RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (28 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "48951-8106-1",
      "PackageDescription": "10 AMPULE in 1 BOX (48951-8106-1)  > 1 mL in 1 AMPULE",
      "NDC11Code": "48951-8106-01",
      "ProductNDC": "48951-8106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Quartz 20 Special Order",
      "NonProprietaryName": "Quartz 20 Special Order",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090901",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Uriel Pharmacy Inc.",
      "SubstanceName": "SILICON DIOXIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "[hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20090901",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0067-8106-04",
      "PackageDescription": "118 mL in 1 BOTTLE (0067-8106-04) ",
      "NDC11Code": "00067-8106-04",
      "ProductNDC": "0067-8106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Triaminic",
      "ProprietaryNameSuffix": "Night Time Cold And Cough",
      "NonProprietaryName": "Diphenhydramine Hcl, Phenylephrine Hcl",
      "DosageFormName": "SYRUP",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121015",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "GlaxoSmithKline Consumer Healthcare Holdings (US) LLC",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "6.25; 2.5",
      "StrengthUnit": "mg/5mL; mg/5mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-11-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20121015",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0067-8112-08",
      "PackageDescription": "1 KIT in 1 CARTON (0067-8112-08)  *  118 mL in 1 BOTTLE, PLASTIC (0067-8105-04)  *  118 mL in 1 BOTTLE (0067-8106-04) ",
      "NDC11Code": "00067-8112-08",
      "ProductNDC": "0067-8112",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Triaminic",
      "ProprietaryNameSuffix": "Day Time Cold And Cough And Night Time Cold And Cough",
      "NonProprietaryName": "Dextromethorphan Hbr, Phenylephrine Hcl And Diphenhydramine Hcl, Phenylephrine Hcl",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160101",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "GlaxoSmithKline Consumer Healthcare Holdings (US) LLC",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20160101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0268-8106-05",
      "PackageDescription": "5.5 mL in 1 VIAL (0268-8106-05) ",
      "NDC11Code": "00268-8106-05",
      "ProductNDC": "0268-8106",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Saccharomyces Cerevisiae",
      "NonProprietaryName": "Saccharomyces Cerevisiae",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "SACCHAROMYCES CEREVISIAE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-03-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19650101",
      "SamplePackage": "N",
      "IndicationAndUsage": "These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been exposed. By measuring skin test response, the physician may assess the degree of sensitivity that patients have to the allergens. For extracts standardized in AU and BAU, see individual directions for use. Allergenic extracts for diagnostic use only of coffee, mosquito, cottonseed, and flaxseed have not been shown by adequate data to be safe and effective for therapeutic use.",
      "Description": "Sterile diagnostic extracts are supplied in either phenol-saline diluent for Intradermal Testing or in diluent containing glycerin 50% (v/v) for Percutaneous Testing and phenol 0.4% (preservative). Inactive ingredients may include: sodium chloride for isotonicity, glycerin, and sodium bicarbonate as a buffer. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds (fungi) are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Foods, miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline or glycerin, filtered aseptically and after final packaging are tested for sterility and safety."
    },
    {
      "NDCCode": "0268-8106-10",
      "PackageDescription": "10.5 mL in 1 VIAL (0268-8106-10) ",
      "NDC11Code": "00268-8106-10",
      "ProductNDC": "0268-8106",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Saccharomyces Cerevisiae",
      "NonProprietaryName": "Saccharomyces Cerevisiae",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "SACCHAROMYCES CEREVISIAE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2020-02-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19650101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.",
      "Description": "Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety."
    },
    {
      "NDCCode": "0268-8106-50",
      "PackageDescription": "53 mL in 1 VIAL (0268-8106-50) ",
      "NDC11Code": "00268-8106-50",
      "ProductNDC": "0268-8106",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Saccharomyces Cerevisiae",
      "NonProprietaryName": "Saccharomyces Cerevisiae",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "SACCHAROMYCES CEREVISIAE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2020-02-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19650101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.",
      "Description": "Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety."
    },
    {
      "NDCCode": "0378-8106-10",
      "PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8106-10)",
      "NDC11Code": "00378-8106-10",
      "ProductNDC": "0378-8106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Galantamine Hydrobromide",
      "NonProprietaryName": "Galantamine Hydrobromide",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110124",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090900",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "GALANTAMINE HYDROBROMIDE",
      "StrengthNumber": "16",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-02-19"
    },
    {
      "NDCCode": "0378-8106-93",
      "PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8106-93)",
      "NDC11Code": "00378-8106-93",
      "ProductNDC": "0378-8106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Galantamine Hydrobromide",
      "NonProprietaryName": "Galantamine Hydrobromide",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110124",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090900",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "GALANTAMINE HYDROBROMIDE",
      "StrengthNumber": "16",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-24",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "0395-8106-19",
      "PackageDescription": "25 g in 1 CONTAINER (0395-8106-19)",
      "NDC11Code": "00395-8106-19",
      "ProductNDC": "0395-8106",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Duloxetine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20180608",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Humco Holding Group, Inc.",
      "SubstanceName": "DULOXETINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "0395-8106-35",
      "PackageDescription": "5 g in 1 CONTAINER (0395-8106-35)",
      "NDC11Code": "00395-8106-35",
      "ProductNDC": "0395-8106",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Duloxetine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20180608",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Humco Holding Group, Inc.",
      "SubstanceName": "DULOXETINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "0527-8106-37",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-8106-37) ",
      "NDC11Code": "00527-8106-37",
      "ProductNDC": "0527-8106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexmethylphenidate Hydrochloride",
      "ProprietaryNameSuffix": "Extended-release",
      "NonProprietaryName": "Dexmethylphenidate Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181009",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210279",
      "LabelerName": "Lannett Company, Inc.",
      "SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181009",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dexmethylphenidate HCl extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].",
      "Description": "Dexmethylphenidate HCl extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate HCl extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate HCl extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate HCl extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note*=asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, D&C Red #28 (5 mg, 10 mg, 25 mg and 35 mg strengths), edible printing ink Red SB-1010N containing Shellac NF and Carmine Powder Red, FD&C Blue #1 (5 mg, 15 mg, 25 mg, 35 mg and 40 mg strengths), FDA/E172 Yellow Iron Oxide (15 mg and 40 mg strengths), gelatin, methacrylic acid copolymer, Opadry Clear containing hypromellose and polyethylene glycol, povidone, sugar spheres containing corn starch as well as sugar syrup and sucrose derived from sugar cane, talc, titanium dioxide, and triethyl citrate."
