RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (9 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "69314-101-42",
      "PackageDescription": "57 g in 1 TUBE (69314-101-42)",
      "NDC11Code": "69314-0101-42",
      "ProductNDC": "69314-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Thermal-aid",
      "ProprietaryNameSuffix": "Headache Relief",
      "NonProprietaryName": "Bryonia Alba Root And Toxicodendron Pubescens Leaf",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140408",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Pacific Shore Holdings, Inc.",
      "SubstanceName": "BRYONIA ALBA ROOT; TOXICODENDRON PUBESCENS LEAF",
      "StrengthNumber": "6; 6",
      "StrengthUnit": "[hp_X]/57g; [hp_X]/57g",
      "Status": "Deprecated",
      "LastUpdate": "2017-03-07"
    },
    {
      "NDCCode": "69314-201-42",
      "PackageDescription": "57 g in 1 TUBE (69314-201-42) ",
      "NDC11Code": "69314-0201-42",
      "ProductNDC": "69314-201",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Thermal-aid",
      "ProprietaryNameSuffix": "Headache Relief",
      "NonProprietaryName": "Bryonia Alba Root And Toxicodendron Pubescens Leaf",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190801",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Pacific Shore Holdings, Inc.",
      "SubstanceName": "BRYONIA ALBA ROOT; TOXICODENDRON PUBESCENS LEAF",
      "StrengthNumber": "6; 6",
      "StrengthUnit": "[hp_X]/57g; [hp_X]/57g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20190801",
      "SamplePackage": "N",
      "IndicationAndUsage": "External analgesic for temporary relief of headache and migraine pain."
    },
    {
      "NDCCode": "10356-101-42",
      "PackageDescription": "1.7 g in 1 PACKET (10356-101-42) ",
      "NDC11Code": "10356-0101-42",
      "ProductNDC": "10356-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aquaphor Healing",
      "NonProprietaryName": "Petrolatum",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19910101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Beiersdorf Inc",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "41",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses.  temporarily protects minor:  cuts  scrapes  burns  temporarily protects and helps relieve chapped or cracked skin and lips  helps protect from the drying effects of wind and cold weather.  helps treat and prevent diaper rash   protects chafed skin associated with diaper rash and helps protect from wetness."
    },
    {
      "NDCCode": "10356-101-43",
      "PackageDescription": "250 PACKET in 1 CARTON (10356-101-43)  / 1.7 g in 1 PACKET (10356-101-42) ",
      "NDC11Code": "10356-0101-43",
      "ProductNDC": "10356-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aquaphor Healing",
      "NonProprietaryName": "Petrolatum",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19910101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Beiersdorf Inc",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "41",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses.  temporarily protects minor:  cuts  scrapes  burns  temporarily protects and helps relieve chapped or cracked skin and lips  helps protect from the drying effects of wind and cold weather.  helps treat and prevent diaper rash   protects chafed skin associated with diaper rash and helps protect from wetness."
    },
    {
      "NDCCode": "43136-101-01",
      "PackageDescription": "1 TUBE in 1 CARTON (43136-101-01)  / 42.5 g in 1 TUBE",
      "NDC11Code": "43136-0101-01",
      "ProductNDC": "43136-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Avon Hexashield Arthritis Pain Relief",
      "ProprietaryNameSuffix": "Cream Capsaisin",
      "NonProprietaryName": "Capsaisin",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190731",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Tai Guk Pharm. Co., Ltd.",
      "SubstanceName": "CAPSAICIN",
      "StrengthNumber": ".75",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2025-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190731",
      "SamplePackage": "N",
      "IndicationAndUsage": "for temporary relieves of minor aches and pains of muscles and joints associated with. : 1 arthritis, 2 simple backache, 3 bruises."
    },
    {
      "NDCCode": "52807-101-42",
      "PackageDescription": "5000 mL in 1 BOTTLE (52807-101-42) ",
      "NDC11Code": "52807-0101-42",
      "ProductNDC": "52807-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Hand Sanitizer",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200320",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Guangdong Longtai Industry Co.,LTD",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand washing to decrease bacteria on the skinre commended for repeated use."
    },
    {
      "NDCCode": "53247-101-42",
      "PackageDescription": "17 g in 1 TUBE (53247-101-42) ",
      "NDC11Code": "53247-0101-42",
      "ProductNDC": "53247-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nature Mint",
      "ProprietaryNameSuffix": "Anti-cavity",
      "NonProprietaryName": "Sodium Monofluorophosphate",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150115",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Bob Barker Company Inc.",
      "SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20150115",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "54157-101-07",
      "PackageDescription": "42.5 g in 1 PACKAGE (54157-101-07)",
      "NDC11Code": "54157-0101-07",
      "ProductNDC": "54157-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Megafresh Antibacterial Deodorant",
      "NonProprietaryName": "Triclocarban",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130304",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "American Amenities, Inc.",
      "SubstanceName": "TRICLOCARBAN",
      "StrengthNumber": ".3",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Uses: For hand washing to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "55037-101-42",
      "PackageDescription": "7800 L in 1 CYLINDER (55037-101-42) ",
      "NDC11Code": "55037-0101-42",
      "ProductNDC": "55037-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxygen",
      "NonProprietaryName": "Oxygen",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19870101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205889",
      "LabelerName": "Matheson Tri-Gas, Inc.",
      "SubstanceName": "OXYGEN",
      "StrengthNumber": "992",
      "StrengthUnit": "1/L",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "19870101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "58133-101-15",
      "PackageDescription": "42 g in 1 TUBE (58133-101-15) ",
      "NDC11Code": "58133-0101-15",
      "ProductNDC": "58133-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Real Time Pain Relief Hemp Oil Plus",
      "NonProprietaryName": "Arnica Montana",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150101",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Cosmetic Specialty Labs, Inc.",
      "SubstanceName": "ARNICA MONTANA",
      "StrengthNumber": "3",
      "StrengthUnit": "[hp_X]/g",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20150101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves symptoms of muscle pain, soreness, bruising and swelling due to overexertion or injury."
