RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (9 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "66915-605-22",
      "PackageDescription": "120 g in 1 TUBE (66915-605-22)",
      "NDC11Code": "66915-0605-22",
      "ProductNDC": "66915-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Day Cream Spf 30",
      "NonProprietaryName": "Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130722",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": ".01; .075; .05; .06",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "66915-413-22",
      "PackageDescription": "30 g in 1 BOTTLE, GLASS (66915-413-22)",
      "NDC11Code": "66915-0413-22",
      "ProductNDC": "66915-413",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Superlightener",
      "NonProprietaryName": "Hydroquinone",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100701",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part358A",
      "LabelerName": "CoValence Inc",
      "SubstanceName": "HYDROQUINONE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-06-19"
    },
    {
      "NDCCode": "66915-438-02",
      "PackageDescription": "1 TUBE in 1 BOX (66915-438-02)  > 22.5 g in 1 TUBE (66915-438-01)",
      "NDC11Code": "66915-0438-02",
      "ProductNDC": "66915-438",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Salicylic Acne Pore Treatment",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20101026",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "CoValence Inc.",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": ".01",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-10-10"
    },
    {
      "NDCCode": "66915-604-22",
      "PackageDescription": "1 TUBE in 1 PACKAGE (66915-604-22)  > 70 g in 1 TUBE (66915-604-08)",
      "NDC11Code": "66915-0604-22",
      "ProductNDC": "66915-604",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Natural Spf 28",
      "NonProprietaryName": "Zinc Oxide 11.6%, Titanium Dioxide 0.67%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20131202",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": ".0067; .116",
      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-08-21",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "66915-610-22",
      "PackageDescription": "120 g in 1 BOTTLE, DISPENSING (66915-610-22)",
      "NDC11Code": "66915-0610-22",
      "ProductNDC": "66915-610",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Elite Natural Spf 30",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110831",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": ".135",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-04-24"
    },
    {
      "NDCCode": "10967-605-22",
      "PackageDescription": "66 mL in 1 CONTAINER (10967-605-22) ",
      "NDC11Code": "10967-0605-22",
      "ProductNDC": "10967-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mitchum Clear Gel",
      "NonProprietaryName": "Aluminum Sesquichlorohydrate",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M019",
      "LabelerName": "Revlon Consumer Products Corp",
      "SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
      "StrengthNumber": ".25",
      "StrengthUnit": "g/mL",
      "Status": "Active",
      "LastUpdate": "2025-12-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Reduces underarm wetness."
    },
    {
      "NDCCode": "13537-605-22",
      "PackageDescription": "1 BOTTLE in 1 BOX (13537-605-22)  > 30 g in 1 BOTTLE (13537-605-21)",
      "NDC11Code": "13537-0605-22",
      "ProductNDC": "13537-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16",
      "ProprietaryNameSuffix": "(medium 6) - Brown",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140428",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": ".065; .024; .015",
      "StrengthUnit": "g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "14783-605-22",
      "PackageDescription": "1 BOTTLE in 1 BOX (14783-605-22)  > 30 g in 1 BOTTLE (14783-605-21)",
      "NDC11Code": "14783-0605-22",
      "ProductNDC": "14783-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16",
      "ProprietaryNameSuffix": "(medium 6) - Brown",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140428",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura International LTD",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": ".065; .024; .015",
      "StrengthUnit": "g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "35000-605-22",
      "PackageDescription": "63.7 g in 1 CONTAINER (35000-605-22) ",
      "NDC11Code": "35000-0605-22",
      "ProductNDC": "35000-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Speed Stick Fresh Antiperspirant Deodorant",
      "NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150903",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Colgate-Palmolive",
      "SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
      "StrengthNumber": "159",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2021-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20160426",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70573-605-21",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (70573-605-21)  / 200 mL in 1 VIAL, GLASS (70573-605-22) ",
      "NDC11Code": "70573-0605-21",
      "ProductNDC": "70573-605",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Yimmugo",
      "NonProprietaryName": "Immune Globulin Intravenous, Human - Dira",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125810",
      "LabelerName": "Kedrion Biopharma Inc",
      "SubstanceName": "HUMAN IMMUNOGLOBULIN G",
      "StrengthNumber": "10",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250701",
      "SamplePackage": "N",
      "IndicationAndUsage": "YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.",
      "Description": "YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
    },
    {
      "NDCCode": "83372-605-21",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (83372-605-21)  / 200 mL in 1 VIAL, GLASS (83372-605-22) ",
      "NDC11Code": "83372-0605-21",
      "ProductNDC": "83372-605",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Yimmugo",
      "NonProprietaryName": "Immune Globulin Intravenous, Human - Dira",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250301",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125810",
      "LabelerName": "Biotest AG",
      "SubstanceName": "HUMAN IMMUNOGLOBULIN G",
      "StrengthNumber": "10",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-05-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250301",
      "SamplePackage": "N",
      "IndicationAndUsage": "YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.",
      "Description": "YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
    },
    {
      "NDCCode": "66915-605-03",
      "PackageDescription": "200000 g in 1 DRUM (66915-605-03)",
      "NDC11Code": "66915-0605-03",
      "ProductNDC": "66915-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Day Cream Spf 30",
