RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "36800-538-52",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (36800-538-52)  > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "36800-0538-52",
      "ProductNDC": "36800-538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare Allergy Relief D",
      "NonProprietaryName": "Loratadine, Pseudoephedrine Sulfate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20030620",
      "EndMarketingDate": "20170607",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075706",
      "LabelerName": "Topco Associates LLC",
      "SubstanceName": "PSEUDOEPHEDRINE SULFATE; LORATADINE",
      "StrengthNumber": "240; 10",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-08"
    },
    {
      "NDCCode": "36800-538-22",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (36800-538-22)  > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "36800-0538-22",
      "ProductNDC": "36800-538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare Allergy Relief D",
      "NonProprietaryName": "Loratadine, Pseudoephedrine Sulfate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20030620",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075706",
      "LabelerName": "Topco Associates LLC",
      "SubstanceName": "PSEUDOEPHEDRINE SULFATE; LORATADINE",
      "StrengthNumber": "240; 10",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "36800-013-52",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (36800-013-52)  > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "36800-0013-52",
      "ProductNDC": "36800-013",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare Allergy Relief D",
      "NonProprietaryName": "Loratadine, Pseudoephedrine",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120501",
      "EndMarketingDate": "20170502",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076050",
      "LabelerName": "Topco Associates LLC",
      "SubstanceName": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
      "StrengthNumber": "5; 120",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-05-09"
    },
    {
      "NDCCode": "36800-054-52",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (36800-054-52)  > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "36800-0054-52",
      "ProductNDC": "36800-054",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare 12 Hour Decongestant",
      "NonProprietaryName": "Pseudoephedrine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20000425",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075153",
      "LabelerName": "Topco Associates LLC",
      "SubstanceName": "PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "120",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-11-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20000425",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily relieves sinus congestion and pressure."
    },
    {
      "NDCCode": "36800-185-59",
      "PackageDescription": "1 TUBE in 1 CARTON (36800-185-59)  > 113 g in 1 TUBE (36800-185-52)",
      "NDC11Code": "36800-0185-59",
      "ProductNDC": "36800-185",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Live Better",
      "ProprietaryNameSuffix": "Extra Whitening",
      "NonProprietaryName": "Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20110120",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "TOPCO Assoc. LLC",
      "SubstanceName": "SODIUM FLUORIDE; POTASSIUM NITRATE",
      "StrengthNumber": ".24; 5",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth."
    },
    {
      "NDCCode": "36800-212-52",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (36800-212-52)  > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
      "NDC11Code": "36800-0212-52",
      "ProductNDC": "36800-212",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare Childrens Allergy Relief",
      "ProprietaryNameSuffix": "24 Hour Non Drowsy",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050302",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075990",
      "LabelerName": "Topco Associates LLC",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "36800-285-59",
      "PackageDescription": "1 TUBE in 1 CARTON (36800-285-59)  > 164 g in 1 TUBE (36800-285-52)",
      "NDC11Code": "36800-0285-59",
      "ProductNDC": "36800-285",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Top Care",
      "ProprietaryNameSuffix": "Brilliant White",
      "NonProprietaryName": "Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20110120",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "TOPCO Assoc. LLC",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".243",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-03-05",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "36800-306-52",
      "PackageDescription": "10 POUCH in 1 CARTON (36800-306-52)  > 17 g in 1 POUCH",
      "NDC11Code": "36800-0306-52",
      "ProductNDC": "36800-306",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare Clearlax",
      "NonProprietaryName": "Polyethylene Glycol 3350",
      "DosageFormName": "POWDER",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091007",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090685",
      "LabelerName": "Topco Associates LLC",
      "SubstanceName": "POLYETHYLENE GLYCOL 3350",
      "StrengthNumber": "17",
      "StrengthUnit": "g/17g",
      "Status": "Deprecated",
      "LastUpdate": "2014-08-17"
    },
    {
      "NDCCode": "36800-311-52",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (36800-311-52)  > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
      "NDC11Code": "36800-0311-52",
      "ProductNDC": "36800-311",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare Allergy Relief",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040203",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075990",
      "LabelerName": "Topco Associates LLC",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "36800-417-52",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (36800-417-52)  > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "36800-0417-52",
      "ProductNDC": "36800-417",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare Sinus And Cold D",
      "NonProprietaryName": "Naproxen Sodium, Pseudoephedrine Hcl",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130814",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076518",
      "LabelerName": "Topco Associates LLC",
      "SubstanceName": "NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "220; 120",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-03-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20130814",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "36800-755-52",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (36800-755-52)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "36800-0755-52",
      "ProductNDC": "36800-755",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare Allergy Relief",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200802",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202538",
      "LabelerName": "Topco Associates LLC",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-02-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200802",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "0941-0424-52",
      "PackageDescription": "2000 mL in 1 BAG (0941-0424-52) ",
      "NDC11Code": "00941-0424-52",
      "ProductNDC": "0941-0424",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dianeal Low Calcium With Dextrose",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19921204",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020183",
      "LabelerName": "Vantive US Healthcare LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "1.5; 538; 448; 18.3; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19921204",
      "SamplePackage": "N",
      "IndicationAndUsage": "DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure.",
      "Description": "DIANEAL peritoneal dialysis solutions are sterile, nonpyrogenic solutions in flexible containers for intraperitoneal administration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents. DIANEAL solutions are hyperosmolar solutions. The plastic container is fabricated from polyvinyl chloride (PVC Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the solution container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by cell culture toxicity studies."
