RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "50102-233-13",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (50102-233-13)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "50102-0233-13",
      "ProductNDC": "50102-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tri-vylibra",
      "NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160706",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205441",
      "LabelerName": "Afaxys Pharma, LLC",
      "Status": "Active",
      "LastUpdate": "2024-02-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160706",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tri-VyLibra is combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Tri-VyLibra is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-VyLibra should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).",
      "Description": "Tri-VyLibra is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Each active white tablet contains 0.180 mg of norgestimate USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each active light blue tablet contains 0.215 mg of norgestimate USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, FD&C #2/Indigo carmine aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each active dark blue tablet contains 0.250 mg of norgestimate USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, FD&C #2/Indigo carmine aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each green tablet contains only inert ingredients, as follows: anhydrous lactose, FD&C Blue No. 2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, and povidone."
    },
    {
      "NDCCode": "50102-233-11",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (50102-233-11)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "50102-0233-11",
      "ProductNDC": "50102-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tri-vylibra",
      "NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160706",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205441",
      "LabelerName": "Afaxys Pharma, LLC",
      "Status": "Active",
      "LastUpdate": "2024-02-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160706",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tri-VyLibra is combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Tri-VyLibra is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-VyLibra should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).",
      "Description": "Tri-VyLibra is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Each active white tablet contains 0.180 mg of norgestimate USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each active light blue tablet contains 0.215 mg of norgestimate USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, FD&C #2/Indigo carmine aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each active dark blue tablet contains 0.250 mg of norgestimate USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, FD&C #2/Indigo carmine aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each green tablet contains only inert ingredients, as follows: anhydrous lactose, FD&C Blue No. 2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, and povidone."
    },
    {
      "NDCCode": "29300-233-13",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-233-13) ",
      "NDC11Code": "29300-0233-13",
      "ProductNDC": "29300-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Valsartan",
      "NonProprietaryName": "Valsartan",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180504",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209261",
      "LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
      "SubstanceName": "VALSARTAN",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-09-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180515",
      "SamplePackage": "N",
      "IndicationAndUsage": "Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension , to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart  failure in adults (1.2), 3 Post-myocardial infarction , for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
      "Description": "Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan, USP is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white or almost white, hygroscopic powder. It is freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride, practically insoluble in water. Valsartan, USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, ferric oxide yellow (in 80 mg, and 160 mg), hypromellose, lactose monhydrate, magnesium stearate, microcrystalline cellulose, polyethelene glycol, povidone, sodium lauryl sulphate, talc (in 40 mg, and 320 mg) and titanium dioxide."
    },
    {
      "NDCCode": "84369-233-01",
      "PackageDescription": "13 g in 1 BOX (84369-233-01) ",
      "NDC11Code": "84369-0233-01",
      "ProductNDC": "84369-233",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Skin Tag Patches",
      "NonProprietaryName": "Skin Tag Patches",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241106",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M028",
      "LabelerName": "Shenzhen Rongxing Trading Co., Ltd.",
      "SubstanceName": "HAMAMELIS VIRGINIANA TOP WATER",
      "StrengthNumber": "72",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241107",
      "SamplePackage": "N",
      "IndicationAndUsage": "For external use only. Avoid direct contact with eyes. Discontinue use if irritation occur. Keep out of reach of childeren. Store in a cool and dry place."
    },
    {
      "NDCCode": "50102-200-13",
      "PackageDescription": "3 PACKAGE in 1 CARTON (50102-200-13)  > 1 BLISTER PACK in 1 PACKAGE (50102-200-11)  > 28 TABLET in 1 BLISTER PACK (50102-200-01) ",
      "NDC11Code": "50102-0200-13",
      "ProductNDC": "50102-200",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tulana",
      "NonProprietaryName": "Norethindrone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160923",
      "EndMarketingDate": "20220630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207304",
      "LabelerName": "Afaxys Pharma, LLC",
      "SubstanceName": "NORETHINDRONE",
      "StrengthNumber": ".35",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160923",
      "EndMarketingDatePackage": "20220630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50102-211-13",
      "PackageDescription": "3 CARTON in 1 PACKAGE (50102-211-13)  / 1 BLISTER PACK in 1 CARTON (50102-211-11)  / 1 TABLET in 1 BLISTER PACK (50102-211-01) ",
      "NDC11Code": "50102-0211-13",
      "ProductNDC": "50102-211",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Econtra One-step",
      "NonProprietaryName": "Levonorgestrel",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180208",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206867",
      "LabelerName": "Afaxys Pharma, LLC",
      "SubstanceName": "LEVONORGESTREL",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201027",
      "SamplePackage": "N",
      "IndicationAndUsage": "for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)."