      "NonProprietaryName": "Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130722",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": ".01; .075; .05; .06",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "66915-605-21",
      "PackageDescription": "30 g in 1 BOTTLE, PLASTIC (66915-605-21)",
      "NDC11Code": "66915-0605-21",
      "ProductNDC": "66915-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Day Cream Spf 30",
      "NonProprietaryName": "Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130722",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": ".01; .075; .05; .06",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "66915-605-23",
      "PackageDescription": "30 g in 1 BOTTLE, DISPENSING (66915-605-23)",
      "NDC11Code": "66915-0605-23",
      "ProductNDC": "66915-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Day Cream Spf 30",
      "NonProprietaryName": "Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130722",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": ".01; .075; .05; .06",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "66915-605-24",
      "PackageDescription": "50 g in 1 BOTTLE (66915-605-24)",
      "NDC11Code": "66915-0605-24",
      "ProductNDC": "66915-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Day Cream Spf 30",
      "NonProprietaryName": "Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130722",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": ".01; .075; .05; .06",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "66915-605-25",
      "PackageDescription": "60 g in 1 TUBE (66915-605-25)",
      "NDC11Code": "66915-0605-25",
      "ProductNDC": "66915-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Day Cream Spf 30",
      "NonProprietaryName": "Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130722",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": ".01; .075; .05; .06",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "66915-605-26",
      "PackageDescription": "120 g in 1 TUBE (66915-605-26)",
      "NDC11Code": "66915-0605-26",
      "ProductNDC": "66915-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Day Cream Spf 30",
      "NonProprietaryName": "Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130722",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": ".01; .075; .05; .06",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "66915-605-27",
      "PackageDescription": "40 g in 1 BOTTLE (66915-605-27)",
      "NDC11Code": "66915-0605-27",
      "ProductNDC": "66915-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Day Cream Spf 30",
      "NonProprietaryName": "Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130722",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": ".01; .075; .05; .06",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "66915-605-28",
      "PackageDescription": "30 g in 1 BOTTLE, DISPENSING (66915-605-28)",
      "NDC11Code": "66915-0605-28",
      "ProductNDC": "66915-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Day Cream Spf 30",
      "NonProprietaryName": "Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130722",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": ".01; .075; .05; .06",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "66915-605-30",
      "PackageDescription": "11 g in 1 TUBE (66915-605-30)",
      "NDC11Code": "66915-0605-30",
      "ProductNDC": "66915-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Day Cream Spf 30",
      "NonProprietaryName": "Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130722",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": ".01; .075; .05; .06",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "66915-605-31",
      "PackageDescription": "60 g in 1 BOTTLE (66915-605-31)",
      "NDC11Code": "66915-0605-31",
      "ProductNDC": "66915-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Day Cream Spf 30",
      "NonProprietaryName": "Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130722",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": ".01; .075; .05; .06",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "66915-605-33",
      "PackageDescription": "30 g in 1 BOTTLE, DISPENSING (66915-605-33)",
      "NDC11Code": "66915-0605-33",
      "ProductNDC": "66915-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Day Cream Spf 30",
      "NonProprietaryName": "Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130722",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": ".01; .075; .05; .06",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "66915-605-34",
      "PackageDescription": "50 g in 1 TUBE (66915-605-34)",
      "NDC11Code": "66915-0605-34",
      "ProductNDC": "66915-605",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Day Cream Spf 30",
      "NonProprietaryName": "Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130722",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": ".01; .075; .05; .06",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "17478-605-10",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (17478-605-10)  > 10 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "17478-0605-10",
      "ProductNDC": "17478-605",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cosopt",
      "NonProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20140430",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020869",
      "LabelerName": "Akorn",
      "SubstanceName": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
      "StrengthNumber": "20; 5",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20140430",
      "SamplePackage": "N",
      "IndicationAndUsage": "COSOPT® is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of COSOPT administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].",
      "Description": "COSOPT (dorzolamide hydrochloride and timolol maleate ophthalmic solution) is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride is described chemically as: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is:. [α]   25°C (C=1, water) = ∼ −17°.       405 nm. Its empirical formula is C10 H16 N2 O4 S3 HCl and its structural formula is:. Dorzolamide hydrochloride has a molecular weight of 360.91. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Timolol maleate is described chemically as: (-)-1-(tert-butylamino)-3-[(4- morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is:. [α]   25°C     in 1N HCl (C = 5) = −12.2°(-11.7° to -12.5°).       405 nm. Its molecular formula is C13 H24 N4 O3 SC4 H4 O4 and its structural formula is:. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. COSOPT is supplied as a sterile, clear, colorless to nearly colorless, isotonic, buffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242 to 323 mOsM. Each mL of COSOPT contains 20 mg dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (equivalent to 6.83 mg timolol maleate). Inactive ingredients are sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and water for injection. Benzalkonium chloride 0.0075% is added as a preservative."
