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How to Find 69646-705-15 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "69646-705-15",
      "PackageDescription": "48 g in 1 TUBE (69646-705-15) ",
      "NDC11Code": "69646-0705-15",
      "ProductNDC": "69646-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alcortin A",
      "NonProprietaryName": "Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150301",
      "EndMarketingDate": "20210831",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Novum Pharma, LLC",
      "SubstanceName": "IODOQUINOL; HYDROCORTISONE ACETATE; ALOE VERA LEAF",
      "StrengthNumber": "10; 20; 10",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150301",
      "EndMarketingDatePackage": "20210831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69646-705-02",
      "PackageDescription": "2 g in 1 PACKET (69646-705-02) ",
      "NDC11Code": "69646-0705-02",
      "ProductNDC": "69646-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alcortin A",
      "NonProprietaryName": "Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150301",
      "EndMarketingDate": "20210831",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Novum Pharma, LLC",
      "SubstanceName": "IODOQUINOL; HYDROCORTISONE ACETATE; ALOE VERA LEAF",
      "StrengthNumber": "10; 20; 10",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150301",
      "EndMarketingDatePackage": "20210831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69646-705-03",
      "PackageDescription": "2 g in 1 TUBE (69646-705-03) ",
      "NDC11Code": "69646-0705-03",
      "ProductNDC": "69646-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alcortin A",
      "NonProprietaryName": "Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150301",
      "EndMarketingDate": "20210831",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Novum Pharma, LLC",
      "SubstanceName": "IODOQUINOL; HYDROCORTISONE ACETATE; ALOE VERA LEAF",
      "StrengthNumber": "10; 20; 10",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180316",
      "EndMarketingDatePackage": "20210831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69646-705-08",
      "PackageDescription": "10 PACKET in 1 CARTON (69646-705-08)  > 2 g in 1 PACKET",
      "NDC11Code": "69646-0705-08",
      "ProductNDC": "69646-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alcortin A",
      "NonProprietaryName": "Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150301",
      "EndMarketingDate": "20210831",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Novum Pharma, LLC",
      "SubstanceName": "IODOQUINOL; HYDROCORTISONE ACETATE; ALOE VERA LEAF",
      "StrengthNumber": "10; 20; 10",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150301",
      "EndMarketingDatePackage": "20210831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69646-705-11",
      "PackageDescription": "10 TUBE in 1 CARTON (69646-705-11)  > 2 g in 1 TUBE (69646-705-03) ",
      "NDC11Code": "69646-0705-11",
      "ProductNDC": "69646-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alcortin A",
      "NonProprietaryName": "Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150301",
      "EndMarketingDate": "20210831",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Novum Pharma, LLC",
      "SubstanceName": "IODOQUINOL; HYDROCORTISONE ACETATE; ALOE VERA LEAF",
      "StrengthNumber": "10; 20; 10",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180316",
      "EndMarketingDatePackage": "20210831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69646-705-13",
      "PackageDescription": "24 PACKET in 1 CARTON (69646-705-13)  > 2 g in 1 PACKET",
      "NDC11Code": "69646-0705-13",
      "ProductNDC": "69646-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alcortin A",
      "NonProprietaryName": "Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150301",
      "EndMarketingDate": "20210831",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Novum Pharma, LLC",
      "SubstanceName": "IODOQUINOL; HYDROCORTISONE ACETATE; ALOE VERA LEAF",
      "StrengthNumber": "10; 20; 10",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150301",
      "EndMarketingDatePackage": "20210831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "17478-705-12",
      "PackageDescription": "1 VIAL in 1 CARTON (17478-705-12)  > 15 mL in 1 VIAL",
      "NDC11Code": "17478-0705-12",
      "ProductNDC": "17478-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Betaxolol",
      "NonProprietaryName": "Betaxolol Hydrochloride",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20030401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075386",
      "LabelerName": "Akorn",
      "SubstanceName": "BETAXOLOL HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-05-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20030401",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "21749-705-50",
      "PackageDescription": "15 mL in 1 PACKAGE (21749-705-50) ",
      "NDC11Code": "21749-0705-50",
      "ProductNDC": "21749-705",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Purell Advanced Refreshing Aloe",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120314",
      "EndMarketingDate": "20220101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "GOJO Industries, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20120314",
      "EndMarketingDatePackage": "20220101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "25010-705-15",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (25010-705-15) ",
      "NDC11Code": "25010-0705-15",
      "ProductNDC": "25010-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cuprimine",
      "NonProprietaryName": "Penicillamine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19701204",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019853",
      "LabelerName": "Bausch Health US, LLC",
      "SubstanceName": "PENICILLAMINE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antirheumatic Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19701204",
      "SamplePackage": "N",
      "IndicationAndUsage": "CUPRIMINE is indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that CUPRIMINE is not of value in ankylosing spondylitis.",
      "Description": "Penicillamine, USP is a chelating agent used in the treatment of Wilson’s disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy (see INDICATIONS). It is 3-mercapto-D-valine. It is a white, or practically white, crystalline powder, freely soluble in water, slightly soluble in alcohol, and insoluble in ether, acetone, benzene, and carbon tetrachloride. Although its configuration is D, it is levorotatory as usually measured. calculated on a dried basis. The empirical formula is C5H11NO2S, giving it a molecular weight of 149.21. The structural formula is. It reacts readily with formaldehyde or acetone to form a thiazolidine-carboxylic acid. CUPRIMINE (penicillamine) Capsules, USP for oral administration contain 250 mg of penicillamine. Each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, lactose monohydrate, magnesium stearate, and titanium dioxide."
    },
    {
      "NDCCode": "43419-705-21",
      "PackageDescription": "2 CONTAINER in 1 CARTON (43419-705-21)  > 15 g in 1 CONTAINER",
      "NDC11Code": "43419-0705-21",
      "ProductNDC": "43419-705",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Laneige Bb Cushion Medium",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141030",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "AMOREPACIFIC",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "1.05; .6225; 1.47",
      "StrengthUnit": "g/15g; g/15g; g/15g",
      "Status": "Deprecated",
      "LastUpdate": "2018-08-13",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "50268-705-15",
      "PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-705-15)  > 1 TABLET in 1 BLISTER PACK (50268-705-11)",
      "NDC11Code": "50268-0705-15",
      "ProductNDC": "50268-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Salsalate",
      "NonProprietaryName": "Salsalate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141118",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "AvPAK",
      "SubstanceName": "SALSALATE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-05-09"
    },
    {
      "NDCCode": "52959-705-01",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (52959-705-01)  > 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "52959-0705-01",
      "ProductNDC": "52959-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Proparacaine Hydrochloride",
      "NonProprietaryName": "Proparacaine Hydrochloride",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19950929",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040074",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "PROPARACAINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Local Anesthesia [PE],Local Anesthetic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Proparacaine hydrochloride ophthalmic solution is indicated for topical anesthesia in ophthalmic practice. Representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction.",
      "Description": "Proparacaine Hydrochloride Ophthalmic Solution USP, 0.5% is a topical anesthetic prepared as a sterile aqueous ophthalmic solution. The active ingredient is represented by the following structural formula. C16H26N2O3  HCI. Mol. wt.: 330.85. Chemical name: Benzoic acid, 3-amino-4-propoxy-,2-(diethylamino) ethyl ester, monohydrochloride. Each mL Contains. ACTIVE: Proparacaine Hydrochloride 5 mg (0.5%); INACTIVES: Glycerin, Hydrochloric Acid, Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (3.5 – 6.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%."
    },
    {
      "NDCCode": "53462-007-27",
      "PackageDescription": "1 KIT in 1 KIT (53462-007-27)  *  1 BOTTLE in 1 KIT > 4 mL in 1 BOTTLE *  15 mL in 1 BOTTLE (53462-003-15)  *  6 CLOTH in 1 PACKAGE (53462-705-23) ",
      "NDC11Code": "53462-0007-27",
      "ProductNDC": "53462-007",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Skin Antisepsis, Oral Cleansing, Nasal Antisepsis",
      "NonProprietaryName": "Chlorhexidine Gluconate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20120206",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021669",
      "LabelerName": "Sage Products LLC",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20120206",
      "SamplePackage": "N",
      "Description": "Chlorhexidine Gluconate is an oral rinse containing 0.12% chlorhexidine gluconate (1,11-hexamethylene bis[5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. Chlorhexidine Gluconate is a near-neutral solution (pH range 5-7). Chlorhexidine Gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:."
    },
    {
      "NDCCode": "58602-705-15",
      "PackageDescription": "1 BOTTLE in 1 CARTON (58602-705-15)  / 60 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "58602-0705-15",
      "ProductNDC": "58602-705",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Famotidine",
      "NonProprietaryName": "Famotidine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160426",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206531",
      "LabelerName": "Aurohealth LLC",
      "SubstanceName": "FAMOTIDINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160426",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "62135-705-51",
      "PackageDescription": "15 mL in 1 BOTTLE (62135-705-51) ",
      "NDC11Code": "62135-0705-51",
      "ProductNDC": "62135-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azithromycin",
      "NonProprietaryName": "Azithromycin",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150515",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065488",
      "LabelerName": "Chartwell RX, LLC",
      "SubstanceName": "AZITHROMYCIN MONOHYDRATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
      "Status": "Active",
      "LastUpdate": "2024-04-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240307",
      "SamplePackage": "N",
      "IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
      "Description": "Azithromycin for Oral Suspension, USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12·H 2O and a molecular weight of 785.0. Azithromycin for Oral Suspension, USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; tribasic sodium phosphate anhydrous; hydroxypropyl cellulose; xanthan gum; colloidal silicon dioxide, FD&C Red #40; and artificial cherry flavor. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin."