    },
    {
      "NDCCode": "58875-101-01",
      "PackageDescription": "42.5 g in 1 TUBE (58875-101-01)",
      "NDC11Code": "58875-0101-01",
      "ProductNDC": "58875-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hard Candy Correction Creme",
      "NonProprietaryName": "Octinoxate, Octisalate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130612",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Xtreme Color Inc.",
      "SubstanceName": "OCTINOXATE; OCTISALATE",
      "StrengthNumber": "2.55; 1.7",
      "StrengthUnit": "g/42.5g; g/42.5g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "66435-101-42",
      "PackageDescription": "42 CAPSULE in 1 BOTTLE, PLASTIC (66435-101-42)",
      "NDC11Code": "66435-0101-42",
      "ProductNDC": "66435-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ribasphere",
      "NonProprietaryName": "Ribavirin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040407",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076203",
      "LabelerName": "Kadmon Pharmaceuticals, LLC",
      "SubstanceName": "RIBAVIRIN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-10-13"
    },
    {
      "NDCCode": "72730-101-01",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (72730-101-01)  > 42 CAPSULE in 1 BLISTER PACK",
      "NDC11Code": "72730-0101-01",
      "ProductNDC": "72730-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Truseltiq",
      "NonProprietaryName": "Infigratinib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210528",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA214622",
      "LabelerName": "QED Therapeutics, Inc.",
      "SubstanceName": "INFIGRATINIB",
      "StrengthNumber": "125",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20210528",
      "SamplePackage": "N",
      "IndicationAndUsage": "TRUSELTIQ is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test [see Dosage and Administration ( 2.1)] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.1)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
      "Description": "Infigratinib is a kinase inhibitor. The chemical name is 3-(2,6-dichloro-3,5-dimethoxyphenyl)-1-{6-[4-(4-ethylpiperazin-1-yl)phenylamino]pyrimidin-4-yl}-1-methylurea phosphate (1:1). The molecular formula is C 26H 31Cl 2N 7O 3H 3PO 4 and the molecular weight is 560.48 g/mol for the free base, 658.47 g/mol for the phosphate salt. The chemical structure of infigratinib phosphate is as follows. Infigratinib phosphate is a white to off-white powder. It shows adequate solubility in water and 0.1N HCl. It is practically insoluble in pH 6.8 buffer and poorly soluble in common organic solvents. TRUSELTIQ (infigratinib) is supplied as 25 mg and 100 mg hard gelatin capsules for oral administration. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate (from vegetable source), and microcrystalline cellulose. The capsule shells contain black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The printing ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
    },
    {
      "NDCCode": "76810-101-42",
      "PackageDescription": "51 mL in 1 POUCH (76810-101-42) ",
      "NDC11Code": "76810-0101-42",
      "ProductNDC": "76810-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200428",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Hand Sanitizer Company LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses ■ to decrease bacteria on the skin that could cause disease ■ recommended for repeated use."
    },
    {
      "NDCCode": "78445-101-42",
      "PackageDescription": "350 mL in 1 BOTTLE (78445-101-42) ",
      "NDC11Code": "78445-0101-42",
      "ProductNDC": "78445-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Guangzhou Kangfei Cosmetics Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "83650-101-01",
      "PackageDescription": "42.5 g in 1 TUBE (83650-101-01) ",
      "NDC11Code": "83650-0101-01",
      "ProductNDC": "83650-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Oral Gel",
      "ProprietaryNameSuffix": "Oral Pain Relief",
      "NonProprietaryName": "Benzocaine Benzalkonium Chloride",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230922",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "Savvy Care and Cosmetics",
      "SubstanceName": "BENZOCAINE; BENZALKONIUM CHLORIDE",
      "StrengthNumber": "20; .1",
      "StrengthUnit": "g/100g; g/100g",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230922",
      "SamplePackage": "N",
      "IndicationAndUsage": "■ for the temporary relief of pain due to toothaches ■ to help protect against infectionin minor oral irritation."
    },
    {
      "NDCCode": "84502-101-42",
      "PackageDescription": "80 g in 1 BOTTLE, PLASTIC (84502-101-42) ",
      "NDC11Code": "84502-0101-42",
      "ProductNDC": "84502-101",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Semaglutide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20240702",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Fujian Genohope Biotech Ltd.",
      "SubstanceName": "SEMAGLUTIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "02-JUL-24"
    },
    {
      "NDCCode": "43526-101-02",
      "PackageDescription": "1 TUBE in 1 CARTON (43526-101-02)  > 14 mL in 1 TUBE (43526-101-01)",
      "NDC11Code": "43526-0101-02",
      "ProductNDC": "43526-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ipkn Artists Touch Bb 02 Medium",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120820",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Inel Cosmetics Co., Ltd.",
      "SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "1.1088; .42; .2688",
      "StrengthUnit": "mL/14mL; mL/14mL; mL/14mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-23",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "70166-101-02",
      "PackageDescription": "30 BAG in 1 BOX (70166-101-02)  > 1 SYRINGE, PLASTIC in 1 BAG > .125 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "70166-0101-02",
      "ProductNDC": "70166-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Morphine Sulfate",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "SOLUTION, CONCENTRATE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA201517",
      "LabelerName": "Lohxa",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20180529",
      "SamplePackage": "N",
      "IndicationAndUsage": "Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain in opioid-tolerant patients severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.2)] , reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Morphine Sulfate Oral Solution is an opioid agonist, available as an oral solution 100 mg per 5 mL (20 mg/mL) for oral administration. The chemical name is 7,8-didehydro-4,5 α-epoxy-17 methylmorphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate.  The molecular weight is 758.  Its molecular formula is (C 17H 19NO 3) 2H 2SO 45H 2O, and it has the following chemical structure. Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). The inactive ingredients in Morphine Sulfate Oral Solution (clear/colorless) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, and purified water. The inactive ingredients in Morphine Sulfate Oral Solution (clear/blue) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, FD&C green no. 3, artificial raspberry flavor, artificial cream flavor, and purified water."