    },
    {
      "NDCCode": "49281-605-01",
      "PackageDescription": "1 KIT in 1 CARTON (49281-605-01)  *  .5 mL in 1 VIAL, SINGLE-DOSE (49281-606-58)  *  .6 mL in 1 VIAL, SINGLE-DOSE (49281-549-58) ",
      "NDC11Code": "49281-0605-01",
      "ProductNDC": "49281-605",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Dengvaxia",
      "NonProprietaryName": "Dengue Tetravalent Vaccine, Live",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20190501",
      "EndMarketingDate": "20260831",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125682",
      "LabelerName": "Sanofi Vaccines US Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2026-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190501",
      "EndMarketingDatePackage": "20260831",
      "SamplePackage": "N",
      "IndicationAndUsage": "DENGVAXIA® (Dengue Tetravalent Vaccine, Live) is a vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4. DENGVAXIA is approved for use in individuals 6 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.",
      "Description": "DENGVAXIA (Dengue Tetravalent Vaccine, Live) is a sterile suspension for subcutaneous injection. DENGVAXIA is supplied as a vial of lyophilized vaccine antigen, which must be reconstituted at the time of use with 0.6 mL from the accompanying vial of diluent (0.4% sodium chloride). After reconstitution, DENGVAXIA is a clear, colorless suspension (trace amounts of white to translucent proteinaceous particles may be present). [See Dosage and Administration (2.3).]. After reconstitution, each 0.5 mL dose of DENGVAXIA contains 4.5 – 6.0 log10 CCID50 of each of the chimeric yellow fever dengue (CYD) virus serotypes 1, 2, 3, and 4. Each 0.5 mL dose is formulated to contain 2 mg sodium chloride and the following ingredients as stabilizers: 0.56 mg essential amino acids (including L-phenylalanine), 0.2 mg non-essential amino acids, 2.5 mg L-arginine hydrochloride, 18.75 mg sucrose, 13.75 mg D-trehalose dihydrate, 9.38 mg D-sorbitol, 0.18 mg trometamol, and 0.63 mg urea. Each of the four CYD viruses (CYD-1, CYD-2, CYD-3, and CYD-4) in DENGVAXIA was constructed using recombinant DNA technology by replacing the sequences encoding the pre-membrane (prM) and envelope (E) proteins in the yellow fever (YF) 17D204 vaccine virus genome with those encoding for the homologous sequences of dengue virus serotypes 1, 2, 3, and 4, respectively. Each CYD virus is cultured separately in Vero cells (African Green Monkey kidney) under serum-free conditions, harvested from the supernatant of the Vero cells and purified by membrane chromatography and ultrafiltration. The purified and concentrated harvest of each CYD virus is then diluted in a stabilizer solution to produce the four monovalent drug substances. The final bulk product is a mixture of the four monovalent drug substances diluted in the stabilizer solution. The final bulk product is sterilized by filtration at 0.22 µm, filled into vials and freeze-dried. DENGVAXIA does not contain preservative. The vial stoppers for the Lyophilized Vaccine Antigen and Diluent vials of DENGVAXIA are not made with natural rubber latex."
    },
    {
      "NDCCode": "51407-605-12",
      "PackageDescription": "1 TUBE in 1 CARTON (51407-605-12)  / 120 g in 1 TUBE",
      "NDC11Code": "51407-0605-12",
      "ProductNDC": "51407-605",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcipotriene",
      "NonProprietaryName": "Calcipotriene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150609",
      "EndMarketingDate": "20250131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205772",
      "LabelerName": "Golden State Medical Supply, Inc.",
      "SubstanceName": "CALCIPOTRIENE",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/g",
      "Pharm_Classes": "Vitamin D Analog [EPC], Vitamin D [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20211209",
      "EndMarketingDatePackage": "20250131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.",
      "Description": "Calcipotriene Cream USP, 0.005% contains calcipotriene, USP, a synthetic vitamin D 3 derivative, for topical dermatological use. Chemically, calcipotriene, USP is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol, with the empirical formula C 27H 40O 3, a molecular weight of 412.62 and the following structural formula:. Calcipotriene, USP is a white or almost white crystalline powder. Calcipotriene Cream USP, 0.005% contains 50 mcg/g anhydrous calcipotriene, USP in a cream base of benzyl alcohol, ceteth-20, cetostearyl alcohol, disodium hydrogen phosphate dihydrate, glycerin, medium chain triglycerides, mineral oil, monosodium phosphate monohydrate, purified water and white petrolatum."