    },
    {
      "NDCCode": "67457-705-75",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (67457-705-75)  / 15 mL in 1 VIAL, SINGLE-DOSE (67457-705-00) ",
      "NDC11Code": "67457-0705-75",
      "ProductNDC": "67457-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vancomycin Hydrochloride",
      "NonProprietaryName": "Vancomycin Hydrochloride",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180831",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209481",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/15mL",
      "Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2024-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180831",
      "SamplePackage": "N",
      "IndicationAndUsage": "Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates and older) for the treatment of: : 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3) , 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).",
      "Description": "Vancomycin Hydrochloride for Injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2, 5, 24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l, 6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24  HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula:. Vancomycin Hydrochloride for Injection, USP is a sterile off-white to light tan colored lyophilized plug or powder for injection. Vancomycin Hydrochloride for Injection, USP is supplied in single-dose vials, containing 256 mg, 769 mg, 1.28 g, 1.54 g, 1.79 g or 2.05 g of vancomycin hydrochloride, USP equivalent to 250 mg, 750 mg, 1.25 g, 1.5 g, 1.75 g or 2 g of vancomycin base. The lyophilized powder is reconstituted with Sterile Water for Injection, USP which forms a clear, colorless or light to dark tan solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)]."
    },
    {
      "NDCCode": "68400-705-15",
      "PackageDescription": "454 g in 1 BOTTLE, PLASTIC (68400-705-15) ",
      "NDC11Code": "68400-0705-15",
      "ProductNDC": "68400-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sorbet Apf",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20121214",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "5.6",
      "StrengthUnit": "g/454g",
      "Status": "Deprecated",
      "LastUpdate": "2024-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20130901",
      "SamplePackage": "N",
      "IndicationAndUsage": "A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Office Use Only. This product is not intended for home or unsupervised consumer use."
    },
    {
      "NDCCode": "71919-705-07",
      "PackageDescription": "15 mL in 1 VIAL, GLASS (71919-705-07) ",
      "NDC11Code": "71919-0705-07",
      "ProductNDC": "71919-705",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Veratrum Album",
      "NonProprietaryName": "Veratrum Album",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110517",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "VERATRUM ALBUM ROOT",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20110517",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "83254-705-15",
      "PackageDescription": "150 mL in 1 BOTTLE (83254-705-15) ",
      "NDC11Code": "83254-0705-15",
      "ProductNDC": "83254-705",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Povidone Iodine",
      "NonProprietaryName": "Povidone Iodine 7.5 Solution",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230504",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "M005",
      "LabelerName": "1201258 Ontario Inc. O/A Nanz Pharma",
      "SubstanceName": "POVIDONE-IODINE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20230504",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the treatment of athlete's foot, jock itch, and ringworm. For the effective relief of burning, cracking, discomfort, redness, scaling, soreness, and chafing that is associated with jock itch."
    },
    {
      "NDCCode": "84756-705-02",
      "PackageDescription": "15 mL in 1 BOTTLE (84756-705-02) ",
      "NDC11Code": "84756-0705-02",
      "ProductNDC": "84756-705",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Morocco Argan Oil Hair Treatment",
      "NonProprietaryName": "Morocco Argan Oil Hair Treatment",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241210",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
      "SubstanceName": "NIACINAMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241210",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "10967-705-19",
      "PackageDescription": "28 mL in 1 BOTTLE, GLASS (10967-705-19) ",
      "NDC11Code": "10967-0705-19",
      "ProductNDC": "10967-705",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Rv Illuminance Serum Tint Broad Spectrum 15",
      "ProprietaryNameSuffix": "Tan Sand",
      "NonProprietaryName": "Face Foundation With Spf",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240326",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "REVLON CONSUMER PR Consumer Products Corp",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE",
      "StrengthNumber": ".868; .28; 1.54",
      "StrengthUnit": "g/28mL; g/28mL; g/28mL",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240326",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. : 1 Helps prevent sunburn., 2 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "13533-705-01",
      "PackageDescription": "1 VIAL in 1 CARTON (13533-705-01)  > 20 mL in 1 VIAL (13533-705-11) ",
      "NDC11Code": "13533-0705-01",
      "ProductNDC": "13533-705",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Prolastin-c Liquid",
      "NonProprietaryName": "Alpha1-proteinase Inhibitor (human)",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19871202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103174",
      "LabelerName": "GRIFOLS USA, LLC",
      "SubstanceName": ".ALPHA.1-PROTEINASE INHIBITOR HUMAN",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/20mL",
      "Pharm_Classes": "Human alpha-1 Proteinase Inhibitor [EPC], Trypsin Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19871202",
      "SamplePackage": "N",
      "IndicationAndUsage": "PROLASTIN®-C LIQUID is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). Limitations of Use: 1 The effect of augmentation therapy with any Alpha1-PI, including PROLASTIN-C LIQUID, on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.   , 2 Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C LIQUID are not available., 3 PROLASTIN-C LIQUID is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.",
      "Description": "PROLASTIN-C LIQUID is a sterile, concentrate of Alpha1-PI for intravenous infusion. The solution is clear, colorless or pale yellow or pale green. The actual amount of functionally active Alpha1-PI in milligrams, as determined by capacity to neutralize porcine pancreatic elastase, is printed on the carton and vial label of PROLASTIN-C LIQUID.  The specific activity of PROLASTIN-C LIQUID is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. PROLASTIN-C LIQUID has a purity of ≥ 90% Alpha1-PI (Alpha1-PI protein/total protein). PROLASTIN-C LIQUID has a pH of 6.6–7.4, a sodium phosphate content of 0.013–0.025 M, and is stabilized with 0.20-0.30 M of alanine. The total sodium concentration is ≤ 100 mEq/L. PROLASTIN-C LIQUID contains no preservative. PROLASTIN-C LIQUID is produced from pooled human plasma through modifications of the PROLASTIN process using purification by polyethylene glycol (PEG) precipitation, anion exchange chromatography, and cation exchange chromatography. All Source Plasma used in the manufacture of PROLASTIN-C LIQUID is non-reactive (negative) by FDA-licensed serological test methods for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 and negative by FDA-licensed Nucleic Acid Technologies (NAT) for HCV and human immunodeficiency virus type 1 (HIV-1). In addition, all Source Plasma is negative for hepatitis B virus (HBV) by either an FDA-licensed or investigational NAT assay. The goal of the investigational HBV NAT test is to detect low levels of viral nucleic acid; however, the significance of a negative result for the investigational HBV NAT test has not been established. By in-process NAT, all Source Plasma is negative for hepatitis A virus (HAV). As a final plasma safety step, all plasma manufacturing pools are tested by serological test methods and NAT. To evaluate further the virus safety profile of PROLASTIN-C LIQUID, in vitro studies have been conducted to validate the capacity of the manufacturing process to reduce the infectious titer of a wide range of viruses with diverse physicochemical properties. These studies evaluated the inactivation/removal of clinically relevant viruses, including human immunodeficiency virus type 1 (HIV-1) and hepatitis A virus (HAV), as well as the following model viruses: bovine viral diarrhea virus (BVDV), a surrogate for hepatitis C virus; pseudorabies virus (PRV), a surrogate for large enveloped DNA viruses (e.g., herpes viruses); vesicular stomatitis virus (VSV), a model for enveloped viruses; reovirus type 3 (Reo3), a non-specific model for non-enveloped viruses; and porcine parvovirus (PPV), a model for human parvovirus B19. The PROLASTIN-C LIQUID manufacturing process has several steps (Cold Ethanol Fractionation, PEG Precipitation, and Depth Filtration) that are important for purifying Alpha1-PI as well as removing potential virus contaminants. Two additional steps, Solvent/Detergent Treatment and 15 nm Virus Removal Nanofiltration, are included in the process as dedicated pathogen reduction steps. The Solvent/Detergent Treatment step effectively inactivates enveloped viruses (such as HIV-1, VSV, HBV, and HCV). The 15 nm Virus Removal Nanofiltration step has been implemented to reduce the risk of transmission of enveloped and non-enveloped viruses as small as 18 nm. Table 6 presents the virus reduction capacity of each process step and the accumulated virus reduction for the process as determined in viral validation studies in which virus was deliberately added to a process model in order to study virus reduction. In addition, the Solvent/Detergent Treatment step inactivates ≥ 5.4 log10 of West Nile virus, a clinically relevant enveloped virus. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. Studies of the PROLASTIN-C LIQUID manufacturing process demonstrate that a minimum of 6 log10 reduction of TSE infectivity is achieved. These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
    },
    {
      "NDCCode": "13533-705-31",
      "PackageDescription": "1 VIAL in 1 CARTON (13533-705-31)  > 10 mL in 1 VIAL (13533-705-32) ",
      "NDC11Code": "13533-0705-31",
      "ProductNDC": "13533-705",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Prolastin-c Liquid",
      "NonProprietaryName": "Alpha1-proteinase Inhibitor (human)",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19871202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103174",
      "LabelerName": "GRIFOLS USA, LLC",
      "SubstanceName": ".ALPHA.1-PROTEINASE INHIBITOR HUMAN",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/20mL",
      "Pharm_Classes": "Human alpha-1 Proteinase Inhibitor [EPC], Trypsin Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19871202",
      "SamplePackage": "N",
      "IndicationAndUsage": "PROLASTIN®-C LIQUID is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). Limitations of Use: 1 The effect of augmentation therapy with any Alpha1-PI, including PROLASTIN-C LIQUID, on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.   , 2 Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C LIQUID are not available., 3 PROLASTIN-C LIQUID is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.",