    },
    {
      "NDCCode": "10888-8106-1",
      "PackageDescription": "20000 CAPSULE, LIQUID FILLED in 1 BOX (10888-8106-1)",
      "NDC11Code": "10888-8106-01",
      "ProductNDC": "10888-8106",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Calcitriol",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "StartMarketingDate": "20130524",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Softgels Inc.",
      "SubstanceName": "CALCITRIOL",
      "StrengthNumber": ".25",
      "StrengthUnit": "ug/1",
      "Status": "Unfinished",
      "LastUpdate": "2018-02-02",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "50909-8106-3",
      "PackageDescription": "15 kg in 1 DRUM (50909-8106-3)",
      "NDC11Code": "50909-8106-03",
      "ProductNDC": "50909-8106",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Doxycycline",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20140730",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "HOVIONE FARMACIENCIA SA",
      "SubstanceName": "DOXYCYCLINE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2020-01-23",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "58597-8106-2",
      "PackageDescription": "5 g in 1 BOTTLE (58597-8106-2)",
      "NDC11Code": "58597-8106-02",
      "ProductNDC": "58597-8106",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Aloe Vera",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20140416",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "AMERICAN PHARMACEUTICAL INGREDIENTS LLC",
      "SubstanceName": "ALOE VERA LEAF",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "58597-8106-4",
      "PackageDescription": "25 g in 1 BOTTLE (58597-8106-4)",
      "NDC11Code": "58597-8106-04",
      "ProductNDC": "58597-8106",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Aloe Vera",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20140416",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "AMERICAN PHARMACEUTICAL INGREDIENTS LLC",
      "SubstanceName": "ALOE VERA LEAF",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "58597-8106-6",
      "PackageDescription": "100 g in 1 BOTTLE (58597-8106-6)",
      "NDC11Code": "58597-8106-06",
      "ProductNDC": "58597-8106",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Aloe Vera",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20140416",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "AMERICAN PHARMACEUTICAL INGREDIENTS LLC",
      "SubstanceName": "ALOE VERA LEAF",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "61589-8106-1",
      "PackageDescription": "1 BOTTLE in 1 CARTON (61589-8106-1)  / 30 g in 1 BOTTLE",
      "NDC11Code": "61589-8106-01",
      "ProductNDC": "61589-8106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "No7 Beautifully Matte Foundation Sunscreen Broad Spectrum Spf 15 Warm Beige",
      "NonProprietaryName": "Octinoxate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160701",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "BCM Cosmetique SAS",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": "1.5; .5",
      "StrengthUnit": "g/30g; g/30g",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20160701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions for suncreen use. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses."
    },
    {
      "NDCCode": "62721-8106-8",
      "PackageDescription": "1 CANISTER in 1 BLISTER PACK (62721-8106-8)  > 2.83 g in 1 CANISTER (62721-8106-6) ",
      "NDC11Code": "62721-8106-08",
      "ProductNDC": "62721-8106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lypsyl Honeyberry",
      "NonProprietaryName": "Octinoxate",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20091001",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Lornamead",
      "SubstanceName": "OCTINOXATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "5.5; 2; 3.5",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20091001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply liberally before sun exposure and as needed. children under 6 months of age. ask a doctor."
    },
    {
      "NDCCode": "63083-8106-2",
      "PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-8106-2) ",
      "NDC11Code": "63083-8106-02",
      "ProductNDC": "63083-8106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Azurite",
      "ProprietaryNameSuffix": "8106",
      "NonProprietaryName": "Azurite",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "19840815",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Professional Complementary Health Formulas",
      "SubstanceName": "AZURITE",
      "StrengthNumber": "6",
      "StrengthUnit": "[hp_X]/59mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "19850815",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves fear of speaking, inability to express thoughts or feelings, apprehension, or lack of confidence.*."