    },
    {
      "NDCCode": "51407-605-60",
      "PackageDescription": "1 TUBE in 1 CARTON (51407-605-60)  / 60 g in 1 TUBE",
      "NDC11Code": "51407-0605-60",
      "ProductNDC": "51407-605",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcipotriene",
      "NonProprietaryName": "Calcipotriene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150609",
      "EndMarketingDate": "20250131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205772",
      "LabelerName": "Golden State Medical Supply, Inc.",
      "SubstanceName": "CALCIPOTRIENE",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/g",
      "Pharm_Classes": "Vitamin D Analog [EPC], Vitamin D [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20211209",
      "EndMarketingDatePackage": "20250131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.",
      "Description": "Calcipotriene Cream USP, 0.005% contains calcipotriene, USP, a synthetic vitamin D 3 derivative, for topical dermatological use. Chemically, calcipotriene, USP is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol, with the empirical formula C 27H 40O 3, a molecular weight of 412.62 and the following structural formula:. Calcipotriene, USP is a white or almost white crystalline powder. Calcipotriene Cream USP, 0.005% contains 50 mcg/g anhydrous calcipotriene, USP in a cream base of benzyl alcohol, ceteth-20, cetostearyl alcohol, disodium hydrogen phosphate dihydrate, glycerin, medium chain triglycerides, mineral oil, monosodium phosphate monohydrate, purified water and white petrolatum."
    },
    {
      "NDCCode": "55700-605-30",
      "PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-605-30) ",
      "NDC11Code": "55700-0605-30",
      "ProductNDC": "55700-605",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duloxetine",
      "NonProprietaryName": "Duloxetine",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180420",
      "EndMarketingDate": "20260531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208706",
      "LabelerName": "Quality Care Products LLC",
      "SubstanceName": "DULOXETINE HYDROCHLORIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180420",
      "EndMarketingDatePackage": "20260531",
      "SamplePackage": "N",
      "IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Generalized Anxiety Disorder [see Clinical Studies (14.2)]. , 3 Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)]. , 4 Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].",
      "Description": "Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is.          Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water.          Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate.          The capsule shell contains gelatin, FD&C Blue No. 2, titanium dioxide, and sodium lauryl sulfate.           For 20 mg, 30 mg  (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.          For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide.          USP Assay & Organic Impurities test pending."
    },
    {
      "NDCCode": "55700-605-60",
      "PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-605-60) ",
      "NDC11Code": "55700-0605-60",
      "ProductNDC": "55700-605",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duloxetine",
      "NonProprietaryName": "Duloxetine",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180420",
      "EndMarketingDate": "20260531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208706",
      "LabelerName": "Quality Care Products LLC",
      "SubstanceName": "DULOXETINE HYDROCHLORIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180420",
      "EndMarketingDatePackage": "20260531",
      "SamplePackage": "N",
      "IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Generalized Anxiety Disorder [see Clinical Studies (14.2)]. , 3 Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)]. , 4 Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].",
      "Description": "Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is.          Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water.          Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate.          The capsule shell contains gelatin, FD&C Blue No. 2, titanium dioxide, and sodium lauryl sulfate.           For 20 mg, 30 mg  (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.          For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide.          USP Assay & Organic Impurities test pending."
    },
    {
      "NDCCode": "59726-605-00",
      "PackageDescription": "947917 BLISTER PACK in 1 CONTAINER (59726-605-00)  / 947917 GUM, CHEWING in 1 BLISTER PACK",
      "NDC11Code": "59726-0605-00",
      "ProductNDC": "59726-605",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Nicotine Polacrilex",
      "DosageFormName": "GUM, CHEWING",
      "StartMarketingDate": "20241022",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "P & L Development, LLC",
      "SubstanceName": "NICOTINE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2026-01-09",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "22-OCT-24"
    }
  ]
}
                    

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    <NDCCode>66915-605-22</NDCCode>
    <PackageDescription>120 g in 1 TUBE (66915-605-22)</PackageDescription>
    <NDC11Code>66915-0605-22</NDC11Code>
    <ProductNDC>66915-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Day Cream Spf 30</ProprietaryName>
    <NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130722</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.01; .075; .05; .06</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66915-413-22</NDCCode>
    <PackageDescription>30 g in 1 BOTTLE, GLASS (66915-413-22)</PackageDescription>
    <NDC11Code>66915-0413-22</NDC11Code>
    <ProductNDC>66915-413</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Superlightener</ProprietaryName>
    <NonProprietaryName>Hydroquinone</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part358A</ApplicationNumber>
    <LabelerName>CoValence Inc</LabelerName>
    <SubstanceName>HYDROQUINONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-06-19</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66915-438-02</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (66915-438-02)  &gt; 22.5 g in 1 TUBE (66915-438-01)</PackageDescription>
    <NDC11Code>66915-0438-02</NDC11Code>
    <ProductNDC>66915-438</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Salicylic Acne Pore Treatment</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20101026</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>CoValence Inc.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>.01</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-10-10</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66915-604-22</NDCCode>