    },
    {
      "NDCCode": "0941-0426-52",
      "PackageDescription": "2000 mL in 1 BAG (0941-0426-52) ",
      "NDC11Code": "00941-0426-52",
      "ProductNDC": "0941-0426",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dianeal Pd-2 With Dextrose",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19921204",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020163",
      "LabelerName": "Vantive US Healthcare LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "1.5; 538; 448; 25.7; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19921204",
      "SamplePackage": "N",
      "IndicationAndUsage": "DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure.",
      "Description": "DIANEAL peritoneal dialysis solutions are sterile, nonpyrogenic solutions in flexible containers for intraperitoneal administration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents. DIANEAL solutions are hyperosmolar solutions. The plastic container is fabricated from polyvinyl chloride (PVC Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the solution container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by cell culture toxicity studies."
    },
    {
      "NDCCode": "0941-0427-52",
      "PackageDescription": "2000 mL in 1 BAG (0941-0427-52) ",
      "NDC11Code": "00941-0427-52",
      "ProductNDC": "0941-0427",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dianeal Pd-2 With Dextrose",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19921204",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020163",
      "LabelerName": "Vantive US Healthcare LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "2.5; 538; 448; 25.7; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19921204",
      "SamplePackage": "N",
      "IndicationAndUsage": "DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure.",
      "Description": "DIANEAL peritoneal dialysis solutions are sterile, nonpyrogenic solutions in flexible containers for intraperitoneal administration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents. DIANEAL solutions are hyperosmolar solutions. The plastic container is fabricated from polyvinyl chloride (PVC Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the solution container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by cell culture toxicity studies."
    },
    {
      "NDCCode": "0941-0429-52",
      "PackageDescription": "2000 mL in 1 BAG (0941-0429-52) ",
      "NDC11Code": "00941-0429-52",
      "ProductNDC": "0941-0429",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dianeal Pd-2 With Dextrose",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19921204",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020163",
      "LabelerName": "Vantive US Healthcare LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "4.25; 538; 448; 25.7; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19921204",
      "SamplePackage": "N",
      "IndicationAndUsage": "DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure.",
      "Description": "DIANEAL peritoneal dialysis solutions are sterile, nonpyrogenic solutions in flexible containers for intraperitoneal administration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents. DIANEAL solutions are hyperosmolar solutions. The plastic container is fabricated from polyvinyl chloride (PVC Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the solution container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by cell culture toxicity studies."
    },
    {
      "NDCCode": "0941-0430-52",
      "PackageDescription": "2000 mL in 1 BAG (0941-0430-52) ",
      "NDC11Code": "00941-0430-52",
      "ProductNDC": "0941-0430",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dianeal Low Calcium With Dextrose",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19921204",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020183",
      "LabelerName": "Vantive US Healthcare LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "2.5; 538; 448; 18.3; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19921204",
      "SamplePackage": "N",
      "IndicationAndUsage": "DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure.",
      "Description": "DIANEAL peritoneal dialysis solutions are sterile, nonpyrogenic solutions in flexible containers for intraperitoneal administration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents. DIANEAL solutions are hyperosmolar solutions. The plastic container is fabricated from polyvinyl chloride (PVC Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the solution container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by cell culture toxicity studies."
