RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (36 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "0185-0613-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (0185-0613-01) ",
      "NDC11Code": "00185-0613-01",
      "ProductNDC": "0185-0613",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydroxyzine Pamoate",
      "NonProprietaryName": "Hydroxyzine Pamoate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19811214",
      "EndMarketingDate": "20190410",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA087479",
      "LabelerName": "Eon Labs, Inc.",
      "SubstanceName": "HYDROXYZINE PAMOATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19811214",
      "EndMarketingDatePackage": "20190410",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0185-0613-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (0185-0613-05) ",
      "NDC11Code": "00185-0613-05",
      "ProductNDC": "0185-0613",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydroxyzine Pamoate",
      "NonProprietaryName": "Hydroxyzine Pamoate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19811214",
      "EndMarketingDate": "20190410",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA087479",
      "LabelerName": "Eon Labs, Inc.",
      "SubstanceName": "HYDROXYZINE PAMOATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19811214",
      "EndMarketingDatePackage": "20190410",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0185-0613-10",
      "PackageDescription": "1000 CAPSULE in 1 BOTTLE (0185-0613-10) ",
      "NDC11Code": "00185-0613-10",
      "ProductNDC": "0185-0613",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydroxyzine Pamoate",
      "NonProprietaryName": "Hydroxyzine Pamoate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19811214",
      "EndMarketingDate": "20190410",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA087479",
      "LabelerName": "Eon Labs, Inc.",
      "SubstanceName": "HYDROXYZINE PAMOATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19811214",
      "EndMarketingDatePackage": "20190410",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "11410-613-01",
      "PackageDescription": "4 g in 1 JAR (11410-613-01)",
      "NDC11Code": "11410-0613-01",
      "ProductNDC": "11410-613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sheer Cover Mineral Foundation",
      "ProprietaryNameSuffix": "Spf-15 Almond",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20070101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Guthy-Renker LLC",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "12",
      "StrengthUnit": "mg/.1g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "12658-0613-1",
      "PackageDescription": "10 kg in 1 DRUM (12658-0613-1) ",
      "NDC11Code": "12658-0613-01",
      "ProductNDC": "12658-0613",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Hydrochlorothiazide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19820101",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Pharmaceutical Works POLPHARMA",
      "SubstanceName": "HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "01-JAN-82"
    },
    {
      "NDCCode": "15631-0613-1",
      "PackageDescription": "4 TABLET in 1 BLISTER PACK (15631-0613-1)",
      "NDC11Code": "15631-0613-01",
      "ProductNDC": "15631-0613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kali Sulphuricum",
      "NonProprietaryName": "Kali Sulphuricum",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151207",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "POTASSIUM SULFATE",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "16714-613-01",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16714-613-01) ",
      "NDC11Code": "16714-0613-01",
      "ProductNDC": "16714-613",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077206",
      "LabelerName": "NorthStar Rx LLC",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-02-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20070206",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].",
      "Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
    },
    {
      "NDCCode": "36800-613-01",
      "PackageDescription": "71 g in 1 BOTTLE, PLASTIC (36800-613-01) ",
      "NDC11Code": "36800-0613-01",
      "ProductNDC": "36800-613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anti-fungal Powder",
      "NonProprietaryName": "Miconazole Nitrate",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240603",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "TopCo Associates",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Active",
      "LastUpdate": "2025-11-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240603",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the cure of most athlete's foot, jock itch and ringworm."
    },
    {
      "NDCCode": "37662-0613-1",
      "PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-0613-1) ",
      "NDC11Code": "37662-0613-01",
      "ProductNDC": "37662-0613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cuprum Muriaticum",
      "NonProprietaryName": "Cuprum Muriaticum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220617",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "CUPRIC CHLORIDE ANHYDROUS",
      "StrengthNumber": "100",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220617",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43406-0613-1",
      "PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43406-0613-1) ",
      "NDC11Code": "43406-0613-01",
      "ProductNDC": "43406-0613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gblv Hp",
      "NonProprietaryName": "Atropa Belladonna, Berberis Vulgaris Root Bark, Milk Thistle, Chelidonium Majus, Citrullus Colocynthis Fruit Pulp, Dioscorea Villosa Tuber, Goldenseal, Lycopodium Clavatum Spore, Sodium Sulfate, Strychnos Nux-vomica Seed, Phosphorus, Anemone Pulsatilla, Veratrum Album Root",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160601",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Natural Creations, Inc.",
      "SubstanceName": "ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; ANEMONE PULSATILLA; VERATRUM ALBUM ROOT",
      "StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
      "StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160601",
      "SamplePackage": "N",
      "IndicationAndUsage": "USES: Temporarily relieves flatulence, constipation, and belching.**."