    <PackageDescription>1 TUBE in 1 PACKAGE (66915-604-22)  &gt; 70 g in 1 TUBE (66915-604-08)</PackageDescription>
    <NDC11Code>66915-0604-22</NDC11Code>
    <ProductNDC>66915-604</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Natural Spf 28</ProprietaryName>
    <NonProprietaryName>Zinc Oxide 11.6%, Titanium Dioxide 0.67%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
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    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.0067; .116</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-08-21</LastUpdate>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>66915-610-22</NDCCode>
    <PackageDescription>120 g in 1 BOTTLE, DISPENSING (66915-610-22)</PackageDescription>
    <NDC11Code>66915-0610-22</NDC11Code>
    <ProductNDC>66915-610</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Elite Natural Spf 30</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110831</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>.135</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-04-24</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>10967-605-22</NDCCode>
    <PackageDescription>66 mL in 1 CONTAINER (10967-605-22) </PackageDescription>
    <NDC11Code>10967-0605-22</NDC11Code>
    <ProductNDC>10967-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mitchum Clear Gel</ProprietaryName>
    <NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M019</ApplicationNumber>
    <LabelerName>Revlon Consumer Products Corp</LabelerName>
    <SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Reduces underarm wetness.</IndicationAndUsage>
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  <NDC>
    <NDCCode>13537-605-22</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (13537-605-22)  &gt; 30 g in 1 BOTTLE (13537-605-21)</PackageDescription>
    <NDC11Code>13537-0605-22</NDC11Code>
    <ProductNDC>13537-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName>
    <ProprietaryNameSuffix>(medium 6) - Brown</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
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    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.065; .024; .015</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
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  <NDC>
    <NDCCode>14783-605-22</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (14783-605-22)  &gt; 30 g in 1 BOTTLE (14783-605-21)</PackageDescription>
    <NDC11Code>14783-0605-22</NDC11Code>
    <ProductNDC>14783-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName>
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    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
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    <LabelerName>Ventura International LTD</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.065; .024; .015</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
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  <NDC>
    <NDCCode>35000-605-22</NDCCode>
    <PackageDescription>63.7 g in 1 CONTAINER (35000-605-22) </PackageDescription>
    <NDC11Code>35000-0605-22</NDC11Code>
    <ProductNDC>35000-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Speed Stick Fresh Antiperspirant Deodorant</ProprietaryName>
    <NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150903</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Colgate-Palmolive</LabelerName>
    <SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
    <StrengthNumber>159</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160426</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70573-605-21</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (70573-605-21)  / 200 mL in 1 VIAL, GLASS (70573-605-22) </PackageDescription>
    <NDC11Code>70573-0605-21</NDC11Code>
    <ProductNDC>70573-605</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Yimmugo</ProprietaryName>
    <NonProprietaryName>Immune Globulin Intravenous, Human - Dira</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250701</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125810</ApplicationNumber>
    <LabelerName>Kedrion Biopharma Inc</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.</IndicationAndUsage>
    <Description>YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>83372-605-21</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (83372-605-21)  / 200 mL in 1 VIAL, GLASS (83372-605-22) </PackageDescription>
    <NDC11Code>83372-0605-21</NDC11Code>
    <ProductNDC>83372-605</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Yimmugo</ProprietaryName>
    <NonProprietaryName>Immune Globulin Intravenous, Human - Dira</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250301</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125810</ApplicationNumber>
    <LabelerName>Biotest AG</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.</IndicationAndUsage>
    <Description>YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>66915-605-03</NDCCode>
    <PackageDescription>200000 g in 1 DRUM (66915-605-03)</PackageDescription>
    <NDC11Code>66915-0605-03</NDC11Code>
    <ProductNDC>66915-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Day Cream Spf 30</ProprietaryName>
    <NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130722</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.01; .075; .05; .06</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66915-605-21</NDCCode>
    <PackageDescription>30 g in 1 BOTTLE, PLASTIC (66915-605-21)</PackageDescription>
    <NDC11Code>66915-0605-21</NDC11Code>
    <ProductNDC>66915-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Day Cream Spf 30</ProprietaryName>
    <NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130722</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.01; .075; .05; .06</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66915-605-23</NDCCode>
    <PackageDescription>30 g in 1 BOTTLE, DISPENSING (66915-605-23)</PackageDescription>
    <NDC11Code>66915-0605-23</NDC11Code>
    <ProductNDC>66915-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Day Cream Spf 30</ProprietaryName>
    <NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130722</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.01; .075; .05; .06</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66915-605-24</NDCCode>
    <PackageDescription>50 g in 1 BOTTLE (66915-605-24)</PackageDescription>
    <NDC11Code>66915-0605-24</NDC11Code>