      "Description": "PROLASTIN-C LIQUID is a sterile, concentrate of Alpha1-PI for intravenous infusion. The solution is clear, colorless or pale yellow or pale green. The actual amount of functionally active Alpha1-PI in milligrams, as determined by capacity to neutralize porcine pancreatic elastase, is printed on the carton and vial label of PROLASTIN-C LIQUID.  The specific activity of PROLASTIN-C LIQUID is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. PROLASTIN-C LIQUID has a purity of ≥ 90% Alpha1-PI (Alpha1-PI protein/total protein). PROLASTIN-C LIQUID has a pH of 6.6–7.4, a sodium phosphate content of 0.013–0.025 M, and is stabilized with 0.20-0.30 M of alanine. The total sodium concentration is ≤ 100 mEq/L. PROLASTIN-C LIQUID contains no preservative. PROLASTIN-C LIQUID is produced from pooled human plasma through modifications of the PROLASTIN process using purification by polyethylene glycol (PEG) precipitation, anion exchange chromatography, and cation exchange chromatography. All Source Plasma used in the manufacture of PROLASTIN-C LIQUID is non-reactive (negative) by FDA-licensed serological test methods for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 and negative by FDA-licensed Nucleic Acid Technologies (NAT) for HCV and human immunodeficiency virus type 1 (HIV-1). In addition, all Source Plasma is negative for hepatitis B virus (HBV) by either an FDA-licensed or investigational NAT assay. The goal of the investigational HBV NAT test is to detect low levels of viral nucleic acid; however, the significance of a negative result for the investigational HBV NAT test has not been established. By in-process NAT, all Source Plasma is negative for hepatitis A virus (HAV). As a final plasma safety step, all plasma manufacturing pools are tested by serological test methods and NAT. To evaluate further the virus safety profile of PROLASTIN-C LIQUID, in vitro studies have been conducted to validate the capacity of the manufacturing process to reduce the infectious titer of a wide range of viruses with diverse physicochemical properties. These studies evaluated the inactivation/removal of clinically relevant viruses, including human immunodeficiency virus type 1 (HIV-1) and hepatitis A virus (HAV), as well as the following model viruses: bovine viral diarrhea virus (BVDV), a surrogate for hepatitis C virus; pseudorabies virus (PRV), a surrogate for large enveloped DNA viruses (e.g., herpes viruses); vesicular stomatitis virus (VSV), a model for enveloped viruses; reovirus type 3 (Reo3), a non-specific model for non-enveloped viruses; and porcine parvovirus (PPV), a model for human parvovirus B19. The PROLASTIN-C LIQUID manufacturing process has several steps (Cold Ethanol Fractionation, PEG Precipitation, and Depth Filtration) that are important for purifying Alpha1-PI as well as removing potential virus contaminants. Two additional steps, Solvent/Detergent Treatment and 15 nm Virus Removal Nanofiltration, are included in the process as dedicated pathogen reduction steps. The Solvent/Detergent Treatment step effectively inactivates enveloped viruses (such as HIV-1, VSV, HBV, and HCV). The 15 nm Virus Removal Nanofiltration step has been implemented to reduce the risk of transmission of enveloped and non-enveloped viruses as small as 18 nm. Table 6 presents the virus reduction capacity of each process step and the accumulated virus reduction for the process as determined in viral validation studies in which virus was deliberately added to a process model in order to study virus reduction. In addition, the Solvent/Detergent Treatment step inactivates ≥ 5.4 log10 of West Nile virus, a clinically relevant enveloped virus. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. Studies of the PROLASTIN-C LIQUID manufacturing process demonstrate that a minimum of 6 log10 reduction of TSE infectivity is achieved. These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
    },
    {
      "NDCCode": "13533-705-51",
      "PackageDescription": "1 VIAL in 1 CARTON (13533-705-51)  > 80 mL in 1 VIAL (13533-705-52) ",
      "NDC11Code": "13533-0705-51",
      "ProductNDC": "13533-705",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Prolastin-c Liquid",
      "NonProprietaryName": "Alpha1-proteinase Inhibitor (human)",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19871202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103174",
      "LabelerName": "GRIFOLS USA, LLC",
      "SubstanceName": ".ALPHA.1-PROTEINASE INHIBITOR HUMAN",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/20mL",
      "Pharm_Classes": "Human alpha-1 Proteinase Inhibitor [EPC], Trypsin Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19871202",
      "SamplePackage": "N",
      "IndicationAndUsage": "PROLASTIN®-C LIQUID is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). Limitations of Use: 1 The effect of augmentation therapy with any Alpha1-PI, including PROLASTIN-C LIQUID, on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.   , 2 Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C LIQUID are not available., 3 PROLASTIN-C LIQUID is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.",
      "Description": "PROLASTIN-C LIQUID is a sterile, concentrate of Alpha1-PI for intravenous infusion. The solution is clear, colorless or pale yellow or pale green. The actual amount of functionally active Alpha1-PI in milligrams, as determined by capacity to neutralize porcine pancreatic elastase, is printed on the carton and vial label of PROLASTIN-C LIQUID.  The specific activity of PROLASTIN-C LIQUID is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. PROLASTIN-C LIQUID has a purity of ≥ 90% Alpha1-PI (Alpha1-PI protein/total protein). PROLASTIN-C LIQUID has a pH of 6.6–7.4, a sodium phosphate content of 0.013–0.025 M, and is stabilized with 0.20-0.30 M of alanine. The total sodium concentration is ≤ 100 mEq/L. PROLASTIN-C LIQUID contains no preservative. PROLASTIN-C LIQUID is produced from pooled human plasma through modifications of the PROLASTIN process using purification by polyethylene glycol (PEG) precipitation, anion exchange chromatography, and cation exchange chromatography. All Source Plasma used in the manufacture of PROLASTIN-C LIQUID is non-reactive (negative) by FDA-licensed serological test methods for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 and negative by FDA-licensed Nucleic Acid Technologies (NAT) for HCV and human immunodeficiency virus type 1 (HIV-1). In addition, all Source Plasma is negative for hepatitis B virus (HBV) by either an FDA-licensed or investigational NAT assay. The goal of the investigational HBV NAT test is to detect low levels of viral nucleic acid; however, the significance of a negative result for the investigational HBV NAT test has not been established. By in-process NAT, all Source Plasma is negative for hepatitis A virus (HAV). As a final plasma safety step, all plasma manufacturing pools are tested by serological test methods and NAT. To evaluate further the virus safety profile of PROLASTIN-C LIQUID, in vitro studies have been conducted to validate the capacity of the manufacturing process to reduce the infectious titer of a wide range of viruses with diverse physicochemical properties. These studies evaluated the inactivation/removal of clinically relevant viruses, including human immunodeficiency virus type 1 (HIV-1) and hepatitis A virus (HAV), as well as the following model viruses: bovine viral diarrhea virus (BVDV), a surrogate for hepatitis C virus; pseudorabies virus (PRV), a surrogate for large enveloped DNA viruses (e.g., herpes viruses); vesicular stomatitis virus (VSV), a model for enveloped viruses; reovirus type 3 (Reo3), a non-specific model for non-enveloped viruses; and porcine parvovirus (PPV), a model for human parvovirus B19. The PROLASTIN-C LIQUID manufacturing process has several steps (Cold Ethanol Fractionation, PEG Precipitation, and Depth Filtration) that are important for purifying Alpha1-PI as well as removing potential virus contaminants. Two additional steps, Solvent/Detergent Treatment and 15 nm Virus Removal Nanofiltration, are included in the process as dedicated pathogen reduction steps. The Solvent/Detergent Treatment step effectively inactivates enveloped viruses (such as HIV-1, VSV, HBV, and HCV). The 15 nm Virus Removal Nanofiltration step has been implemented to reduce the risk of transmission of enveloped and non-enveloped viruses as small as 18 nm. Table 6 presents the virus reduction capacity of each process step and the accumulated virus reduction for the process as determined in viral validation studies in which virus was deliberately added to a process model in order to study virus reduction. In addition, the Solvent/Detergent Treatment step inactivates ≥ 5.4 log10 of West Nile virus, a clinically relevant enveloped virus. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. Studies of the PROLASTIN-C LIQUID manufacturing process demonstrate that a minimum of 6 log10 reduction of TSE infectivity is achieved. These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
    },
    {
      "NDCCode": "13537-705-02",
      "PackageDescription": "1 TUBE in 1 BOX (13537-705-02)  > 12 mL in 1 TUBE (13537-705-01)",
      "NDC11Code": "13537-0705-02",
      "ProductNDC": "13537-705",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Divine Lip Gloss Lip Gloss Spf 15 Fm Brillo Labial Fps 15 Fm",
      "ProprietaryNameSuffix": "Sweet Framboise - Pink",
      "NonProprietaryName": "Octinoxate And Oxybenzone",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20151222",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE; OXYBENZONE",
      "StrengthNumber": ".075; .03",
      "StrengthUnit": "g/mL; g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "13668-095-15",
      "PackageDescription": "1500 TABLET in 1 BOTTLE (13668-095-15) ",
      "NDC11Code": "13668-0095-15",
      "ProductNDC": "13668-095",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pramipexole Dihydrochloride",
      "NonProprietaryName": "Pramipexole Dihydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101008",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090865",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20101008",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: 1   Parkinson's disease (PD) (1.1), 2   Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).",
      "Description": "Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is ( S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S·2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of colloidal silicon dioxide, corn starch, ferric oxide red (0.25, 0.5 and 1 mg tablets), ferric oxide yellow (0.25 and 0.75 mg tablets), magnesium stearate, mannitol, povidone K-30 and pregelatinized maize starch. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.118 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.235 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.47 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.705 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.94 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 1.41 mg pramipexole dihydrochloride (in anhydrous basis)."
    },
    {
      "NDCCode": "16729-271-10",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (16729-271-10) ",
      "NDC11Code": "16729-0271-10",
      "ProductNDC": "16729-271",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Itraconazole",
      "NonProprietaryName": "Itraconazole",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170530",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205991",
      "LabelerName": "Accord Healthcare Inc.",
      "SubstanceName": "ITRACONAZOLE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-05-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20170530",
      "SamplePackage": "N",
      "IndicationAndUsage": "Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: : 1 Blastomycosis, pulmonary and extrapulmonary , 2 Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and , 3 Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. .",
      "Description": "Itraconazole is an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. (±)-1-[( R*)- sec-butyl]-4-[ p-[4-[ p-[[(2 R*,4 S*)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one mixture with (±)-1-[( R*)- sec-butyl]-4-[ p-[4-[ p-[[(2 S*,4 R*)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one. or. (±)-1-[( RS)- sec-butyl]-4-[ p-[4-[ p-[[(2 R,4 S)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one. Itraconazole has a molecular formula of C 35H 38Cl 2N 8O 4 and a molecular weight of 705.64. It is a white to slightly yellowish powder. It is insoluble in water, very slightly soluble in alcohols, and freely soluble in dichloromethane. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules contain 100 mg of itraconazole coated on sugar spheres. Inactive ingredients are hard gelatin capsule, hypromellose, polyglykol (PEG 20,000), purified talc, and sugar spheres (maize starch and sucrose). Components of the gelatin capsule include FD&C Blue No. 1, FD&C Blue No. 2, gelatin, D&C Red No. 28, and titanium dioxide. The printing ink contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide."