    },
    {
      "NDCCode": "50102-231-13",
      "PackageDescription": "3 PACKAGE in 1 CARTON (50102-231-13)  / 1 BLISTER PACK in 1 PACKAGE (50102-231-11)  / 1 KIT in 1 BLISTER PACK (50102-231-01) ",
      "NDC11Code": "50102-0231-13",
      "ProductNDC": "50102-231",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tri-vylibra Lo",
      "NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20161104",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205762",
      "LabelerName": "Afaxys Pharma, LLC",
      "Status": "Active",
      "LastUpdate": "2023-05-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161104",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).",
      "Description": "Tri-VyLibra Lo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol)."
    },
    {
      "NDCCode": "50102-235-13",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (50102-235-13)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "50102-0235-13",
      "ProductNDC": "50102-235",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vylibra",
      "NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160707",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205449",
      "LabelerName": "Afaxys Pharma, LLC",
      "Status": "Active",
      "LastUpdate": "2025-01-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160707",
      "SamplePackage": "N",
      "IndicationAndUsage": "VyLibra is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1).",
      "Description": "VyLibra is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol)."
    },
    {
      "NDCCode": "50102-300-13",
      "PackageDescription": "3 PACKAGE in 1 CARTON (50102-300-13)  / 1 BLISTER PACK in 1 PACKAGE (50102-300-11)  / 28 TABLET in 1 BLISTER PACK (50102-300-01) ",
      "NDC11Code": "50102-0300-13",
      "ProductNDC": "50102-300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lyleq",
      "NonProprietaryName": "Norethindrone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160923",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207304",
      "LabelerName": "Afaxys Pharma, LLC",
      "SubstanceName": "NORETHINDRONE",
      "StrengthNumber": ".35",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-04-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160923",
      "SamplePackage": "N",
      "IndicationAndUsage": "1. Indications  Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Emergency Contraceptive Pills Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 Lactational Amenorrhea Method LAM is a highly effective, temporary method of contraception.10 Source: Trussell, J, Contraceptive Efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.",
      "Description": "Each light yellow to yellow Lyleq®tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone USP daily, and the inactive ingredients include corn starch, D&C Yellow No. 10 aluminum lake, FD&C Yellow # 6 aluminum lake, lactose monohydrate, magnesium stearate, povidone and talc. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17α-pregn-4-en-20-yn-3-one. The structural formula follows."
    },
    {
      "NDCCode": "50102-211-16",
      "PackageDescription": "6 CARTON in 1 PACKAGE (50102-211-16)  > 1 BLISTER PACK in 1 CARTON (50102-211-11)  > 1 TABLET in 1 BLISTER PACK (50102-211-01) ",
      "NDC11Code": "50102-0211-16",
      "ProductNDC": "50102-211",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Econtra One-step",
      "NonProprietaryName": "Levonorgestrel",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180208",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206867",
      "LabelerName": "Afaxys Pharma, LLC",
      "SubstanceName": "LEVONORGESTREL",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine Device [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-04-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20180208",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50102-230-23",
      "PackageDescription": "3 POUCH in 1 CARTON (50102-230-23)  / 1 BLISTER PACK in 1 POUCH (50102-230-21)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "50102-0230-23",
      "ProductNDC": "50102-230",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Chateal Eq",
      "NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160923",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206866",
      "LabelerName": "Afaxys Pharma, LLC",
      "Status": "Active",
      "LastUpdate": "2025-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160923",
      "SamplePackage": "N",
      "IndicationAndUsage": "Chateal EQ is indicated for use by females of reproductive potential to prevent pregnancy.",
      "Description": "Chateal EQ (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 orange active tablets, each containing 0.15 mg of levonorgestrel USP, a synthetic progestin and 0.03 mg of ethinyl estradiol USP, an estrogen, and 7 green inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,(17α)- (-)-. Ethinyl Estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each orange active tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Each green inert tablet contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, FD & C Blue No. 2 Aluminum Lake, ferric oxide (sicovit yellow 10), magnesium stearate, microcrystalline cellulose, and povidone."
    },
    {
      "NDCCode": "50102-235-11",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (50102-235-11)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "50102-0235-11",
      "ProductNDC": "50102-235",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vylibra",
      "NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160707",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205449",
      "LabelerName": "Afaxys Pharma, LLC",
      "Status": "Active",
      "LastUpdate": "2025-01-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160707",
      "SamplePackage": "N",
      "IndicationAndUsage": "VyLibra is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1).",
      "Description": "VyLibra is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol)."