    <ProductNDC>66915-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Day Cream Spf 30</ProprietaryName>
    <NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130722</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.01; .075; .05; .06</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66915-605-25</NDCCode>
    <PackageDescription>60 g in 1 TUBE (66915-605-25)</PackageDescription>
    <NDC11Code>66915-0605-25</NDC11Code>
    <ProductNDC>66915-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Day Cream Spf 30</ProprietaryName>
    <NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130722</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.01; .075; .05; .06</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66915-605-26</NDCCode>
    <PackageDescription>120 g in 1 TUBE (66915-605-26)</PackageDescription>
    <NDC11Code>66915-0605-26</NDC11Code>
    <ProductNDC>66915-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Day Cream Spf 30</ProprietaryName>
    <NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130722</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.01; .075; .05; .06</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66915-605-27</NDCCode>
    <PackageDescription>40 g in 1 BOTTLE (66915-605-27)</PackageDescription>
    <NDC11Code>66915-0605-27</NDC11Code>
    <ProductNDC>66915-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Day Cream Spf 30</ProprietaryName>
    <NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130722</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.01; .075; .05; .06</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66915-605-28</NDCCode>
    <PackageDescription>30 g in 1 BOTTLE, DISPENSING (66915-605-28)</PackageDescription>
    <NDC11Code>66915-0605-28</NDC11Code>
    <ProductNDC>66915-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Day Cream Spf 30</ProprietaryName>
    <NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130722</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.01; .075; .05; .06</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66915-605-30</NDCCode>
    <PackageDescription>11 g in 1 TUBE (66915-605-30)</PackageDescription>
    <NDC11Code>66915-0605-30</NDC11Code>
    <ProductNDC>66915-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Day Cream Spf 30</ProprietaryName>
    <NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130722</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.01; .075; .05; .06</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66915-605-31</NDCCode>
    <PackageDescription>60 g in 1 BOTTLE (66915-605-31)</PackageDescription>
    <NDC11Code>66915-0605-31</NDC11Code>
    <ProductNDC>66915-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Day Cream Spf 30</ProprietaryName>
    <NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130722</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.01; .075; .05; .06</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66915-605-33</NDCCode>
    <PackageDescription>30 g in 1 BOTTLE, DISPENSING (66915-605-33)</PackageDescription>
    <NDC11Code>66915-0605-33</NDC11Code>
    <ProductNDC>66915-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Day Cream Spf 30</ProprietaryName>
    <NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130722</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.01; .075; .05; .06</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>66915-605-34</NDCCode>
    <PackageDescription>50 g in 1 TUBE (66915-605-34)</PackageDescription>
    <NDC11Code>66915-0605-34</NDC11Code>
    <ProductNDC>66915-605</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Day Cream Spf 30</ProprietaryName>
    <NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130722</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.01; .075; .05; .06</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>17478-605-10</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (17478-605-10)  &gt; 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>17478-0605-10</NDC11Code>
    <ProductNDC>17478-605</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cosopt</ProprietaryName>
    <NonProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20140430</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020869</ApplicationNumber>
    <LabelerName>Akorn</LabelerName>
    <SubstanceName>DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>20; 5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>COSOPT® is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of COSOPT administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>COSOPT (dorzolamide hydrochloride and timolol maleate ophthalmic solution) is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride is described chemically as: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is:. [α]   25°C (C=1, water) = ∼ −17°.       405 nm. Its empirical formula is C10 H16 N2 O4 S3 HCl and its structural formula is:. Dorzolamide hydrochloride has a molecular weight of 360.91. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Timolol maleate is described chemically as: (-)-1-(tert-butylamino)-3-[(4- morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is:. [α]   25°C     in 1N HCl (C = 5) = −12.2°(-11.7° to -12.5°).       405 nm. Its molecular formula is C13 H24 N4 O3 SC4 H4 O4 and its structural formula is:. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. COSOPT is supplied as a sterile, clear, colorless to nearly colorless, isotonic, buffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242 to 323 mOsM. Each mL of COSOPT contains 20 mg dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (equivalent to 6.83 mg timolol maleate). Inactive ingredients are sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and water for injection. Benzalkonium chloride 0.0075% is added as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-605-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (49281-605-01)  *  .5 mL in 1 VIAL, SINGLE-DOSE (49281-606-58)  *  .6 mL in 1 VIAL, SINGLE-DOSE (49281-549-58) </PackageDescription>
    <NDC11Code>49281-0605-01</NDC11Code>
    <ProductNDC>49281-605</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Dengvaxia</ProprietaryName>
    <NonProprietaryName>Dengue Tetravalent Vaccine, Live</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20190501</StartMarketingDate>
    <EndMarketingDate>20260831</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125682</ApplicationNumber>