    },
    {
      "NDCCode": "17314-705-00",
      "PackageDescription": "571500 TABLET, FILM COATED in 1 DRUM (17314-705-00) ",
      "NDC11Code": "17314-0705-00",
      "ProductNDC": "17314-705",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Cetirizine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20081001",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Janssen Ortho LLC",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-07-15",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-OCT-08"
    },
    {
      "NDCCode": "17478-705-10",
      "PackageDescription": "1 VIAL in 1 CARTON (17478-705-10)  > 5 mL in 1 VIAL",
      "NDC11Code": "17478-0705-10",
      "ProductNDC": "17478-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Betaxolol",
      "NonProprietaryName": "Betaxolol Hydrochloride",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20030401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075386",
      "LabelerName": "Akorn",
      "SubstanceName": "BETAXOLOL HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20030401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Betaxolol Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs. In clinical studies, betaxolol ophthalmic solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. However, caution should be used in treating patients with severe reactive airway disease or a history of asthma.",
      "Description": "Betaxolol Ophthalmic Solution USP, contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor blocking agent, in a sterile isotonic solution. Betaxolol hydrochloride is a white, crystalline powder, soluble in water, with a molecular weight of 343.90. The structural formula is presented below:. Molecular Formula: C18H29NO3HCl. Chemical Name: (±)-1[p-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride. Each mL of Betaxolol Ophthalmic Solution for ophthalmic administration contains: Active: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg; Inactives: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH and Water for Injection; Preservative: Benzalkonium Chloride 0.01%."
    },
    {
      "NDCCode": "17478-705-11",
      "PackageDescription": "1 VIAL in 1 CARTON (17478-705-11)  > 10 mL in 1 VIAL",
      "NDC11Code": "17478-0705-11",
      "ProductNDC": "17478-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Betaxolol",
      "NonProprietaryName": "Betaxolol Hydrochloride",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20030401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075386",
      "LabelerName": "Akorn",
      "SubstanceName": "BETAXOLOL HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20030401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Betaxolol Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs. In clinical studies, betaxolol ophthalmic solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. However, caution should be used in treating patients with severe reactive airway disease or a history of asthma.",
      "Description": "Betaxolol Ophthalmic Solution USP, contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor blocking agent, in a sterile isotonic solution. Betaxolol hydrochloride is a white, crystalline powder, soluble in water, with a molecular weight of 343.90. The structural formula is presented below:. Molecular Formula: C18H29NO3HCl. Chemical Name: (±)-1[p-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride. Each mL of Betaxolol Ophthalmic Solution for ophthalmic administration contains: Active: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg; Inactives: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH and Water for Injection; Preservative: Benzalkonium Chloride 0.01%."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"69646-705-15","ProprietaryName":"Alcortin A","NonProprietaryName":"Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf"},{"NDCCode":"69646-705-02","ProprietaryName":"Alcortin A","NonProprietaryName":"Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf"},{"NDCCode":"69646-705-03","ProprietaryName":"Alcortin A","NonProprietaryName":"Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf"},{"NDCCode":"69646-705-08","ProprietaryName":"Alcortin A","NonProprietaryName":"Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf"},{"NDCCode":"69646-705-11","ProprietaryName":"Alcortin A","NonProprietaryName":"Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf"},{"NDCCode":"69646-705-13","ProprietaryName":"Alcortin A","NonProprietaryName":"Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf"},{"NDCCode":"17478-705-12","ProprietaryName":"Betaxolol","NonProprietaryName":"Betaxolol Hydrochloride"},{"NDCCode":"21749-705-50","ProprietaryName":"Purell Advanced Refreshing Aloe","NonProprietaryName":"Alcohol"},{"NDCCode":"25010-705-15","ProprietaryName":"Cuprimine","NonProprietaryName":"Penicillamine"},{"NDCCode":"43419-705-21","ProprietaryName":"Laneige Bb Cushion Medium","NonProprietaryName":"Octinoxate, Titanium Dioxide, And Zinc Oxide"},{"NDCCode":"50268-705-15","ProprietaryName":"Salsalate","NonProprietaryName":"Salsalate"},{"NDCCode":"52959-705-01","ProprietaryName":"Proparacaine Hydrochloride","NonProprietaryName":"Proparacaine Hydrochloride"},{"NDCCode":"53462-007-27","ProprietaryName":"Skin Antisepsis, Oral Cleansing, Nasal Antisepsis","NonProprietaryName":"Chlorhexidine Gluconate"},{"NDCCode":"58602-705-15","ProprietaryName":"Famotidine","NonProprietaryName":"Famotidine"},{"NDCCode":"62135-705-51","ProprietaryName":"Azithromycin","NonProprietaryName":"Azithromycin"},{"NDCCode":"67457-705-75","ProprietaryName":"Vancomycin Hydrochloride","NonProprietaryName":"Vancomycin Hydrochloride"},{"NDCCode":"68400-705-15","ProprietaryName":"Sorbet Apf","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"71919-705-07","ProprietaryName":"Veratrum Album","NonProprietaryName":"Veratrum Album"},{"NDCCode":"83254-705-15","ProprietaryName":"Povidone Iodine","NonProprietaryName":"Povidone Iodine 7.5 Solution"},{"NDCCode":"84756-705-02","ProprietaryName":"Morocco Argan Oil Hair Treatment","NonProprietaryName":"Morocco Argan Oil Hair Treatment"},{"NDCCode":"10967-705-19","ProprietaryName":"Rv Illuminance Serum Tint Broad Spectrum 15","NonProprietaryName":"Face Foundation With Spf"},{"NDCCode":"13533-705-01","ProprietaryName":"Prolastin-c Liquid","NonProprietaryName":"Alpha1-proteinase Inhibitor (human)"},{"NDCCode":"13533-705-31","ProprietaryName":"Prolastin-c Liquid","NonProprietaryName":"Alpha1-proteinase Inhibitor (human)"},{"NDCCode":"13533-705-51","ProprietaryName":"Prolastin-c Liquid","NonProprietaryName":"Alpha1-proteinase Inhibitor (human)"},{"NDCCode":"13537-705-02","ProprietaryName":"Lbel Divine Lip Gloss Lip Gloss Spf 15 Fm Brillo Labial Fps 15 Fm","NonProprietaryName":"Octinoxate And Oxybenzone"},{"NDCCode":"13668-095-15","ProprietaryName":"Pramipexole Dihydrochloride","NonProprietaryName":"Pramipexole Dihydrochloride"},{"NDCCode":"16729-271-10","ProprietaryName":"Itraconazole","NonProprietaryName":"Itraconazole"},{"NDCCode":"17314-705-00","NonProprietaryName":"Cetirizine Hydrochloride"},{"NDCCode":"17478-705-10","ProprietaryName":"Betaxolol","NonProprietaryName":"Betaxolol Hydrochloride"},{"NDCCode":"17478-705-11","ProprietaryName":"Betaxolol","NonProprietaryName":"Betaxolol Hydrochloride"}]}
                    
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<NDCList>
  <NDC>
    <NDCCode>69646-705-15</NDCCode>
    <PackageDescription>48 g in 1 TUBE (69646-705-15) </PackageDescription>
    <NDC11Code>69646-0705-15</NDC11Code>
    <ProductNDC>69646-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alcortin A</ProprietaryName>
    <NonProprietaryName>Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150301</StartMarketingDate>
    <EndMarketingDate>20210831</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Novum Pharma, LLC</LabelerName>
    <SubstanceName>IODOQUINOL; HYDROCORTISONE ACETATE; ALOE VERA LEAF</SubstanceName>
    <StrengthNumber>10; 20; 10</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150301</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69646-705-02</NDCCode>
    <PackageDescription>2 g in 1 PACKET (69646-705-02) </PackageDescription>
    <NDC11Code>69646-0705-02</NDC11Code>
    <ProductNDC>69646-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alcortin A</ProprietaryName>
    <NonProprietaryName>Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150301</StartMarketingDate>
    <EndMarketingDate>20210831</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Novum Pharma, LLC</LabelerName>
    <SubstanceName>IODOQUINOL; HYDROCORTISONE ACETATE; ALOE VERA LEAF</SubstanceName>
    <StrengthNumber>10; 20; 10</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150301</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69646-705-03</NDCCode>
    <PackageDescription>2 g in 1 TUBE (69646-705-03) </PackageDescription>
    <NDC11Code>69646-0705-03</NDC11Code>
    <ProductNDC>69646-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alcortin A</ProprietaryName>
    <NonProprietaryName>Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150301</StartMarketingDate>
    <EndMarketingDate>20210831</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Novum Pharma, LLC</LabelerName>
    <SubstanceName>IODOQUINOL; HYDROCORTISONE ACETATE; ALOE VERA LEAF</SubstanceName>
    <StrengthNumber>10; 20; 10</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180316</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69646-705-08</NDCCode>
    <PackageDescription>10 PACKET in 1 CARTON (69646-705-08)  &gt; 2 g in 1 PACKET</PackageDescription>
    <NDC11Code>69646-0705-08</NDC11Code>
    <ProductNDC>69646-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alcortin A</ProprietaryName>
    <NonProprietaryName>Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150301</StartMarketingDate>
    <EndMarketingDate>20210831</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Novum Pharma, LLC</LabelerName>
    <SubstanceName>IODOQUINOL; HYDROCORTISONE ACETATE; ALOE VERA LEAF</SubstanceName>
    <StrengthNumber>10; 20; 10</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150301</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
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    <NDCCode>69646-705-11</NDCCode>
    <PackageDescription>10 TUBE in 1 CARTON (69646-705-11)  &gt; 2 g in 1 TUBE (69646-705-03) </PackageDescription>
    <NDC11Code>69646-0705-11</NDC11Code>
    <ProductNDC>69646-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alcortin A</ProprietaryName>
    <NonProprietaryName>Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150301</StartMarketingDate>
    <EndMarketingDate>20210831</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Novum Pharma, LLC</LabelerName>
    <SubstanceName>IODOQUINOL; HYDROCORTISONE ACETATE; ALOE VERA LEAF</SubstanceName>
    <StrengthNumber>10; 20; 10</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180316</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
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    <NDCCode>69646-705-13</NDCCode>
    <PackageDescription>24 PACKET in 1 CARTON (69646-705-13)  &gt; 2 g in 1 PACKET</PackageDescription>
    <NDC11Code>69646-0705-13</NDC11Code>
    <ProductNDC>69646-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alcortin A</ProprietaryName>
    <NonProprietaryName>Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150301</StartMarketingDate>
    <EndMarketingDate>20210831</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Novum Pharma, LLC</LabelerName>
    <SubstanceName>IODOQUINOL; HYDROCORTISONE ACETATE; ALOE VERA LEAF</SubstanceName>