    },
    {
      "NDCCode": "43742-0613-1",
      "PackageDescription": "960 mL in 1 BOTTLE (43742-0613-1) ",
      "NDC11Code": "43742-0613-01",
      "ProductNDC": "43742-0613",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Gluten",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20150721",
      "EndMarketingDate": "20231229",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Deseret Biologicals, Inc.",
      "SubstanceName": "WHEAT GLUTEN",
      "StrengthNumber": "12",
      "StrengthUnit": "[hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "StartMarketingDatePackage": "21-JUL-15",
      "EndMarketingDatePackage": "29-DEC-23"
    },
    {
      "NDCCode": "43857-0613-1",
      "PackageDescription": "30 mL in 1 PACKAGE (43857-0613-1) ",
      "NDC11Code": "43857-0613-01",
      "ProductNDC": "43857-0613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bio Chem Detox",
      "NonProprietaryName": "Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Rhamnus Purshiana, Stillingia Sylvatica, Trifolium Pratense, Triticum Aestivum, Xanthoxylum Fraxineum, Phytolacca Decandra, Glandula Suprarenalis Suis, Hepar Suis, Lymph Node (suis), Thyroidinum (suis), Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Aconitum Napellus, Arsenicum Album, Belladonna, Carbo Vegetabilis, Cinchona Officinalis, Conium Maculatum, Mercurius Corrosivus, Phosphorus, Sulphur, Tabacum, Nitricum Acidum, Agaricus Muscarius,",
      "DosageFormName": "SPRAY",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210902",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "BioActive Nutritional, Inc.",
      "SubstanceName": "BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; FRANGULA PURSHIANA BARK; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; TRITICUM AESTIVUM WHOLE; ZANTHOXYLUM AMERICANUM BARK; PHYTOLACCA AMERICANA ROOT; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA LYMPH; THYROID; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; ACONITUM NAPELLUS WHOLE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ACTIVATED CHARCOAL; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; MERCURIC CHLORIDE; PHOSPHORUS; SULFUR; TOBACCO LEAF; NITRIC ACID; AMANITA MUSCARIA FRUITING BODY; LACHESIS MUTA VENOM; PHYSOSTIGMA VENENOSUM SEED; TUBOCURARINE CHLORIDE",
      "StrengthNumber": "3; 3; 3; 3; 3; 3; 3; 3; 4; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210902",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of numbness, tingling, trembling, paralysis, short of breath, burning eyes.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
    },
    {
      "NDCCode": "44911-0613-1",
      "PackageDescription": "30 mL in 1 BOTTLE, DROPPER (44911-0613-1) ",
      "NDC11Code": "44911-0613-01",
      "ProductNDC": "44911-0613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Male Balance",
      "NonProprietaryName": "Avena Sativa, Hepar Suis, Orchitinum (suis), Testosterone, Agnus Castus, Damiana, Ginkgo Biloba, Hypothalamus (suis), Lycopodium Clabatum, Human Growth Hormone, Epimedium Grandiflorum, Serotonin (hydrochloride)",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210525",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Energique,Inc.",
      "SubstanceName": "AVENA SATIVA FLOWERING TOP; PORK LIVER; SUS SCROFA TESTICLE; TESTOSTERONE; CHASTE TREE FRUIT; TURNERA DIFFUSA LEAFY TWIG; GINKGO; SUS SCROFA HYPOTHALAMUS; LYCOPODIUM CLAVATUM SPORE; SOMATROPIN; EPIMEDIUM GRANDIFLORUM TOP; SEROTONIN HYDROCHLORIDE",
      "StrengthNumber": "6; 6; 6; 6; 12; 12; 12; 12; 12; 26; 30; 30",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS], Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
      "DEASchedule": "CIII",
      "Status": "Active",
      "LastUpdate": "2024-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210525",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of sexual debility from nervous prostration, for enhancing sexual function, nervous exhaustion causing lack of sexual desire.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
    },
    {
      "NDCCode": "45865-613-01",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (45865-613-01)  > 5 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "45865-0613-01",
      "ProductNDC": "45865-613",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketorolac Tromethamine",
      "NonProprietaryName": "Ketorolac Tromethamine",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20091207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076109",
      "LabelerName": "Medsource Pharmaceuticals",
      "SubstanceName": "KETOROLAC TROMETHAMINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.",
      "Description": "Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-benzoyl-2,3-dihydro-1 H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure. Ketorolac Tromethamine Ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac Tromethamine Ophthalmic Solution is a racemic mixture of R-(+) and S-(-) - ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of Ketorolac Tromethamine Ophthalmic Solution is 290 mOsmol/kg. Each mL of Ketorolac Tromethamine Ophthalmic Solution contains: Active: Ketorolac tromethamine 0.5%. Preservative: Benzalkonium chloride 0.01%. Inactives: Edetate disodium dihydrate 0.1%; octoxynol 40; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH; and water for injection."