    },
    {
      "NDCCode": "0941-0433-52",
      "PackageDescription": "2000 mL in 1 BAG (0941-0433-52) ",
      "NDC11Code": "00941-0433-52",
      "ProductNDC": "0941-0433",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dianeal Low Calcium With Dextrose",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19921204",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020183",
      "LabelerName": "Vantive US Healthcare LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "4.25; 538; 448; 18.3; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19921204",
      "SamplePackage": "N",
      "IndicationAndUsage": "DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure.",
      "Description": "DIANEAL peritoneal dialysis solutions are sterile, nonpyrogenic solutions in flexible containers for intraperitoneal administration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents. DIANEAL solutions are hyperosmolar solutions. The plastic container is fabricated from polyvinyl chloride (PVC Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the solution container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by cell culture toxicity studies."
    },
    {
      "NDCCode": "49230-206-52",
      "PackageDescription": "2 BAG in 1 CARTON (49230-206-52)  / 5000 mL in 1 BAG",
      "NDC11Code": "49230-0206-52",
      "ProductNDC": "49230-206",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19920819",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "1.5; 538; 448; 18.4; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920819",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "49230-209-52",
      "PackageDescription": "2 BAG in 1 CARTON (49230-209-52)  / 5000 mL in 1 BAG",
      "NDC11Code": "49230-0209-52",
      "ProductNDC": "49230-209",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19920819",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE",
      "StrengthNumber": "538; 448; 18.4; 5.08; 2.5",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920819",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "49230-212-52",
      "PackageDescription": "2 BAG in 1 CARTON (49230-212-52)  / 5000 mL in 1 BAG",
      "NDC11Code": "49230-0212-52",
      "ProductNDC": "49230-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19920819",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "4.25; 538; 448; 18.4; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920819",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "63304-538-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (63304-538-01)",
      "NDC11Code": "63304-0538-01",
      "ProductNDC": "63304-538",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisinopril And Hydrochlorothiazide",
      "NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020702",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076007",
      "LabelerName": "Ranbaxy Pharmaceuticals Inc.",
      "SubstanceName": "LISINOPRIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Lisinopril and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 lisinopril and hydrochlorothiazide. 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 1 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 (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, USP, consideration should be given to the fact that an angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk (See WARNINGS). In considering the use of lisinopril and hydrochlorothiazide tablets, USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients (see WARNINGS, Lisinopril).",
      "Description": "Lisinopril and hydrochlorothiazide tablets, USP combine an angiotensin converting enzyme inhibitor, lisinopril, USP, and a diuretic, hydrochlorothiazide, USP. Lisinopril, USP, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O5  2H2O and its structural formula is. Lisinopril, USP is a white crystalline powder, with a molecular weight of 441.52. It is soluble in water and sparingly soluble in methanol and practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Lisinopril and hydrochlorothiazide is available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 containing 10 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; lisinopril and hydrochlorothiazide tablets, USP 20-12.5 containing 20 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; and, lisinopril and hydrochlorothiazide tablets, USP 20-25 containing 20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch, and starch (corn). Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 mg also contain FD&C blue #2 aluminum lake. Lisinopril and hydrochlorothiazide tablets, USP 20-12.5 mg contain yellow iron oxide. Lisinopril and hydrochlorothiazide tablets, USP 20-25 mg contain yellow and red iron oxide."
