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How to Find 59469-058-20 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "59469-058-20",
      "PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-058-20)  > 50 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "59469-0058-20",
      "ProductNDC": "59469-058",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Helmin",
      "NonProprietaryName": "Onion, Artemisia Abrotanum Flowering Top, Artemisia Cina Pre-flowering Top, Cupric Oxide, Okoubaka Aubrevillei Bark, Schoenocaulon Officinale Seed, And Spigelia Anthelmia",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080412",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PEKANA Naturheilmittel GmbH",
      "SubstanceName": "ONION; ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA CINA PRE-FLOWERING TOP; CUPRIC OXIDE; OKOUBAKA AUBREVILLEI BARK; SCHOENOCAULON OFFICINALE SEED; SPIGELIA ANTHELMIA WHOLE",
      "StrengthNumber": "6; 8; 12; 12; 4; 6; 4",
      "StrengthUnit": "[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]",
      "Status": "Active",
      "LastUpdate": "2022-12-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20080412",
      "SamplePackage": "N",
      "IndicationAndUsage": "For relief of minor occasional digestive pain. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
    },
    {
      "NDCCode": "59469-101-20",
      "PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-101-20)  > 125 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "59469-0101-20",
      "ProductNDC": "59469-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Apo-pulm",
      "NonProprietaryName": "Onion, Bryonia Dioica Root, Hedera Helix Flowering Twig, Hyoscyamus Niger, Phosphorus, Polygala Senega Root, Antimony Potassium Tartrate, And Pulmonaria Officinalis Whole",
      "DosageFormName": "SYRUP",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081211",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PEKANA Naturheilmittel GmbH",
      "SubstanceName": "ONION; BRYONIA DIOICA ROOT; HEDERA HELIX FLOWERING TWIG; HYOSCYAMUS NIGER; PHOSPHORUS; POLYGALA SENEGA ROOT; ANTIMONY POTASSIUM TARTRATE; PULMONARIA OFFICINALIS WHOLE",
      "StrengthNumber": "4; 4; 8; 4; 10; 4; 6; 4",
      "StrengthUnit": "[hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-02-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20081211",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59469-108-20",
      "PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-108-20)  > 125 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "59469-0108-20",
      "ProductNDC": "59469-108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bronchi-pertu",
      "NonProprietaryName": "Bryonia Dioica Root, Protortonia Cacti, Guaiacum Officinale Resin, Oenanthe Aquatica Fruit, Phosphorus, Antimony Potassium Tartrate, Usnea Barbata, And Grindelia Hirsutula Whole",
      "DosageFormName": "SYRUP",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081211",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PEKANA Naturheilmittel GmbH",
      "SubstanceName": "BRYONIA DIOICA ROOT; PROTORTONIA CACTI; GUAIACUM OFFICINALE RESIN; OENANTHE AQUATICA FRUIT; PHOSPHORUS; ANTIMONY POTASSIUM TARTRATE; USNEA BARBATA; GRINDELIA HIRSUTULA WHOLE",
      "StrengthNumber": "3; 2; 3; 4; 6; 4; 12; 8",
      "StrengthUnit": "[hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20081211",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59469-149-60",
      "PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-149-60)  > 20 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "59469-0149-60",
      "ProductNDC": "59469-149",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Demyc Spag.",
      "NonProprietaryName": "Ranunculus Bulbosus, Delphinium Staphisagria Seed, Piper Methysticum Root, Anagallis Arvensis, Calendula Officinalis Flowering Top, And Sage",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20080412",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PEKANA Naturheilmittel GmbH",
      "SubstanceName": "RANUNCULUS BULBOSUS; DELPHINIUM STAPHISAGRIA SEED; MACROPIPER METHYSTICUM ROOT; ANAGALLIS ARVENSIS; CALENDULA OFFICINALIS FLOWERING TOP; SAGE",
      "StrengthNumber": "5; 3; 8; 237; 806; 774",
      "StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; mg/20mL; mg/20mL; mg/20mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20081204",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59469-303-20",
      "PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-303-20)  > 125 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "59469-0303-20",
      "ProductNDC": "59469-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bronchi-pertu",
      "NonProprietaryName": "Bryonia Dioica Root, Protortonia Cacti, Guaiacum Officinale Resin, Oenanthe Aquatica Fruit, Phosphorus, Antimony Potassium Tartrate, Usnea Barbata, And Grindelia Hirsutula Whole",
      "DosageFormName": "SYRUP",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190624",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PEKANA Naturheilmittel GmbH",
      "SubstanceName": "BRYONIA DIOICA ROOT; PROTORTONIA CACTI; GUAIACUM OFFICINALE RESIN; OENANTHE AQUATICA FRUIT; PHOSPHORUS; ANTIMONY POTASSIUM TARTRATE; USNEA BARBATA; GRINDELIA HIRSUTULA WHOLE",
      "StrengthNumber": "3; 2; 3; 4; 6; 6; 12; 8",
      "StrengthUnit": "[hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190624",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59469-306-20",
      "PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-306-20)  > 20 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "59469-0306-20",
      "ProductNDC": "59469-306",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Demyc",
      "NonProprietaryName": "Ranunculus Bulbosus, Delphinium Staphisagria Seed, Macropiper Methysticum Root, Anagallis Arvensis, Calendula Officinalis Flowering Top, And Sage",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190624",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PEKANA Naturheilmittel GmbH",
      "SubstanceName": "RANUNCULUS BULBOSUS WHOLE; DELPHINIUM STAPHISAGRIA SEED; PIPER METHYSTICUM ROOT; LYSIMACHIA ARVENSIS WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; SAGE",
      "StrengthNumber": "5; 6; 8; 237; 806; 774",
      "StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; mg/20mL; mg/20mL; mg/20mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
      "Status": "Active",
      "LastUpdate": "2023-01-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190624",
      "SamplePackage": "N",
      "IndicationAndUsage": "For relief of minor skin fungus, such as athlete's foot. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
    },
    {
      "NDCCode": "11084-058-20",
      "PackageDescription": "2000 mL in 1 BOTTLE, PLASTIC (11084-058-20)",
      "NDC11Code": "11084-0058-20",
      "ProductNDC": "11084-058",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Instantfoam Non-alcohol",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Deb USA, Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".13",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Uses. For hand sanitizing to reduce bacteria on the skin."
    },
    {
      "NDCCode": "33261-058-20",
      "PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (33261-058-20) ",
      "NDC11Code": "33261-0058-20",
      "ProductNDC": "33261-058",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20000531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040355",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
      "StrengthNumber": "10; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20000531",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
    },
    {
      "NDCCode": "49999-058-20",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49999-058-20)",
      "NDC11Code": "49999-0058-20",
      "ProductNDC": "49999-058",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960514",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074480",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "550",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-03-03"
    },
    {
      "NDCCode": "51079-058-20",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-058-20)  / 1 TABLET in 1 BLISTER PACK (51079-058-01) ",
      "NDC11Code": "51079-0058-20",
      "ProductNDC": "51079-058",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Chlorthalidone",
      "NonProprietaryName": "Chlorthalidone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19980612",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA086831",
      "LabelerName": "Mylan Institutional Inc.",
      "SubstanceName": "CHLORTHALIDONE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980612",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.",
      "Description": "Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide with the following structural formula. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No.10 Aluminum Lake, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate (potato), stearic acid. The 50 mg tablets also contain FD&C Blue No.1 Aluminum Lake."