    },
    {
      "NDCCode": "49288-0613-1",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0613-1)",
      "NDC11Code": "49288-0613-01",
      "ProductNDC": "49288-0613",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Western Wheatgrass",
      "NonProprietaryName": "Western Wheatgrass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "PASCOPYRUM SMITHII POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "50090-0613-1",
      "PackageDescription": "21 CAPSULE in 1 BOTTLE (50090-0613-1) ",
      "NDC11Code": "50090-0613-01",
      "ProductNDC": "50090-0613",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Etodolac",
      "NonProprietaryName": "Etodolac",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20030501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075419",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "ETODOLAC",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20141128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac.  Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac capsules are indicated.  For acute and long-term use in the management of signs and symptoms of the following: 1 Osteoarthritis, 2 Rheumatoid arthritis.",
      "Description": "Etodolac is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each etodolac capsule, USP is for oral administration, contains 200 mg or 300 mg of etodolac. In addition, each capsule contains the following inactive ingredients: black iron oxide, black SW-9008/SW-9009, colloidal silicon dioxide, croscarmellose sodium, gelatin, lactose monohydrate, sodium lauryl sulfate, stearic acid, talc and titanium dioxide."
    },
    {
      "NDCCode": "50742-613-01",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-613-01) ",
      "NDC11Code": "50742-0613-01",
      "ProductNDC": "50742-613",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxcarbazepine",
      "NonProprietaryName": "Oxcarbazepine",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215796",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "OXCARBAZEPINE",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.",
      "Description": "Oxcarbazepine is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is Light orange to creamish white or Off-white powder. Oxcarbazepine is sparingly soluble in chloroform (30-100 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 40 mg/L (0.04 g/L) at pH 7.0, 25°C.  The molecular formula is C15H12N2O2 and its molecular weight is 252.27. Oxcarbazepine extended-release tablets tablets contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, fumaric acid, povidone, hypromellose, colloidal silicon dioxide, magnesium stearate, Carboxymethyl cellulose sodium, polyvinyl alcohol, FD&C Yellow 6 lake, polyethylene glycol, talc, D&C Red No. 30 Lake and titanium dioxide."
    },
    {
      "NDCCode": "52862-613-01",
      "PackageDescription": "50 PATCH in 1 BAG (52862-613-01)  / 3.2 g in 1 PATCH",
      "NDC11Code": "52862-0613-01",
      "ProductNDC": "52862-613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Health Smart Antibacterial Wet Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201001",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "International Wholesale, Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20201001",
      "SamplePackage": "N",
      "IndicationAndUsage": "decreases bacteria on skin."
    },
    {
      "NDCCode": "53808-0613-1",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (53808-0613-1)",
      "NDC11Code": "53808-0613-01",
      "ProductNDC": "53808-0613",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077336",
      "LabelerName": "State of Florida DOH Central Pharmacy",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Metformin hydrochloride extended - release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride extended - release tablets are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended - release tablets contain 500 mg or 750 mg of metformin hydrochloride USP as the active ingredient. Metformin hydrochloride extended-release tablets 500 mg contain the inactive ingredients xanthan gum, hypromellose, sodium carbonate, povidone, talc, colloidal silicon dioxide and magnesium stearate. Metformin hydrochloride extended-release tablets 750 mg contain the inactive ingredients xanthan gum, hypromellose, sodium carbonate, povidone, talc, colloidal silicon dioxide, magnesium stearate and ferric oxide (red). System Components and Performance- Metformin hydrochloride extended - release tablets comprises a hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass."
    },
    {
      "NDCCode": "54860-613-01",
      "PackageDescription": "59 mL in 1 BOTTLE (54860-613-01) ",
      "NDC11Code": "54860-0613-01",
      "ProductNDC": "54860-613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Non -alcohol Blueberry Scented Hand Sanitizer",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260716",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Shenzhen Lantern Scicence Co.,Ltd.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260716",
      "SamplePackage": "N",
      "IndicationAndUsage": "Rub a dime sized drop into hands. For children under 6 use under adult supervision."
    },
    {
      "NDCCode": "54973-0613-1",
      "PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0613-1)",
      "NDC11Code": "54973-0613-01",
      "ProductNDC": "54973-0613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gelsemium Semp",
      "NonProprietaryName": "Gelsemium Sempervirens Root",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19550101",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hyland's",
      "SubstanceName": "GELSEMIUM SEMPERVIRENS ROOT",
      "StrengthNumber": "6",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-20",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "56136-613-01",
      "PackageDescription": "29 mL in 1 BOTTLE (56136-613-01) ",
      "NDC11Code": "56136-0613-01",
      "ProductNDC": "56136-613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Peppermint Cream Scented Anti-bacterial Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210720",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Ganzhou Olivee Cosmetic Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210720",
      "SamplePackage": "N",
      "IndicationAndUsage": "Decrease bacteria on hands."