    },
    {
      "NDCCode": "50102-240-23",
      "PackageDescription": "3 POUCH in 1 CARTON (50102-240-23)  / 1 BLISTER PACK in 1 POUCH (50102-240-21)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "50102-0240-23",
      "ProductNDC": "50102-240",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Jasmiel",
      "NonProprietaryName": "Drospirenone And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20180227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209632",
      "LabelerName": "Afaxys Pharma, LLC",
      "Status": "Active",
      "LastUpdate": "2024-05-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180227",
      "SamplePackage": "N",
      "IndicationAndUsage": "Jasmiel is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).",
      "Description": "Jasmiel (drospirenone and ethinyl estradiol tablets, USP) provides an oral contraceptive regimen consisting of 24 light pink to pink active uncoated tablets each containing 3 mg of drospirenone USP and 0.02 mg of ethinyl estradiol USP and 4 green inert uncoated tablets. The inactive ingredients in the light pink to pink tablets are corn starch, FD&C Red No. 40, lactose monohydrate, magnesium stearate, povidone, talc and vitamin-E. The green inert uncoated tablets contain anhydrous lactose, croscarmellose sodium, FD &C Blue No. 2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro­-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "50102-254-23",
      "PackageDescription": "3 POUCH in 1 CARTON (50102-254-23)  / 1 BLISTER PACK in 1 POUCH (50102-254-21)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "50102-0254-23",
      "ProductNDC": "50102-254",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyred Eq",
      "NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20170517",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207081",
      "LabelerName": "Afaxys Pharma, LLC",
      "Status": "Active",
      "LastUpdate": "2025-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170517",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyred EQ® tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Cyred EQ®, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.§. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.¶. Source: Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York, NY; Irvington Publishers, 1998. *  Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. †Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. ‡ Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year   if they do not stop use for any other reason. §  The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). ¶ However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. # The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. Þ Foams, creams, gels, vaginal suppositories, and vaginal film. ß Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. à With spermicidal cream or jelly. è Without spermicides. Cyred EQ® has not been studied for and is not indicated for use in emergency contraception.",
      "Description": "Cyred EQ® tablets provide an oral contraceptive regimen of 21 white to off-white round tablets each containing 0.15 mg desogestrel USP (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17,diol). Inactive ingredients include colloidal silicon dioxide, lactose monohydrate, potato starch, povidone, stearic acid, and vitamin E. Each green tablet contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, FD&C Blue No.2 Aluminum Lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, and povidone. Cyred EQ meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "0054-0326-56",
      "PackageDescription": "1 POUCH in 1 CARTON (0054-0326-56)  / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER",
      "NDC11Code": "00054-0326-56",
      "ProductNDC": "0054-0326",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluticasone Propionate And Salmeterol",
      "NonProprietaryName": "Fluticasone Propionate And Salmeterol",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20201217",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203433",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE",
      "StrengthNumber": "50; 100",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201217",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
      "Description": "Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder is fluticasone propionate, a corticosteroid having the chemical name S-fluoromethyl-6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate is a white or almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 1,3-benzenedimethanol, 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-(±)-,1-hydroxy-2-naphthalenecarboxylate (salt) and the following chemical structure. Salmeterol xinafoate is a white to off-white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder is in a gray plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100 mcg, 250 mcg, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder delivers 93 mcg, 233 mcg, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4‑year‑old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8‑year‑old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "0054-0327-56",
      "PackageDescription": "1 POUCH in 1 CARTON (0054-0327-56)  / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER",
      "NDC11Code": "00054-0327-56",
      "ProductNDC": "0054-0327",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluticasone Propionate And Salmeterol",
      "NonProprietaryName": "Fluticasone Propionate And Salmeterol",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20201217",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203433",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE",
      "StrengthNumber": "50; 250",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201217",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
      "Description": "Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder is fluticasone propionate, a corticosteroid having the chemical name S-fluoromethyl-6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate is a white or almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 1,3-benzenedimethanol, 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-(±)-,1-hydroxy-2-naphthalenecarboxylate (salt) and the following chemical structure. Salmeterol xinafoate is a white to off-white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder is in a gray plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100 mcg, 250 mcg, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder delivers 93 mcg, 233 mcg, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4‑year‑old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8‑year‑old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "0054-0328-56",
      "PackageDescription": "1 POUCH in 1 CARTON (0054-0328-56)  / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER",
      "NDC11Code": "00054-0328-56",
      "ProductNDC": "0054-0328",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluticasone Propionate And Salmeterol",
      "NonProprietaryName": "Fluticasone Propionate And Salmeterol",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20201217",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203433",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE",
      "StrengthNumber": "50; 500",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231219",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
      "Description": "Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder is fluticasone propionate, a corticosteroid having the chemical name S-fluoromethyl-6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate is a white or almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 1,3-benzenedimethanol, 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-(±)-,1-hydroxy-2-naphthalenecarboxylate (salt) and the following chemical structure. Salmeterol xinafoate is a white to off-white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder is in a gray plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100 mcg, 250 mcg, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder delivers 93 mcg, 233 mcg, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4‑year‑old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8‑year‑old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "0093-7516-31",
      "PackageDescription": "1 POUCH in 1 CARTON (0093-7516-31)  > 1 INHALER in 1 POUCH > 60 POWDER in 1 INHALER",
      "NDC11Code": "00093-7516-31",