    },
    {
      "NDCCode": "51495-058-01",
      "PackageDescription": "20 kg in 1 DRUM (51495-058-01)",
      "NDC11Code": "51495-0058-01",
      "ProductNDC": "51495-058",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "L-alanyl-l-glutamine",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20060102",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Ajinomoto Health & Nutrition North America, Inc.",
      "SubstanceName": "ALANYL GLUTAMINE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20221231"
    },
    {
      "NDCCode": "52125-058-20",
      "PackageDescription": "100 CAPSULE in 1 VIAL (52125-058-20)",
      "NDC11Code": "52125-0058-20",
      "ProductNDC": "52125-058",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dicyclomine Hydrochloride",
      "NonProprietaryName": "Dicyclomine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130529",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA084285",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-22"
    },
    {
      "NDCCode": "53747-058-00",
      "PackageDescription": "1 BAG in 1 DRUM (53747-058-00)  / 20 kg in 1 BAG",
      "NDC11Code": "53747-0058-00",
      "ProductNDC": "53747-058",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Lurasidone Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20150331",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Unichem Laboratories Limited, India",
      "SubstanceName": "LURASIDONE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-12-13",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "31-MAR-15"
    },
    {
      "NDCCode": "55289-058-20",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-20) ",
      "NDC11Code": "55289-0058-20",
      "ProductNDC": "55289-058",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19900930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062702",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-11-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110606",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: 1 Respiratory tract infection ( 1.1) , 2 Otitis media ( 1.2) , 3 Skin and skin structure infections ( 1.3) , 4 Bone infections ( 1.4) , 5 Genitourinary tract infections (  1.5)  .",
      "Description": "Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate. Cephalexin, USP has the following structural formula. C 16H 17N 3O 4SH 2O          M.W. 365.41. The nucleus of cephalexin, USP is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin, USP in water is approximately 4.5 to 5. The crystalline form of cephalexin, USP which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin, USP has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate, USP equivalent to 250 mg (720 μmol) or 500 mg (1,439 μmol) of cephalexin. Inactive Ingredients: CAPSULES: magnesium stearate, silicon dioxide, and sodium starch glycolate. Capsule Shell and Print Constituents: black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, pharmaceutical glaze modified in SD-45, silicon dioxide or carboxymethylcellulose sodium, sodium lauryl sulfate, titanium dioxide and may contain propylene glycol. In addition, the 250 mg capsule shell contains yellow iron oxide. After mixing, each 5 mL of cephalexin for oral suspension USP will contain cephalexin monohydrate, USP equivalent to 125 mg (360 μmol) or 250 mg (720 μmol) of cephalexin. Inactive Ingredients: SUSPENSION: FD&C Red #40, cherry mixed fruit flavor (artificial flavors, benzyl alcohol, maltodextrin, and modified corn starch), silicon dioxide, sodium benzoate, sugar (fruit granulated), and xanthan gum."
    },
    {
      "NDCCode": "57237-058-20",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (57237-058-20) ",
      "NDC11Code": "57237-0058-20",
      "ProductNDC": "57237-058",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cefuroxime Axetil",
      "NonProprietaryName": "Cefuroxime Axetil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060329",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065308",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "CEFUROXIME AXETIL",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2024-05-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20060329",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1): 1 Pharyngitis/tonsillitis (adults and pediatric patients) (1.1), 2 Acute bacterial otitis media (pediatric patients) (1.2), 3 Acute bacterial maxillary sinusitis (adults and pediatric patients) (1.3), 4 Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) (1.4), 5 Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) (1.5), 6 Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) (1.6), 7 Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) (1.7), 8 Early Lyme disease (adults and pediatric patients 13 years and older) (1.8).",
      "Description": "Cefuroxime axetil tablets, USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula: Tablets are film-coated and contain the equivalent of 250 mg or 500 mg of cefuroxime as cefuroxime axetil USP. Tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide."
    },
    {
      "NDCCode": "60000-058-67",
      "PackageDescription": "1 BOTTLE in 1 CARTON (60000-058-67)  / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE",
      "NDC11Code": "60000-0058-67",
      "ProductNDC": "60000-058",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mucus Relief Dm",
      "NonProprietaryName": "Guaifenesin And Dextromethorphan Hbr",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170317",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206941",
      "LabelerName": "Ahold U.S.A., Inc,",
      "SubstanceName": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE",
      "StrengthNumber": "600; 30",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-12-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170317",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69842-058-20",
      "PackageDescription": "1 TUBE in 1 CARTON (69842-058-20)  > 113.4 g in 1 TUBE",
      "NDC11Code": "69842-0058-20",
      "ProductNDC": "69842-058",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cvs Health Diaper Rash",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100331",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "CVS Health",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2017-03-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100331",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps treat and prevent diaper rash. protects chafed skin due to diaper rash and helps seal out wetness."
    },
    {
      "NDCCode": "70954-058-20",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (70954-058-20) ",
      "NDC11Code": "70954-0058-20",
      "ProductNDC": "70954-058",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211575",
      "LabelerName": "ANI Pharmaceuticals, Inc.",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisone Tablets, USP are indicated in the following conditions:Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable, in infancy mineralocorticoid supplementation is of particular importance), Congenital adrenal hyperplasia, Hypercalcemia associated with cancer, nonsuppurative thyroiditisRheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitisCollagen Diseases During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.Dermatologic Diseases Pemphigus, Bullous dermatitis herpetiformis, severe erythema multiforme (stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis.Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis.Respiratory Diseases Symptomatic sarcoidosis, loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis.Hematologic Disorders Idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia.Neoplastic Diseases For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosusGastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritisNervous System Acute exacerbations of multiple sclerosisMiscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement.",
      "Description": "Prednisone Tablets, USP are available for oral administration containing 2.5 mg, 5 mg, 10 mg, 20 mg and 50 mg of prednisone, USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-. The structural formula is represented below. Molecular Formula: C21H26O5. Molecular Weight: 358.44. Prednisone is a white or almost white crystalline powder. It is slightly soluble in acetone, ethanol, ethylacetate and methanol. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "76397-058-07",
      "PackageDescription": "20 g in 1 DRUM (76397-058-07) ",
      "NDC11Code": "76397-0058-07",
      "ProductNDC": "76397-058",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Efinaconazole",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20260714",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Zhejiang Ausun Pharmaceutical Co., Ltd.",
      "SubstanceName": "EFINACONAZOLE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2026-07-20",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "14-JUL-26"
    },
    {
      "NDCCode": "82868-058-20",
      "PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (82868-058-20) ",
      "NDC11Code": "82868-0058-20",
      "ProductNDC": "82868-058",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Meclizine Hydrochloride",
      "NonProprietaryName": "Meclizine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240611",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201451",
      "LabelerName": "Northwind Health Company, LLC",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250627",
      "SamplePackage": "N",
      "IndicationAndUsage": "Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.",
      "Description": "Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. Its molecular formula is C 25H 27ClN 2.2HCl.H 2O and its molecular weight is 481.88. It has the following structural formula:. Chemically, meclizine hydrochloride is 1-( p-chloro-α-phenylbenzyl)-4-( m-methylbenzyl) piperazine dihydrochloride monohydrate. Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base. Inactive ingredients for the tablets are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and talc. The 12.5 mg tablets also contain FD&C Blue #1 Aluminum Lake. The 25 mg tablets also contain D&C Yellow #10 Aluminum Lake."