    },
    {
      "NDCCode": "57520-0613-1",
      "PackageDescription": "30 mL in 1 BOTTLE, DROPPER (57520-0613-1)",
      "NDC11Code": "57520-0613-01",
      "ProductNDC": "57520-0613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Metabolism",
      "NonProprietaryName": "Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Rhamnus Purshiana, Trifolium Pratense, Xanthoxylum Fraxineum, Ascorbic Acid, Cyanocobalamin, Riboflavinum, Thiaminum Hydrochloricum, German Sesquioxide,",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110610",
      "EndMarketingDate": "20180426",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Apotheca Company",
      "SubstanceName": "BERBERIS VULGARIS FRUIT; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; FRANGULA PURSHIANA BARK; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; ASCORBIC ACID; CYANOCOBALAMIN; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; GERMANIUM SESQUIOXIDE; CYSTEINE; MANGANESE GLUCONATE; ADENOSINE TRIPHOSPHATE; .ALPHA.-KETOGLUTARIC ACID; FUMARIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM DIETHYL OXALACETATE; PULSATILLA VULGARIS; PYRUVIC ACID; UBIDECARENONE; CALCIUM SULFIDE",
      "StrengthNumber": "3; 3; 3; 3; 3; 3; 6; 6; 6; 6; 8; 9; 10; 12; 12; 12; 12; 12; 12; 12; 12; 30",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-04-26",
      "ProductNdcExcludeFlag": "N"
    },
    {
      "NDCCode": "58578-0613-1",
      "PackageDescription": "473 mL in 1 BOTTLE (58578-0613-1) ",
      "NDC11Code": "58578-0613-01",
      "ProductNDC": "58578-0613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Closys",
      "NonProprietaryName": "Hydrogen Peroxide",
      "DosageFormName": "RINSE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250127",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "Rowpar Pharmaceuticals, Inc.",
      "SubstanceName": "HYDROGEN PEROXIDE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250127",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums. Assist in the removal of foreign material from minor oral wounds."
    },
    {
      "NDCCode": "60510-613-01",
      "PackageDescription": "50000 TABLET, FILM COATED in 1 DRUM (60510-613-01) ",
      "NDC11Code": "60510-0613-01",
      "ProductNDC": "60510-613",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Donepezil Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "19961125",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Eisai Manufacturing Ltd.",
      "SubstanceName": "DONEPEZIL HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2022-06-16",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "25-NOV-96"
    },
    {
      "NDCCode": "60905-0613-1",
      "PackageDescription": "1 BOTTLE in 1 CARTON (60905-0613-1)  / 30 mL in 1 BOTTLE",
      "NDC11Code": "60905-0613-01",
      "ProductNDC": "60905-0613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Matissime Velvet Radiant Mat Fluid Foundation With Sunscreen Broad Spectrum Spf 20",
      "ProprietaryNameSuffix": "Mat Mocha 10",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "LVMH Fragrance Brands",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "31.6",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180901",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions."
    },
    {
      "NDCCode": "62032-613-01",
      "PackageDescription": "1 KIT in 1 CARTON (62032-613-01)  *  148 mL in 1 BOTTLE, PLASTIC (62032-612-04)  *  47 mL in 1 BOTTLE, PLASTIC (62032-611-01)  *  118 mL in 1 BOTTLE, PLASTIC (62032-610-04) ",
      "NDC11Code": "62032-0613-01",
      "ProductNDC": "62032-613",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clenziderm M.d. System",
      "ProprietaryNameSuffix": "Acne Therapeutic System",
      "NonProprietaryName": "Salicylic Acid And Benzoyl Peroxide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20120101",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "OBAGI COSMECEUTICAL LLC",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20120101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "62157-613-01",
      "PackageDescription": "500 g in 1 JAR (62157-613-01)",
      "NDC11Code": "62157-0613-01",
      "ProductNDC": "62157-613",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Vorinostat",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20180724",
      "MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
      "LabelerName": "AX Pharmaceutical Corp",
      "SubstanceName": "VORINOSTAT",
      "StrengthNumber": "495",
      "StrengthUnit": "g/500g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "62577-613-01",
      "PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (62577-613-01)  > .5 mL in 1 SYRINGE, GLASS (62577-613-11)",
      "NDC11Code": "62577-0613-01",
      "ProductNDC": "62577-613",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Flucelvax",
      "NonProprietaryName": "Influenza A Virus A/brisbane/10/2010 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (mdck Cell Derived, Propiolactone Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20140701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125408",
      "LabelerName": "Novartis Vaccines and Diagnostics, Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "63187-613-01",
      "PackageDescription": "1 TABLET in 1 BLISTER PACK (63187-613-01) ",
      "NDC11Code": "63187-0613-01",
      "ProductNDC": "63187-613",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluconazole",
      "NonProprietaryName": "Fluconazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040729",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076077",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "FLUCONAZOLE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20181201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluconazole Tablets USP are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing Fluconazole Tablets USP for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.",
      "Description": "Fluconazole, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-Difluoro-1′,1′-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol and has the following structural formula. C13H12F2N6O M.W. 306.27. Fluconazole, USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Tablets USP, for oral administration, contain 50, 100, 150, or 200 mg of fluconazole, USP and have the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red #40 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc."