      "ProductNDC": "0093-7516",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluticasone Propionate And Salmeterol",
      "NonProprietaryName": "Fluticasone Propionate And Salmeterol",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20220323",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213948",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
      "StrengthNumber": "500; 50",
      "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": "2022-09-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220323",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
      "Description": "Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder, USP is fluticasone propionate USP, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate, USP is a white powder with a molecular weight of 500.57, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder, USP is salmeterol xinafoate USP, a beta2-adrenergic bronchodilator. Salmeterol xinafoate, USP is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino] methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate, USP is a white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder, USP is supplied in a green plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate, USP (100, 250, or 500 mcg) and micronized salmeterol xinafoate, USP salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder inhaler delivers 93, 233, and 465 mcg of fluticasone propionate, USP and 45 mcg of salmeterol base, per blister from fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "0093-7517-31",
      "PackageDescription": "1 POUCH in 1 CARTON (0093-7517-31)  > 1 INHALER in 1 POUCH > 60 POWDER in 1 INHALER",
      "NDC11Code": "00093-7517-31",
      "ProductNDC": "0093-7517",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluticasone Propionate And Salmeterol",
      "NonProprietaryName": "Fluticasone Propionate And Salmeterol",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20220323",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213948",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
      "StrengthNumber": "100; 50",
      "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": "2022-09-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220323",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
      "Description": "Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder, USP is fluticasone propionate USP, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate, USP is a white powder with a molecular weight of 500.57, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder, USP is salmeterol xinafoate USP, a beta2-adrenergic bronchodilator. Salmeterol xinafoate, USP is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino] methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate, USP is a white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder, USP is supplied in a green plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate, USP (100, 250, or 500 mcg) and micronized salmeterol xinafoate, USP salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder inhaler delivers 93, 233, and 465 mcg of fluticasone propionate, USP and 45 mcg of salmeterol base, per blister from fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "0093-7518-31",
      "PackageDescription": "1 POUCH in 1 CARTON (0093-7518-31)  > 1 INHALER in 1 POUCH > 60 POWDER in 1 INHALER",
      "NDC11Code": "00093-7518-31",
      "ProductNDC": "0093-7518",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluticasone Propionate And Salmeterol",
      "NonProprietaryName": "Fluticasone Propionate And Salmeterol",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20220323",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213948",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
      "StrengthNumber": "250; 50",
      "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": "2022-09-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220323",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
      "Description": "Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder, USP is fluticasone propionate USP, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate, USP is a white powder with a molecular weight of 500.57, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder, USP is salmeterol xinafoate USP, a beta2-adrenergic bronchodilator. Salmeterol xinafoate, USP is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino] methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate, USP is a white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder, USP is supplied in a green plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate, USP (100, 250, or 500 mcg) and micronized salmeterol xinafoate, USP salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder inhaler delivers 93, 233, and 465 mcg of fluticasone propionate, USP and 45 mcg of salmeterol base, per blister from fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "0264-7387-50",
      "PackageDescription": "4 CONTAINER in 1 CASE (0264-7387-50)  / 2000 mL in 1 CONTAINER",
      "NDC11Code": "00264-7387-50",
      "ProductNDC": "0264-7387",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextrose",
      "NonProprietaryName": "Dextrose",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20150219",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019626",
      "LabelerName": "B. Braun Medical Inc.",
      "SubstanceName": "DEXTROSE",
      "StrengthNumber": "70",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2024-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150219",
      "SamplePackage": "N",
      "IndicationAndUsage": "70% Dextrose Injection USP is indicated as a caloric component in a parenteral nutrition regimen. 70% Dextrose Injection USP is used with an appropriate protein (nitrogen) source in the prevention of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.",
      "Description": "Each 100 mL of 70% Dextrose Injection USP contains. Hydrous Dextrose USP 70 g; Water for Injection USP qs. pH: 4.0 (3.2-6.5); Calculated Osmolarity: 3532 mOsmol/liter, hypertonic. Specific gravity 1.233 at 25°C. Calories per liter: 2380 calculated on the basis of 3.4 kcal/g of dextrose, hydrous. 70% Dextrose Injection USP is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration after appropriate admixture or dilution as a caloric source. The formula of the active ingredient is:. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during use. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary."
    },
    {
      "NDCCode": "0378-9320-32",
      "PackageDescription": "1 INHALER in 1 CARTON (0378-9320-32)  > 60 POWDER in 1 INHALER",
      "NDC11Code": "00378-9320-32",
      "ProductNDC": "0378-9320",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Wixela Inhub",
      "NonProprietaryName": "Fluticasone Propionate And Salmeterol",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20190211",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208891",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
      "StrengthNumber": "100; 50",
      "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": "2022-09-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190211",
      "SamplePackage": "N",
      "IndicationAndUsage": "Wixela Inhub® is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: : 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1) , 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
      "Description": "Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Wixela Inhub® is fluticasone propionate, a corticosteroid having the chemical name S-Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate, USP is a white to almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of Wixela Inhub® is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name (±)-4-Hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-m-xylene-α,α'-diol 1-hydroxy-2-naphthoate (salt) and the following chemical structure. Salmeterol xinafoate, USP is a white to almost white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Wixela Inhub® is a grey colored plastic inhaler containing two foil sealed discs, each disc containing 30 pre-metered doses. Each of the 60 doses contains a white to off white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, Wixela Inhub® delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per dose from Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Meets USP Aerodynamic Particle Size Distribution Test 2."
