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How to Find 84010-168-03 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "84010-168-03",
      "PackageDescription": "3 TUBE in 1 BOX (84010-168-03)  / 8 mL in 1 TUBE",
      "NDC11Code": "84010-0168-03",
      "ProductNDC": "84010-168",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Qsoowis Wart Removal",
      "NonProprietaryName": "Salicylic Acid 17% Wart Removal",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250806",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M028",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "17",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250806",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the removal of common warts and plantar warts.Common warts have a rough\"cauliflower-like\" surface and are easily recognizable.Plantar warts are located only on the soles of the feet, tender to touch, with an interrupted footprint pattern."
    },
    {
      "NDCCode": "84010-168-01",
      "PackageDescription": "3 TUBE in 1 BOX (84010-168-01)  / 4 mL in 1 TUBE",
      "NDC11Code": "84010-0168-01",
      "ProductNDC": "84010-168",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Qsoowis Wart Removal",
      "NonProprietaryName": "Salicylic Acid 17% Wart Removal",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250806",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M028",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "17",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250806",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the removal of common warts and plantar warts.Common warts have a rough\"cauliflower-like\" surface and are easily recognizable.Plantar warts are located only on the soles of the feet, tender to touch, with an interrupted footprint pattern."
    },
    {
      "NDCCode": "84010-168-02",
      "PackageDescription": "3 TUBE in 1 BOX (84010-168-02)  / 6 mL in 1 TUBE",
      "NDC11Code": "84010-0168-02",
      "ProductNDC": "84010-168",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Qsoowis Wart Removal",
      "NonProprietaryName": "Salicylic Acid 17% Wart Removal",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250806",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M028",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "17",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250806",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the removal of common warts and plantar warts.Common warts have a rough\"cauliflower-like\" surface and are easily recognizable.Plantar warts are located only on the soles of the feet, tender to touch, with an interrupted footprint pattern."
    },
    {
      "NDCCode": "84010-018-03",
      "PackageDescription": "30 g in 1 BOTTLE (84010-018-03) ",
      "NDC11Code": "84010-0018-03",
      "ProductNDC": "84010-018",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Baodao Tattoo Numbing",
      "NonProprietaryName": "Lidocaine 5% Tattoo Numbing",
      "DosageFormName": "CREAM",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20240711",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "LIDOCAINE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240711",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of local discomfort, itching, pain, soreness, or burning related to the tattoo process."
    },
    {
      "NDCCode": "84010-029-03",
      "PackageDescription": "42.5 g in 1 TUBE (84010-029-03) ",
      "NDC11Code": "84010-0029-03",
      "ProductNDC": "84010-029",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nekvnro Fungal Nail",
      "NonProprietaryName": "Tolnaftate 1% Fungal Nail",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240911",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "TOLNAFTATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240911",
      "SamplePackage": "N",
      "IndicationAndUsage": "●Proven effective in the treatment of most athlete's foot (tinea pedis)and ringworm(tinea corporis). ● Helps prevent most athlete's foot with daily use. ● For effective relief of itching, burning and cracking."
    },
    {
      "NDCCode": "84010-030-03",
      "PackageDescription": "42.5 g in 1 TUBE (84010-030-03) ",
      "NDC11Code": "84010-0030-03",
      "ProductNDC": "84010-030",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nekvnro Clotrimazole",
      "NonProprietaryName": "Clotrimazole1%, Miconazole1%clotrimazole",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240913",
      "EndMarketingDate": "20250911",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "CLOTRIMAZOLE; MICONAZOLE",
      "StrengthNumber": "1; 1",
      "StrengthUnit": "g/100g; g/100g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azole Antifungal [EPC], Azoles [CS], Azoles [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240913",
      "EndMarketingDatePackage": "20250911",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "84010-037-03",
      "PackageDescription": "42.5 g in 1 TUBE (84010-037-03) ",
      "NDC11Code": "84010-0037-03",
      "ProductNDC": "84010-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Qiuningtang Hemorrhoid",
      "NonProprietaryName": "Lidocaine 4%, Phenylephrine Hcl 0.25%, Hemorrhoid",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241017",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "4; .25",
      "StrengthUnit": "g/100g; g/100g",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-10-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241017",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily shrinks hemorrhoidal tissue,for the temporary relief of pain,soreness,or burning,and helps relieve the local it ching and discomfort associated with hemorrhoids."