    },
    {
      "NDCCode": "85207-058-03",
      "PackageDescription": "20 g in 1 BAG (85207-058-03) ",
      "NDC11Code": "85207-0058-03",
      "ProductNDC": "85207-058",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "5-amino-1-methyl-1-quinolinium Iodide Anhydrous",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20260331",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "SCH Global Services Private Limited",
      "SubstanceName": "5-AMINO-1-METHYLQUINOLINIUM IODIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "g/100g",
      "Status": "Unfinished",
      "LastUpdate": "2026-08-14",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "31-MAR-26"
    },
    {
      "NDCCode": "59469-141-10",
      "PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-141-10)  > 50 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "59469-0141-10",
      "ProductNDC": "59469-141",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Habifac",
      "NonProprietaryName": "Formic Acid, Nitric Acid, Baptisia Tinctoria Root, Graphite, Calcium Sulfide, Thuja Occidentalis Leafy Twig, Cynanchum Vincetoxicum Leaf, And Glechoma Hederacea Flowering Top",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080412",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PEKANA Naturheilmittel GmbH",
      "SubstanceName": "FORMIC ACID; NITRIC ACID; BAPTISIA TINCTORIA ROOT; GRAPHITE; CALCIUM SULFIDE; THUJA OCCIDENTALIS LEAFY TWIG; VINCETOXICUM HIRUNDINARIA LEAF; GLECHOMA HEDERACEA FLOWERING TOP",
      "StrengthNumber": "8; 6; 5; 8; 8; 10; 8; 4",
      "StrengthUnit": "[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL",
      "Status": "Active",
      "LastUpdate": "2022-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20080412",
      "SamplePackage": "N",
      "IndicationAndUsage": "Restorative remedy for minor systemic weakness. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
    },
    {
      "NDCCode": "59469-165-40",
      "PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-165-40)  > 100 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "59469-0165-40",
      "ProductNDC": "59469-165",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Inflamyar",
      "NonProprietaryName": "Arnica Montana Root, Bellis Perennis, Bryonia Dioica Root, Guaiacum Officinale Resin, Ledum Palustre Twig, Ruta Graveolens Flowering Top, Toxicodendron Pubescens Shoot, And Viscum Album Fruiting Top",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080412",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PEKANA Naturheilmittel GmbH",
      "SubstanceName": "ARNICA MONTANA ROOT; BELLIS PERENNIS WHOLE; BRYONIA DIOICA ROOT; GUAIACUM OFFICINALE RESIN; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS SHOOT; VISCUM ALBUM FRUITING TOP",
      "StrengthNumber": "4; 4; 4; 6; 12; 4; 8; 4",
      "StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
      "Status": "Active",
      "LastUpdate": "2022-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20080412",
      "SamplePackage": "N",
      "IndicationAndUsage": "For relief of minor sports injuries, including muscle strains, joint pain, sprains, and bruises. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
    },
    {
      "NDCCode": "59469-172-10",
      "PackageDescription": "1 BOTTLE in 1 CARTON (59469-172-10)  > 480 PELLET in 1 BOTTLE",
      "NDC11Code": "59469-0172-10",
      "ProductNDC": "59469-172",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Inflamyar",
      "NonProprietaryName": "Arnica Montana, Bellis Perennis, Bryonia Cretica Subsp. Dioica Root, Guaiacum Officinale Resin, Ledum Palustre Twig, Ruta Graveolens Whole, Toxicodendron Pubescens Leaf, And Viscum Album Fruit",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110901",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Pekana-Naturheilmittel GmbH",
      "SubstanceName": "ARNICA MONTANA WHOLE; BELLIS PERENNIS WHOLE; BRYONIA DIOICA ROOT; GUAIACUM OFFICINALE RESIN; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS WHOLE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUIT",
      "StrengthNumber": "4; 4; 4; 6; 12; 4; 8; 4",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
      "Status": "Active",
      "LastUpdate": "2022-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110901",
      "SamplePackage": "N",
      "IndicationAndUsage": "For relief of minor sports injuries, including muscle strains, joint pain, sprains, and bruises. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
    },
    {
      "NDCCode": "59469-307-30",
      "PackageDescription": "1 TUBE in 1 BOX (59469-307-30)  > 30 g in 1 TUBE",
      "NDC11Code": "59469-0307-30",
      "ProductNDC": "59469-307",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dercut",
      "NonProprietaryName": "Euphorbia Resinifera Resin, Goldenseal, Wood Creosote, Toxicodendron Pubescens Shoot, Sempervivum Tectorum Leaf, Bellis Perennis, Vinca Minor, And Viola Tricolor",
      "DosageFormName": "OINTMENT",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20190624",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PEKANA Naturheilmittel GmbH",
      "SubstanceName": "EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; WOOD CREOSOTE; TOXICODENDRON PUBESCENS SHOOT; SEMPERVIVUM TECTORUM LEAF; BELLIS PERENNIS WHOLE; PERVINCA MINOR WHOLE; VIOLA TRICOLOR WHOLE",
      "StrengthNumber": "4; 4; 6; 8; 3; 8; 3; 2",
      "StrengthUnit": "[hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g",
      "Status": "Active",
      "LastUpdate": "2022-01-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190624",
      "SamplePackage": "N",
      "IndicationAndUsage": "For relief of acne, eczema, itching, psoriasis, and skin irritation."
    },
    {
      "NDCCode": "59469-307-40",
      "PackageDescription": "1 TUBE in 1 BOX (59469-307-40)  > 100 g in 1 TUBE",
      "NDC11Code": "59469-0307-40",
      "ProductNDC": "59469-307",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dercut",
      "NonProprietaryName": "Euphorbia Resinifera Resin, Goldenseal, Wood Creosote, Toxicodendron Pubescens Shoot, Sempervivum Tectorum Leaf, Bellis Perennis, Vinca Minor, And Viola Tricolor",
      "DosageFormName": "OINTMENT",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20190624",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PEKANA Naturheilmittel GmbH",
      "SubstanceName": "EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; WOOD CREOSOTE; TOXICODENDRON PUBESCENS SHOOT; SEMPERVIVUM TECTORUM LEAF; BELLIS PERENNIS WHOLE; PERVINCA MINOR WHOLE; VIOLA TRICOLOR WHOLE",
      "StrengthNumber": "4; 4; 6; 8; 3; 8; 3; 2",
      "StrengthUnit": "[hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g",
      "Status": "Active",
      "LastUpdate": "2022-01-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190624",
      "SamplePackage": "N",
      "IndicationAndUsage": "For relief of acne, eczema, itching, psoriasis, and skin irritation."
    },
    {
      "NDCCode": "11788-058-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (11788-058-01) ",
      "NDC11Code": "11788-0058-01",
      "ProductNDC": "11788-058",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Buspirone Hydrochloride",
      "NonProprietaryName": "Buspirone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250926",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202087",
      "LabelerName": "AiPing Pharmaceutical, Inc.",
      "SubstanceName": "BUSPIRONE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2026-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250926",
      "SamplePackage": "N",
      "IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
      "Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg, 7.5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
    },
    {
      "NDCCode": "24510-058-01",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (24510-058-01)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "24510-0058-01",
      "ProductNDC": "24510-058",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nucynta",
      "ProprietaryNameSuffix": "Er",
      "NonProprietaryName": "Tapentadol Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190419",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA200533",
      "LabelerName": "Collegium Pharmaceutical, Inc.",
      "SubstanceName": "TAPENTADOL HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2026-01-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190419",
      "SamplePackage": "N",
      "IndicationAndUsage": "NUCYNTA ER (tapentadol) is indicated for the management of: 1 Severe and persistent pain in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
      "Description": "NUCYNTA ER (tapentadol) is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO∙HCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets)."