    },
    {
      "NDCCode": "63304-538-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (63304-538-05)",
      "NDC11Code": "63304-0538-05",
      "ProductNDC": "63304-538",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisinopril And Hydrochlorothiazide",
      "NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020702",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076007",
      "LabelerName": "Ranbaxy Pharmaceuticals Inc.",
      "SubstanceName": "LISINOPRIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Lisinopril and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 lisinopril and hydrochlorothiazide. 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 1 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 (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, USP, consideration should be given to the fact that an angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk (See WARNINGS). In considering the use of lisinopril and hydrochlorothiazide tablets, USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients (see WARNINGS, Lisinopril).",
      "Description": "Lisinopril and hydrochlorothiazide tablets, USP combine an angiotensin converting enzyme inhibitor, lisinopril, USP, and a diuretic, hydrochlorothiazide, USP. Lisinopril, USP, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O5  2H2O and its structural formula is. Lisinopril, USP is a white crystalline powder, with a molecular weight of 441.52. It is soluble in water and sparingly soluble in methanol and practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Lisinopril and hydrochlorothiazide is available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 containing 10 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; lisinopril and hydrochlorothiazide tablets, USP 20-12.5 containing 20 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; and, lisinopril and hydrochlorothiazide tablets, USP 20-25 containing 20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch, and starch (corn). Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 mg also contain FD&C blue #2 aluminum lake. Lisinopril and hydrochlorothiazide tablets, USP 20-12.5 mg contain yellow iron oxide. Lisinopril and hydrochlorothiazide tablets, USP 20-25 mg contain yellow and red iron oxide."
    },
    {
      "NDCCode": "0173-0859-10",
      "PackageDescription": "1 TRAY in 1 CARTON (0173-0859-10)  / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER",
      "NDC11Code": "00173-0859-10",
      "ProductNDC": "0173-0859",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Breo Ellipta",
      "NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20130826",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204275",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
      "StrengthNumber": "100; 25",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130826",
      "SamplePackage": "N",
      "IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
      "Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "0173-0859-14",
      "PackageDescription": "1 TRAY in 1 CARTON (0173-0859-14)  / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
      "NDC11Code": "00173-0859-14",
      "ProductNDC": "0173-0859",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Breo Ellipta",
      "NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20130826",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204275",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
      "StrengthNumber": "100; 25",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130826",
      "SamplePackage": "N",
      "IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
      "Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "0173-0859-61",
      "PackageDescription": "1 TRAY in 1 CARTON (0173-0859-61)  / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
      "NDC11Code": "00173-0859-61",
      "ProductNDC": "0173-0859",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Breo Ellipta",
      "NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20130826",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204275",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
      "StrengthNumber": "100; 25",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20130826",
      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
      "Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "0173-0874-10",
      "PackageDescription": "1 INHALER in 1 CARTON (0173-0874-10)  / 30 POWDER in 1 INHALER",
      "NDC11Code": "00173-0874-10",
      "ProductNDC": "0173-0874",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Arnuity Ellipta",
      "NonProprietaryName": "Fluticasone Furoate",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20140820",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205625",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "FLUTICASONE FUROATE",
      "StrengthNumber": "100",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140820",
      "SamplePackage": "N",
      "IndicationAndUsage": "ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.",
      "Description": "ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "0173-0874-14",
      "PackageDescription": "1 INHALER in 1 CARTON (0173-0874-14)  / 14 POWDER in 1 INHALER",
      "NDC11Code": "00173-0874-14",
      "ProductNDC": "0173-0874",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Arnuity Ellipta",
      "NonProprietaryName": "Fluticasone Furoate",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20140820",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205625",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "FLUTICASONE FUROATE",
      "StrengthNumber": "100",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140820",
      "SamplePackage": "N",
      "IndicationAndUsage": "ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.",
      "Description": "ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "0173-0876-10",
      "PackageDescription": "1 INHALER in 1 CARTON (0173-0876-10)  / 30 POWDER in 1 INHALER",
      "NDC11Code": "00173-0876-10",
      "ProductNDC": "0173-0876",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Arnuity Ellipta",