    },
    {
      "NDCCode": "84010-040-03",
      "PackageDescription": "50 mL in 1 BOTTLE (84010-040-03) ",
      "NDC11Code": "84010-0040-03",
      "ProductNDC": "84010-040",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Healmusz Wart Remover",
      "NonProprietaryName": "Salicylic Acid Wart Remover",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241025",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M028",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241025",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "84010-045-03",
      "PackageDescription": "60 g in 1 TUBE (84010-045-03) ",
      "NDC11Code": "84010-0045-03",
      "ProductNDC": "84010-045",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mrkayll Tattoo Numbing",
      "NonProprietaryName": "Lidocaine5% Tattoo Numbing",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241119",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "LIDOCAINE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241119",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of local discomfort, itching, pain, soreness, or burning related to the tattoo process."
    },
    {
      "NDCCode": "84010-105-03",
      "PackageDescription": "4 TUBE in 1 BOX (84010-105-03)  / 4 mL in 1 TUBE",
      "NDC11Code": "84010-0105-03",
      "ProductNDC": "84010-105",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Natuheal Wart Remover",
      "NonProprietaryName": "Salicylic Acid 17% Wart Remover",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250506",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M028",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "17",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250506",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the removal of common warts and plantar warts.Common warts have a rough\"cauliflower-like\" surface and are easily recognizable.Plantar warts are located only on the soles of the feet, tender to touch, with an interrupted footprint pattern."
    },
    {
      "NDCCode": "84010-155-03",
      "PackageDescription": "15 mL in 1 BOTTLE (84010-155-03) ",
      "NDC11Code": "84010-0155-03",
      "ProductNDC": "84010-155",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Johohula Common And Plantar Wart Remover",
      "NonProprietaryName": "Salicylic Acid 17% Common And Plantar Wart Remover",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250717",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M028",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "17",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250717",
      "SamplePackage": "N",
      "IndicationAndUsage": "■For the removal of common andplantar warts."
    },
    {
      "NDCCode": "84010-166-03",
      "PackageDescription": "30 mL in 1 BOTTLE (84010-166-03) ",
      "NDC11Code": "84010-0166-03",
      "ProductNDC": "84010-166",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Elsatimy Multi-purpose Treatment",
      "NonProprietaryName": "Tolnaftate 1% Multi-purpose Treatment",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250729",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "TOLNAFTATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250729",
      "SamplePackage": "N",
      "IndicationAndUsage": "For most Nail Fungus,Relieves itching, sorenes,discoloration, thickening, splitting and nai brittleness."
    },
    {
      "NDCCode": "84010-237-03",
      "PackageDescription": "100 g in 1 BOTTLE (84010-237-03) ",
      "NDC11Code": "84010-0237-03",
      "ProductNDC": "84010-237",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Jovynex Women Estriol",
      "NonProprietaryName": "Micronized Estriol 0.1% Women Estriol",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251222",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "ESTRIOL",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251222",
      "SamplePackage": "N",
      "IndicationAndUsage": "·Provides temporary relief from intimate dryness and discomfort.·Moisturizes and soothes the intimate area."
    },
    {
      "NDCCode": "84010-238-03",
      "PackageDescription": "42 PATCH in 1 BOX (84010-238-03) ",
      "NDC11Code": "84010-0238-03",
      "ProductNDC": "84010-238",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Patloom Quit Smoking Nicotine Patches",
      "NonProprietaryName": "Nicotine14% Quit Smoking Nicotine Patches",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251224",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "NICOTINE",
      "StrengthNumber": "14",
      "StrengthUnit": "mg/1001",
      "Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251224",
      "SamplePackage": "N",
      "IndicationAndUsage": "reduces withdrawal symptoms,including nicotine craving,associated with quitting smoking."
    },
    {
      "NDCCode": "84010-239-03",
      "PackageDescription": "42 PATCH in 1 BOX (84010-239-03) ",
      "NDC11Code": "84010-0239-03",
      "ProductNDC": "84010-239",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Patloom Quit Smoking Nicotine Patches",
      "NonProprietaryName": "Nicotine7% Quit Smoking Nicotine Patches",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251224",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Jiangxi Hemei Pharmaceutical Co., Ltd",
      "SubstanceName": "NICOTINE",
      "StrengthNumber": "7",
      "StrengthUnit": "mg/1001",
      "Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251224",
      "SamplePackage": "N",
      "IndicationAndUsage": "reduces withdrawal symptoms,including nicotine craving,associated with quitting smoking."