    },
    {
      "NDCCode": "24510-058-60",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24510-058-60) ",
      "NDC11Code": "24510-0058-60",
      "ProductNDC": "24510-058",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nucynta",
      "ProprietaryNameSuffix": "Er",
      "NonProprietaryName": "Tapentadol Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190419",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA200533",
      "LabelerName": "Collegium Pharmaceutical, Inc.",
      "SubstanceName": "TAPENTADOL HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2026-01-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190419",
      "SamplePackage": "N",
      "IndicationAndUsage": "NUCYNTA ER (tapentadol) is indicated for the management of: 1 Severe and persistent pain in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
      "Description": "NUCYNTA ER (tapentadol) is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO∙HCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets)."
    },
    {
      "NDCCode": "35192-058-14",
      "PackageDescription": "50 g in 1 BOTTLE, PLASTIC (35192-058-14) ",
      "NDC11Code": "35192-0058-14",
      "ProductNDC": "35192-058",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bion Pure Mineral Sunscreen",
      "NonProprietaryName": "Sunscreen",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250417",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "CA Botana International INC",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "19",
      "StrengthUnit": "g/19g",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250417",
      "SamplePackage": "N",
      "IndicationAndUsage": "Keep out of reach of children. If product is swallowed, get medical help or contact poison control center right away."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"59469-058-20","ProprietaryName":"Helmin","NonProprietaryName":"Onion, Artemisia Abrotanum Flowering Top, Artemisia Cina Pre-flowering Top, Cupric Oxide, Okoubaka Aubrevillei Bark, Schoenocaulon Officinale Seed, And Spigelia Anthelmia"},{"NDCCode":"59469-101-20","ProprietaryName":"Apo-pulm","NonProprietaryName":"Onion, Bryonia Dioica Root, Hedera Helix Flowering Twig, Hyoscyamus Niger, Phosphorus, Polygala Senega Root, Antimony Potassium Tartrate, And Pulmonaria Officinalis Whole"},{"NDCCode":"59469-108-20","ProprietaryName":"Bronchi-pertu","NonProprietaryName":"Bryonia Dioica Root, Protortonia Cacti, Guaiacum Officinale Resin, Oenanthe Aquatica Fruit, Phosphorus, Antimony Potassium Tartrate, Usnea Barbata, And Grindelia Hirsutula Whole"},{"NDCCode":"59469-149-60","ProprietaryName":"Demyc Spag.","NonProprietaryName":"Ranunculus Bulbosus, Delphinium Staphisagria Seed, Piper Methysticum Root, Anagallis Arvensis, Calendula Officinalis Flowering Top, And Sage"},{"NDCCode":"59469-303-20","ProprietaryName":"Bronchi-pertu","NonProprietaryName":"Bryonia Dioica Root, Protortonia Cacti, Guaiacum Officinale Resin, Oenanthe Aquatica Fruit, Phosphorus, Antimony Potassium Tartrate, Usnea Barbata, And Grindelia Hirsutula Whole"},{"NDCCode":"59469-306-20","ProprietaryName":"Demyc","NonProprietaryName":"Ranunculus Bulbosus, Delphinium Staphisagria Seed, Macropiper Methysticum Root, Anagallis Arvensis, Calendula Officinalis Flowering Top, And Sage"},{"NDCCode":"11084-058-20","ProprietaryName":"Instantfoam Non-alcohol","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"33261-058-20","ProprietaryName":"Hydrocodone Bitartrate And Acetaminophen","NonProprietaryName":"Hydrocodone Bitartrate And Acetaminophen"},{"NDCCode":"49999-058-20","ProprietaryName":"Naproxen","NonProprietaryName":"Naproxen Sodium"},{"NDCCode":"51079-058-20","ProprietaryName":"Chlorthalidone","NonProprietaryName":"Chlorthalidone"},{"NDCCode":"51495-058-01","NonProprietaryName":"L-alanyl-l-glutamine"},{"NDCCode":"52125-058-20","ProprietaryName":"Dicyclomine Hydrochloride","NonProprietaryName":"Dicyclomine Hydrochloride"},{"NDCCode":"53747-058-00","NonProprietaryName":"Lurasidone Hydrochloride"},{"NDCCode":"55289-058-20","ProprietaryName":"Cephalexin","NonProprietaryName":"Cephalexin"},{"NDCCode":"57237-058-20","ProprietaryName":"Cefuroxime Axetil","NonProprietaryName":"Cefuroxime Axetil"},{"NDCCode":"60000-058-67","ProprietaryName":"Mucus Relief Dm","NonProprietaryName":"Guaifenesin And Dextromethorphan Hbr"},{"NDCCode":"69842-058-20","ProprietaryName":"Cvs Health Diaper Rash","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"70954-058-20","ProprietaryName":"Prednisone","NonProprietaryName":"Prednisone"},{"NDCCode":"76397-058-07","NonProprietaryName":"Efinaconazole"},{"NDCCode":"82868-058-20","ProprietaryName":"Meclizine Hydrochloride","NonProprietaryName":"Meclizine Hydrochloride"},{"NDCCode":"85207-058-03","NonProprietaryName":"5-amino-1-methyl-1-quinolinium Iodide Anhydrous"},{"NDCCode":"59469-141-10","ProprietaryName":"Habifac","NonProprietaryName":"Formic Acid, Nitric Acid, Baptisia Tinctoria Root, Graphite, Calcium Sulfide, Thuja Occidentalis Leafy Twig, Cynanchum Vincetoxicum Leaf, And Glechoma Hederacea Flowering Top"},{"NDCCode":"59469-165-40","ProprietaryName":"Inflamyar","NonProprietaryName":"Arnica Montana Root, Bellis Perennis, Bryonia Dioica Root, Guaiacum Officinale Resin, Ledum Palustre Twig, Ruta Graveolens Flowering Top, Toxicodendron Pubescens Shoot, And Viscum Album Fruiting Top"},{"NDCCode":"59469-172-10","ProprietaryName":"Inflamyar","NonProprietaryName":"Arnica Montana, Bellis Perennis, Bryonia Cretica Subsp. Dioica Root, Guaiacum Officinale Resin, Ledum Palustre Twig, Ruta Graveolens Whole, Toxicodendron Pubescens Leaf, And Viscum Album Fruit"},{"NDCCode":"59469-307-30","ProprietaryName":"Dercut","NonProprietaryName":"Euphorbia Resinifera Resin, Goldenseal, Wood Creosote, Toxicodendron Pubescens Shoot, Sempervivum Tectorum Leaf, Bellis Perennis, Vinca Minor, And Viola Tricolor"},{"NDCCode":"59469-307-40","ProprietaryName":"Dercut","NonProprietaryName":"Euphorbia Resinifera Resin, Goldenseal, Wood Creosote, Toxicodendron Pubescens Shoot, Sempervivum Tectorum Leaf, Bellis Perennis, Vinca Minor, And Viola Tricolor"},{"NDCCode":"11788-058-01","ProprietaryName":"Buspirone Hydrochloride","NonProprietaryName":"Buspirone Hydrochloride"},{"NDCCode":"24510-058-01","ProprietaryName":"Nucynta","NonProprietaryName":"Tapentadol Hydrochloride"},{"NDCCode":"24510-058-60","ProprietaryName":"Nucynta","NonProprietaryName":"Tapentadol Hydrochloride"},{"NDCCode":"35192-058-14","ProprietaryName":"Bion Pure Mineral Sunscreen","NonProprietaryName":"Sunscreen"}]}
                    
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<NDCList>
  <NDC>
    <NDCCode>59469-058-20</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-058-20)  &gt; 50 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>59469-0058-20</NDC11Code>
    <ProductNDC>59469-058</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Helmin</ProprietaryName>
    <NonProprietaryName>Onion, Artemisia Abrotanum Flowering Top, Artemisia Cina Pre-flowering Top, Cupric Oxide, Okoubaka Aubrevillei Bark, Schoenocaulon Officinale Seed, And Spigelia Anthelmia</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080412</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
    <SubstanceName>ONION; ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA CINA PRE-FLOWERING TOP; CUPRIC OXIDE; OKOUBAKA AUBREVILLEI BARK; SCHOENOCAULON OFFICINALE SEED; SPIGELIA ANTHELMIA WHOLE</SubstanceName>
    <StrengthNumber>6; 8; 12; 12; 4; 6; 4</StrengthNumber>
    <StrengthUnit>[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For relief of minor occasional digestive pain. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59469-101-20</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-101-20)  &gt; 125 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>59469-0101-20</NDC11Code>
    <ProductNDC>59469-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Apo-pulm</ProprietaryName>
    <NonProprietaryName>Onion, Bryonia Dioica Root, Hedera Helix Flowering Twig, Hyoscyamus Niger, Phosphorus, Polygala Senega Root, Antimony Potassium Tartrate, And Pulmonaria Officinalis Whole</NonProprietaryName>