    },
    {
      "NDCCode": "63629-8106-1",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (63629-8106-1) ",
      "NDC11Code": "63629-8106-01",
      "ProductNDC": "63629-8106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Montelukast Sodium",
      "NonProprietaryName": "Montelukast Sodium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202717",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "MONTELUKAST SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20190715",
      "SamplePackage": "N",
      "IndicationAndUsage": "Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: 1 Prophylaxis and chronic treatment of asthma in patients 15 years of age and older ( 1.1). , 2 Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older ( 1.2). , 3 Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (  1.3).  .",
      "Description": "Montelukast sodium, the active ingredient in montelukast sodium tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium is described chemically as [ R-( E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35ClNNaO 3S, and its molecular weight is 608.18. The structural formula is:. Montelukast sodium is a hygroscopic, optically active, white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 10-mg film-coated montelukast sodium tablet, USP contains 10.4 mg montelukast sodium, USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: microcelac 100, croscarmellose sodium, low substituted hydroxypropyl cellulose, and magnesium stearate. The film coating consists of hypromellose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 6000, iron oxide red and iron oxide yellow."
    },
    {
      "NDCCode": "63629-8106-2",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (63629-8106-2) ",
      "NDC11Code": "63629-8106-02",
      "ProductNDC": "63629-8106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Montelukast Sodium",
      "NonProprietaryName": "Montelukast Sodium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202717",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "MONTELUKAST SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20190715",
      "SamplePackage": "N",
      "IndicationAndUsage": "Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: 1 Prophylaxis and chronic treatment of asthma in patients 15 years of age and older ( 1.1). , 2 Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older ( 1.2). , 3 Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (  1.3).  .",
      "Description": "Montelukast sodium, the active ingredient in montelukast sodium tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium is described chemically as [ R-( E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35ClNNaO 3S, and its molecular weight is 608.18. The structural formula is:. Montelukast sodium is a hygroscopic, optically active, white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 10-mg film-coated montelukast sodium tablet, USP contains 10.4 mg montelukast sodium, USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: microcelac 100, croscarmellose sodium, low substituted hydroxypropyl cellulose, and magnesium stearate. The film coating consists of hypromellose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 6000, iron oxide red and iron oxide yellow."
    },
    {
      "NDCCode": "63850-8106-4",
      "PackageDescription": "1 kg in 1 DRUM (63850-8106-4) ",
      "NDC11Code": "63850-8106-04",
      "ProductNDC": "63850-8106",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Nilotinib Hydrochloride Monohydrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20210519",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Natco Pharma Limited",
      "SubstanceName": "NILOTINIB HYDROCHLORIDE MONOHYDRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-12-20",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "19-MAY-21"
    },
    {
      "NDCCode": "68788-8106-1",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8106-1) ",
      "NDC11Code": "68788-8106-01",
      "ProductNDC": "68788-8106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenofibrate",
      "NonProprietaryName": "Fenofibrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204598",
      "LabelerName": "Preferred Pharmaceuticals, Inc.",
      "SubstanceName": "FENOFIBRATE",
      "StrengthNumber": "145",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fenofibratetablets are indicated as adjunctive therapy to diet:   to reduce triglyceride (TG) levels in adultswith severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).  to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is notpossible.  Limitations of Use   Markedlyelevated levels of serum TG (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions ( 5.7)].   Fenofibrate did not reducecoronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions ( 5.1) and ClinicalStudies ( 14.4)].",
      "Description": "Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula:. The molecular formula is C 20H 21ClO 4and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&C Yellow # 10 aluminum lake, FD&C Blue # 2 / indigo caramine aluminum lake, FD&C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum."
    },
    {
      "NDCCode": "68788-8106-3",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8106-3) ",
      "NDC11Code": "68788-8106-03",
      "ProductNDC": "68788-8106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenofibrate",
      "NonProprietaryName": "Fenofibrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204598",
      "LabelerName": "Preferred Pharmaceuticals, Inc.",
      "SubstanceName": "FENOFIBRATE",
      "StrengthNumber": "145",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fenofibratetablets are indicated as adjunctive therapy to diet:   to reduce triglyceride (TG) levels in adultswith severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).  to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is notpossible.  Limitations of Use   Markedlyelevated levels of serum TG (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions ( 5.7)].   Fenofibrate did not reducecoronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions ( 5.1) and ClinicalStudies ( 14.4)].",
      "Description": "Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula:. The molecular formula is C 20H 21ClO 4and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&C Yellow # 10 aluminum lake, FD&C Blue # 2 / indigo caramine aluminum lake, FD&C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum."
    },
    {
      "NDCCode": "68788-8106-6",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8106-6) ",
      "NDC11Code": "68788-8106-06",
      "ProductNDC": "68788-8106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenofibrate",
      "NonProprietaryName": "Fenofibrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204598",
      "LabelerName": "Preferred Pharmaceuticals, Inc.",
      "SubstanceName": "FENOFIBRATE",
      "StrengthNumber": "145",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fenofibratetablets are indicated as adjunctive therapy to diet:   to reduce triglyceride (TG) levels in adultswith severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).  to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is notpossible.  Limitations of Use   Markedlyelevated levels of serum TG (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions ( 5.7)].   Fenofibrate did not reducecoronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions ( 5.1) and ClinicalStudies ( 14.4)].",
      "Description": "Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula:. The molecular formula is C 20H 21ClO 4and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&C Yellow # 10 aluminum lake, FD&C Blue # 2 / indigo caramine aluminum lake, FD&C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum."
