantage Vial is intended for intravenous use only after further dilution with appropriate volume of ADD-Vantage diluent base solution (see Directions for Use). CLEOCIN PHOSPHATE IV Solution in the GALAXY 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. The plastic container is fabricated from a specially designed multilayer plastic, PL 2501. 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": "0009-4073-04",
      "PackageDescription": "25 VIAL in 1 CARTON (0009-4073-04)  / 4 mL in 1 VIAL (0009-4073-03) ",
      "NDC11Code": "00009-4073-04",
      "ProductNDC": "0009-4073",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cleocin Phosphate",
      "NonProprietaryName": "Clindamycin Phosphate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20191118",
      "EndMarketingDate": "20261130",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050441",
      "LabelerName": "Pharmacia & Upjohn Company LLC",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2026-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191118",
      "EndMarketingDatePackage": "20261130",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. CLEOCIN PHOSPHATE products are 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. CLEOCIN PHOSPHATE 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 CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE 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": "CLEOCIN PHOSPHATE Sterile Solution in vials contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. 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 504.96. The structural formula is represented below."
    }
  ]
}
                    

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