    },
    {
      "NDCCode": "70166-101-05",
      "PackageDescription": "30 BAG in 1 BOX (70166-101-05)  > 1 SYRINGE, PLASTIC in 1 BAG > .25 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "70166-0101-05",
      "ProductNDC": "70166-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Morphine Sulfate",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "SOLUTION, CONCENTRATE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA201517",
      "LabelerName": "Lohxa",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20180529",
      "SamplePackage": "N",
      "IndicationAndUsage": "Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain in opioid-tolerant patients severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.2)] , reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Morphine Sulfate Oral Solution is an opioid agonist, available as an oral solution 100 mg per 5 mL (20 mg/mL) for oral administration. The chemical name is 7,8-didehydro-4,5 α-epoxy-17 methylmorphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate.  The molecular weight is 758.  Its molecular formula is (C 17H 19NO 3) 2H 2SO 45H 2O, and it has the following chemical structure. Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). The inactive ingredients in Morphine Sulfate Oral Solution (clear/colorless) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, and purified water. The inactive ingredients in Morphine Sulfate Oral Solution (clear/blue) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, FD&C green no. 3, artificial raspberry flavor, artificial cream flavor, and purified water."
    },
    {
      "NDCCode": "70166-101-10",
      "PackageDescription": "30 BAG in 1 BOX (70166-101-10)  > 1 SYRINGE, PLASTIC in 1 BAG > .5 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "70166-0101-10",
      "ProductNDC": "70166-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Morphine Sulfate",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "SOLUTION, CONCENTRATE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA201517",
      "LabelerName": "Lohxa",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20180529",
      "SamplePackage": "N",
      "IndicationAndUsage": "Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain in opioid-tolerant patients severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.2)] , reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Morphine Sulfate Oral Solution is an opioid agonist, available as an oral solution 100 mg per 5 mL (20 mg/mL) for oral administration. The chemical name is 7,8-didehydro-4,5 α-epoxy-17 methylmorphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate.  The molecular weight is 758.  Its molecular formula is (C 17H 19NO 3) 2H 2SO 45H 2O, and it has the following chemical structure. Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). The inactive ingredients in Morphine Sulfate Oral Solution (clear/colorless) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, and purified water. The inactive ingredients in Morphine Sulfate Oral Solution (clear/blue) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, FD&C green no. 3, artificial raspberry flavor, artificial cream flavor, and purified water."
    },
    {
      "NDCCode": "70166-101-20",
      "PackageDescription": "30 BAG in 1 BOX (70166-101-20)  > 1 SYRINGE, PLASTIC in 1 BAG > 1 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "70166-0101-20",
      "ProductNDC": "70166-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Morphine Sulfate",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "SOLUTION, CONCENTRATE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA201517",
      "LabelerName": "Lohxa",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20180529",
      "SamplePackage": "N",
      "IndicationAndUsage": "Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain in opioid-tolerant patients severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.2)] , reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Morphine Sulfate Oral Solution is an opioid agonist, available as an oral solution 100 mg per 5 mL (20 mg/mL) for oral administration. The chemical name is 7,8-didehydro-4,5 α-epoxy-17 methylmorphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate.  The molecular weight is 758.  Its molecular formula is (C 17H 19NO 3) 2H 2SO 45H 2O, and it has the following chemical structure. Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). The inactive ingredients in Morphine Sulfate Oral Solution (clear/colorless) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, and purified water. The inactive ingredients in Morphine Sulfate Oral Solution (clear/blue) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, FD&C green no. 3, artificial raspberry flavor, artificial cream flavor, and purified water."
    },
    {
      "NDCCode": "70436-101-09",
      "PackageDescription": "112 TABLET in 1 BOTTLE (70436-101-09) ",
      "NDC11Code": "70436-0101-09",
      "ProductNDC": "70436-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tetrabenazine",
      "NonProprietaryName": "Tetrabenazine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200302",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213316",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "TETRABENAZINE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2021-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200302",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington’s disease.",
      "Description": "Tetrabenazine tablets contains tetrabenazine is a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.42; the pKa is 6.51. Tetrabenazine is a hexahydro-dimethoxy‑benzoquinolizine derivative and has the following chemical name: cis rac –1,3,4,6,7,11b‑ hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The empirical formula C19H27NO3 is represented by the following structural formula. Tetrabenazine is a white to pale yellow powder that is soluble in chloroform and sparingly soluble in methanol. Each tetrabenazine tablet contains either 12.5 or 25 mg of tetrabenazine as the active ingredient. Tetrabenazine tablets contain tetrabenazine as the active ingredient and the following inactive ingredients: lactose monohydrate, pregelatinized starch, ferric oxide yellow, talc and magnesium stearate. Tetrabenazine tablets are supplied as a light yellow to yellow, functionally scored tablet containing 25 mg of tetrabenazine or as a light yellow to yellow, non-scored tablet containing 12.5 mg of tetrabenazine."
    },
    {
      "NDCCode": "71335-0451-5",
      "PackageDescription": "42 TABLET in 1 BOTTLE (71335-0451-5) ",
      "NDC11Code": "71335-0451-05",
      "ProductNDC": "71335-0451",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benzphetamine Hydrochloride",
      "NonProprietaryName": "Benzphetamine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100721",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090968",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "BENZPHETAMINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
      "DEASchedule": "CIII",
      "Status": "Active",
      "LastUpdate": "2024-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180423",
      "SamplePackage": "N",
      "IndicationAndUsage": "Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below. Benzphetamine hydrochloride tablets are indicated for use as monotherapy only.",
      "Description": "Benzphetamine hydrochloride tablets contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N,α-Dimethyl-N -(phenylmethyl)-benzeneethanamine hydrochloride and its molecular weight is 275.82. The structural formula (dextro form) is represented below. Each benzphetamine hydrochloride tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride. Inactive Ingredients: carnauba wax powder, colloidal silicon dioxide, FD&C red # 40 aluminum lake, FD&C yellow # 6 aluminum lake, lactose monohydrate, macrogol/polyethylene glycol 3350, magnesium stearate, microcrystalline cellulose 101, polyvinyl alcohol – partially hydrolyzed, sodium starch glycolate, talc and titanium dioxide."