    },
    {
      "NDCCode": "68788-8106-9",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8106-9) ",
      "NDC11Code": "68788-8106-09",
      "ProductNDC": "68788-8106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenofibrate",
      "NonProprietaryName": "Fenofibrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204598",
      "LabelerName": "Preferred Pharmaceuticals, Inc.",
      "SubstanceName": "FENOFIBRATE",
      "StrengthNumber": "145",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fenofibratetablets are indicated as adjunctive therapy to diet:   to reduce triglyceride (TG) levels in adultswith severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).  to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is notpossible.  Limitations of Use   Markedlyelevated levels of serum TG (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions ( 5.7)].   Fenofibrate did not reducecoronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions ( 5.1) and ClinicalStudies ( 14.4)].",
      "Description": "Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula:. The molecular formula is C 20H 21ClO 4and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&C Yellow # 10 aluminum lake, FD&C Blue # 2 / indigo caramine aluminum lake, FD&C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum."
    },
    {
      "NDCCode": "48951-0076-1",
      "PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-0076-1)",
      "NDC11Code": "48951-0076-01",
      "ProductNDC": "48951-0076",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Apis Levisticum Ear Irritation Relief",
      "NonProprietaryName": "Apis Mellifera, Levisticum Officinale Leaf",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090901",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Uriel Pharmacy Inc",
      "SubstanceName": "APIS MELLIFERA; LEVISTICUM OFFICINALE LEAF",
      "StrengthNumber": "3; 3",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-25"
    },
    {
      "NDCCode": "48951-0077-1",
      "PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-0077-1)",
      "NDC11Code": "48951-0077-01",
      "ProductNDC": "48951-0077",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arnica Echinacea First Aid",
      "NonProprietaryName": "Bellis Perennis, Echinacea Unspecified, Hamamelis Virginiana Root Bark/stem Bark, St. Johns Wort, Achillea Millefolium, Aconitum Napellus, Arnica Montana, Atropa Belladonna, Calendula Officinalis Flowering Top, Matricaria Recutita, Calcium Sulfide, Mercurius Solubilis, Comfrey Root",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090901",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Uriel Pharmacy Inc",
      "SubstanceName": "BELLIS PERENNIS; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ST. JOHN'S WORT; ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; COMFREY ROOT",
      "StrengthNumber": "5; 5; 5; 5; 6; 6; 6; 6; 6; 6; 9; 9; 9",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-25"
    },
    {
      "NDCCode": "48951-0078-1",
      "PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-0078-1)",
      "NDC11Code": "48951-0078-01",
      "ProductNDC": "48951-0078",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Avena Valeriana Nerve Relief",
      "NonProprietaryName": "Avena Sativa Flowering Top, Valerian, Ostrea Edulis Shell, Phosphorus, Sulfur",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091201",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Uriel Pharmacy Inc",
      "SubstanceName": "AVENA SATIVA FLOWERING TOP; VALERIAN; OSTREA EDULIS SHELL; PHOSPHORUS; SULFUR",
      "StrengthNumber": "3; 3; 7; 30; 30",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-25"
    },
    {
      "NDCCode": "48951-1001-1",
      "PackageDescription": "10 AMPULE in 1 PACKAGE (48951-1001-1)  / 1 mL in 1 AMPULE",
      "NDC11Code": "48951-1001-01",
      "ProductNDC": "48951-1001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Viscum Abietis",
      "NonProprietaryName": "Viscum Album Fruiting Top",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090901",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Uriel Pharmacy Inc",
      "SubstanceName": "VISCUM ALBUM FRUITING TOP",
      "StrengthNumber": "2",
      "StrengthUnit": "[hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20090901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions: FOR ORAL USE."
    }
  ]
}
                    

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  <NDC>
    <NDCCode>48951-8106-1</NDCCode>
    <PackageDescription>10 AMPULE in 1 BOX (48951-8106-1)  &gt; 1 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>48951-8106-01</NDC11Code>
    <ProductNDC>48951-8106</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Quartz 20 Special Order</ProprietaryName>
    <NonProprietaryName>Quartz 20 Special Order</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090901</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Uriel Pharmacy Inc.</LabelerName>
    <SubstanceName>SILICON DIOXIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>[hp_X]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0067-8106-04</NDCCode>
    <PackageDescription>118 mL in 1 BOTTLE (0067-8106-04) </PackageDescription>
    <NDC11Code>00067-8106-04</NDC11Code>
    <ProductNDC>0067-8106</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Triaminic</ProprietaryName>
    <ProprietaryNameSuffix>Night Time Cold And Cough</ProprietaryNameSuffix>
    <NonProprietaryName>Diphenhydramine Hcl, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>SYRUP</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121015</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Consumer Healthcare Holdings (US) LLC</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>6.25; 2.5</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>0067-8112-08</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0067-8112-08)  *  118 mL in 1 BOTTLE, PLASTIC (0067-8105-04)  *  118 mL in 1 BOTTLE (0067-8106-04) </PackageDescription>
    <NDC11Code>00067-8112-08</NDC11Code>
    <ProductNDC>0067-8112</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Triaminic</ProprietaryName>
    <ProprietaryNameSuffix>Day Time Cold And Cough And Night Time Cold And Cough</ProprietaryNameSuffix>
    <NonProprietaryName>Dextromethorphan Hbr, Phenylephrine Hcl And Diphenhydramine Hcl, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Consumer Healthcare Holdings (US) LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0268-8106-05</NDCCode>
    <PackageDescription>5.5 mL in 1 VIAL (0268-8106-05) </PackageDescription>
    <NDC11Code>00268-8106-05</NDC11Code>
    <ProductNDC>0268-8106</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Saccharomyces Cerevisiae</ProprietaryName>