    <StrengthNumber>10; 20; 10</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150301</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>17478-705-12</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (17478-705-12)  &gt; 15 mL in 1 VIAL</PackageDescription>
    <NDC11Code>17478-0705-12</NDC11Code>
    <ProductNDC>17478-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Betaxolol</ProprietaryName>
    <NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20030401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075386</ApplicationNumber>
    <LabelerName>Akorn</LabelerName>
    <SubstanceName>BETAXOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>21749-705-50</NDCCode>
    <PackageDescription>15 mL in 1 PACKAGE (21749-705-50) </PackageDescription>
    <NDC11Code>21749-0705-50</NDC11Code>
    <ProductNDC>21749-705</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Purell Advanced Refreshing Aloe</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120314</StartMarketingDate>
    <EndMarketingDate>20220101</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>GOJO Industries, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120314</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220101</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>25010-705-15</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (25010-705-15) </PackageDescription>
    <NDC11Code>25010-0705-15</NDC11Code>
    <ProductNDC>25010-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cuprimine</ProprietaryName>
    <NonProprietaryName>Penicillamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19701204</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019853</ApplicationNumber>
    <LabelerName>Bausch Health US, LLC</LabelerName>
    <SubstanceName>PENICILLAMINE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antirheumatic Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19701204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CUPRIMINE is indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that CUPRIMINE is not of value in ankylosing spondylitis.</IndicationAndUsage>
    <Description>Penicillamine, USP is a chelating agent used in the treatment of Wilson’s disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy (see INDICATIONS). It is 3-mercapto-D-valine. It is a white, or practically white, crystalline powder, freely soluble in water, slightly soluble in alcohol, and insoluble in ether, acetone, benzene, and carbon tetrachloride. Although its configuration is D, it is levorotatory as usually measured. calculated on a dried basis. The empirical formula is C5H11NO2S, giving it a molecular weight of 149.21. The structural formula is. It reacts readily with formaldehyde or acetone to form a thiazolidine-carboxylic acid. CUPRIMINE (penicillamine) Capsules, USP for oral administration contain 250 mg of penicillamine. Each capsule contains the following inactive ingredients: D&amp;C Yellow No. 10, gelatin, lactose monohydrate, magnesium stearate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>43419-705-21</NDCCode>
    <PackageDescription>2 CONTAINER in 1 CARTON (43419-705-21)  &gt; 15 g in 1 CONTAINER</PackageDescription>
    <NDC11Code>43419-0705-21</NDC11Code>
    <ProductNDC>43419-705</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Laneige Bb Cushion Medium</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141030</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>AMOREPACIFIC</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>1.05; .6225; 1.47</StrengthNumber>
    <StrengthUnit>g/15g; g/15g; g/15g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-08-13</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>50268-705-15</NDCCode>
    <PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-705-15)  &gt; 1 TABLET in 1 BLISTER PACK (50268-705-11)</PackageDescription>
    <NDC11Code>50268-0705-15</NDC11Code>
    <ProductNDC>50268-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Salsalate</ProprietaryName>
    <NonProprietaryName>Salsalate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141118</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>AvPAK</LabelerName>
    <SubstanceName>SALSALATE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-05-09</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>52959-705-01</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (52959-705-01)  &gt; 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>52959-0705-01</NDC11Code>
    <ProductNDC>52959-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Proparacaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Proparacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19950929</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040074</ApplicationNumber>
    <LabelerName>H.J. Harkins Company, Inc.</LabelerName>
    <SubstanceName>PROPARACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Local Anesthesia [PE],Local Anesthetic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Proparacaine hydrochloride ophthalmic solution is indicated for topical anesthesia in ophthalmic practice. Representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction.</IndicationAndUsage>
    <Description>Proparacaine Hydrochloride Ophthalmic Solution USP, 0.5% is a topical anesthetic prepared as a sterile aqueous ophthalmic solution. The active ingredient is represented by the following structural formula. C16H26N2O3  HCI. Mol. wt.: 330.85. Chemical name: Benzoic acid, 3-amino-4-propoxy-,2-(diethylamino) ethyl ester, monohydrochloride. Each mL Contains. ACTIVE: Proparacaine Hydrochloride 5 mg (0.5%); INACTIVES: Glycerin, Hydrochloric Acid, Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (3.5 – 6.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.</Description>
  </NDC>
  <NDC>
    <NDCCode>53462-007-27</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (53462-007-27)  *  1 BOTTLE in 1 KIT &gt; 4 mL in 1 BOTTLE *  15 mL in 1 BOTTLE (53462-003-15)  *  6 CLOTH in 1 PACKAGE (53462-705-23) </PackageDescription>
    <NDC11Code>53462-0007-27</NDC11Code>
    <ProductNDC>53462-007</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Skin Antisepsis, Oral Cleansing, Nasal Antisepsis</ProprietaryName>
    <NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20120206</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021669</ApplicationNumber>
    <LabelerName>Sage Products LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Chlorhexidine Gluconate is an oral rinse containing 0.12% chlorhexidine gluconate (1,11-hexamethylene bis[5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&amp;C Blue No. 1. Chlorhexidine Gluconate is a near-neutral solution (pH range 5-7). Chlorhexidine Gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>58602-705-15</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (58602-705-15)  / 60 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>58602-0705-15</NDC11Code>
    <ProductNDC>58602-705</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160426</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206531</ApplicationNumber>
    <LabelerName>Aurohealth LLC</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160426</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62135-705-51</NDCCode>
    <PackageDescription>15 mL in 1 BOTTLE (62135-705-51) </PackageDescription>
    <NDC11Code>62135-0705-51</NDC11Code>
    <ProductNDC>62135-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azithromycin</ProprietaryName>
    <NonProprietaryName>Azithromycin</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065488</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC</LabelerName>
    <SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
    <Description>Azithromycin for Oral Suspension, USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12·H 2O and a molecular weight of 785.0. Azithromycin for Oral Suspension, USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; tribasic sodium phosphate anhydrous; hydroxypropyl cellulose; xanthan gum; colloidal silicon dioxide, FD&amp;C Red #40; and artificial cherry flavor. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-705-75</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (67457-705-75)  / 15 mL in 1 VIAL, SINGLE-DOSE (67457-705-00) </PackageDescription>
    <NDC11Code>67457-0705-75</NDC11Code>
    <ProductNDC>67457-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180831</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209481</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/15mL</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180831</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates and older) for the treatment of: : 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3) , 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).</IndicationAndUsage>
    <Description>Vancomycin Hydrochloride for Injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2, 5, 24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l, 6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24  HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula:. Vancomycin Hydrochloride for Injection, USP is a sterile off-white to light tan colored lyophilized plug or powder for injection. Vancomycin Hydrochloride for Injection, USP is supplied in single-dose vials, containing 256 mg, 769 mg, 1.28 g, 1.54 g, 1.79 g or 2.05 g of vancomycin hydrochloride, USP equivalent to 250 mg, 750 mg, 1.25 g, 1.5 g, 1.75 g or 2 g of vancomycin base. The lyophilized powder is reconstituted with Sterile Water for Injection, USP which forms a clear, colorless or light to dark tan solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)].</Description>
  </NDC>
  <NDC>
    <NDCCode>68400-705-15</NDCCode>
    <PackageDescription>454 g in 1 BOTTLE, PLASTIC (68400-705-15) </PackageDescription>
    <NDC11Code>68400-0705-15</NDC11Code>
    <ProductNDC>68400-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sorbet Apf</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20121214</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>5.6</StrengthNumber>
    <StrengthUnit>g/454g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71919-705-07</NDCCode>
    <PackageDescription>15 mL in 1 VIAL, GLASS (71919-705-07) </PackageDescription>
    <NDC11Code>71919-0705-07</NDC11Code>
    <ProductNDC>71919-705</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Veratrum Album</ProprietaryName>
    <NonProprietaryName>Veratrum Album</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110517</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>VERATRUM ALBUM ROOT</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>83254-705-15</NDCCode>
    <PackageDescription>150 mL in 1 BOTTLE (83254-705-15) </PackageDescription>
    <NDC11Code>83254-0705-15</NDC11Code>
    <ProductNDC>83254-705</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Povidone Iodine</ProprietaryName>
    <NonProprietaryName>Povidone Iodine 7.5 Solution</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230504</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>1201258 Ontario Inc. O/A Nanz Pharma</LabelerName>
    <SubstanceName>POVIDONE-IODINE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230504</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the treatment of athlete's foot, jock itch, and ringworm. For the effective relief of burning, cracking, discomfort, redness, scaling, soreness, and chafing that is associated with jock itch.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84756-705-02</NDCCode>
    <PackageDescription>15 mL in 1 BOTTLE (84756-705-02) </PackageDescription>
    <NDC11Code>84756-0705-02</NDC11Code>
    <ProductNDC>84756-705</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Morocco Argan Oil Hair Treatment</ProprietaryName>