    <LabelerName>Sanofi Vaccines US Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190501</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DENGVAXIA® (Dengue Tetravalent Vaccine, Live) is a vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4. DENGVAXIA is approved for use in individuals 6 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.</IndicationAndUsage>
    <Description>DENGVAXIA (Dengue Tetravalent Vaccine, Live) is a sterile suspension for subcutaneous injection. DENGVAXIA is supplied as a vial of lyophilized vaccine antigen, which must be reconstituted at the time of use with 0.6 mL from the accompanying vial of diluent (0.4% sodium chloride). After reconstitution, DENGVAXIA is a clear, colorless suspension (trace amounts of white to translucent proteinaceous particles may be present). [See Dosage and Administration (2.3).]. After reconstitution, each 0.5 mL dose of DENGVAXIA contains 4.5 – 6.0 log10 CCID50 of each of the chimeric yellow fever dengue (CYD) virus serotypes 1, 2, 3, and 4. Each 0.5 mL dose is formulated to contain 2 mg sodium chloride and the following ingredients as stabilizers: 0.56 mg essential amino acids (including L-phenylalanine), 0.2 mg non-essential amino acids, 2.5 mg L-arginine hydrochloride, 18.75 mg sucrose, 13.75 mg D-trehalose dihydrate, 9.38 mg D-sorbitol, 0.18 mg trometamol, and 0.63 mg urea. Each of the four CYD viruses (CYD-1, CYD-2, CYD-3, and CYD-4) in DENGVAXIA was constructed using recombinant DNA technology by replacing the sequences encoding the pre-membrane (prM) and envelope (E) proteins in the yellow fever (YF) 17D204 vaccine virus genome with those encoding for the homologous sequences of dengue virus serotypes 1, 2, 3, and 4, respectively. Each CYD virus is cultured separately in Vero cells (African Green Monkey kidney) under serum-free conditions, harvested from the supernatant of the Vero cells and purified by membrane chromatography and ultrafiltration. The purified and concentrated harvest of each CYD virus is then diluted in a stabilizer solution to produce the four monovalent drug substances. The final bulk product is a mixture of the four monovalent drug substances diluted in the stabilizer solution. The final bulk product is sterilized by filtration at 0.22 µm, filled into vials and freeze-dried. DENGVAXIA does not contain preservative. The vial stoppers for the Lyophilized Vaccine Antigen and Diluent vials of DENGVAXIA are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>51407-605-12</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (51407-605-12)  / 120 g in 1 TUBE</PackageDescription>
    <NDC11Code>51407-0605-12</NDC11Code>
    <ProductNDC>51407-605</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcipotriene</ProprietaryName>
    <NonProprietaryName>Calcipotriene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150609</StartMarketingDate>
    <EndMarketingDate>20250131</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205772</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>CALCIPOTRIENE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/g</StrengthUnit>
    <Pharm_Classes>Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20211209</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.</IndicationAndUsage>
    <Description>Calcipotriene Cream USP, 0.005% contains calcipotriene, USP, a synthetic vitamin D 3 derivative, for topical dermatological use. Chemically, calcipotriene, USP is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol, with the empirical formula C 27H 40O 3, a molecular weight of 412.62 and the following structural formula:. Calcipotriene, USP is a white or almost white crystalline powder. Calcipotriene Cream USP, 0.005% contains 50 mcg/g anhydrous calcipotriene, USP in a cream base of benzyl alcohol, ceteth-20, cetostearyl alcohol, disodium hydrogen phosphate dihydrate, glycerin, medium chain triglycerides, mineral oil, monosodium phosphate monohydrate, purified water and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>51407-605-60</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (51407-605-60)  / 60 g in 1 TUBE</PackageDescription>
    <NDC11Code>51407-0605-60</NDC11Code>
    <ProductNDC>51407-605</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcipotriene</ProprietaryName>
    <NonProprietaryName>Calcipotriene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150609</StartMarketingDate>
    <EndMarketingDate>20250131</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205772</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>CALCIPOTRIENE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/g</StrengthUnit>
    <Pharm_Classes>Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20211209</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.</IndicationAndUsage>
    <Description>Calcipotriene Cream USP, 0.005% contains calcipotriene, USP, a synthetic vitamin D 3 derivative, for topical dermatological use. Chemically, calcipotriene, USP is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol, with the empirical formula C 27H 40O 3, a molecular weight of 412.62 and the following structural formula:. Calcipotriene, USP is a white or almost white crystalline powder. Calcipotriene Cream USP, 0.005% contains 50 mcg/g anhydrous calcipotriene, USP in a cream base of benzyl alcohol, ceteth-20, cetostearyl alcohol, disodium hydrogen phosphate dihydrate, glycerin, medium chain triglycerides, mineral oil, monosodium phosphate monohydrate, purified water and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>55700-605-30</NDCCode>
    <PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-605-30) </PackageDescription>
    <NDC11Code>55700-0605-30</NDC11Code>
    <ProductNDC>55700-605</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Duloxetine</ProprietaryName>
    <NonProprietaryName>Duloxetine</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180420</StartMarketingDate>
    <EndMarketingDate>20260531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208706</ApplicationNumber>
    <LabelerName>Quality Care Products LLC</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180420</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Generalized Anxiety Disorder [see Clinical Studies (14.2)]. , 3 Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)]. , 4 Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].</IndicationAndUsage>
    <Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is.          Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water.          Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate.          The capsule shell contains gelatin, FD&amp;C Blue No. 2, titanium dioxide, and sodium lauryl sulfate.           For 20 mg, 30 mg  (body &amp; cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.          For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide.          USP Assay &amp; Organic Impurities test pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>55700-605-60</NDCCode>