    <DosageFormName>SYRUP</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081211</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
    <SubstanceName>ONION; BRYONIA DIOICA ROOT; HEDERA HELIX FLOWERING TWIG; HYOSCYAMUS NIGER; PHOSPHORUS; POLYGALA SENEGA ROOT; ANTIMONY POTASSIUM TARTRATE; PULMONARIA OFFICINALIS WHOLE</SubstanceName>
    <StrengthNumber>4; 4; 8; 4; 10; 4; 6; 4</StrengthNumber>
    <StrengthUnit>[hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20081211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59469-108-20</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-108-20)  &gt; 125 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>59469-0108-20</NDC11Code>
    <ProductNDC>59469-108</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bronchi-pertu</ProprietaryName>
    <NonProprietaryName>Bryonia Dioica Root, Protortonia Cacti, Guaiacum Officinale Resin, Oenanthe Aquatica Fruit, Phosphorus, Antimony Potassium Tartrate, Usnea Barbata, And Grindelia Hirsutula Whole</NonProprietaryName>
    <DosageFormName>SYRUP</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081211</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
    <SubstanceName>BRYONIA DIOICA ROOT; PROTORTONIA CACTI; GUAIACUM OFFICINALE RESIN; OENANTHE AQUATICA FRUIT; PHOSPHORUS; ANTIMONY POTASSIUM TARTRATE; USNEA BARBATA; GRINDELIA HIRSUTULA WHOLE</SubstanceName>
    <StrengthNumber>3; 2; 3; 4; 6; 4; 12; 8</StrengthNumber>
    <StrengthUnit>[hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20081211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59469-149-60</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-149-60)  &gt; 20 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>59469-0149-60</NDC11Code>
    <ProductNDC>59469-149</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Demyc Spag.</ProprietaryName>
    <NonProprietaryName>Ranunculus Bulbosus, Delphinium Staphisagria Seed, Piper Methysticum Root, Anagallis Arvensis, Calendula Officinalis Flowering Top, And Sage</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20080412</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
    <SubstanceName>RANUNCULUS BULBOSUS; DELPHINIUM STAPHISAGRIA SEED; MACROPIPER METHYSTICUM ROOT; ANAGALLIS ARVENSIS; CALENDULA OFFICINALIS FLOWERING TOP; SAGE</SubstanceName>
    <StrengthNumber>5; 3; 8; 237; 806; 774</StrengthNumber>
    <StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; mg/20mL; mg/20mL; mg/20mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20081204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59469-303-20</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-303-20)  &gt; 125 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>59469-0303-20</NDC11Code>
    <ProductNDC>59469-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bronchi-pertu</ProprietaryName>
    <NonProprietaryName>Bryonia Dioica Root, Protortonia Cacti, Guaiacum Officinale Resin, Oenanthe Aquatica Fruit, Phosphorus, Antimony Potassium Tartrate, Usnea Barbata, And Grindelia Hirsutula Whole</NonProprietaryName>
    <DosageFormName>SYRUP</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190624</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
    <SubstanceName>BRYONIA DIOICA ROOT; PROTORTONIA CACTI; GUAIACUM OFFICINALE RESIN; OENANTHE AQUATICA FRUIT; PHOSPHORUS; ANTIMONY POTASSIUM TARTRATE; USNEA BARBATA; GRINDELIA HIRSUTULA WHOLE</SubstanceName>
    <StrengthNumber>3; 2; 3; 4; 6; 6; 12; 8</StrengthNumber>
    <StrengthUnit>[hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190624</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59469-306-20</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-306-20)  &gt; 20 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>59469-0306-20</NDC11Code>
    <ProductNDC>59469-306</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Demyc</ProprietaryName>
    <NonProprietaryName>Ranunculus Bulbosus, Delphinium Staphisagria Seed, Macropiper Methysticum Root, Anagallis Arvensis, Calendula Officinalis Flowering Top, And Sage</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190624</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
    <SubstanceName>RANUNCULUS BULBOSUS WHOLE; DELPHINIUM STAPHISAGRIA SEED; PIPER METHYSTICUM ROOT; LYSIMACHIA ARVENSIS WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; SAGE</SubstanceName>
    <StrengthNumber>5; 6; 8; 237; 806; 774</StrengthNumber>
    <StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; mg/20mL; mg/20mL; mg/20mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190624</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For relief of minor skin fungus, such as athlete's foot. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11084-058-20</NDCCode>
    <PackageDescription>2000 mL in 1 BOTTLE, PLASTIC (11084-058-20)</PackageDescription>
    <NDC11Code>11084-0058-20</NDC11Code>
    <ProductNDC>11084-058</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instantfoam Non-alcohol</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Deb USA, Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.13</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses. For hand sanitizing to reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>33261-058-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (33261-058-20) </PackageDescription>
    <NDC11Code>33261-0058-20</NDC11Code>
    <ProductNDC>33261-058</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20000531</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040355</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20000531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49999-058-20</NDCCode>
    <PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49999-058-20)</PackageDescription>
    <NDC11Code>49999-0058-20</NDC11Code>
    <ProductNDC>49999-058</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074480</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>NAPROXEN SODIUM</SubstanceName>
    <StrengthNumber>550</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-03-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>51079-058-20</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (51079-058-20)  / 1 TABLET in 1 BLISTER PACK (51079-058-01) </PackageDescription>
    <NDC11Code>51079-0058-20</NDC11Code>
    <ProductNDC>51079-058</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Chlorthalidone</ProprietaryName>
    <NonProprietaryName>Chlorthalidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA086831</ApplicationNumber>
    <LabelerName>Mylan Institutional Inc.</LabelerName>
    <SubstanceName>CHLORTHALIDONE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
    <Description>Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide with the following structural formula. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, D&amp;C Yellow No.10 Aluminum Lake, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate (potato), stearic acid. The 50 mg tablets also contain FD&amp;C Blue No.1 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>51495-058-01</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (51495-058-01)</PackageDescription>
    <NDC11Code>51495-0058-01</NDC11Code>
    <ProductNDC>51495-058</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>L-alanyl-l-glutamine</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20060102</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Ajinomoto Health &amp; Nutrition North America, Inc.</LabelerName>
    <SubstanceName>ALANYL GLUTAMINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>52125-058-20</NDCCode>
    <PackageDescription>100 CAPSULE in 1 VIAL (52125-058-20)</PackageDescription>
    <NDC11Code>52125-0058-20</NDC11Code>
    <ProductNDC>52125-058</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130529</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA084285</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>53747-058-00</NDCCode>