      "NonProprietaryName": "Fluticasone Furoate",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20140820",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205625",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "FLUTICASONE FUROATE",
      "StrengthNumber": "200",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140820",
      "SamplePackage": "N",
      "IndicationAndUsage": "ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.",
      "Description": "ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "0173-0876-14",
      "PackageDescription": "1 INHALER in 1 CARTON (0173-0876-14)  / 14 POWDER in 1 INHALER",
      "NDC11Code": "00173-0876-14",
      "ProductNDC": "0173-0876",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Arnuity Ellipta",
      "NonProprietaryName": "Fluticasone Furoate",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20140820",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205625",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "FLUTICASONE FUROATE",
      "StrengthNumber": "200",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140820",
      "SamplePackage": "N",
      "IndicationAndUsage": "ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.",
      "Description": "ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "0173-0882-10",
      "PackageDescription": "1 TRAY in 1 CARTON (0173-0882-10)  / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER",
      "NDC11Code": "00173-0882-10",
      "ProductNDC": "0173-0882",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Breo Ellipta",
      "NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20150430",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204275",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
      "StrengthNumber": "200; 25",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150430",
      "SamplePackage": "N",
      "IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
      "Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    }
  ]
}
                    

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<NDCList><NDC><NDCCode>36800-538-52</NDCCode><ProprietaryName>Topcare Allergy Relief D</ProprietaryName><NonProprietaryName>Loratadine, Pseudoephedrine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>36800-538-22</NDCCode><ProprietaryName>Topcare Allergy Relief D</ProprietaryName><NonProprietaryName>Loratadine, Pseudoephedrine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>36800-013-52</NDCCode><ProprietaryName>Topcare Allergy Relief D</ProprietaryName><NonProprietaryName>Loratadine, Pseudoephedrine</NonProprietaryName></NDC><NDC><NDCCode>36800-054-52</NDCCode><ProprietaryName>Topcare 12 Hour Decongestant</ProprietaryName><NonProprietaryName>Pseudoephedrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>36800-185-59</NDCCode><ProprietaryName>Live Better</ProprietaryName><NonProprietaryName>Fluoride</NonProprietaryName></NDC><NDC><NDCCode>36800-212-52</NDCCode><ProprietaryName>Topcare Childrens Allergy Relief</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>36800-285-59</NDCCode><ProprietaryName>Top Care</ProprietaryName><NonProprietaryName>Fluoride</NonProprietaryName></NDC><NDC><NDCCode>36800-306-52</NDCCode><ProprietaryName>Topcare Clearlax</ProprietaryName><NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName></NDC><NDC><NDCCode>36800-311-52</NDCCode><ProprietaryName>Topcare Allergy Relief</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>36800-417-52</NDCCode><ProprietaryName>Topcare Sinus And Cold D</ProprietaryName><NonProprietaryName>Naproxen Sodium, Pseudoephedrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>36800-755-52</NDCCode><ProprietaryName>Topcare Allergy Relief</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>0941-0424-52</NDCCode><ProprietaryName>Dianeal Low Calcium With Dextrose</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0941-0426-52</NDCCode><ProprietaryName>Dianeal Pd-2 With Dextrose</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0941-0427-52</NDCCode><ProprietaryName>Dianeal Pd-2 With Dextrose</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0941-0429-52</NDCCode><ProprietaryName>Dianeal Pd-2 With Dextrose</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0941-0430-52</NDCCode><ProprietaryName>Dianeal Low Calcium With Dextrose</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0941-0433-52</NDCCode><ProprietaryName>Dianeal Low Calcium With Dextrose</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose</NonProprietaryName></NDC><NDC><NDCCode>49230-206-52</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>49230-209-52</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>49230-212-52</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>63304-538-01</NDCCode><ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>63304-538-05</NDCCode><ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>0173-0859-10</NDCCode><ProprietaryName>Breo Ellipta</ProprietaryName><NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName></NDC><NDC><NDCCode>0173-0859-14</NDCCode><ProprietaryName>Breo Ellipta</ProprietaryName><NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName></NDC><NDC><NDCCode>0173-0859-61</NDCCode><ProprietaryName>Breo Ellipta</ProprietaryName><NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName></NDC><NDC><NDCCode>0173-0874-10</NDCCode><ProprietaryName>Arnuity Ellipta</ProprietaryName><NonProprietaryName>Fluticasone Furoate</NonProprietaryName></NDC><NDC><NDCCode>0173-0874-14</NDCCode><ProprietaryName>Arnuity Ellipta</ProprietaryName><NonProprietaryName>Fluticasone Furoate</NonProprietaryName></NDC><NDC><NDCCode>0173-0876-10</NDCCode><ProprietaryName>Arnuity Ellipta</ProprietaryName><NonProprietaryName>Fluticasone Furoate</NonProprietaryName></NDC><NDC><NDCCode>0173-0876-14</NDCCode><ProprietaryName>Arnuity Ellipta</ProprietaryName><NonProprietaryName>Fluticasone Furoate</NonProprietaryName></NDC><NDC><NDCCode>0173-0882-10</NDCCode><ProprietaryName>Breo Ellipta</ProprietaryName><NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName></NDC></NDCList>