    <NonProprietaryName>Morocco Argan Oil Hair Treatment</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241210</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10967-705-19</NDCCode>
    <PackageDescription>28 mL in 1 BOTTLE, GLASS (10967-705-19) </PackageDescription>
    <NDC11Code>10967-0705-19</NDC11Code>
    <ProductNDC>10967-705</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rv Illuminance Serum Tint Broad Spectrum 15</ProprietaryName>
    <ProprietaryNameSuffix>Tan Sand</ProprietaryNameSuffix>
    <NonProprietaryName>Face Foundation With Spf</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240326</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>REVLON CONSUMER PR Consumer Products Corp</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE</SubstanceName>
    <StrengthNumber>.868; .28; 1.54</StrengthNumber>
    <StrengthUnit>g/28mL; g/28mL; g/28mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. : 1 Helps prevent sunburn., 2 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13533-705-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (13533-705-01)  &gt; 20 mL in 1 VIAL (13533-705-11) </PackageDescription>
    <NDC11Code>13533-0705-01</NDC11Code>
    <ProductNDC>13533-705</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Prolastin-c Liquid</ProprietaryName>
    <NonProprietaryName>Alpha1-proteinase Inhibitor (human)</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19871202</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103174</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <SubstanceName>.ALPHA.1-PROTEINASE INHIBITOR HUMAN</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Human alpha-1 Proteinase Inhibitor [EPC], Trypsin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19871202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PROLASTIN®-C LIQUID is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). Limitations of Use: 1 The effect of augmentation therapy with any Alpha1-PI, including PROLASTIN-C LIQUID, on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.   , 2 Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C LIQUID are not available., 3 PROLASTIN-C LIQUID is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.</IndicationAndUsage>
    <Description>PROLASTIN-C LIQUID is a sterile, concentrate of Alpha1-PI for intravenous infusion. The solution is clear, colorless or pale yellow or pale green. The actual amount of functionally active Alpha1-PI in milligrams, as determined by capacity to neutralize porcine pancreatic elastase, is printed on the carton and vial label of PROLASTIN-C LIQUID.  The specific activity of PROLASTIN-C LIQUID is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. PROLASTIN-C LIQUID has a purity of ≥ 90% Alpha1-PI (Alpha1-PI protein/total protein). PROLASTIN-C LIQUID has a pH of 6.6–7.4, a sodium phosphate content of 0.013–0.025 M, and is stabilized with 0.20-0.30 M of alanine. The total sodium concentration is ≤ 100 mEq/L. PROLASTIN-C LIQUID contains no preservative. PROLASTIN-C LIQUID is produced from pooled human plasma through modifications of the PROLASTIN process using purification by polyethylene glycol (PEG) precipitation, anion exchange chromatography, and cation exchange chromatography. All Source Plasma used in the manufacture of PROLASTIN-C LIQUID is non-reactive (negative) by FDA-licensed serological test methods for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 and negative by FDA-licensed Nucleic Acid Technologies (NAT) for HCV and human immunodeficiency virus type 1 (HIV-1). In addition, all Source Plasma is negative for hepatitis B virus (HBV) by either an FDA-licensed or investigational NAT assay. The goal of the investigational HBV NAT test is to detect low levels of viral nucleic acid; however, the significance of a negative result for the investigational HBV NAT test has not been established. By in-process NAT, all Source Plasma is negative for hepatitis A virus (HAV). As a final plasma safety step, all plasma manufacturing pools are tested by serological test methods and NAT. To evaluate further the virus safety profile of PROLASTIN-C LIQUID, in vitro studies have been conducted to validate the capacity of the manufacturing process to reduce the infectious titer of a wide range of viruses with diverse physicochemical properties. These studies evaluated the inactivation/removal of clinically relevant viruses, including human immunodeficiency virus type 1 (HIV-1) and hepatitis A virus (HAV), as well as the following model viruses: bovine viral diarrhea virus (BVDV), a surrogate for hepatitis C virus; pseudorabies virus (PRV), a surrogate for large enveloped DNA viruses (e.g., herpes viruses); vesicular stomatitis virus (VSV), a model for enveloped viruses; reovirus type 3 (Reo3), a non-specific model for non-enveloped viruses; and porcine parvovirus (PPV), a model for human parvovirus B19. The PROLASTIN-C LIQUID manufacturing process has several steps (Cold Ethanol Fractionation, PEG Precipitation, and Depth Filtration) that are important for purifying Alpha1-PI as well as removing potential virus contaminants. Two additional steps, Solvent/Detergent Treatment and 15 nm Virus Removal Nanofiltration, are included in the process as dedicated pathogen reduction steps. The Solvent/Detergent Treatment step effectively inactivates enveloped viruses (such as HIV-1, VSV, HBV, and HCV). The 15 nm Virus Removal Nanofiltration step has been implemented to reduce the risk of transmission of enveloped and non-enveloped viruses as small as 18 nm. Table 6 presents the virus reduction capacity of each process step and the accumulated virus reduction for the process as determined in viral validation studies in which virus was deliberately added to a process model in order to study virus reduction. In addition, the Solvent/Detergent Treatment step inactivates ≥ 5.4 log10 of West Nile virus, a clinically relevant enveloped virus. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. Studies of the PROLASTIN-C LIQUID manufacturing process demonstrate that a minimum of 6 log10 reduction of TSE infectivity is achieved. These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>13533-705-31</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (13533-705-31)  &gt; 10 mL in 1 VIAL (13533-705-32) </PackageDescription>
    <NDC11Code>13533-0705-31</NDC11Code>
    <ProductNDC>13533-705</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Prolastin-c Liquid</ProprietaryName>
    <NonProprietaryName>Alpha1-proteinase Inhibitor (human)</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19871202</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103174</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <SubstanceName>.ALPHA.1-PROTEINASE INHIBITOR HUMAN</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Human alpha-1 Proteinase Inhibitor [EPC], Trypsin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19871202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PROLASTIN®-C LIQUID is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). Limitations of Use: 1 The effect of augmentation therapy with any Alpha1-PI, including PROLASTIN-C LIQUID, on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.   , 2 Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C LIQUID are not available., 3 PROLASTIN-C LIQUID is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.</IndicationAndUsage>
    <Description>PROLASTIN-C LIQUID is a sterile, concentrate of Alpha1-PI for intravenous infusion. The solution is clear, colorless or pale yellow or pale green. The actual amount of functionally active Alpha1-PI in milligrams, as determined by capacity to neutralize porcine pancreatic elastase, is printed on the carton and vial label of PROLASTIN-C LIQUID.  The specific activity of PROLASTIN-C LIQUID is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. PROLASTIN-C LIQUID has a purity of ≥ 90% Alpha1-PI (Alpha1-PI protein/total protein). PROLASTIN-C LIQUID has a pH of 6.6–7.4, a sodium phosphate content of 0.013–0.025 M, and is stabilized with 0.20-0.30 M of alanine. The total sodium concentration is ≤ 100 mEq/L. PROLASTIN-C LIQUID contains no preservative. PROLASTIN-C LIQUID is produced from pooled human plasma through modifications of the PROLASTIN process using purification by polyethylene glycol (PEG) precipitation, anion exchange chromatography, and cation exchange chromatography. All Source Plasma used in the manufacture of PROLASTIN-C LIQUID is non-reactive (negative) by FDA-licensed serological test methods for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 and negative by FDA-licensed Nucleic Acid Technologies (NAT) for HCV and human immunodeficiency virus type 1 (HIV-1). In addition, all Source Plasma is negative for hepatitis B virus (HBV) by either an FDA-licensed or investigational NAT assay. The goal of the investigational HBV NAT test is to detect low levels of viral nucleic acid; however, the significance of a negative result for the investigational HBV NAT test has not been established. By in-process NAT, all Source Plasma is negative for hepatitis A virus (HAV). As a final plasma safety step, all plasma manufacturing pools are tested by serological test methods and NAT. To evaluate further the virus safety profile of PROLASTIN-C LIQUID, in vitro studies have been conducted to validate the capacity of the manufacturing process to reduce the infectious titer of a wide range of viruses with diverse physicochemical properties. These studies evaluated the inactivation/removal of clinically relevant viruses, including human immunodeficiency virus type 1 (HIV-1) and hepatitis A virus (HAV), as well as the following model viruses: bovine viral diarrhea virus (BVDV), a surrogate for hepatitis C virus; pseudorabies virus (PRV), a surrogate for large enveloped DNA viruses (e.g., herpes viruses); vesicular stomatitis virus (VSV), a model for enveloped viruses; reovirus type 3 (Reo3), a non-specific model for non-enveloped viruses; and porcine parvovirus (PPV), a model for human parvovirus B19. The PROLASTIN-C LIQUID manufacturing process has several steps (Cold Ethanol Fractionation, PEG Precipitation, and Depth Filtration) that are important for purifying Alpha1-PI as well as removing potential virus contaminants. Two additional steps, Solvent/Detergent Treatment and 15 nm Virus Removal Nanofiltration, are included in the process as dedicated pathogen reduction steps. The Solvent/Detergent Treatment step effectively inactivates enveloped viruses (such as HIV-1, VSV, HBV, and HCV). The 15 nm Virus Removal Nanofiltration step has been implemented to reduce the risk of transmission of enveloped and non-enveloped viruses as small as 18 nm. Table 6 presents the virus reduction capacity of each process step and the accumulated virus reduction for the process as determined in viral validation studies in which virus was deliberately added to a process model in order to study virus reduction. In addition, the Solvent/Detergent Treatment step inactivates ≥ 5.4 log10 of West Nile virus, a clinically relevant enveloped virus. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. Studies of the PROLASTIN-C LIQUID manufacturing process demonstrate that a minimum of 6 log10 reduction of TSE infectivity is achieved. These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>13533-705-51</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (13533-705-51)  &gt; 80 mL in 1 VIAL (13533-705-52) </PackageDescription>
    <NDC11Code>13533-0705-51</NDC11Code>
    <ProductNDC>13533-705</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Prolastin-c Liquid</ProprietaryName>