    },
    {
      "NDCCode": "72205-101-07",
      "PackageDescription": "10 VIAL in 1 CARTON (72205-101-07)  > 4 mL in 1 VIAL (72205-101-01) ",
      "NDC11Code": "72205-0101-07",
      "ProductNDC": "72205-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bumetanide",
      "NonProprietaryName": "Bumetanide",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20220806",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215364",
      "LabelerName": "Novadoz Pharmaceuticals LLC",
      "SubstanceName": "BUMETANIDE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220806",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bumetanide Injection is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
      "Description": "Bumetanide, USP is a loop diuretic, available as 4 mL vials and 10 mL vials (0.25 mg/mL) for intravenous or intramuscular injection as a sterile solution. Each mL contains bumetanide 0.25 mg, sodium chloride 8.5 mg and ammonium acetate 4 mg as buffers, edetate disodium 0.1 mg and benzyl alcohol 10 mg as preservative in Water for Injection. pH adjusted to 6.8 – 7.8 with sodium hydroxide. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a white or almost white, crystalline powder, soluble in acetone, methanol and practically insoluble in water, having the following structural formula. C17H20N2O5S                 Molecular weight: 364.42."
    },
    {
      "NDCCode": "72362-101-01",
      "PackageDescription": "1 TUBE in 1 CARTON (72362-101-01)  > 3.5 g in 1 TUBE",
      "NDC11Code": "72362-0101-01",
      "ProductNDC": "72362-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Moistu-eyes",
      "NonProprietaryName": "White Petrolatum, Mineral Oil",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20180611",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part349",
      "LabelerName": "BRASSICA PHARMA PRIVATE LIMITED",
      "SubstanceName": "PETROLATUM; MINERAL OIL",
      "StrengthNumber": "57.3; 42.5",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20180611",
      "SamplePackage": "N",
      "IndicationAndUsage": "To lubricate and protect your eyes in certain eye conditions, or during or after surgery."
    },
    {
      "NDCCode": "72362-101-02",
      "PackageDescription": "1 TUBE in 1 CARTON (72362-101-02)  > 5 g in 1 TUBE",
      "NDC11Code": "72362-0101-02",
      "ProductNDC": "72362-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Moistu-eyes",
      "NonProprietaryName": "White Petrolatum, Mineral Oil",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20180611",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part349",
      "LabelerName": "BRASSICA PHARMA PRIVATE LIMITED",
      "SubstanceName": "PETROLATUM; MINERAL OIL",
      "StrengthNumber": "57.3; 42.5",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20180611",
      "SamplePackage": "N",
      "IndicationAndUsage": "To lubricate and protect your eyes in certain eye conditions, or during or after surgery."
    },
    {
      "NDCCode": "0002-4483-54",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (0002-4483-54)  / 14 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00002-4483-54",
      "ProductNDC": "0002-4483",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Verzenio",
      "NonProprietaryName": "Abemaciclib",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170928",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA208716",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "ABEMACICLIB",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20171006",
      "SamplePackage": "N",
      "IndicationAndUsage": "VERZENIO® is a kinase inhibitor indicated: : 1 in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. (1.1, 14.1) , 2 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (1.2) , 3 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (1.2) , 4 as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. (1.2) .",
      "Description": "Abemaciclib is a kinase inhibitor for oral administration. It is a white to yellow powder with the empirical formula C27H32F2N8 and a molecular weight 506.59. The chemical name for abemaciclib is 2-Pyrimidinamine, N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl]-. Abemaciclib has the following structure:. VERZENIO (abemaciclib) tablets are provided as immediate-release oval white, beige, or yellow tablets. Inactive ingredients are as follows: Excipients—microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide. Color mixture ingredients—polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red."
    },
    {
      "NDCCode": "0002-4483-62",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (0002-4483-62)  / 14 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00002-4483-62",
      "ProductNDC": "0002-4483",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Verzenio",
      "NonProprietaryName": "Abemaciclib",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170928",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA208716",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "ABEMACICLIB",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250215",
      "SamplePackage": "Y",
      "IndicationAndUsage": "VERZENIO® is a kinase inhibitor indicated: : 1 in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. (1.1, 14.1) , 2 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (1.2) , 3 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (1.2) , 4 as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. (1.2) .",
      "Description": "Abemaciclib is a kinase inhibitor for oral administration. It is a white to yellow powder with the empirical formula C27H32F2N8 and a molecular weight 506.59. The chemical name for abemaciclib is 2-Pyrimidinamine, N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl]-. Abemaciclib has the following structure:. VERZENIO (abemaciclib) tablets are provided as immediate-release oval white, beige, or yellow tablets. Inactive ingredients are as follows: Excipients—microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide. Color mixture ingredients—polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red."
    },
    {
      "NDCCode": "0002-4815-54",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (0002-4815-54)  / 14 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00002-4815-54",
      "ProductNDC": "0002-4815",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Verzenio",
      "NonProprietaryName": "Abemaciclib",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170928",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA208716",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "ABEMACICLIB",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20171006",
      "SamplePackage": "N",
      "IndicationAndUsage": "VERZENIO® is a kinase inhibitor indicated: : 1 in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. (1.1, 14.1) , 2 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (1.2) , 3 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (1.2) , 4 as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. (1.2) .",
      "Description": "Abemaciclib is a kinase inhibitor for oral administration. It is a white to yellow powder with the empirical formula C27H32F2N8 and a molecular weight 506.59. The chemical name for abemaciclib is 2-Pyrimidinamine, N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl]-. Abemaciclib has the following structure:. VERZENIO (abemaciclib) tablets are provided as immediate-release oval white, beige, or yellow tablets. Inactive ingredients are as follows: Excipients—microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide. Color mixture ingredients—polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red."