    },
    {
      "NDCCode": "0378-9321-32",
      "PackageDescription": "1 INHALER in 1 CARTON (0378-9321-32)  > 60 POWDER in 1 INHALER",
      "NDC11Code": "00378-9321-32",
      "ProductNDC": "0378-9321",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Wixela Inhub",
      "NonProprietaryName": "Fluticasone Propionate And Salmeterol",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20190211",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208891",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
      "StrengthNumber": "250; 50",
      "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": "2022-09-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190211",
      "SamplePackage": "N",
      "IndicationAndUsage": "Wixela Inhub® is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: : 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1) , 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
      "Description": "Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Wixela Inhub® is fluticasone propionate, a corticosteroid having the chemical name S-Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate, USP is a white to almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of Wixela Inhub® is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name (±)-4-Hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-m-xylene-α,α'-diol 1-hydroxy-2-naphthoate (salt) and the following chemical structure. Salmeterol xinafoate, USP is a white to almost white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Wixela Inhub® is a grey colored plastic inhaler containing two foil sealed discs, each disc containing 30 pre-metered doses. Each of the 60 doses contains a white to off white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, Wixela Inhub® delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per dose from Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Meets USP Aerodynamic Particle Size Distribution Test 2."
    },
    {
      "NDCCode": "0378-9322-32",
      "PackageDescription": "1 INHALER in 1 CARTON (0378-9322-32)  > 60 POWDER in 1 INHALER",
      "NDC11Code": "00378-9322-32",
      "ProductNDC": "0378-9322",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Wixela Inhub",
      "NonProprietaryName": "Fluticasone Propionate And Salmeterol",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20190211",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208891",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
      "StrengthNumber": "500; 50",
      "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": "2022-09-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190211",
      "SamplePackage": "N",
      "IndicationAndUsage": "Wixela Inhub® is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: : 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1) , 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
      "Description": "Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Wixela Inhub® is fluticasone propionate, a corticosteroid having the chemical name S-Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate, USP is a white to almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of Wixela Inhub® is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name (±)-4-Hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-m-xylene-α,α'-diol 1-hydroxy-2-naphthoate (salt) and the following chemical structure. Salmeterol xinafoate, USP is a white to almost white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Wixela Inhub® is a grey colored plastic inhaler containing two foil sealed discs, each disc containing 30 pre-metered doses. Each of the 60 doses contains a white to off white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, Wixela Inhub® delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per dose from Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Meets USP Aerodynamic Particle Size Distribution Test 2."
    },
    {
      "NDCCode": "0527-6010-06",
      "PackageDescription": "1 INHALER in 1 CARTON (0527-6010-06)  / 60 POWDER in 1 INHALER",
      "NDC11Code": "00527-6010-06",
      "ProductNDC": "0527-6010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluticasone Propionate And Salmeterol",
      "NonProprietaryName": "Fluticasone Propionate And Salmeterol",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20260112",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214464",
      "LabelerName": "Lannett Company, Inc.",
      "SubstanceName": "SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE",
      "StrengthNumber": "50; 100",
      "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": "2026-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260112",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
      "Description": "Fluticasone Propionate and Salmeterol Inhalation Powder USP 100 mcg/50 mcg and 250 mcg/50 mcg, is a mixture of fluticasone propionate and salmeterol xinafoate for use in dry powder inhalers. The Inhalation Powder contains NLT 90% and NMT 110% of the labeled amount of fluticasone propionate (C25H31F3O5S) and NLT 90% and NMT 110% of the labeled amount of salmeterol (C25H37NO4) as salmeterol xinafoate. One active component of fluticasone propionate and salmeterol inhalation powder is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder is a gray plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100 or 250 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder delivers 93 and 233 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg and fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "0527-6011-06",