    <NonProprietaryName>Alpha1-proteinase Inhibitor (human)</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19871202</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103174</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <SubstanceName>.ALPHA.1-PROTEINASE INHIBITOR HUMAN</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Human alpha-1 Proteinase Inhibitor [EPC], Trypsin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19871202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PROLASTIN®-C LIQUID is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). Limitations of Use: 1 The effect of augmentation therapy with any Alpha1-PI, including PROLASTIN-C LIQUID, on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.   , 2 Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C LIQUID are not available., 3 PROLASTIN-C LIQUID is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.</IndicationAndUsage>
    <Description>PROLASTIN-C LIQUID is a sterile, concentrate of Alpha1-PI for intravenous infusion. The solution is clear, colorless or pale yellow or pale green. The actual amount of functionally active Alpha1-PI in milligrams, as determined by capacity to neutralize porcine pancreatic elastase, is printed on the carton and vial label of PROLASTIN-C LIQUID.  The specific activity of PROLASTIN-C LIQUID is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. PROLASTIN-C LIQUID has a purity of ≥ 90% Alpha1-PI (Alpha1-PI protein/total protein). PROLASTIN-C LIQUID has a pH of 6.6–7.4, a sodium phosphate content of 0.013–0.025 M, and is stabilized with 0.20-0.30 M of alanine. The total sodium concentration is ≤ 100 mEq/L. PROLASTIN-C LIQUID contains no preservative. PROLASTIN-C LIQUID is produced from pooled human plasma through modifications of the PROLASTIN process using purification by polyethylene glycol (PEG) precipitation, anion exchange chromatography, and cation exchange chromatography. All Source Plasma used in the manufacture of PROLASTIN-C LIQUID is non-reactive (negative) by FDA-licensed serological test methods for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 and negative by FDA-licensed Nucleic Acid Technologies (NAT) for HCV and human immunodeficiency virus type 1 (HIV-1). In addition, all Source Plasma is negative for hepatitis B virus (HBV) by either an FDA-licensed or investigational NAT assay. The goal of the investigational HBV NAT test is to detect low levels of viral nucleic acid; however, the significance of a negative result for the investigational HBV NAT test has not been established. By in-process NAT, all Source Plasma is negative for hepatitis A virus (HAV). As a final plasma safety step, all plasma manufacturing pools are tested by serological test methods and NAT. To evaluate further the virus safety profile of PROLASTIN-C LIQUID, in vitro studies have been conducted to validate the capacity of the manufacturing process to reduce the infectious titer of a wide range of viruses with diverse physicochemical properties. These studies evaluated the inactivation/removal of clinically relevant viruses, including human immunodeficiency virus type 1 (HIV-1) and hepatitis A virus (HAV), as well as the following model viruses: bovine viral diarrhea virus (BVDV), a surrogate for hepatitis C virus; pseudorabies virus (PRV), a surrogate for large enveloped DNA viruses (e.g., herpes viruses); vesicular stomatitis virus (VSV), a model for enveloped viruses; reovirus type 3 (Reo3), a non-specific model for non-enveloped viruses; and porcine parvovirus (PPV), a model for human parvovirus B19. The PROLASTIN-C LIQUID manufacturing process has several steps (Cold Ethanol Fractionation, PEG Precipitation, and Depth Filtration) that are important for purifying Alpha1-PI as well as removing potential virus contaminants. Two additional steps, Solvent/Detergent Treatment and 15 nm Virus Removal Nanofiltration, are included in the process as dedicated pathogen reduction steps. The Solvent/Detergent Treatment step effectively inactivates enveloped viruses (such as HIV-1, VSV, HBV, and HCV). The 15 nm Virus Removal Nanofiltration step has been implemented to reduce the risk of transmission of enveloped and non-enveloped viruses as small as 18 nm. Table 6 presents the virus reduction capacity of each process step and the accumulated virus reduction for the process as determined in viral validation studies in which virus was deliberately added to a process model in order to study virus reduction. In addition, the Solvent/Detergent Treatment step inactivates ≥ 5.4 log10 of West Nile virus, a clinically relevant enveloped virus. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. Studies of the PROLASTIN-C LIQUID manufacturing process demonstrate that a minimum of 6 log10 reduction of TSE infectivity is achieved. These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>13537-705-02</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (13537-705-02)  &gt; 12 mL in 1 TUBE (13537-705-01)</PackageDescription>
    <NDC11Code>13537-0705-02</NDC11Code>
    <ProductNDC>13537-705</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Divine Lip Gloss Lip Gloss Spf 15 Fm Brillo Labial Fps 15 Fm</ProprietaryName>
    <ProprietaryNameSuffix>Sweet Framboise - Pink</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20151222</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.075; .03</StrengthNumber>
    <StrengthUnit>g/mL; g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13668-095-15</NDCCode>
    <PackageDescription>1500 TABLET in 1 BOTTLE (13668-095-15) </PackageDescription>
    <NDC11Code>13668-0095-15</NDC11Code>
    <ProductNDC>13668-095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101008</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090865</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101008</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: 1   Parkinson's disease (PD) (1.1), 2   Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is ( S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S·2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of colloidal silicon dioxide, corn starch, ferric oxide red (0.25, 0.5 and 1 mg tablets), ferric oxide yellow (0.25 and 0.75 mg tablets), magnesium stearate, mannitol, povidone K-30 and pregelatinized maize starch. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.118 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.235 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.47 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.705 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.94 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 1.41 mg pramipexole dihydrochloride (in anhydrous basis).</Description>
  </NDC>
  <NDC>
    <NDCCode>16729-271-10</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (16729-271-10) </PackageDescription>
    <NDC11Code>16729-0271-10</NDC11Code>
    <ProductNDC>16729-271</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Itraconazole</ProprietaryName>
    <NonProprietaryName>Itraconazole</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170530</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205991</ApplicationNumber>
    <LabelerName>Accord Healthcare Inc.</LabelerName>
    <SubstanceName>ITRACONAZOLE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170530</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: : 1 Blastomycosis, pulmonary and extrapulmonary , 2 Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and , 3 Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. .</IndicationAndUsage>
    <Description>Itraconazole is an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. (±)-1-[( R*)- sec-butyl]-4-[ p-[4-[ p-[[(2 R*,4 S*)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one mixture with (±)-1-[( R*)- sec-butyl]-4-[ p-[4-[ p-[[(2 S*,4 R*)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one. or. (±)-1-[( RS)- sec-butyl]-4-[ p-[4-[ p-[[(2 R,4 S)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one. Itraconazole has a molecular formula of C 35H 38Cl 2N 8O 4 and a molecular weight of 705.64. It is a white to slightly yellowish powder. It is insoluble in water, very slightly soluble in alcohols, and freely soluble in dichloromethane. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules contain 100 mg of itraconazole coated on sugar spheres. Inactive ingredients are hard gelatin capsule, hypromellose, polyglykol (PEG 20,000), purified talc, and sugar spheres (maize starch and sucrose). Components of the gelatin capsule include FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, gelatin, D&amp;C Red No. 28, and titanium dioxide. The printing ink contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>17314-705-00</NDCCode>
    <PackageDescription>571500 TABLET, FILM COATED in 1 DRUM (17314-705-00) </PackageDescription>
    <NDC11Code>17314-0705-00</NDC11Code>
    <ProductNDC>17314-705</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20081001</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Janssen Ortho LLC</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-07-15</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-OCT-08</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>17478-705-10</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (17478-705-10)  &gt; 5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>17478-0705-10</NDC11Code>
    <ProductNDC>17478-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Betaxolol</ProprietaryName>
    <NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20030401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075386</ApplicationNumber>
    <LabelerName>Akorn</LabelerName>
    <SubstanceName>BETAXOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Betaxolol Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs. In clinical studies, betaxolol ophthalmic solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. However, caution should be used in treating patients with severe reactive airway disease or a history of asthma.</IndicationAndUsage>
    <Description>Betaxolol Ophthalmic Solution USP, contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor blocking agent, in a sterile isotonic solution. Betaxolol hydrochloride is a white, crystalline powder, soluble in water, with a molecular weight of 343.90. The structural formula is presented below:. Molecular Formula: C18H29NO3HCl. Chemical Name: (±)-1[p-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride. Each mL of Betaxolol Ophthalmic Solution for ophthalmic administration contains: Active: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg; Inactives: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH and Water for Injection; Preservative: Benzalkonium Chloride 0.01%.</Description>
  </NDC>
  <NDC>
    <NDCCode>17478-705-11</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (17478-705-11)  &gt; 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>17478-0705-11</NDC11Code>
    <ProductNDC>17478-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Betaxolol</ProprietaryName>
    <NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20030401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075386</ApplicationNumber>
    <LabelerName>Akorn</LabelerName>
    <SubstanceName>BETAXOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Betaxolol Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs. In clinical studies, betaxolol ophthalmic solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. However, caution should be used in treating patients with severe reactive airway disease or a history of asthma.</IndicationAndUsage>