    }
  ]
}
                    

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    <PackageDescription>57 g in 1 TUBE (69314-101-42)</PackageDescription>
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    <ProprietaryNameSuffix>Headache Relief</ProprietaryNameSuffix>
    <NonProprietaryName>Bryonia Alba Root And Toxicodendron Pubescens Leaf</NonProprietaryName>
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  <NDC>
    <NDCCode>69314-201-42</NDCCode>
    <PackageDescription>57 g in 1 TUBE (69314-201-42) </PackageDescription>
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    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
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    <IndicationAndUsage>External analgesic for temporary relief of headache and migraine pain.</IndicationAndUsage>
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    <NDCCode>10356-101-42</NDCCode>
    <PackageDescription>1.7 g in 1 PACKET (10356-101-42) </PackageDescription>
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    <SubstanceName>PETROLATUM</SubstanceName>
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    <Status>Active</Status>
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <IndicationAndUsage>Uses.  temporarily protects minor:  cuts  scrapes  burns  temporarily protects and helps relieve chapped or cracked skin and lips  helps protect from the drying effects of wind and cold weather.  helps treat and prevent diaper rash   protects chafed skin associated with diaper rash and helps protect from wetness.</IndicationAndUsage>
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  <NDC>
    <NDCCode>10356-101-43</NDCCode>
    <PackageDescription>250 PACKET in 1 CARTON (10356-101-43)  / 1.7 g in 1 PACKET (10356-101-42) </PackageDescription>
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    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <IndicationAndUsage>Uses.  temporarily protects minor:  cuts  scrapes  burns  temporarily protects and helps relieve chapped or cracked skin and lips  helps protect from the drying effects of wind and cold weather.  helps treat and prevent diaper rash   protects chafed skin associated with diaper rash and helps protect from wetness.</IndicationAndUsage>
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    <NDCCode>43136-101-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (43136-101-01)  / 42.5 g in 1 TUBE</PackageDescription>
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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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    <DosageFormName>CREAM</DosageFormName>
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    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Tai Guk Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>CAPSAICIN</SubstanceName>
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    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <NDCCode>52807-101-42</NDCCode>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Guangdong Longtai Industry Co.,LTD</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
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    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
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    <IndicationAndUsage>For hand washing to decrease bacteria on the skinre commended for repeated use.</IndicationAndUsage>
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    <NDCCode>53247-101-42</NDCCode>
    <PackageDescription>17 g in 1 TUBE (53247-101-42) </PackageDescription>
    <NDC11Code>53247-0101-42</NDC11Code>
    <ProductNDC>53247-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nature Mint</ProprietaryName>
    <ProprietaryNameSuffix>Anti-cavity</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
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    <LabelerName>Bob Barker Company Inc.</LabelerName>
    <SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
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    <StrengthUnit>g/100g</StrengthUnit>
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
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    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>American Amenities, Inc.</LabelerName>
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    <StrengthNumber>.3</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses: For hand washing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
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    <NDCCode>55037-101-42</NDCCode>
    <PackageDescription>7800 L in 1 CYLINDER (55037-101-42) </PackageDescription>
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    <ProductNDC>55037-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen</ProprietaryName>
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    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19870101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205889</ApplicationNumber>
    <LabelerName>Matheson Tri-Gas, Inc.</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>992</StrengthNumber>
    <StrengthUnit>1/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19870101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>58133-101-15</NDCCode>
    <PackageDescription>42 g in 1 TUBE (58133-101-15) </PackageDescription>
    <NDC11Code>58133-0101-15</NDC11Code>
    <ProductNDC>58133-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Real Time Pain Relief Hemp Oil Plus</ProprietaryName>
    <NonProprietaryName>Arnica Montana</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Cosmetic Specialty Labs, Inc.</LabelerName>
    <SubstanceName>ARNICA MONTANA</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>[hp_X]/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves symptoms of muscle pain, soreness, bruising and swelling due to overexertion or injury.</IndicationAndUsage>
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  <NDC>
    <NDCCode>58875-101-01</NDCCode>
    <PackageDescription>42.5 g in 1 TUBE (58875-101-01)</PackageDescription>
    <NDC11Code>58875-0101-01</NDC11Code>
    <ProductNDC>58875-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hard Candy Correction Creme</ProprietaryName>
    <NonProprietaryName>Octinoxate, Octisalate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
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    <StartMarketingDate>20130612</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Xtreme Color Inc.</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE</SubstanceName>
    <StrengthNumber>2.55; 1.7</StrengthNumber>
    <StrengthUnit>g/42.5g; g/42.5g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
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    <NDCCode>66435-101-42</NDCCode>
    <PackageDescription>42 CAPSULE in 1 BOTTLE, PLASTIC (66435-101-42)</PackageDescription>
    <NDC11Code>66435-0101-42</NDC11Code>
    <ProductNDC>66435-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ribasphere</ProprietaryName>
    <NonProprietaryName>Ribavirin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076203</ApplicationNumber>
    <LabelerName>Kadmon Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>RIBAVIRIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-10-13</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>72730-101-01</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (72730-101-01)  &gt; 42 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>72730-0101-01</NDC11Code>
    <ProductNDC>72730-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Truseltiq</ProprietaryName>
    <NonProprietaryName>Infigratinib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210528</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA214622</ApplicationNumber>
    <LabelerName>QED Therapeutics, Inc.</LabelerName>
    <SubstanceName>INFIGRATINIB</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210528</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TRUSELTIQ is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test [see Dosage and Administration ( 2.1)] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.1)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