      "PackageDescription": "1 INHALER in 1 CARTON (0527-6011-06)  / 60 POWDER in 1 INHALER",
      "NDC11Code": "00527-6011-06",
      "ProductNDC": "0527-6011",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluticasone Propionate And Salmeterol",
      "NonProprietaryName": "Fluticasone Propionate And Salmeterol",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20241129",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214464",
      "LabelerName": "Lannett Company, Inc.",
      "SubstanceName": "SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE",
      "StrengthNumber": "50; 250",
      "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": "2026-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260112",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
      "Description": "Fluticasone Propionate and Salmeterol Inhalation Powder USP 100 mcg/50 mcg and 250 mcg/50 mcg, is a mixture of fluticasone propionate and salmeterol xinafoate for use in dry powder inhalers. The Inhalation Powder contains NLT 90% and NMT 110% of the labeled amount of fluticasone propionate (C25H31F3O5S) and NLT 90% and NMT 110% of the labeled amount of salmeterol (C25H37NO4) as salmeterol xinafoate. One active component of fluticasone propionate and salmeterol inhalation powder is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder is a gray plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100 or 250 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder delivers 93 and 233 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg and fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "10361-778-31",
      "PackageDescription": "100 TABLET in 1 BOTTLE, GLASS (10361-778-31) ",
      "NDC11Code": "10361-0778-31",
      "ProductNDC": "10361-778",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "E-z-disk",
      "NonProprietaryName": "Barium Sulfate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090201",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA219840",
      "LabelerName": "E-Z-EM, INC.",
      "SubstanceName": "BARIUM SULFATE",
      "StrengthNumber": "700",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20090201",
      "SamplePackage": "N",
      "IndicationAndUsage": "E-Z-DISK is indicated for the evaluation of esophageal patency in adults and pediatric patients aged 12 years and older.",
      "Description": "E-Z-DISK (barium sulfate) tablet is a radiographic contrast agent for oral use. Barium sulfate is designated chemically as BaSO4 with molecular weight of 233.4 g/mol, density of 4.5 g/cm3, and the following chemical structure. E-Z-DISK is a white to lightly colored, flat-sided disk, between 11.5 mm and 13.5 mm (0.45 inch and 0.53 inch) in diameter. Each tablet contains 700 mg barium sulfate and the following inactive ingredients: confectioner’s sugar, microcrystalline cellulose, corn starch, povidone, croscarmellose sodium, and magnesium stearate."
    },
    {
      "NDCCode": "50181-0018-1",
      "PackageDescription": "30 mL in 1 BOTTLE, DROPPER (50181-0018-1) ",
      "NDC11Code": "50181-0018-01",
      "ProductNDC": "50181-0018",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mbm 13 Female",
      "NonProprietaryName": "Oxytocin, Phytolacca Decandra, Pituitary (suis), Scrophularia Nodosa, Hypothalamus (suis), Calcarea Carbonica, Cumicifuga Racemosa, Lilium Tigrinum, Sulphur, Causticum, Graphites, Kali Phosphoricum",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130404",
      "EndMarketingDate": "20220331",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "The Wellness Center for Research and Education",
      "SubstanceName": "BLACK COHOSH; CAUSTICUM; GRAPHITE; LILIUM LANCIFOLIUM WHOLE FLOWERING; OXYTOCIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM PHOSPHATE, DIBASIC; SCROPHULARIA NODOSA; SULFUR; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND, POSTERIOR",
      "StrengthNumber": "89; 144; 144; 89; 6; 89; 3; 233; 3; 89; 5; 3",
      "StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
      "Pharm_Classes": "Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20130404",
      "EndMarketingDatePackage": "20220331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50181-0084-1",
      "PackageDescription": "30 mL in 1 BOTTLE, DROPPER (50181-0084-1) ",
      "NDC11Code": "50181-0084-01",
      "ProductNDC": "50181-0084",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mbm 13 Female",
      "NonProprietaryName": "Phytolacca Decandra, Hypophysis (suis), Scrophularia Nodosa, Hypothalamus (suis), Calcarea Carbonica, Cimicifuga Racemosa, Lilium Tigrinum, Sulphur, Causticum, Graphites, Kali Phosphoricum",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220503",
      "EndMarketingDate": "20270609",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "The Wellness Center for Research and Education, Inc.",
      "SubstanceName": "PHYTOLACCA AMERICANA ROOT; SUS SCROFA PITUITARY GLAND; SCROPHULARIA NODOSA WHOLE; BOS TAURUS HYPOTHALAMUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; BLACK COHOSH; LILIUM LANCIFOLIUM WHOLE FLOWERING; SULFUR; CAUSTICUM; GRAPHITE; DIBASIC POTASSIUM PHOSPHATE",
      "StrengthNumber": "3; 3; 3; 5; 89; 89; 89; 89; 144; 144; 233",
      "StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
      "Status": "Active",
      "LastUpdate": "2025-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20220503",
      "EndMarketingDatePackage": "20270609",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of emotionlessness, denial, numbness, and unresponsiveness."