    }
  ]
}
                    

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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>BioActive Nutritional, Inc.</LabelerName>
    <SubstanceName>BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; FRANGULA PURSHIANA BARK; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; TRITICUM AESTIVUM WHOLE; ZANTHOXYLUM AMERICANUM BARK; PHYTOLACCA AMERICANA ROOT; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA LYMPH; THYROID; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; ACONITUM NAPELLUS WHOLE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ACTIVATED CHARCOAL; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; MERCURIC CHLORIDE; PHOSPHORUS; SULFUR; TOBACCO LEAF; NITRIC ACID; AMANITA MUSCARIA FRUITING BODY; LACHESIS MUTA VENOM; PHYSOSTIGMA VENENOSUM SEED; TUBOCURARINE CHLORIDE</SubstanceName>
    <StrengthNumber>3; 3; 3; 3; 3; 3; 3; 3; 4; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30</StrengthNumber>
    <StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210902</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of numbness, tingling, trembling, paralysis, short of breath, burning eyes.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>44911-0613-1</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, DROPPER (44911-0613-1) </PackageDescription>
    <NDC11Code>44911-0613-01</NDC11Code>
    <ProductNDC>44911-0613</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Male Balance</ProprietaryName>
    <NonProprietaryName>Avena Sativa, Hepar Suis, Orchitinum (suis), Testosterone, Agnus Castus, Damiana, Ginkgo Biloba, Hypothalamus (suis), Lycopodium Clabatum, Human Growth Hormone, Epimedium Grandiflorum, Serotonin (hydrochloride)</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210525</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Energique,Inc.</LabelerName>
    <SubstanceName>AVENA SATIVA FLOWERING TOP; PORK LIVER; SUS SCROFA TESTICLE; TESTOSTERONE; CHASTE TREE FRUIT; TURNERA DIFFUSA LEAFY TWIG; GINKGO; SUS SCROFA HYPOTHALAMUS; LYCOPODIUM CLAVATUM SPORE; SOMATROPIN; EPIMEDIUM GRANDIFLORUM TOP; SEROTONIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>6; 6; 6; 6; 12; 12; 12; 12; 12; 26; 30; 30</StrengthNumber>
    <StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
    <Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS], Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210525</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of sexual debility from nervous prostration, for enhancing sexual function, nervous exhaustion causing lack of sexual desire.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>45865-613-01</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (45865-613-01)  &gt; 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>45865-0613-01</NDC11Code>
    <ProductNDC>45865-613</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20091207</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076109</ApplicationNumber>
    <LabelerName>Medsource Pharmaceuticals</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.</IndicationAndUsage>
    <Description>Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-benzoyl-2,3-dihydro-1 H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure. Ketorolac Tromethamine Ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac Tromethamine Ophthalmic Solution is a racemic mixture of R-(+) and S-(-) - ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of Ketorolac Tromethamine Ophthalmic Solution is 290 mOsmol/kg. Each mL of Ketorolac Tromethamine Ophthalmic Solution contains: Active: Ketorolac tromethamine 0.5%. Preservative: Benzalkonium chloride 0.01%. Inactives: Edetate disodium dihydrate 0.1%; octoxynol 40; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH; and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0613-1</NDCCode>
    <PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0613-1)</PackageDescription>
    <NDC11Code>49288-0613-01</NDC11Code>
    <ProductNDC>49288-0613</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Western Wheatgrass</ProprietaryName>
    <NonProprietaryName>Western Wheatgrass</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>PASCOPYRUM SMITHII POLLEN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-0613-1</NDCCode>
    <PackageDescription>21 CAPSULE in 1 BOTTLE (50090-0613-1) </PackageDescription>
    <NDC11Code>50090-0613-01</NDC11Code>
    <ProductNDC>50090-0613</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Etodolac</ProprietaryName>
    <NonProprietaryName>Etodolac</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075419</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>ETODOLAC</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac.  Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac capsules are indicated.  For acute and long-term use in the management of signs and symptoms of the following: 1 Osteoarthritis, 2 Rheumatoid arthritis.</IndicationAndUsage>
    <Description>Etodolac is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each etodolac capsule, USP is for oral administration, contains 200 mg or 300 mg of etodolac. In addition, each capsule contains the following inactive ingredients: black iron oxide, black SW-9008/SW-9009, colloidal silicon dioxide, croscarmellose sodium, gelatin, lactose monohydrate, sodium lauryl sulfate, stearic acid, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>50742-613-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-613-01) </PackageDescription>