    <Description>Infigratinib is a kinase inhibitor. The chemical name is 3-(2,6-dichloro-3,5-dimethoxyphenyl)-1-{6-[4-(4-ethylpiperazin-1-yl)phenylamino]pyrimidin-4-yl}-1-methylurea phosphate (1:1). The molecular formula is C 26H 31Cl 2N 7O 3H 3PO 4 and the molecular weight is 560.48 g/mol for the free base, 658.47 g/mol for the phosphate salt. The chemical structure of infigratinib phosphate is as follows. Infigratinib phosphate is a white to off-white powder. It shows adequate solubility in water and 0.1N HCl. It is practically insoluble in pH 6.8 buffer and poorly soluble in common organic solvents. TRUSELTIQ (infigratinib) is supplied as 25 mg and 100 mg hard gelatin capsules for oral administration. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate (from vegetable source), and microcrystalline cellulose. The capsule shells contain black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The printing ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>76810-101-42</NDCCode>
    <PackageDescription>51 mL in 1 POUCH (76810-101-42) </PackageDescription>
    <NDC11Code>76810-0101-42</NDC11Code>
    <ProductNDC>76810-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200428</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Hand Sanitizer Company LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses ■ to decrease bacteria on the skin that could cause disease ■ recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>78445-101-42</NDCCode>
    <PackageDescription>350 mL in 1 BOTTLE (78445-101-42) </PackageDescription>
    <NDC11Code>78445-0101-42</NDC11Code>
    <ProductNDC>78445-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Guangzhou Kangfei Cosmetics Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>83650-101-01</NDCCode>
    <PackageDescription>42.5 g in 1 TUBE (83650-101-01) </PackageDescription>
    <NDC11Code>83650-0101-01</NDC11Code>
    <ProductNDC>83650-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Oral Gel</ProprietaryName>
    <ProprietaryNameSuffix>Oral Pain Relief</ProprietaryNameSuffix>
    <NonProprietaryName>Benzocaine Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230922</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M022</ApplicationNumber>
    <LabelerName>Savvy Care and Cosmetics</LabelerName>
    <SubstanceName>BENZOCAINE; BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>20; .1</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230922</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ for the temporary relief of pain due to toothaches ■ to help protect against infectionin minor oral irritation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84502-101-42</NDCCode>
    <PackageDescription>80 g in 1 BOTTLE, PLASTIC (84502-101-42) </PackageDescription>
    <NDC11Code>84502-0101-42</NDC11Code>
    <ProductNDC>84502-101</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Semaglutide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20240702</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Fujian Genohope Biotech Ltd.</LabelerName>
    <SubstanceName>SEMAGLUTIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>02-JUL-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>43526-101-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (43526-101-02)  &gt; 14 mL in 1 TUBE (43526-101-01)</PackageDescription>
    <NDC11Code>43526-0101-02</NDC11Code>
    <ProductNDC>43526-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ipkn Artists Touch Bb 02 Medium</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120820</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Inel Cosmetics Co., Ltd.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>1.1088; .42; .2688</StrengthNumber>
    <StrengthUnit>mL/14mL; mL/14mL; mL/14mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-23</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>70166-101-02</NDCCode>
    <PackageDescription>30 BAG in 1 BOX (70166-101-02)  &gt; 1 SYRINGE, PLASTIC in 1 BAG &gt; .125 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>70166-0101-02</NDC11Code>
    <ProductNDC>70166-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180529</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA201517</ApplicationNumber>
    <LabelerName>Lohxa</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain in opioid-tolerant patients severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.2)] , reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Morphine Sulfate Oral Solution is an opioid agonist, available as an oral solution 100 mg per 5 mL (20 mg/mL) for oral administration. The chemical name is 7,8-didehydro-4,5 α-epoxy-17 methylmorphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate.  The molecular weight is 758.  Its molecular formula is (C 17H 19NO 3) 2H 2SO 45H 2O, and it has the following chemical structure. Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). The inactive ingredients in Morphine Sulfate Oral Solution (clear/colorless) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, and purified water. The inactive ingredients in Morphine Sulfate Oral Solution (clear/blue) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, FD&amp;C green no. 3, artificial raspberry flavor, artificial cream flavor, and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>70166-101-05</NDCCode>
    <PackageDescription>30 BAG in 1 BOX (70166-101-05)  &gt; 1 SYRINGE, PLASTIC in 1 BAG &gt; .25 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>70166-0101-05</NDC11Code>
    <ProductNDC>70166-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180529</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA201517</ApplicationNumber>
    <LabelerName>Lohxa</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain in opioid-tolerant patients severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.2)] , reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Morphine Sulfate Oral Solution is an opioid agonist, available as an oral solution 100 mg per 5 mL (20 mg/mL) for oral administration. The chemical name is 7,8-didehydro-4,5 α-epoxy-17 methylmorphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate.  The molecular weight is 758.  Its molecular formula is (C 17H 19NO 3) 2H 2SO 45H 2O, and it has the following chemical structure. Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). The inactive ingredients in Morphine Sulfate Oral Solution (clear/colorless) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, and purified water. The inactive ingredients in Morphine Sulfate Oral Solution (clear/blue) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, FD&amp;C green no. 3, artificial raspberry flavor, artificial cream flavor, and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>70166-101-10</NDCCode>
    <PackageDescription>30 BAG in 1 BOX (70166-101-10)  &gt; 1 SYRINGE, PLASTIC in 1 BAG &gt; .5 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>70166-0101-10</NDC11Code>
    <ProductNDC>70166-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180529</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA201517</ApplicationNumber>
    <LabelerName>Lohxa</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain in opioid-tolerant patients severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.2)] , reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Morphine Sulfate Oral Solution is an opioid agonist, available as an oral solution 100 mg per 5 mL (20 mg/mL) for oral administration. The chemical name is 7,8-didehydro-4,5 α-epoxy-17 methylmorphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate.  The molecular weight is 758.  Its molecular formula is (C 17H 19NO 3) 2H 2SO 45H 2O, and it has the following chemical structure. Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). The inactive ingredients in Morphine Sulfate Oral Solution (clear/colorless) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, and purified water. The inactive ingredients in Morphine Sulfate Oral Solution (clear/blue) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, FD&amp;C green no. 3, artificial raspberry flavor, artificial cream flavor, and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>70166-101-20</NDCCode>
    <PackageDescription>30 BAG in 1 BOX (70166-101-20)  &gt; 1 SYRINGE, PLASTIC in 1 BAG &gt; 1 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>70166-0101-20</NDC11Code>