    <NonProprietaryName>Saccharomyces Cerevisiae</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS</RouteName>
    <StartMarketingDate>19650101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103753</ApplicationNumber>
    <LabelerName>ALK-Abello, Inc.</LabelerName>
    <SubstanceName>SACCHAROMYCES CEREVISIAE</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-03-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19650101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been exposed. By measuring skin test response, the physician may assess the degree of sensitivity that patients have to the allergens. For extracts standardized in AU and BAU, see individual directions for use. Allergenic extracts for diagnostic use only of coffee, mosquito, cottonseed, and flaxseed have not been shown by adequate data to be safe and effective for therapeutic use.</IndicationAndUsage>
    <Description>Sterile diagnostic extracts are supplied in either phenol-saline diluent for Intradermal Testing or in diluent containing glycerin 50% (v/v) for Percutaneous Testing and phenol 0.4% (preservative). Inactive ingredients may include: sodium chloride for isotonicity, glycerin, and sodium bicarbonate as a buffer. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds (fungi) are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Foods, miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline or glycerin, filtered aseptically and after final packaging are tested for sterility and safety.</Description>
  </NDC>
  <NDC>
    <NDCCode>0268-8106-10</NDCCode>
    <PackageDescription>10.5 mL in 1 VIAL (0268-8106-10) </PackageDescription>
    <NDC11Code>00268-8106-10</NDC11Code>
    <ProductNDC>0268-8106</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Saccharomyces Cerevisiae</ProprietaryName>
    <NonProprietaryName>Saccharomyces Cerevisiae</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19650101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103753</ApplicationNumber>
    <LabelerName>ALK-Abello, Inc.</LabelerName>
    <SubstanceName>SACCHAROMYCES CEREVISIAE</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-02-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19650101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.</IndicationAndUsage>
    <Description>Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety.</Description>
  </NDC>
  <NDC>
    <NDCCode>0268-8106-50</NDCCode>
    <PackageDescription>53 mL in 1 VIAL (0268-8106-50) </PackageDescription>
    <NDC11Code>00268-8106-50</NDC11Code>
    <ProductNDC>0268-8106</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Saccharomyces Cerevisiae</ProprietaryName>
    <NonProprietaryName>Saccharomyces Cerevisiae</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19650101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103753</ApplicationNumber>
    <LabelerName>ALK-Abello, Inc.</LabelerName>
    <SubstanceName>SACCHAROMYCES CEREVISIAE</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-02-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19650101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.</IndicationAndUsage>
    <Description>Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-8106-10</NDCCode>
    <PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8106-10)</PackageDescription>
    <NDC11Code>00378-8106-10</NDC11Code>
    <ProductNDC>0378-8106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Galantamine Hydrobromide</ProprietaryName>
    <NonProprietaryName>Galantamine Hydrobromide</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110124</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090900</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-02-19</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0378-8106-93</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8106-93)</PackageDescription>
    <NDC11Code>00378-8106-93</NDC11Code>
    <ProductNDC>0378-8106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Galantamine Hydrobromide</ProprietaryName>
    <NonProprietaryName>Galantamine Hydrobromide</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110124</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090900</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-24</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0395-8106-19</NDCCode>
    <PackageDescription>25 g in 1 CONTAINER (0395-8106-19)</PackageDescription>
    <NDC11Code>00395-8106-19</NDC11Code>
    <ProductNDC>0395-8106</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20180608</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Humco Holding Group, Inc.</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0395-8106-35</NDCCode>
    <PackageDescription>5 g in 1 CONTAINER (0395-8106-35)</PackageDescription>
    <NDC11Code>00395-8106-35</NDC11Code>
    <ProductNDC>0395-8106</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20180608</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Humco Holding Group, Inc.</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0527-8106-37</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-8106-37) </PackageDescription>
    <NDC11Code>00527-8106-37</NDC11Code>
    <ProductNDC>0527-8106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
    <NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181009</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210279</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181009</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dexmethylphenidate HCl extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Dexmethylphenidate HCl extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate HCl extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate HCl extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate HCl extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note*=asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, D&amp;C Red #28 (5 mg, 10 mg, 25 mg and 35 mg strengths), edible printing ink Red SB-1010N containing Shellac NF and Carmine Powder Red, FD&amp;C Blue #1 (5 mg, 15 mg, 25 mg, 35 mg and 40 mg strengths), FDA/E172 Yellow Iron Oxide (15 mg and 40 mg strengths), gelatin, methacrylic acid copolymer, Opadry Clear containing hypromellose and polyethylene glycol, povidone, sugar spheres containing corn starch as well as sugar syrup and sucrose derived from sugar cane, talc, titanium dioxide, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>10888-8106-1</NDCCode>
    <PackageDescription>20000 CAPSULE, LIQUID FILLED in 1 BOX (10888-8106-1)</PackageDescription>
    <NDC11Code>10888-8106-01</NDC11Code>
    <ProductNDC>10888-8106</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Calcitriol</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <StartMarketingDate>20130524</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Softgels Inc.</LabelerName>