    <PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-605-60) </PackageDescription>
    <NDC11Code>55700-0605-60</NDC11Code>
    <ProductNDC>55700-605</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Duloxetine</ProprietaryName>
    <NonProprietaryName>Duloxetine</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180420</StartMarketingDate>
    <EndMarketingDate>20260531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208706</ApplicationNumber>
    <LabelerName>Quality Care Products LLC</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180420</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Generalized Anxiety Disorder [see Clinical Studies (14.2)]. , 3 Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)]. , 4 Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].</IndicationAndUsage>
    <Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is.          Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water.          Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate.          The capsule shell contains gelatin, FD&amp;C Blue No. 2, titanium dioxide, and sodium lauryl sulfate.           For 20 mg, 30 mg  (body &amp; cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.          For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide.          USP Assay &amp; Organic Impurities test pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>59726-605-00</NDCCode>
    <PackageDescription>947917 BLISTER PACK in 1 CONTAINER (59726-605-00)  / 947917 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59726-0605-00</NDC11Code>
    <ProductNDC>59726-605</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>GUM, CHEWING</DosageFormName>
    <StartMarketingDate>20241022</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>P &amp; L Development, LLC</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>22-OCT-24</StartMarketingDatePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>66915-605-22</NDCCode><ProprietaryName>Day Cream Spf 30</ProprietaryName><NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName></NDC><NDC><NDCCode>66915-413-22</NDCCode><ProprietaryName>Superlightener</ProprietaryName><NonProprietaryName>Hydroquinone</NonProprietaryName></NDC><NDC><NDCCode>66915-438-02</NDCCode><ProprietaryName>Salicylic Acne Pore Treatment</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>66915-604-22</NDCCode><ProprietaryName>Natural Spf 28</ProprietaryName><NonProprietaryName>Zinc Oxide 11.6%, Titanium Dioxide 0.67%</NonProprietaryName></NDC><NDC><NDCCode>66915-610-22</NDCCode><ProprietaryName>Elite Natural Spf 30</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>10967-605-22</NDCCode><ProprietaryName>Mitchum Clear Gel</ProprietaryName><NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>13537-605-22</NDCCode><ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>14783-605-22</NDCCode><ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>35000-605-22</NDCCode><ProprietaryName>Speed Stick Fresh Antiperspirant Deodorant</ProprietaryName><NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName></NDC><NDC><NDCCode>70573-605-21</NDCCode><ProprietaryName>Yimmugo</ProprietaryName><NonProprietaryName>Immune Globulin Intravenous, Human - Dira</NonProprietaryName></NDC><NDC><NDCCode>83372-605-21</NDCCode><ProprietaryName>Yimmugo</ProprietaryName><NonProprietaryName>Immune Globulin Intravenous, Human - Dira</NonProprietaryName></NDC><NDC><NDCCode>66915-605-03</NDCCode><ProprietaryName>Day Cream Spf 30</ProprietaryName><NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName></NDC><NDC><NDCCode>66915-605-21</NDCCode><ProprietaryName>Day Cream Spf 30</ProprietaryName><NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName></NDC><NDC><NDCCode>66915-605-23</NDCCode><ProprietaryName>Day Cream Spf 30</ProprietaryName><NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName></NDC><NDC><NDCCode>66915-605-24</NDCCode><ProprietaryName>Day Cream Spf 30</ProprietaryName><NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName></NDC><NDC><NDCCode>66915-605-25</NDCCode><ProprietaryName>Day Cream Spf 30</ProprietaryName><NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName></NDC><NDC><NDCCode>66915-605-26</NDCCode><ProprietaryName>Day Cream Spf 30</ProprietaryName><NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName></NDC><NDC><NDCCode>66915-605-27</NDCCode><ProprietaryName>Day Cream Spf 30</ProprietaryName><NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName></NDC><NDC><NDCCode>66915-605-28</NDCCode><ProprietaryName>Day Cream Spf 30</ProprietaryName><NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName></NDC><NDC><NDCCode>66915-605-30</NDCCode><ProprietaryName>Day Cream Spf 30</ProprietaryName><NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName></NDC><NDC><NDCCode>66915-605-31</NDCCode><ProprietaryName>Day Cream Spf 30</ProprietaryName><NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName></NDC><NDC><NDCCode>66915-605-33</NDCCode><ProprietaryName>Day Cream Spf 30</ProprietaryName><NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName></NDC><NDC><NDCCode>66915-605-34</NDCCode><ProprietaryName>Day Cream Spf 30</ProprietaryName><NonProprietaryName>Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1%</NonProprietaryName></NDC><NDC><NDCCode>17478-605-10</NDCCode><ProprietaryName>Cosopt</ProprietaryName><NonProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</NonProprietaryName></NDC><NDC><NDCCode>49281-605-01</NDCCode><ProprietaryName>Dengvaxia</ProprietaryName><NonProprietaryName>Dengue Tetravalent Vaccine, Live</NonProprietaryName></NDC><NDC><NDCCode>51407-605-12</NDCCode><ProprietaryName>Calcipotriene</ProprietaryName><NonProprietaryName>Calcipotriene</NonProprietaryName></NDC><NDC><NDCCode>51407-605-60</NDCCode><ProprietaryName>Calcipotriene</ProprietaryName><NonProprietaryName>Calcipotriene</NonProprietaryName></NDC><NDC><NDCCode>55700-605-30</NDCCode><ProprietaryName>Duloxetine</ProprietaryName><NonProprietaryName>Duloxetine</NonProprietaryName></NDC><NDC><NDCCode>55700-605-60</NDCCode><ProprietaryName>Duloxetine</ProprietaryName><NonProprietaryName>Duloxetine</NonProprietaryName></NDC><NDC><NDCCode>59726-605-00</NDCCode><NonProprietaryName>Nicotine Polacrilex</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
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      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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