    <ProductNDC>70166-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180529</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA201517</ApplicationNumber>
    <LabelerName>Lohxa</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain in opioid-tolerant patients severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.2)] , reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Morphine Sulfate Oral Solution is an opioid agonist, available as an oral solution 100 mg per 5 mL (20 mg/mL) for oral administration. The chemical name is 7,8-didehydro-4,5 α-epoxy-17 methylmorphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate.  The molecular weight is 758.  Its molecular formula is (C 17H 19NO 3) 2H 2SO 45H 2O, and it has the following chemical structure. Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). The inactive ingredients in Morphine Sulfate Oral Solution (clear/colorless) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, and purified water. The inactive ingredients in Morphine Sulfate Oral Solution (clear/blue) include: anhydrous citric acid, edetate disodium dihydrate, glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol, FD&amp;C green no. 3, artificial raspberry flavor, artificial cream flavor, and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-101-09</NDCCode>
    <PackageDescription>112 TABLET in 1 BOTTLE (70436-101-09) </PackageDescription>
    <NDC11Code>70436-0101-09</NDC11Code>
    <ProductNDC>70436-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tetrabenazine</ProprietaryName>
    <NonProprietaryName>Tetrabenazine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200302</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213316</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>TETRABENAZINE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200302</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington’s disease.</IndicationAndUsage>
    <Description>Tetrabenazine tablets contains tetrabenazine is a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.42; the pKa is 6.51. Tetrabenazine is a hexahydro-dimethoxy‑benzoquinolizine derivative and has the following chemical name: cis rac –1,3,4,6,7,11b‑ hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The empirical formula C19H27NO3 is represented by the following structural formula. Tetrabenazine is a white to pale yellow powder that is soluble in chloroform and sparingly soluble in methanol. Each tetrabenazine tablet contains either 12.5 or 25 mg of tetrabenazine as the active ingredient. Tetrabenazine tablets contain tetrabenazine as the active ingredient and the following inactive ingredients: lactose monohydrate, pregelatinized starch, ferric oxide yellow, talc and magnesium stearate. Tetrabenazine tablets are supplied as a light yellow to yellow, functionally scored tablet containing 25 mg of tetrabenazine or as a light yellow to yellow, non-scored tablet containing 12.5 mg of tetrabenazine.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0451-5</NDCCode>
    <PackageDescription>42 TABLET in 1 BOTTLE (71335-0451-5) </PackageDescription>
    <NDC11Code>71335-0451-05</NDC11Code>
    <ProductNDC>71335-0451</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benzphetamine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Benzphetamine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100721</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090968</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>BENZPHETAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180423</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below. Benzphetamine hydrochloride tablets are indicated for use as monotherapy only.</IndicationAndUsage>
    <Description>Benzphetamine hydrochloride tablets contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N,α-Dimethyl-N -(phenylmethyl)-benzeneethanamine hydrochloride and its molecular weight is 275.82. The structural formula (dextro form) is represented below. Each benzphetamine hydrochloride tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride. Inactive Ingredients: carnauba wax powder, colloidal silicon dioxide, FD&amp;C red # 40 aluminum lake, FD&amp;C yellow # 6 aluminum lake, lactose monohydrate, macrogol/polyethylene glycol 3350, magnesium stearate, microcrystalline cellulose 101, polyvinyl alcohol – partially hydrolyzed, sodium starch glycolate, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-101-07</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (72205-101-07)  &gt; 4 mL in 1 VIAL (72205-101-01) </PackageDescription>
    <NDC11Code>72205-0101-07</NDC11Code>
    <ProductNDC>72205-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bumetanide</ProprietaryName>
    <NonProprietaryName>Bumetanide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20220806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215364</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>BUMETANIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bumetanide Injection is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
    <Description>Bumetanide, USP is a loop diuretic, available as 4 mL vials and 10 mL vials (0.25 mg/mL) for intravenous or intramuscular injection as a sterile solution. Each mL contains bumetanide 0.25 mg, sodium chloride 8.5 mg and ammonium acetate 4 mg as buffers, edetate disodium 0.1 mg and benzyl alcohol 10 mg as preservative in Water for Injection. pH adjusted to 6.8 – 7.8 with sodium hydroxide. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a white or almost white, crystalline powder, soluble in acetone, methanol and practically insoluble in water, having the following structural formula. C17H20N2O5S                 Molecular weight: 364.42.</Description>
  </NDC>
  <NDC>
    <NDCCode>72362-101-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (72362-101-01)  &gt; 3.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>72362-0101-01</NDC11Code>
    <ProductNDC>72362-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Moistu-eyes</ProprietaryName>
    <NonProprietaryName>White Petrolatum, Mineral Oil</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20180611</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>BRASSICA PHARMA PRIVATE LIMITED</LabelerName>
    <SubstanceName>PETROLATUM; MINERAL OIL</SubstanceName>
    <StrengthNumber>57.3; 42.5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180611</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To lubricate and protect your eyes in certain eye conditions, or during or after surgery.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72362-101-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (72362-101-02)  &gt; 5 g in 1 TUBE</PackageDescription>
    <NDC11Code>72362-0101-02</NDC11Code>
    <ProductNDC>72362-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Moistu-eyes</ProprietaryName>
    <NonProprietaryName>White Petrolatum, Mineral Oil</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20180611</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>BRASSICA PHARMA PRIVATE LIMITED</LabelerName>
    <SubstanceName>PETROLATUM; MINERAL OIL</SubstanceName>
    <StrengthNumber>57.3; 42.5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180611</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To lubricate and protect your eyes in certain eye conditions, or during or after surgery.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0002-4483-54</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (0002-4483-54)  / 14 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00002-4483-54</NDC11Code>
    <ProductNDC>0002-4483</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Verzenio</ProprietaryName>
    <NonProprietaryName>Abemaciclib</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170928</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208716</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>ABEMACICLIB</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171006</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VERZENIO® is a kinase inhibitor indicated: : 1 in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. (1.1, 14.1) , 2 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (1.2) , 3 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (1.2) , 4 as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. (1.2) .</IndicationAndUsage>