    <NDC11Code>50742-0613-01</NDC11Code>
    <ProductNDC>50742-613</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxcarbazepine</ProprietaryName>
    <NonProprietaryName>Oxcarbazepine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215796</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>OXCARBAZEPINE</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.</IndicationAndUsage>
    <Description>Oxcarbazepine is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is Light orange to creamish white or Off-white powder. Oxcarbazepine is sparingly soluble in chloroform (30-100 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 40 mg/L (0.04 g/L) at pH 7.0, 25°C.  The molecular formula is C15H12N2O2 and its molecular weight is 252.27. Oxcarbazepine extended-release tablets tablets contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, fumaric acid, povidone, hypromellose, colloidal silicon dioxide, magnesium stearate, Carboxymethyl cellulose sodium, polyvinyl alcohol, FD&amp;C Yellow 6 lake, polyethylene glycol, talc, D&amp;C Red No. 30 Lake and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>52862-613-01</NDCCode>
    <PackageDescription>50 PATCH in 1 BAG (52862-613-01)  / 3.2 g in 1 PATCH</PackageDescription>
    <NDC11Code>52862-0613-01</NDC11Code>
    <ProductNDC>52862-613</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Health Smart Antibacterial Wet Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>International Wholesale, Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>decreases bacteria on skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>53808-0613-1</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (53808-0613-1)</PackageDescription>
    <NDC11Code>53808-0613-01</NDC11Code>
    <ProductNDC>53808-0613</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077336</ApplicationNumber>
    <LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Metformin hydrochloride extended - release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride extended - release tablets are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended - release tablets contain 500 mg or 750 mg of metformin hydrochloride USP as the active ingredient. Metformin hydrochloride extended-release tablets 500 mg contain the inactive ingredients xanthan gum, hypromellose, sodium carbonate, povidone, talc, colloidal silicon dioxide and magnesium stearate. Metformin hydrochloride extended-release tablets 750 mg contain the inactive ingredients xanthan gum, hypromellose, sodium carbonate, povidone, talc, colloidal silicon dioxide, magnesium stearate and ferric oxide (red). System Components and Performance- Metformin hydrochloride extended - release tablets comprises a hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
  </NDC>
  <NDC>
    <NDCCode>54860-613-01</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE (54860-613-01) </PackageDescription>
    <NDC11Code>54860-0613-01</NDC11Code>
    <ProductNDC>54860-613</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Non -alcohol Blueberry Scented Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260716</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Shenzhen Lantern Scicence Co.,Ltd.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260716</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rub a dime sized drop into hands. For children under 6 use under adult supervision.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54973-0613-1</NDCCode>
    <PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0613-1)</PackageDescription>
    <NDC11Code>54973-0613-01</NDC11Code>
    <ProductNDC>54973-0613</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gelsemium Semp</ProprietaryName>
    <NonProprietaryName>Gelsemium Sempervirens Root</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19550101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hyland's</LabelerName>
    <SubstanceName>GELSEMIUM SEMPERVIRENS ROOT</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>56136-613-01</NDCCode>
    <PackageDescription>29 mL in 1 BOTTLE (56136-613-01) </PackageDescription>
    <NDC11Code>56136-0613-01</NDC11Code>
    <ProductNDC>56136-613</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Peppermint Cream Scented Anti-bacterial Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210720</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Ganzhou Olivee Cosmetic Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Decrease bacteria on hands.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>57520-0613-1</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, DROPPER (57520-0613-1)</PackageDescription>
    <NDC11Code>57520-0613-01</NDC11Code>
    <ProductNDC>57520-0613</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Metabolism</ProprietaryName>
    <NonProprietaryName>Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Rhamnus Purshiana, Trifolium Pratense, Xanthoxylum Fraxineum, Ascorbic Acid, Cyanocobalamin, Riboflavinum, Thiaminum Hydrochloricum, German Sesquioxide,</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110610</StartMarketingDate>
    <EndMarketingDate>20180426</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Apotheca Company</LabelerName>