    },
    {
      "NDCCode": "10825-002-03",
      "PackageDescription": "168 L in 1 DEWAR (10825-002-03)",
      "NDC11Code": "10825-0002-03",
      "ProductNDC": "10825-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxygen",
      "NonProprietaryName": "Oxygen",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19740101",
      "MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
      "LabelerName": "Northern Welding Supply",
      "SubstanceName": "OXYGEN",
      "StrengthNumber": "99",
      "StrengthUnit": "L/100L",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "11534-168-03",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (11534-168-03)",
      "NDC11Code": "11534-0168-03",
      "ProductNDC": "11534-168",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benztropine Mesylate",
      "NonProprietaryName": "Benztropine Mesylate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150715",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204713",
      "LabelerName": "SUNRISE PHARMACEUTICAL, INC",
      "SubstanceName": "BENZTROPINE MESYLATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-07",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "55289-168-03",
      "PackageDescription": "3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-168-03) ",
      "NDC11Code": "55289-0168-03",
      "ProductNDC": "55289-168",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Famciclovir",
      "NonProprietaryName": "Famciclovir",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070905",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077487",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "FAMCICLOVIR",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
      "Status": "Active",
      "LastUpdate": "2025-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110414",
      "SamplePackage": "N",
      "IndicationAndUsage": "Famciclovir tablets, a prodrug of penciclovir, are a deoxynucleoside analog DNA polymerase inhibitor indicated for. Immunocompetent Adult Patients( 1.1) : 1 Herpes labialis (cold sores) Treatment of recurrent episodes, 2 Genital herpes Treatment of recurrent episodesSuppressive therapy of recurrent episodes, 3 Herpes zoster (shingles).",
      "Description": "Famciclovir Tablets, USP contain famciclovir, USP, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir, USP is known as 2-[2-(2-amino-9 H-purin-9-yl)ethyl]-1,3-propanediol diacetate. It is a synthetic acyclic guanine derivative and has the following structure:. C 14H 19N 5O 4M.W. 321.3. Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P= 1.09 and octanol/phosphate buffer (pH 7.4) P= 2.08. Each white, film-coated tablet contains famciclovir, USP. The 125 mg and 250 mg tablets are round; the 500 mg tablets are capsule-shaped. Inactive ingredients consist of croscarmellose sodium, hydroxypropyl cellulose, hypromellose, polydextrose, polyethylene glycol, silicified microcrystalline cellulose, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide, and triacetin. Product meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "63304-168-03",
      "PackageDescription": "10 TABLET, COATED in 1 BOTTLE (63304-168-03)",
      "NDC11Code": "63304-0168-03",
      "ProductNDC": "63304-168",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077977",
      "LabelerName": "Ranbaxy Pharmaceuticals Inc.",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Major Depressive Disorder–Sertraline hydrochloride tablets are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder–Sertraline hydrochloride tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder–Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of sertraline hydrochloride was established in three 10 to 12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)–Sertraline hydrochloride is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-III-R/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride tablets are indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).",
      "Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The molecular formula C17H17NCl2HCl is represented by the following molecular structure. Sertraline hydrochloride is a white to off-white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50, 100, 150, and 200 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide."