    <Description>Abemaciclib is a kinase inhibitor for oral administration. It is a white to yellow powder with the empirical formula C27H32F2N8 and a molecular weight 506.59. The chemical name for abemaciclib is 2-Pyrimidinamine, N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl]-. Abemaciclib has the following structure:. VERZENIO (abemaciclib) tablets are provided as immediate-release oval white, beige, or yellow tablets. Inactive ingredients are as follows: Excipients—microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide. Color mixture ingredients—polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-4483-62</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (0002-4483-62)  / 14 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00002-4483-62</NDC11Code>
    <ProductNDC>0002-4483</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Verzenio</ProprietaryName>
    <NonProprietaryName>Abemaciclib</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170928</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208716</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>ABEMACICLIB</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250215</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>VERZENIO® is a kinase inhibitor indicated: : 1 in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. (1.1, 14.1) , 2 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (1.2) , 3 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (1.2) , 4 as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. (1.2) .</IndicationAndUsage>
    <Description>Abemaciclib is a kinase inhibitor for oral administration. It is a white to yellow powder with the empirical formula C27H32F2N8 and a molecular weight 506.59. The chemical name for abemaciclib is 2-Pyrimidinamine, N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl]-. Abemaciclib has the following structure:. VERZENIO (abemaciclib) tablets are provided as immediate-release oval white, beige, or yellow tablets. Inactive ingredients are as follows: Excipients—microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide. Color mixture ingredients—polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-4815-54</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (0002-4815-54)  / 14 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00002-4815-54</NDC11Code>
    <ProductNDC>0002-4815</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Verzenio</ProprietaryName>
    <NonProprietaryName>Abemaciclib</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170928</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208716</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>ABEMACICLIB</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171006</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VERZENIO® is a kinase inhibitor indicated: : 1 in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. (1.1, 14.1) , 2 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (1.2) , 3 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (1.2) , 4 as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. (1.2) .</IndicationAndUsage>
    <Description>Abemaciclib is a kinase inhibitor for oral administration. It is a white to yellow powder with the empirical formula C27H32F2N8 and a molecular weight 506.59. The chemical name for abemaciclib is 2-Pyrimidinamine, N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl]-. Abemaciclib has the following structure:. VERZENIO (abemaciclib) tablets are provided as immediate-release oval white, beige, or yellow tablets. Inactive ingredients are as follows: Excipients—microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide. Color mixture ingredients—polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>69314-101-42</NDCCode><ProprietaryName>Thermal-aid</ProprietaryName><NonProprietaryName>Bryonia Alba Root And Toxicodendron Pubescens Leaf</NonProprietaryName></NDC><NDC><NDCCode>69314-201-42</NDCCode><ProprietaryName>Thermal-aid</ProprietaryName><NonProprietaryName>Bryonia Alba Root And Toxicodendron Pubescens Leaf</NonProprietaryName></NDC><NDC><NDCCode>10356-101-42</NDCCode><ProprietaryName>Aquaphor Healing</ProprietaryName><NonProprietaryName>Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>10356-101-43</NDCCode><ProprietaryName>Aquaphor Healing</ProprietaryName><NonProprietaryName>Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>43136-101-01</NDCCode><ProprietaryName>Avon Hexashield Arthritis Pain Relief</ProprietaryName><NonProprietaryName>Capsaisin</NonProprietaryName></NDC><NDC><NDCCode>52807-101-42</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>53247-101-42</NDCCode><ProprietaryName>Nature Mint</ProprietaryName><NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName></NDC><NDC><NDCCode>54157-101-07</NDCCode><ProprietaryName>Megafresh Antibacterial Deodorant</ProprietaryName><NonProprietaryName>Triclocarban</NonProprietaryName></NDC><NDC><NDCCode>55037-101-42</NDCCode><ProprietaryName>Oxygen</ProprietaryName><NonProprietaryName>Oxygen</NonProprietaryName></NDC><NDC><NDCCode>58133-101-15</NDCCode><ProprietaryName>Real Time Pain Relief Hemp Oil Plus</ProprietaryName><NonProprietaryName>Arnica Montana</NonProprietaryName></NDC><NDC><NDCCode>58875-101-01</NDCCode><ProprietaryName>Hard Candy Correction Creme</ProprietaryName><NonProprietaryName>Octinoxate, Octisalate</NonProprietaryName></NDC><NDC><NDCCode>66435-101-42</NDCCode><ProprietaryName>Ribasphere</ProprietaryName><NonProprietaryName>Ribavirin</NonProprietaryName></NDC><NDC><NDCCode>72730-101-01</NDCCode><ProprietaryName>Truseltiq</ProprietaryName><NonProprietaryName>Infigratinib</NonProprietaryName></NDC><NDC><NDCCode>76810-101-42</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>78445-101-42</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>83650-101-01</NDCCode><ProprietaryName>Oral Gel</ProprietaryName><NonProprietaryName>Benzocaine Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>84502-101-42</NDCCode><NonProprietaryName>Semaglutide</NonProprietaryName></NDC><NDC><NDCCode>43526-101-02</NDCCode><ProprietaryName>Ipkn Artists Touch Bb 02 Medium</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>70166-101-02</NDCCode><ProprietaryName>Morphine Sulfate</ProprietaryName><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>70166-101-05</NDCCode><ProprietaryName>Morphine Sulfate</ProprietaryName><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>70166-101-10</NDCCode><ProprietaryName>Morphine Sulfate</ProprietaryName><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>70166-101-20</NDCCode><ProprietaryName>Morphine Sulfate</ProprietaryName><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>70436-101-09</NDCCode><ProprietaryName>Tetrabenazine</ProprietaryName><NonProprietaryName>Tetrabenazine</NonProprietaryName></NDC><NDC><NDCCode>71335-0451-5</NDCCode><ProprietaryName>Benzphetamine Hydrochloride</ProprietaryName><NonProprietaryName>Benzphetamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>72205-101-07</NDCCode><ProprietaryName>Bumetanide</ProprietaryName><NonProprietaryName>Bumetanide</NonProprietaryName></NDC><NDC><NDCCode>72362-101-01</NDCCode><ProprietaryName>Moistu-eyes</ProprietaryName><NonProprietaryName>White Petrolatum, Mineral Oil</NonProprietaryName></NDC><NDC><NDCCode>72362-101-02</NDCCode><ProprietaryName>Moistu-eyes</ProprietaryName><NonProprietaryName>White Petrolatum, Mineral Oil</NonProprietaryName></NDC><NDC><NDCCode>0002-4483-54</NDCCode><ProprietaryName>Verzenio</ProprietaryName><NonProprietaryName>Abemaciclib</NonProprietaryName></NDC><NDC><NDCCode>0002-4483-62</NDCCode><ProprietaryName>Verzenio</ProprietaryName><NonProprietaryName>Abemaciclib</NonProprietaryName></NDC><NDC><NDCCode>0002-4815-54</NDCCode><ProprietaryName>Verzenio</ProprietaryName><NonProprietaryName>Abemaciclib</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
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      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
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}
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