    <SubstanceName>BERBERIS VULGARIS FRUIT; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; FRANGULA PURSHIANA BARK; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; ASCORBIC ACID; CYANOCOBALAMIN; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; GERMANIUM SESQUIOXIDE; CYSTEINE; MANGANESE GLUCONATE; ADENOSINE TRIPHOSPHATE; .ALPHA.-KETOGLUTARIC ACID; FUMARIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM DIETHYL OXALACETATE; PULSATILLA VULGARIS; PYRUVIC ACID; UBIDECARENONE; CALCIUM SULFIDE</SubstanceName>
    <StrengthNumber>3; 3; 3; 3; 3; 3; 6; 6; 6; 6; 8; 9; 10; 12; 12; 12; 12; 12; 12; 12; 12; 30</StrengthNumber>
    <StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-26</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
  </NDC>
  <NDC>
    <NDCCode>58578-0613-1</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (58578-0613-1) </PackageDescription>
    <NDC11Code>58578-0613-01</NDC11Code>
    <ProductNDC>58578-0613</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Closys</ProprietaryName>
    <NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
    <DosageFormName>RINSE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250127</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M022</ApplicationNumber>
    <LabelerName>Rowpar Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums. Assist in the removal of foreign material from minor oral wounds.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>60510-613-01</NDCCode>
    <PackageDescription>50000 TABLET, FILM COATED in 1 DRUM (60510-613-01) </PackageDescription>
    <NDC11Code>60510-0613-01</NDC11Code>
    <ProductNDC>60510-613</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>19961125</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Eisai Manufacturing Ltd.</LabelerName>
    <SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-06-16</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>25-NOV-96</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>60905-0613-1</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (60905-0613-1)  / 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>60905-0613-01</NDC11Code>
    <ProductNDC>60905-0613</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Matissime Velvet Radiant Mat Fluid Foundation With Sunscreen Broad Spectrum Spf 20</ProprietaryName>
    <ProprietaryNameSuffix>Mat Mocha 10</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>LVMH Fragrance Brands</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>31.6</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62032-613-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (62032-613-01)  *  148 mL in 1 BOTTLE, PLASTIC (62032-612-04)  *  47 mL in 1 BOTTLE, PLASTIC (62032-611-01)  *  118 mL in 1 BOTTLE, PLASTIC (62032-610-04) </PackageDescription>
    <NDC11Code>62032-0613-01</NDC11Code>
    <ProductNDC>62032-613</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clenziderm M.d. System</ProprietaryName>
    <ProprietaryNameSuffix>Acne Therapeutic System</ProprietaryNameSuffix>
    <NonProprietaryName>Salicylic Acid And Benzoyl Peroxide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>OBAGI COSMECEUTICAL LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62157-613-01</NDCCode>
    <PackageDescription>500 g in 1 JAR (62157-613-01)</PackageDescription>
    <NDC11Code>62157-0613-01</NDC11Code>
    <ProductNDC>62157-613</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Vorinostat</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20180724</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
    <LabelerName>AX Pharmaceutical Corp</LabelerName>
    <SubstanceName>VORINOSTAT</SubstanceName>
    <StrengthNumber>495</StrengthNumber>
    <StrengthUnit>g/500g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>62577-613-01</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 CARTON (62577-613-01)  &gt; .5 mL in 1 SYRINGE, GLASS (62577-613-11)</PackageDescription>
    <NDC11Code>62577-0613-01</NDC11Code>
    <ProductNDC>62577-613</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Flucelvax</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/brisbane/10/2010 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (mdck Cell Derived, Propiolactone Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20140701</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125408</ApplicationNumber>
    <LabelerName>Novartis Vaccines and Diagnostics, Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>63187-613-01</NDCCode>
    <PackageDescription>1 TABLET in 1 BLISTER PACK (63187-613-01) </PackageDescription>
    <NDC11Code>63187-0613-01</NDC11Code>
    <ProductNDC>63187-613</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluconazole</ProprietaryName>
    <NonProprietaryName>Fluconazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040729</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076077</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>FLUCONAZOLE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluconazole Tablets USP are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing Fluconazole Tablets USP for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.</IndicationAndUsage>