    <PackageDescription>1 BAG in 1 DRUM (53747-058-00)  / 20 kg in 1 BAG</PackageDescription>
    <NDC11Code>53747-0058-00</NDC11Code>
    <ProductNDC>53747-058</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20150331</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Unichem Laboratories Limited, India</LabelerName>
    <SubstanceName>LURASIDONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-MAR-15</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>55289-058-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-20) </PackageDescription>
    <NDC11Code>55289-0058-20</NDC11Code>
    <ProductNDC>55289-058</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062702</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110606</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: 1 Respiratory tract infection ( 1.1) , 2 Otitis media ( 1.2) , 3 Skin and skin structure infections ( 1.3) , 4 Bone infections ( 1.4) , 5 Genitourinary tract infections (  1.5)  .</IndicationAndUsage>
    <Description>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate. Cephalexin, USP has the following structural formula. C 16H 17N 3O 4SH 2O          M.W. 365.41. The nucleus of cephalexin, USP is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin, USP in water is approximately 4.5 to 5. The crystalline form of cephalexin, USP which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin, USP has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate, USP equivalent to 250 mg (720 μmol) or 500 mg (1,439 μmol) of cephalexin. Inactive Ingredients: CAPSULES: magnesium stearate, silicon dioxide, and sodium starch glycolate. Capsule Shell and Print Constituents: black iron oxide, D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Blue #1 Aluminum Lake, FD&amp;C Blue #2 Aluminum Lake, FD&amp;C Red #40 Aluminum Lake, gelatin, pharmaceutical glaze modified in SD-45, silicon dioxide or carboxymethylcellulose sodium, sodium lauryl sulfate, titanium dioxide and may contain propylene glycol. In addition, the 250 mg capsule shell contains yellow iron oxide. After mixing, each 5 mL of cephalexin for oral suspension USP will contain cephalexin monohydrate, USP equivalent to 125 mg (360 μmol) or 250 mg (720 μmol) of cephalexin. Inactive Ingredients: SUSPENSION: FD&amp;C Red #40, cherry mixed fruit flavor (artificial flavors, benzyl alcohol, maltodextrin, and modified corn starch), silicon dioxide, sodium benzoate, sugar (fruit granulated), and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>57237-058-20</NDCCode>
    <PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (57237-058-20) </PackageDescription>
    <NDC11Code>57237-0058-20</NDC11Code>
    <ProductNDC>57237-058</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefuroxime Axetil</ProprietaryName>
    <NonProprietaryName>Cefuroxime Axetil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065308</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>CEFUROXIME AXETIL</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1): 1 Pharyngitis/tonsillitis (adults and pediatric patients) (1.1), 2 Acute bacterial otitis media (pediatric patients) (1.2), 3 Acute bacterial maxillary sinusitis (adults and pediatric patients) (1.3), 4 Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) (1.4), 5 Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) (1.5), 6 Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) (1.6), 7 Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) (1.7), 8 Early Lyme disease (adults and pediatric patients 13 years and older) (1.8).</IndicationAndUsage>
    <Description>Cefuroxime axetil tablets, USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula: Tablets are film-coated and contain the equivalent of 250 mg or 500 mg of cefuroxime as cefuroxime axetil USP. Tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60000-058-67</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (60000-058-67)  / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>60000-0058-67</NDC11Code>
    <ProductNDC>60000-058</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mucus Relief Dm</ProprietaryName>
    <NonProprietaryName>Guaifenesin And Dextromethorphan Hbr</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170317</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206941</ApplicationNumber>
    <LabelerName>Ahold U.S.A., Inc,</LabelerName>
    <SubstanceName>GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>600; 30</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69842-058-20</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (69842-058-20)  &gt; 113.4 g in 1 TUBE</PackageDescription>
    <NDC11Code>69842-0058-20</NDC11Code>
    <ProductNDC>69842-058</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cvs Health Diaper Rash</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100331</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>CVS Health</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2017-03-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps treat and prevent diaper rash. protects chafed skin due to diaper rash and helps seal out wetness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70954-058-20</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (70954-058-20) </PackageDescription>
    <NDC11Code>70954-0058-20</NDC11Code>
    <ProductNDC>70954-058</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211575</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone Tablets, USP are indicated in the following conditions:Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable, in infancy mineralocorticoid supplementation is of particular importance), Congenital adrenal hyperplasia, Hypercalcemia associated with cancer, nonsuppurative thyroiditisRheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitisCollagen Diseases During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.Dermatologic Diseases Pemphigus, Bullous dermatitis herpetiformis, severe erythema multiforme (stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis.Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis.Respiratory Diseases Symptomatic sarcoidosis, loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis.Hematologic Disorders Idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia.Neoplastic Diseases For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosusGastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritisNervous System Acute exacerbations of multiple sclerosisMiscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Prednisone Tablets, USP are available for oral administration containing 2.5 mg, 5 mg, 10 mg, 20 mg and 50 mg of prednisone, USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-. The structural formula is represented below. Molecular Formula: C21H26O5. Molecular Weight: 358.44. Prednisone is a white or almost white crystalline powder. It is slightly soluble in acetone, ethanol, ethylacetate and methanol. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>76397-058-07</NDCCode>
    <PackageDescription>20 g in 1 DRUM (76397-058-07) </PackageDescription>
    <NDC11Code>76397-0058-07</NDC11Code>
    <ProductNDC>76397-058</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Efinaconazole</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20260714</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Zhejiang Ausun Pharmaceutical Co., Ltd.</LabelerName>
    <SubstanceName>EFINACONAZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-07-20</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>14-JUL-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>82868-058-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (82868-058-20) </PackageDescription>
    <NDC11Code>82868-0058-20</NDC11Code>
    <ProductNDC>82868-058</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240611</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201451</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</LabelerName>
    <SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250627</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