    <SubstanceName>CALCITRIOL</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2018-02-02</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>50909-8106-3</NDCCode>
    <PackageDescription>15 kg in 1 DRUM (50909-8106-3)</PackageDescription>
    <NDC11Code>50909-8106-03</NDC11Code>
    <ProductNDC>50909-8106</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140730</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>HOVIONE FARMACIENCIA SA</LabelerName>
    <SubstanceName>DOXYCYCLINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2020-01-23</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>58597-8106-2</NDCCode>
    <PackageDescription>5 g in 1 BOTTLE (58597-8106-2)</PackageDescription>
    <NDC11Code>58597-8106-02</NDC11Code>
    <ProductNDC>58597-8106</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Aloe Vera</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140416</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>AMERICAN PHARMACEUTICAL INGREDIENTS LLC</LabelerName>
    <SubstanceName>ALOE VERA LEAF</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>58597-8106-4</NDCCode>
    <PackageDescription>25 g in 1 BOTTLE (58597-8106-4)</PackageDescription>
    <NDC11Code>58597-8106-04</NDC11Code>
    <ProductNDC>58597-8106</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Aloe Vera</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140416</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>AMERICAN PHARMACEUTICAL INGREDIENTS LLC</LabelerName>
    <SubstanceName>ALOE VERA LEAF</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>58597-8106-6</NDCCode>
    <PackageDescription>100 g in 1 BOTTLE (58597-8106-6)</PackageDescription>
    <NDC11Code>58597-8106-06</NDC11Code>
    <ProductNDC>58597-8106</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Aloe Vera</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140416</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>AMERICAN PHARMACEUTICAL INGREDIENTS LLC</LabelerName>
    <SubstanceName>ALOE VERA LEAF</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>61589-8106-1</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (61589-8106-1)  / 30 g in 1 BOTTLE</PackageDescription>
    <NDC11Code>61589-8106-01</NDC11Code>
    <ProductNDC>61589-8106</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>No7 Beautifully Matte Foundation Sunscreen Broad Spectrum Spf 15 Warm Beige</ProprietaryName>
    <NonProprietaryName>Octinoxate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>BCM Cosmetique SAS</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>1.5; .5</StrengthNumber>
    <StrengthUnit>g/30g; g/30g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions for suncreen use. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62721-8106-8</NDCCode>
    <PackageDescription>1 CANISTER in 1 BLISTER PACK (62721-8106-8)  &gt; 2.83 g in 1 CANISTER (62721-8106-6) </PackageDescription>
    <NDC11Code>62721-8106-08</NDC11Code>
    <ProductNDC>62721-8106</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lypsyl Honeyberry</ProprietaryName>
    <NonProprietaryName>Octinoxate</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20091001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Lornamead</LabelerName>
    <SubstanceName>OCTINOXATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>5.5; 2; 3.5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply liberally before sun exposure and as needed. children under 6 months of age. ask a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63083-8106-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-8106-2) </PackageDescription>
    <NDC11Code>63083-8106-02</NDC11Code>
    <ProductNDC>63083-8106</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Azurite</ProprietaryName>
    <ProprietaryNameSuffix>8106</ProprietaryNameSuffix>
    <NonProprietaryName>Azurite</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
    <SubstanceName>AZURITE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves fear of speaking, inability to express thoughts or feelings, apprehension, or lack of confidence.*.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63629-8106-1</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (63629-8106-1) </PackageDescription>
    <NDC11Code>63629-8106-01</NDC11Code>
    <ProductNDC>63629-8106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Montelukast Sodium</ProprietaryName>
    <NonProprietaryName>Montelukast Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130411</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202717</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>MONTELUKAST SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: 1 Prophylaxis and chronic treatment of asthma in patients 15 years of age and older ( 1.1). , 2 Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older ( 1.2). , 3 Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (  1.3).  .</IndicationAndUsage>
    <Description>Montelukast sodium, the active ingredient in montelukast sodium tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium is described chemically as [ R-( E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35ClNNaO 3S, and its molecular weight is 608.18. The structural formula is:. Montelukast sodium is a hygroscopic, optically active, white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 10-mg film-coated montelukast sodium tablet, USP contains 10.4 mg montelukast sodium, USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: microcelac 100, croscarmellose sodium, low substituted hydroxypropyl cellulose, and magnesium stearate. The film coating consists of hypromellose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 6000, iron oxide red and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>63629-8106-2</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (63629-8106-2) </PackageDescription>
    <NDC11Code>63629-8106-02</NDC11Code>
    <ProductNDC>63629-8106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Montelukast Sodium</ProprietaryName>
    <NonProprietaryName>Montelukast Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130411</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202717</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>MONTELUKAST SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: 1 Prophylaxis and chronic treatment of asthma in patients 15 years of age and older ( 1.1). , 2 Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older ( 1.2). , 3 Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (  1.3).  .</IndicationAndUsage>