    <Description>Fluconazole, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-Difluoro-1′,1′-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol and has the following structural formula. C13H12F2N6O M.W. 306.27. Fluconazole, USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Tablets USP, for oral administration, contain 50, 100, 150, or 200 mg of fluconazole, USP and have the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&amp;C red #40 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0185-0613-01</NDCCode><ProprietaryName>Hydroxyzine Pamoate</ProprietaryName><NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName></NDC><NDC><NDCCode>0185-0613-05</NDCCode><ProprietaryName>Hydroxyzine Pamoate</ProprietaryName><NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName></NDC><NDC><NDCCode>0185-0613-10</NDCCode><ProprietaryName>Hydroxyzine Pamoate</ProprietaryName><NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName></NDC><NDC><NDCCode>11410-613-01</NDCCode><ProprietaryName>Sheer Cover Mineral Foundation</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>12658-0613-1</NDCCode><NonProprietaryName>Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>15631-0613-1</NDCCode><ProprietaryName>Kali Sulphuricum</ProprietaryName><NonProprietaryName>Kali Sulphuricum</NonProprietaryName></NDC><NDC><NDCCode>16714-613-01</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>36800-613-01</NDCCode><ProprietaryName>Anti-fungal Powder</ProprietaryName><NonProprietaryName>Miconazole Nitrate</NonProprietaryName></NDC><NDC><NDCCode>37662-0613-1</NDCCode><ProprietaryName>Cuprum Muriaticum</ProprietaryName><NonProprietaryName>Cuprum Muriaticum</NonProprietaryName></NDC><NDC><NDCCode>43406-0613-1</NDCCode><ProprietaryName>Gblv Hp</ProprietaryName><NonProprietaryName>Atropa Belladonna, Berberis Vulgaris Root Bark, Milk Thistle, Chelidonium Majus, Citrullus Colocynthis Fruit Pulp, Dioscorea Villosa Tuber, Goldenseal, Lycopodium Clavatum Spore, Sodium Sulfate, Strychnos Nux-vomica Seed, Phosphorus, Anemone Pulsatilla, Veratrum Album Root</NonProprietaryName></NDC><NDC><NDCCode>43742-0613-1</NDCCode><NonProprietaryName>Gluten</NonProprietaryName></NDC><NDC><NDCCode>43857-0613-1</NDCCode><ProprietaryName>Bio Chem Detox</ProprietaryName><NonProprietaryName>Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Rhamnus Purshiana, Stillingia Sylvatica, Trifolium Pratense, Triticum Aestivum, Xanthoxylum Fraxineum, Phytolacca Decandra, Glandula Suprarenalis Suis, Hepar Suis, Lymph Node (suis), Thyroidinum (suis), Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Aconitum Napellus, Arsenicum Album, Belladonna, Carbo Vegetabilis, Cinchona Officinalis, Conium Maculatum, Mercurius Corrosivus, Phosphorus, Sulphur, Tabacum, Nitricum Acidum, Agaricus Muscarius,</NonProprietaryName></NDC><NDC><NDCCode>44911-0613-1</NDCCode><ProprietaryName>Male Balance</ProprietaryName><NonProprietaryName>Avena Sativa, Hepar Suis, Orchitinum (suis), Testosterone, Agnus Castus, Damiana, Ginkgo Biloba, Hypothalamus (suis), Lycopodium Clabatum, Human Growth Hormone, Epimedium Grandiflorum, Serotonin (hydrochloride)</NonProprietaryName></NDC><NDC><NDCCode>45865-613-01</NDCCode><ProprietaryName>Ketorolac Tromethamine</ProprietaryName><NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName></NDC><NDC><NDCCode>49288-0613-1</NDCCode><ProprietaryName>Western Wheatgrass</ProprietaryName><NonProprietaryName>Western Wheatgrass</NonProprietaryName></NDC><NDC><NDCCode>50090-0613-1</NDCCode><ProprietaryName>Etodolac</ProprietaryName><NonProprietaryName>Etodolac</NonProprietaryName></NDC><NDC><NDCCode>50742-613-01</NDCCode><ProprietaryName>Oxcarbazepine</ProprietaryName><NonProprietaryName>Oxcarbazepine</NonProprietaryName></NDC><NDC><NDCCode>52862-613-01</NDCCode><ProprietaryName>Health Smart Antibacterial Wet Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>53808-0613-1</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54860-613-01</NDCCode><ProprietaryName>Non -alcohol Blueberry Scented Hand Sanitizer</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>54973-0613-1</NDCCode><ProprietaryName>Gelsemium Semp</ProprietaryName><NonProprietaryName>Gelsemium Sempervirens Root</NonProprietaryName></NDC><NDC><NDCCode>56136-613-01</NDCCode><ProprietaryName>Peppermint Cream Scented Anti-bacterial Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>57520-0613-1</NDCCode><ProprietaryName>Metabolism</ProprietaryName><NonProprietaryName>Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Rhamnus Purshiana, Trifolium Pratense, Xanthoxylum Fraxineum, Ascorbic Acid, Cyanocobalamin, Riboflavinum, Thiaminum Hydrochloricum, German Sesquioxide,</NonProprietaryName></NDC><NDC><NDCCode>58578-0613-1</NDCCode><ProprietaryName>Closys</ProprietaryName><NonProprietaryName>Hydrogen Peroxide</NonProprietaryName></NDC><NDC><NDCCode>60510-613-01</NDCCode><NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>60905-0613-1</NDCCode><ProprietaryName>Matissime Velvet Radiant Mat Fluid Foundation With Sunscreen Broad Spectrum Spf 20</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>62032-613-01</NDCCode><ProprietaryName>Clenziderm M.d. System</ProprietaryName><NonProprietaryName>Salicylic Acid And Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>62157-613-01</NDCCode><NonProprietaryName>Vorinostat</NonProprietaryName></NDC><NDC><NDCCode>62577-613-01</NDCCode><ProprietaryName>Flucelvax</ProprietaryName><NonProprietaryName>Influenza A Virus A/brisbane/10/2010 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (mdck Cell Derived, Propiolactone Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>63187-613-01</NDCCode><ProprietaryName>Fluconazole</ProprietaryName><NonProprietaryName>Fluconazole</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
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      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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