    },
    {
      "NDCCode": "50563-233-01",
      "PackageDescription": "500 mL in 1 BOTTLE (50563-233-01) ",
      "NDC11Code": "50563-0233-01",
      "ProductNDC": "50563-233",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Livegreen Eucalyptus Mint Antibacterial Foaming Hand Wash",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200630",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "ENCHANTE ACCESSORIES INC.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".13",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200630",
      "SamplePackage": "N",
      "IndicationAndUsage": "■ To decrease bacteria on hands."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"50102-233-13","ProprietaryName":"Tri-vylibra","NonProprietaryName":"Norgestimate And Ethinyl Estradiol"},{"NDCCode":"50102-233-11","ProprietaryName":"Tri-vylibra","NonProprietaryName":"Norgestimate And Ethinyl Estradiol"},{"NDCCode":"29300-233-13","ProprietaryName":"Valsartan","NonProprietaryName":"Valsartan"},{"NDCCode":"84369-233-01","ProprietaryName":"Skin Tag Patches","NonProprietaryName":"Skin Tag Patches"},{"NDCCode":"50102-200-13","ProprietaryName":"Tulana","NonProprietaryName":"Norethindrone"},{"NDCCode":"50102-211-13","ProprietaryName":"Econtra One-step","NonProprietaryName":"Levonorgestrel"},{"NDCCode":"50102-231-13","ProprietaryName":"Tri-vylibra Lo","NonProprietaryName":"Norgestimate And Ethinyl Estradiol"},{"NDCCode":"50102-235-13","ProprietaryName":"Vylibra","NonProprietaryName":"Norgestimate And Ethinyl Estradiol"},{"NDCCode":"50102-300-13","ProprietaryName":"Lyleq","NonProprietaryName":"Norethindrone"},{"NDCCode":"50102-211-16","ProprietaryName":"Econtra One-step","NonProprietaryName":"Levonorgestrel"},{"NDCCode":"50102-230-23","ProprietaryName":"Chateal Eq","NonProprietaryName":"Levonorgestrel And Ethinyl Estradiol"},{"NDCCode":"50102-235-11","ProprietaryName":"Vylibra","NonProprietaryName":"Norgestimate And Ethinyl Estradiol"},{"NDCCode":"50102-240-23","ProprietaryName":"Jasmiel","NonProprietaryName":"Drospirenone And Ethinyl Estradiol"},{"NDCCode":"50102-254-23","ProprietaryName":"Cyred Eq","NonProprietaryName":"Desogestrel And Ethinyl Estradiol"},{"NDCCode":"0054-0326-56","ProprietaryName":"Fluticasone Propionate And Salmeterol","NonProprietaryName":"Fluticasone Propionate And Salmeterol"},{"NDCCode":"0054-0327-56","ProprietaryName":"Fluticasone Propionate And Salmeterol","NonProprietaryName":"Fluticasone Propionate And Salmeterol"},{"NDCCode":"0054-0328-56","ProprietaryName":"Fluticasone Propionate And Salmeterol","NonProprietaryName":"Fluticasone Propionate And Salmeterol"},{"NDCCode":"0093-7516-31","ProprietaryName":"Fluticasone Propionate And Salmeterol","NonProprietaryName":"Fluticasone Propionate And Salmeterol"},{"NDCCode":"0093-7517-31","ProprietaryName":"Fluticasone Propionate And Salmeterol","NonProprietaryName":"Fluticasone Propionate And Salmeterol"},{"NDCCode":"0093-7518-31","ProprietaryName":"Fluticasone Propionate And Salmeterol","NonProprietaryName":"Fluticasone Propionate And Salmeterol"},{"NDCCode":"0264-7387-50","ProprietaryName":"Dextrose","NonProprietaryName":"Dextrose"},{"NDCCode":"0378-9320-32","ProprietaryName":"Wixela Inhub","NonProprietaryName":"Fluticasone Propionate And Salmeterol"},{"NDCCode":"0378-9321-32","ProprietaryName":"Wixela Inhub","NonProprietaryName":"Fluticasone Propionate And Salmeterol"},{"NDCCode":"0378-9322-32","ProprietaryName":"Wixela Inhub","NonProprietaryName":"Fluticasone Propionate And Salmeterol"},{"NDCCode":"0527-6010-06","ProprietaryName":"Fluticasone Propionate And Salmeterol","NonProprietaryName":"Fluticasone Propionate And Salmeterol"},{"NDCCode":"0527-6011-06","ProprietaryName":"Fluticasone Propionate And Salmeterol","NonProprietaryName":"Fluticasone Propionate And Salmeterol"},{"NDCCode":"10361-778-31","ProprietaryName":"E-z-disk","NonProprietaryName":"Barium Sulfate"},{"NDCCode":"50181-0018-1","ProprietaryName":"Mbm 13 Female","NonProprietaryName":"Oxytocin, Phytolacca Decandra, Pituitary (suis), Scrophularia Nodosa, Hypothalamus (suis), Calcarea Carbonica, Cumicifuga Racemosa, Lilium Tigrinum, Sulphur, Causticum, Graphites, Kali Phosphoricum"},{"NDCCode":"50181-0084-1","ProprietaryName":"Mbm 13 Female","NonProprietaryName":"Phytolacca Decandra, Hypophysis (suis), Scrophularia Nodosa, Hypothalamus (suis), Calcarea Carbonica, Cimicifuga Racemosa, Lilium Tigrinum, Sulphur, Causticum, Graphites, Kali Phosphoricum"},{"NDCCode":"50563-233-01","ProprietaryName":"Livegreen Eucalyptus Mint Antibacterial Foaming Hand Wash","NonProprietaryName":"Benzalkonium Chloride"}]}
                    