    <Description>Montelukast sodium, the active ingredient in montelukast sodium tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium is described chemically as [ R-( E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35ClNNaO 3S, and its molecular weight is 608.18. The structural formula is:. Montelukast sodium is a hygroscopic, optically active, white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 10-mg film-coated montelukast sodium tablet, USP contains 10.4 mg montelukast sodium, USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: microcelac 100, croscarmellose sodium, low substituted hydroxypropyl cellulose, and magnesium stearate. The film coating consists of hypromellose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 6000, iron oxide red and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>63850-8106-4</NDCCode>
    <PackageDescription>1 kg in 1 DRUM (63850-8106-4) </PackageDescription>
    <NDC11Code>63850-8106-04</NDC11Code>
    <ProductNDC>63850-8106</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nilotinib Hydrochloride Monohydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20210519</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Natco Pharma Limited</LabelerName>
    <SubstanceName>NILOTINIB HYDROCHLORIDE MONOHYDRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-12-20</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19-MAY-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>68788-8106-1</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (68788-8106-1) </PackageDescription>
    <NDC11Code>68788-8106-01</NDC11Code>
    <ProductNDC>68788-8106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204598</ApplicationNumber>
    <LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibratetablets are indicated as adjunctive therapy to diet:   to reduce triglyceride (TG) levels in adultswith severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).  to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is notpossible.  Limitations of Use   Markedlyelevated levels of serum TG (e.g. &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions ( 5.7)].   Fenofibrate did not reducecoronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions ( 5.1) and ClinicalStudies ( 14.4)].</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula:. The molecular formula is C 20H 21ClO 4and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&amp;C Yellow # 10 aluminum lake, FD&amp;C Blue # 2 / indigo caramine aluminum lake, FD&amp;C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>68788-8106-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68788-8106-3) </PackageDescription>
    <NDC11Code>68788-8106-03</NDC11Code>
    <ProductNDC>68788-8106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204598</ApplicationNumber>
    <LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibratetablets are indicated as adjunctive therapy to diet:   to reduce triglyceride (TG) levels in adultswith severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).  to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is notpossible.  Limitations of Use   Markedlyelevated levels of serum TG (e.g. &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions ( 5.7)].   Fenofibrate did not reducecoronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions ( 5.1) and ClinicalStudies ( 14.4)].</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula:. The molecular formula is C 20H 21ClO 4and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&amp;C Yellow # 10 aluminum lake, FD&amp;C Blue # 2 / indigo caramine aluminum lake, FD&amp;C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>68788-8106-6</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68788-8106-6) </PackageDescription>
    <NDC11Code>68788-8106-06</NDC11Code>
    <ProductNDC>68788-8106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204598</ApplicationNumber>
    <LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibratetablets are indicated as adjunctive therapy to diet:   to reduce triglyceride (TG) levels in adultswith severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).  to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is notpossible.  Limitations of Use   Markedlyelevated levels of serum TG (e.g. &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions ( 5.7)].   Fenofibrate did not reducecoronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions ( 5.1) and ClinicalStudies ( 14.4)].</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula:. The molecular formula is C 20H 21ClO 4and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&amp;C Yellow # 10 aluminum lake, FD&amp;C Blue # 2 / indigo caramine aluminum lake, FD&amp;C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>68788-8106-9</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68788-8106-9) </PackageDescription>
    <NDC11Code>68788-8106-09</NDC11Code>
    <ProductNDC>68788-8106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204598</ApplicationNumber>
    <LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibratetablets are indicated as adjunctive therapy to diet:   to reduce triglyceride (TG) levels in adultswith severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).  to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is notpossible.  Limitations of Use   Markedlyelevated levels of serum TG (e.g. &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions ( 5.7)].   Fenofibrate did not reducecoronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions ( 5.1) and ClinicalStudies ( 14.4)].</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula:. The molecular formula is C 20H 21ClO 4and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&amp;C Yellow # 10 aluminum lake, FD&amp;C Blue # 2 / indigo caramine aluminum lake, FD&amp;C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>48951-0076-1</NDCCode>
    <PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-0076-1)</PackageDescription>
    <NDC11Code>48951-0076-01</NDC11Code>
    <ProductNDC>48951-0076</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Apis Levisticum Ear Irritation Relief</ProprietaryName>
    <NonProprietaryName>Apis Mellifera, Levisticum Officinale Leaf</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090901</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Uriel Pharmacy Inc</LabelerName>
    <SubstanceName>APIS MELLIFERA; LEVISTICUM OFFICINALE LEAF</SubstanceName>
    <StrengthNumber>3; 3</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-07-25</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>48951-0077-1</NDCCode>
    <PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-0077-1)</PackageDescription>
    <NDC11Code>48951-0077-01</NDC11Code>
    <ProductNDC>48951-0077</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Arnica Echinacea First Aid</ProprietaryName>