    <Description>Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. Its molecular formula is C 25H 27ClN 2.2HCl.H 2O and its molecular weight is 481.88. It has the following structural formula:. Chemically, meclizine hydrochloride is 1-( p-chloro-α-phenylbenzyl)-4-( m-methylbenzyl) piperazine dihydrochloride monohydrate. Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base. Inactive ingredients for the tablets are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and talc. The 12.5 mg tablets also contain FD&amp;C Blue #1 Aluminum Lake. The 25 mg tablets also contain D&amp;C Yellow #10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>85207-058-03</NDCCode>
    <PackageDescription>20 g in 1 BAG (85207-058-03) </PackageDescription>
    <NDC11Code>85207-0058-03</NDC11Code>
    <ProductNDC>85207-058</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>5-amino-1-methyl-1-quinolinium Iodide Anhydrous</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20260331</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>SCH Global Services Private Limited</LabelerName>
    <SubstanceName>5-AMINO-1-METHYLQUINOLINIUM IODIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-08-14</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-MAR-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>59469-141-10</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-141-10)  &gt; 50 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>59469-0141-10</NDC11Code>
    <ProductNDC>59469-141</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Habifac</ProprietaryName>
    <NonProprietaryName>Formic Acid, Nitric Acid, Baptisia Tinctoria Root, Graphite, Calcium Sulfide, Thuja Occidentalis Leafy Twig, Cynanchum Vincetoxicum Leaf, And Glechoma Hederacea Flowering Top</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080412</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
    <SubstanceName>FORMIC ACID; NITRIC ACID; BAPTISIA TINCTORIA ROOT; GRAPHITE; CALCIUM SULFIDE; THUJA OCCIDENTALIS LEAFY TWIG; VINCETOXICUM HIRUNDINARIA LEAF; GLECHOMA HEDERACEA FLOWERING TOP</SubstanceName>
    <StrengthNumber>8; 6; 5; 8; 8; 10; 8; 4</StrengthNumber>
    <StrengthUnit>[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Restorative remedy for minor systemic weakness. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59469-165-40</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-165-40)  &gt; 100 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>59469-0165-40</NDC11Code>
    <ProductNDC>59469-165</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Inflamyar</ProprietaryName>
    <NonProprietaryName>Arnica Montana Root, Bellis Perennis, Bryonia Dioica Root, Guaiacum Officinale Resin, Ledum Palustre Twig, Ruta Graveolens Flowering Top, Toxicodendron Pubescens Shoot, And Viscum Album Fruiting Top</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080412</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
    <SubstanceName>ARNICA MONTANA ROOT; BELLIS PERENNIS WHOLE; BRYONIA DIOICA ROOT; GUAIACUM OFFICINALE RESIN; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS SHOOT; VISCUM ALBUM FRUITING TOP</SubstanceName>
    <StrengthNumber>4; 4; 4; 6; 12; 4; 8; 4</StrengthNumber>
    <StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For relief of minor sports injuries, including muscle strains, joint pain, sprains, and bruises. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59469-172-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (59469-172-10)  &gt; 480 PELLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>59469-0172-10</NDC11Code>
    <ProductNDC>59469-172</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Inflamyar</ProprietaryName>
    <NonProprietaryName>Arnica Montana, Bellis Perennis, Bryonia Cretica Subsp. Dioica Root, Guaiacum Officinale Resin, Ledum Palustre Twig, Ruta Graveolens Whole, Toxicodendron Pubescens Leaf, And Viscum Album Fruit</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110901</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Pekana-Naturheilmittel GmbH</LabelerName>
    <SubstanceName>ARNICA MONTANA WHOLE; BELLIS PERENNIS WHOLE; BRYONIA DIOICA ROOT; GUAIACUM OFFICINALE RESIN; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS WHOLE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUIT</SubstanceName>
    <StrengthNumber>4; 4; 4; 6; 12; 4; 8; 4</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For relief of minor sports injuries, including muscle strains, joint pain, sprains, and bruises. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59469-307-30</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (59469-307-30)  &gt; 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>59469-0307-30</NDC11Code>
    <ProductNDC>59469-307</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dercut</ProprietaryName>
    <NonProprietaryName>Euphorbia Resinifera Resin, Goldenseal, Wood Creosote, Toxicodendron Pubescens Shoot, Sempervivum Tectorum Leaf, Bellis Perennis, Vinca Minor, And Viola Tricolor</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20190624</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
    <SubstanceName>EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; WOOD CREOSOTE; TOXICODENDRON PUBESCENS SHOOT; SEMPERVIVUM TECTORUM LEAF; BELLIS PERENNIS WHOLE; PERVINCA MINOR WHOLE; VIOLA TRICOLOR WHOLE</SubstanceName>
    <StrengthNumber>4; 4; 6; 8; 3; 8; 3; 2</StrengthNumber>
    <StrengthUnit>[hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-01-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190624</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For relief of acne, eczema, itching, psoriasis, and skin irritation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59469-307-40</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (59469-307-40)  &gt; 100 g in 1 TUBE</PackageDescription>
    <NDC11Code>59469-0307-40</NDC11Code>
    <ProductNDC>59469-307</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dercut</ProprietaryName>
    <NonProprietaryName>Euphorbia Resinifera Resin, Goldenseal, Wood Creosote, Toxicodendron Pubescens Shoot, Sempervivum Tectorum Leaf, Bellis Perennis, Vinca Minor, And Viola Tricolor</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20190624</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
    <SubstanceName>EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; WOOD CREOSOTE; TOXICODENDRON PUBESCENS SHOOT; SEMPERVIVUM TECTORUM LEAF; BELLIS PERENNIS WHOLE; PERVINCA MINOR WHOLE; VIOLA TRICOLOR WHOLE</SubstanceName>
    <StrengthNumber>4; 4; 6; 8; 3; 8; 3; 2</StrengthNumber>
    <StrengthUnit>[hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-01-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190624</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For relief of acne, eczema, itching, psoriasis, and skin irritation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11788-058-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (11788-058-01) </PackageDescription>
    <NDC11Code>11788-0058-01</NDC11Code>
    <ProductNDC>11788-058</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250926</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202087</ApplicationNumber>
    <LabelerName>AiPing Pharmaceutical, Inc.</LabelerName>
    <SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250926</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
    <Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg, 7.5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>24510-058-01</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (24510-058-01)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>24510-0058-01</NDC11Code>
    <ProductNDC>24510-058</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nucynta</ProprietaryName>
    <ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
    <NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA200533</ApplicationNumber>
    <LabelerName>Collegium Pharmaceutical, Inc.</LabelerName>