<NDCList><NDC><NDCCode>50102-233-13</NDCCode><ProprietaryName>Tri-vylibra</ProprietaryName><NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>50102-233-11</NDCCode><ProprietaryName>Tri-vylibra</ProprietaryName><NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>29300-233-13</NDCCode><ProprietaryName>Valsartan</ProprietaryName><NonProprietaryName>Valsartan</NonProprietaryName></NDC><NDC><NDCCode>84369-233-01</NDCCode><ProprietaryName>Skin Tag Patches</ProprietaryName><NonProprietaryName>Skin Tag Patches</NonProprietaryName></NDC><NDC><NDCCode>50102-200-13</NDCCode><ProprietaryName>Tulana</ProprietaryName><NonProprietaryName>Norethindrone</NonProprietaryName></NDC><NDC><NDCCode>50102-211-13</NDCCode><ProprietaryName>Econtra One-step</ProprietaryName><NonProprietaryName>Levonorgestrel</NonProprietaryName></NDC><NDC><NDCCode>50102-231-13</NDCCode><ProprietaryName>Tri-vylibra Lo</ProprietaryName><NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>50102-235-13</NDCCode><ProprietaryName>Vylibra</ProprietaryName><NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>50102-300-13</NDCCode><ProprietaryName>Lyleq</ProprietaryName><NonProprietaryName>Norethindrone</NonProprietaryName></NDC><NDC><NDCCode>50102-211-16</NDCCode><ProprietaryName>Econtra One-step</ProprietaryName><NonProprietaryName>Levonorgestrel</NonProprietaryName></NDC><NDC><NDCCode>50102-230-23</NDCCode><ProprietaryName>Chateal Eq</ProprietaryName><NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>50102-235-11</NDCCode><ProprietaryName>Vylibra</ProprietaryName><NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>50102-240-23</NDCCode><ProprietaryName>Jasmiel</ProprietaryName><NonProprietaryName>Drospirenone And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>50102-254-23</NDCCode><ProprietaryName>Cyred Eq</ProprietaryName><NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>0054-0326-56</NDCCode><ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName><NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName></NDC><NDC><NDCCode>0054-0327-56</NDCCode><ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName><NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName></NDC><NDC><NDCCode>0054-0328-56</NDCCode><ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName><NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName></NDC><NDC><NDCCode>0093-7516-31</NDCCode><ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName><NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName></NDC><NDC><NDCCode>0093-7517-31</NDCCode><ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName><NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName></NDC><NDC><NDCCode>0093-7518-31</NDCCode><ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName><NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName></NDC><NDC><NDCCode>0264-7387-50</NDCCode><ProprietaryName>Dextrose</ProprietaryName><NonProprietaryName>Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0378-9320-32</NDCCode><ProprietaryName>Wixela Inhub</ProprietaryName><NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName></NDC><NDC><NDCCode>0378-9321-32</NDCCode><ProprietaryName>Wixela Inhub</ProprietaryName><NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName></NDC><NDC><NDCCode>0378-9322-32</NDCCode><ProprietaryName>Wixela Inhub</ProprietaryName><NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName></NDC><NDC><NDCCode>0527-6010-06</NDCCode><ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName><NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName></NDC><NDC><NDCCode>0527-6011-06</NDCCode><ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName><NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName></NDC><NDC><NDCCode>10361-778-31</NDCCode><ProprietaryName>E-z-disk</ProprietaryName><NonProprietaryName>Barium Sulfate</NonProprietaryName></NDC><NDC><NDCCode>50181-0018-1</NDCCode><ProprietaryName>Mbm 13 Female</ProprietaryName><NonProprietaryName>Oxytocin, Phytolacca Decandra, Pituitary (suis), Scrophularia Nodosa, Hypothalamus (suis), Calcarea Carbonica, Cumicifuga Racemosa, Lilium Tigrinum, Sulphur, Causticum, Graphites, Kali Phosphoricum</NonProprietaryName></NDC><NDC><NDCCode>50181-0084-1</NDCCode><ProprietaryName>Mbm 13 Female</ProprietaryName><NonProprietaryName>Phytolacca Decandra, Hypophysis (suis), Scrophularia Nodosa, Hypothalamus (suis), Calcarea Carbonica, Cimicifuga Racemosa, Lilium Tigrinum, Sulphur, Causticum, Graphites, Kali Phosphoricum</NonProprietaryName></NDC><NDC><NDCCode>50563-233-01</NDCCode><ProprietaryName>Livegreen Eucalyptus Mint Antibacterial Foaming Hand Wash</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC></NDCList>