    <NonProprietaryName>Bellis Perennis, Echinacea Unspecified, Hamamelis Virginiana Root Bark/stem Bark, St. Johns Wort, Achillea Millefolium, Aconitum Napellus, Arnica Montana, Atropa Belladonna, Calendula Officinalis Flowering Top, Matricaria Recutita, Calcium Sulfide, Mercurius Solubilis, Comfrey Root</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090901</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Uriel Pharmacy Inc</LabelerName>
    <SubstanceName>BELLIS PERENNIS; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ST. JOHN'S WORT; ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; COMFREY ROOT</SubstanceName>
    <StrengthNumber>5; 5; 5; 5; 6; 6; 6; 6; 6; 6; 9; 9; 9</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-07-25</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>48951-0078-1</NDCCode>
    <PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-0078-1)</PackageDescription>
    <NDC11Code>48951-0078-01</NDC11Code>
    <ProductNDC>48951-0078</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Avena Valeriana Nerve Relief</ProprietaryName>
    <NonProprietaryName>Avena Sativa Flowering Top, Valerian, Ostrea Edulis Shell, Phosphorus, Sulfur</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091201</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Uriel Pharmacy Inc</LabelerName>
    <SubstanceName>AVENA SATIVA FLOWERING TOP; VALERIAN; OSTREA EDULIS SHELL; PHOSPHORUS; SULFUR</SubstanceName>
    <StrengthNumber>3; 3; 7; 30; 30</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-07-25</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>48951-1001-1</NDCCode>
    <PackageDescription>10 AMPULE in 1 PACKAGE (48951-1001-1)  / 1 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>48951-1001-01</NDC11Code>
    <ProductNDC>48951-1001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Viscum Abietis</ProprietaryName>
    <NonProprietaryName>Viscum Album Fruiting Top</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090901</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Uriel Pharmacy Inc</LabelerName>
    <SubstanceName>VISCUM ALBUM FRUITING TOP</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>[hp_X]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions: FOR ORAL USE.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>48951-8106-1</NDCCode><ProprietaryName>Quartz 20 Special Order</ProprietaryName><NonProprietaryName>Quartz 20 Special Order</NonProprietaryName></NDC><NDC><NDCCode>0067-8106-04</NDCCode><ProprietaryName>Triaminic</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>0067-8112-08</NDCCode><ProprietaryName>Triaminic</ProprietaryName><NonProprietaryName>Dextromethorphan Hbr, Phenylephrine Hcl And Diphenhydramine Hcl, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>0268-8106-05</NDCCode><ProprietaryName>Saccharomyces Cerevisiae</ProprietaryName><NonProprietaryName>Saccharomyces Cerevisiae</NonProprietaryName></NDC><NDC><NDCCode>0268-8106-10</NDCCode><ProprietaryName>Saccharomyces Cerevisiae</ProprietaryName><NonProprietaryName>Saccharomyces Cerevisiae</NonProprietaryName></NDC><NDC><NDCCode>0268-8106-50</NDCCode><ProprietaryName>Saccharomyces Cerevisiae</ProprietaryName><NonProprietaryName>Saccharomyces Cerevisiae</NonProprietaryName></NDC><NDC><NDCCode>0378-8106-10</NDCCode><ProprietaryName>Galantamine Hydrobromide</ProprietaryName><NonProprietaryName>Galantamine Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>0378-8106-93</NDCCode><ProprietaryName>Galantamine Hydrobromide</ProprietaryName><NonProprietaryName>Galantamine Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>0395-8106-19</NDCCode><NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0395-8106-35</NDCCode><NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0527-8106-37</NDCCode><ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName><NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>10888-8106-1</NDCCode><NonProprietaryName>Calcitriol</NonProprietaryName></NDC><NDC><NDCCode>50909-8106-3</NDCCode><NonProprietaryName>Doxycycline</NonProprietaryName></NDC><NDC><NDCCode>58597-8106-2</NDCCode><NonProprietaryName>Aloe Vera</NonProprietaryName></NDC><NDC><NDCCode>58597-8106-4</NDCCode><NonProprietaryName>Aloe Vera</NonProprietaryName></NDC><NDC><NDCCode>58597-8106-6</NDCCode><NonProprietaryName>Aloe Vera</NonProprietaryName></NDC><NDC><NDCCode>61589-8106-1</NDCCode><ProprietaryName>No7 Beautifully Matte Foundation Sunscreen Broad Spectrum Spf 15 Warm Beige</ProprietaryName><NonProprietaryName>Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>62721-8106-8</NDCCode><ProprietaryName>Lypsyl Honeyberry</ProprietaryName><NonProprietaryName>Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>63083-8106-2</NDCCode><ProprietaryName>Azurite</ProprietaryName><NonProprietaryName>Azurite</NonProprietaryName></NDC><NDC><NDCCode>63629-8106-1</NDCCode><ProprietaryName>Montelukast Sodium</ProprietaryName><NonProprietaryName>Montelukast Sodium</NonProprietaryName></NDC><NDC><NDCCode>63629-8106-2</NDCCode><ProprietaryName>Montelukast Sodium</ProprietaryName><NonProprietaryName>Montelukast Sodium</NonProprietaryName></NDC><NDC><NDCCode>63850-8106-4</NDCCode><NonProprietaryName>Nilotinib Hydrochloride Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>68788-8106-1</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>68788-8106-3</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>68788-8106-6</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>68788-8106-9</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>48951-0076-1</NDCCode><ProprietaryName>Apis Levisticum Ear Irritation Relief</ProprietaryName><NonProprietaryName>Apis Mellifera, Levisticum Officinale Leaf</NonProprietaryName></NDC><NDC><NDCCode>48951-0077-1</NDCCode><ProprietaryName>Arnica Echinacea First Aid</ProprietaryName><NonProprietaryName>Bellis Perennis, Echinacea Unspecified, Hamamelis Virginiana Root Bark/stem Bark, St. Johns Wort, Achillea Millefolium, Aconitum Napellus, Arnica Montana, Atropa Belladonna, Calendula Officinalis Flowering Top, Matricaria Recutita, Calcium Sulfide, Mercurius Solubilis, Comfrey Root</NonProprietaryName></NDC><NDC><NDCCode>48951-0078-1</NDCCode><ProprietaryName>Avena Valeriana Nerve Relief</ProprietaryName><NonProprietaryName>Avena Sativa Flowering Top, Valerian, Ostrea Edulis Shell, Phosphorus, Sulfur</NonProprietaryName></NDC><NDC><NDCCode>48951-1001-1</NDCCode><ProprietaryName>Viscum Abietis</ProprietaryName><NonProprietaryName>Viscum Album Fruiting Top</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",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "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."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
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      "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",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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