    <SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NUCYNTA ER (tapentadol) is indicated for the management of: 1 Severe and persistent pain in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
    <Description>NUCYNTA ER (tapentadol) is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO∙HCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&amp;C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets).</Description>
  </NDC>
  <NDC>
    <NDCCode>24510-058-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24510-058-60) </PackageDescription>
    <NDC11Code>24510-0058-60</NDC11Code>
    <ProductNDC>24510-058</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nucynta</ProprietaryName>
    <ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
    <NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA200533</ApplicationNumber>
    <LabelerName>Collegium Pharmaceutical, Inc.</LabelerName>
    <SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NUCYNTA ER (tapentadol) is indicated for the management of: 1 Severe and persistent pain in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
    <Description>NUCYNTA ER (tapentadol) is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO∙HCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&amp;C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets).</Description>
  </NDC>
  <NDC>
    <NDCCode>35192-058-14</NDCCode>
    <PackageDescription>50 g in 1 BOTTLE, PLASTIC (35192-058-14) </PackageDescription>
    <NDC11Code>35192-0058-14</NDC11Code>
    <ProductNDC>35192-058</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bion Pure Mineral Sunscreen</ProprietaryName>
    <NonProprietaryName>Sunscreen</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250417</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>CA Botana International INC</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>19</StrengthNumber>
    <StrengthUnit>g/19g</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250417</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Keep out of reach of children. If product is swallowed, get medical help or contact poison control center right away.</IndicationAndUsage>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>59469-058-20</NDCCode><ProprietaryName>Helmin</ProprietaryName><NonProprietaryName>Onion, Artemisia Abrotanum Flowering Top, Artemisia Cina Pre-flowering Top, Cupric Oxide, Okoubaka Aubrevillei Bark, Schoenocaulon Officinale Seed, And Spigelia Anthelmia</NonProprietaryName></NDC><NDC><NDCCode>59469-101-20</NDCCode><ProprietaryName>Apo-pulm</ProprietaryName><NonProprietaryName>Onion, Bryonia Dioica Root, Hedera Helix Flowering Twig, Hyoscyamus Niger, Phosphorus, Polygala Senega Root, Antimony Potassium Tartrate, And Pulmonaria Officinalis Whole</NonProprietaryName></NDC><NDC><NDCCode>59469-108-20</NDCCode><ProprietaryName>Bronchi-pertu</ProprietaryName><NonProprietaryName>Bryonia Dioica Root, Protortonia Cacti, Guaiacum Officinale Resin, Oenanthe Aquatica Fruit, Phosphorus, Antimony Potassium Tartrate, Usnea Barbata, And Grindelia Hirsutula Whole</NonProprietaryName></NDC><NDC><NDCCode>59469-149-60</NDCCode><ProprietaryName>Demyc Spag.</ProprietaryName><NonProprietaryName>Ranunculus Bulbosus, Delphinium Staphisagria Seed, Piper Methysticum Root, Anagallis Arvensis, Calendula Officinalis Flowering Top, And Sage</NonProprietaryName></NDC><NDC><NDCCode>59469-303-20</NDCCode><ProprietaryName>Bronchi-pertu</ProprietaryName><NonProprietaryName>Bryonia Dioica Root, Protortonia Cacti, Guaiacum Officinale Resin, Oenanthe Aquatica Fruit, Phosphorus, Antimony Potassium Tartrate, Usnea Barbata, And Grindelia Hirsutula Whole</NonProprietaryName></NDC><NDC><NDCCode>59469-306-20</NDCCode><ProprietaryName>Demyc</ProprietaryName><NonProprietaryName>Ranunculus Bulbosus, Delphinium Staphisagria Seed, Macropiper Methysticum Root, Anagallis Arvensis, Calendula Officinalis Flowering Top, And Sage</NonProprietaryName></NDC><NDC><NDCCode>11084-058-20</NDCCode><ProprietaryName>Instantfoam Non-alcohol</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>33261-058-20</NDCCode><ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName><NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>49999-058-20</NDCCode><ProprietaryName>Naproxen</ProprietaryName><NonProprietaryName>Naproxen Sodium</NonProprietaryName></NDC><NDC><NDCCode>51079-058-20</NDCCode><ProprietaryName>Chlorthalidone</ProprietaryName><NonProprietaryName>Chlorthalidone</NonProprietaryName></NDC><NDC><NDCCode>51495-058-01</NDCCode><NonProprietaryName>L-alanyl-l-glutamine</NonProprietaryName></NDC><NDC><NDCCode>52125-058-20</NDCCode><ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName><NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>53747-058-00</NDCCode><NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55289-058-20</NDCCode><ProprietaryName>Cephalexin</ProprietaryName><NonProprietaryName>Cephalexin</NonProprietaryName></NDC><NDC><NDCCode>57237-058-20</NDCCode><ProprietaryName>Cefuroxime Axetil</ProprietaryName><NonProprietaryName>Cefuroxime Axetil</NonProprietaryName></NDC><NDC><NDCCode>60000-058-67</NDCCode><ProprietaryName>Mucus Relief Dm</ProprietaryName><NonProprietaryName>Guaifenesin And Dextromethorphan Hbr</NonProprietaryName></NDC><NDC><NDCCode>69842-058-20</NDCCode><ProprietaryName>Cvs Health Diaper Rash</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>70954-058-20</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>76397-058-07</NDCCode><NonProprietaryName>Efinaconazole</NonProprietaryName></NDC><NDC><NDCCode>82868-058-20</NDCCode><ProprietaryName>Meclizine Hydrochloride</ProprietaryName><NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>85207-058-03</NDCCode><NonProprietaryName>5-amino-1-methyl-1-quinolinium Iodide Anhydrous</NonProprietaryName></NDC><NDC><NDCCode>59469-141-10</NDCCode><ProprietaryName>Habifac</ProprietaryName><NonProprietaryName>Formic Acid, Nitric Acid, Baptisia Tinctoria Root, Graphite, Calcium Sulfide, Thuja Occidentalis Leafy Twig, Cynanchum Vincetoxicum Leaf, And Glechoma Hederacea Flowering Top</NonProprietaryName></NDC><NDC><NDCCode>59469-165-40</NDCCode><ProprietaryName>Inflamyar</ProprietaryName><NonProprietaryName>Arnica Montana Root, Bellis Perennis, Bryonia Dioica Root, Guaiacum Officinale Resin, Ledum Palustre Twig, Ruta Graveolens Flowering Top, Toxicodendron Pubescens Shoot, And Viscum Album Fruiting Top</NonProprietaryName></NDC><NDC><NDCCode>59469-172-10</NDCCode><ProprietaryName>Inflamyar</ProprietaryName><NonProprietaryName>Arnica Montana, Bellis Perennis, Bryonia Cretica Subsp. Dioica Root, Guaiacum Officinale Resin, Ledum Palustre Twig, Ruta Graveolens Whole, Toxicodendron Pubescens Leaf, And Viscum Album Fruit</NonProprietaryName></NDC><NDC><NDCCode>59469-307-30</NDCCode><ProprietaryName>Dercut</ProprietaryName><NonProprietaryName>Euphorbia Resinifera Resin, Goldenseal, Wood Creosote, Toxicodendron Pubescens Shoot, Sempervivum Tectorum Leaf, Bellis Perennis, Vinca Minor, And Viola Tricolor</NonProprietaryName></NDC><NDC><NDCCode>59469-307-40</NDCCode><ProprietaryName>Dercut</ProprietaryName><NonProprietaryName>Euphorbia Resinifera Resin, Goldenseal, Wood Creosote, Toxicodendron Pubescens Shoot, Sempervivum Tectorum Leaf, Bellis Perennis, Vinca Minor, And Viola Tricolor</NonProprietaryName></NDC><NDC><NDCCode>11788-058-01</NDCCode><ProprietaryName>Buspirone Hydrochloride</ProprietaryName><NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>24510-058-01</NDCCode><ProprietaryName>Nucynta</ProprietaryName><NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>24510-058-60</NDCCode><ProprietaryName>Nucynta</ProprietaryName><NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35192-058-14</NDCCode><ProprietaryName>Bion Pure Mineral Sunscreen</ProprietaryName><NonProprietaryName>Sunscreen</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",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
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      "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",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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