    <Description>Betaxolol Ophthalmic Solution USP, contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor blocking agent, in a sterile isotonic solution. Betaxolol hydrochloride is a white, crystalline powder, soluble in water, with a molecular weight of 343.90. The structural formula is presented below:. Molecular Formula: C18H29NO3HCl. Chemical Name: (±)-1[p-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride. Each mL of Betaxolol Ophthalmic Solution for ophthalmic administration contains: Active: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg; Inactives: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH and Water for Injection; Preservative: Benzalkonium Chloride 0.01%.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>69646-705-15</NDCCode><ProprietaryName>Alcortin A</ProprietaryName><NonProprietaryName>Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf</NonProprietaryName></NDC><NDC><NDCCode>69646-705-02</NDCCode><ProprietaryName>Alcortin A</ProprietaryName><NonProprietaryName>Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf</NonProprietaryName></NDC><NDC><NDCCode>69646-705-03</NDCCode><ProprietaryName>Alcortin A</ProprietaryName><NonProprietaryName>Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf</NonProprietaryName></NDC><NDC><NDCCode>69646-705-08</NDCCode><ProprietaryName>Alcortin A</ProprietaryName><NonProprietaryName>Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf</NonProprietaryName></NDC><NDC><NDCCode>69646-705-11</NDCCode><ProprietaryName>Alcortin A</ProprietaryName><NonProprietaryName>Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf</NonProprietaryName></NDC><NDC><NDCCode>69646-705-13</NDCCode><ProprietaryName>Alcortin A</ProprietaryName><NonProprietaryName>Iodoquinol, Hydrocortisone Acetate And Aloe Vera Leaf</NonProprietaryName></NDC><NDC><NDCCode>17478-705-12</NDCCode><ProprietaryName>Betaxolol</ProprietaryName><NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>21749-705-50</NDCCode><ProprietaryName>Purell Advanced Refreshing Aloe</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>25010-705-15</NDCCode><ProprietaryName>Cuprimine</ProprietaryName><NonProprietaryName>Penicillamine</NonProprietaryName></NDC><NDC><NDCCode>43419-705-21</NDCCode><ProprietaryName>Laneige Bb Cushion Medium</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>50268-705-15</NDCCode><ProprietaryName>Salsalate</ProprietaryName><NonProprietaryName>Salsalate</NonProprietaryName></NDC><NDC><NDCCode>52959-705-01</NDCCode><ProprietaryName>Proparacaine Hydrochloride</ProprietaryName><NonProprietaryName>Proparacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>53462-007-27</NDCCode><ProprietaryName>Skin Antisepsis, Oral Cleansing, Nasal Antisepsis</ProprietaryName><NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName></NDC><NDC><NDCCode>58602-705-15</NDCCode><ProprietaryName>Famotidine</ProprietaryName><NonProprietaryName>Famotidine</NonProprietaryName></NDC><NDC><NDCCode>62135-705-51</NDCCode><ProprietaryName>Azithromycin</ProprietaryName><NonProprietaryName>Azithromycin</NonProprietaryName></NDC><NDC><NDCCode>67457-705-75</NDCCode><ProprietaryName>Vancomycin Hydrochloride</ProprietaryName><NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>68400-705-15</NDCCode><ProprietaryName>Sorbet Apf</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>71919-705-07</NDCCode><ProprietaryName>Veratrum Album</ProprietaryName><NonProprietaryName>Veratrum Album</NonProprietaryName></NDC><NDC><NDCCode>83254-705-15</NDCCode><ProprietaryName>Povidone Iodine</ProprietaryName><NonProprietaryName>Povidone Iodine 7.5 Solution</NonProprietaryName></NDC><NDC><NDCCode>84756-705-02</NDCCode><ProprietaryName>Morocco Argan Oil Hair Treatment</ProprietaryName><NonProprietaryName>Morocco Argan Oil Hair Treatment</NonProprietaryName></NDC><NDC><NDCCode>10967-705-19</NDCCode><ProprietaryName>Rv Illuminance Serum Tint Broad Spectrum 15</ProprietaryName><NonProprietaryName>Face Foundation With Spf</NonProprietaryName></NDC><NDC><NDCCode>13533-705-01</NDCCode><ProprietaryName>Prolastin-c Liquid</ProprietaryName><NonProprietaryName>Alpha1-proteinase Inhibitor (human)</NonProprietaryName></NDC><NDC><NDCCode>13533-705-31</NDCCode><ProprietaryName>Prolastin-c Liquid</ProprietaryName><NonProprietaryName>Alpha1-proteinase Inhibitor (human)</NonProprietaryName></NDC><NDC><NDCCode>13533-705-51</NDCCode><ProprietaryName>Prolastin-c Liquid</ProprietaryName><NonProprietaryName>Alpha1-proteinase Inhibitor (human)</NonProprietaryName></NDC><NDC><NDCCode>13537-705-02</NDCCode><ProprietaryName>Lbel Divine Lip Gloss Lip Gloss Spf 15 Fm Brillo Labial Fps 15 Fm</ProprietaryName><NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>13668-095-15</NDCCode><ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName><NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16729-271-10</NDCCode><ProprietaryName>Itraconazole</ProprietaryName><NonProprietaryName>Itraconazole</NonProprietaryName></NDC><NDC><NDCCode>17314-705-00</NDCCode><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>17478-705-10</NDCCode><ProprietaryName>Betaxolol</ProprietaryName><NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>17478-705-11</NDCCode><ProprietaryName>Betaxolol</ProprietaryName><NonProprietaryName>Betaxolol Hydrochloride</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.

Parameter Meaning Notes
domain Domain
  • Currently following data domains are supported:
    • NPI - NPI Number Lookup
    • HCPCS - Healthcare Provider Procedure Coding System Lookup
    • NDC - National Drug Code Lookup
    • NDCA - Animal Drug Product Listing Directory Lookup
    • CLIA - Clinical Laboratory Improvement Amendments
    • HPTC - Healthcare Provider Taxonomy Code Lookup
    • NAICS - North American Industry Classification System Lookup
    • LOINC - Logical Observation Identifiers Names and Codes (LOINC®) Lookup
    • DRG - Diagnosis-Related Group Lookup
    • ICD9 - Ninth Revision of the International Classification of Diseases Lookup
    • ICD10 - Tenth Revision of the International Classification of Diseases Lookup
    • ICD10DRUGS - ICD-10-CM Table Of Drugs And Chemicals Lookup
    • ZIP - Postal Codes used by the United States Postal Service
operation Operation
  • Generic operations:
    • check_status - this method allows to get current code status.
    • search - allows retrieval of set of items (up to 30) 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.
    • 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.
  • 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.
q Query
  • The search expression. May vary depending on the operation.
    • Free form text like: “q=blood glucose monitor” (search operation)
    • Exact code value : “q=1285636522” (getcode operation)
    • List of codes : “q=1285636522,1730198755,1427145176,1487730636” (getcodes operation)
zipcode Query for NPI by Zip code/radius Lookup
  • The search expression for zip code.
    • Exact code value : “zipcode=98052” (search operation)
radius Query for NPI by Zip code/radius Lookup
  • The search expression for radius.
    • Exact code value : “radius=20” (search operation)
fromdate Query for Deactivated NPI
  • The search expression for fromdate.
    • Exact code value : “fromdate=05/01/2023” (search operation - format MM/DD/YYYY)
todate Query for Deactivated NPI
  • The search expression for tomdate.
    • Exact code value : “todate=05/31/2023” (search operation - format MM/DD/YYYY)
tin Query for IRS Lookup
  • The search expression for tin number.
    • Exact code value : “tin=942404110” (search operation)
tinname Query for IRS Lookup
  • The search expression for tin name.
    • Free form text like: “tinname=apple inc.” (search operation)
rt Data format
  • If you don't specify an rt parameter, the API returns data in the JSON format. This is equivalent to rt=json.
  • Accepted values are:
    • json
    • minjson (minified json)
    • xml
    • minxml (minified xml)
token Your API key
num Number of search results to return
  • You can specify the how many results to return for the current search.
  • Valid values are integers between 1 and 100, inclusive.
  • If num is not used, a value of 30 is assumed.
friendlyprint Returns a response with indentations and line breaks
  • If friendlyprint is not used, a “true” value is assumed. This is equivalent to friendlyprint=true.
  • Accepted values are:
    • true - the results returned by the server will be more “human readable”.
    • false - the results returned by the server will not have indentations and line breaks.
ICD9/ICD10 Parameters
codeType Specifies whether ICD code is "dx"(Diagnosis) or "pcs"(Procedure).
  • Required for ICD only.
  • If you don't specify an codeType parameter this is equivalent to codeType=dx.
  • Accepted values are:
    • dx (diagnosis)
    • pcs (procedure)
qf Specifies predicate in form of tuple "qf=City:true:Phoenix".
  • Expected to be one or many "qf" parameters in request.
  • Required for following operations:
    • validate
    • paginate_with_predicates
    • search_with_predicates
  • Tuple values are (order based):
    • NPI Field Name
      • NPI
      • Phone
      • Fax
      • FirstName
      • LastName
      • OrganizationName
      • OtherOrganizationName
      • Address1
      • Address2
      • Zip
      • City
      • State
      • IndividualOrganizationCode
    • Exact Match
      • true
      • false
    • Expected Field Value
orderField Sort order field name
  • Expected to be one "orderField" parameter in request.
  • Required for following operations:
    • paginate_with_predicates
  • Values are:
    • NPI
    • Phone
    • Fax
    • FirstName
    • LastName
    • OrganizationName
    • OtherOrganizationName
    • Address1
    • Address2
    • Zip
    • City
    • State
    • IndividualOrganizationCode
pageNo Page Number
  • Ordinal page number.
  • Required for following operations:
    • paginate_with_predicates
    • zipradius
    • npideactivated
pageSize Page Size
  • Expected page size.
  • Required for following operations:
    • paginate_with_predicates

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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();
    }
}
            
        

Output

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

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

Everybody uses full text search. Full-text search is the most common technique used in search engines. The amount of information has just become too much to access it using navigation and categories alone. Full-text search reduces the hassle of searching for a keyword in huge amounts of metadata, such as the World Wide Web and commercial-scale databases. Full-text search became popular in late 1990s, when the Internet and Big Data began to became a part of everyday life.

How does it work

Users only provide keywords and expect the search engine to provide good results. Relevancy of documents is expected to be good and users want the results they are looking to be present in the top ten. How relevant a document is search engine decides based on scientifically proven algorithms. Besides getting the best results the user wants to be supported during the search process. Features like suggestions and highlighting on the result excerpt can help with this.

Full Text Search & DataLabs REST API

DataLabs REST API allows you to search the full text of healthcare providers database (NPI Registry). To find the information you need and make your search easy, please use our REST API for automation, or visit our NPI Lookup page for manual search ( NPI Number Lookup). We are still improving and enhancing Full Text NPI Search based on users feedbacks. Please email your comments and suggestions for improvement using our feedback page.

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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
{
  "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",
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}
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