    },
    {
      "NDCCode": "63545-168-03",
      "PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (63545-168-03) ",
      "NDC11Code": "63545-0168-03",
      "ProductNDC": "63545-168",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arsenicum Album",
      "NonProprietaryName": "Arsenicum Album",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210323",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, Inc.",
      "SubstanceName": "ARSENIC TRIOXIDE",
      "StrengthNumber": "6",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2021-03-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210323",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65841-046-03",
      "PackageDescription": "168 TABLET, FILM COATED in 1 BOTTLE (65841-046-03) ",
      "NDC11Code": "65841-0046-03",
      "ProductNDC": "65841-046",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ribavirin",
      "NonProprietaryName": "Ribavirin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20051205",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077094",
      "LabelerName": "Zydus Lifesciences Limited",
      "SubstanceName": "RIBAVIRIN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20051205",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65841-260-03",
      "PackageDescription": "168 CAPSULE in 1 BOTTLE (65841-260-03) ",
      "NDC11Code": "65841-0260-03",
      "ProductNDC": "65841-260",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ribavirin",
      "NonProprietaryName": "Ribavirin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060125",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077224",
      "LabelerName": "Zydus Lifesciences Limited",
      "SubstanceName": "RIBAVIRIN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20060125",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68382-046-03",
      "PackageDescription": "168 TABLET, FILM COATED in 1 BOTTLE (68382-046-03) ",
      "NDC11Code": "68382-0046-03",
      "ProductNDC": "68382-046",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ribavirin",
      "NonProprietaryName": "Ribavirin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20051205",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077094",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "RIBAVIRIN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20051205",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ribavirin is a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with peginterferon alfa-2a in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients coinfected with HIV (1).",
      "Description": "Ribavirin is a nucleoside analogue with antiviral activity. The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula. The molecular formula of ribavirin is C8H12N4O5 and the molecular weight is 244.2. Ribavirin, USP is white, crystalline powder. It is freely soluble in water and slightly soluble in dehydrated alcohol. Each film-coated ribavirin tablet intended for oral administration contains 200 mg or 400 mg or 500 mg or 600 mg of ribavirin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, talc and titanium dioxide. Organic test number pending in the USP."
    },
    {
      "NDCCode": "68382-260-03",
      "PackageDescription": "168 CAPSULE in 1 BOTTLE (68382-260-03) ",
      "NDC11Code": "68382-0260-03",
      "ProductNDC": "68382-260",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ribavirin",
      "NonProprietaryName": "Ribavirin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060125",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077224",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "RIBAVIRIN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20060125",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ribavirin is a nucleoside analogue indicated in combination with interferon alfa- 2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease.  (1.1). Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.",
      "Description": "Ribavirin is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see Figure 1). Figure 1: Structural Formula. Ribavirin, USP is a white, crystalline powder. It is freely soluble in water and slightly soluble in dehydrated alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21. Each ribavirin capsule, USP intended for oral administration contains 200 mg of ribavirin, USP in white, hard gelatin capsule shells. In addition, each capsule contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, and silicon dioxide. The capsule shell consists of gelatin and titanium dioxide. It may also contain sodium lauryl sulfate. The capsule is printed with black pharmaceutical ink."
    },
    {
      "NDCCode": "69339-168-03",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69339-168-03) ",
      "NDC11Code": "69339-0168-03",
      "ProductNDC": "69339-168",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gefitinib",
      "NonProprietaryName": "Gefitinib",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230605",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212827",
      "LabelerName": "Natco Pharma USA LLC",
      "SubstanceName": "GEFITINIB",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-03-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230605",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14)]. Limitation of Use: Safety and efficacy of gefitinib tablets have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [seeClinical Studies (14)].",
      "Description": "Gefitinib is a kinase inhibitor. The chemical name of gefitinib is N-(3ʹ-Chloro-4ʹ-fluorophenyl)-7-methoxy-6-{3-(4- morpholinyl)proproxy}-4-quinazolinamine and the following structural formula. Gefitinib has the molecular formula C22H24ClFN4O3, a relative molecular mass of 446.9 daltons and is a White to off-white crystalline powder. Gefitinib is a free base. The molecule has pKa1 is 6.5 & pKa2 is 6.9. Gefitinib can be defined as soluble at pH 1, but insoluble above pH 7, freely soluble in dimethylformamide and acetic acid, slightly soluble in methanol. Gefitinib tablets are available as brown film-coated tablets, containing 250 mg of gefitinib, for oral administration. The inactive ingredients of the tablet core of gefitinib tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, and sodium lauryl sulfate and magnesium stearate. Tablet coating contains: polyvinyl alcohol, polyethylene glycol/PEG, talc, titanium dioxide, yellow iron oxide and red iron oxide."
    },
    {
      "NDCCode": "70436-168-03",
      "PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70436-168-03) ",
      "NDC11Code": "70436-0168-03",
      "ProductNDC": "70436-168",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenofibric Acid",
      "NonProprietaryName": "Fenofibric Acid",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212562",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "FENOFIBRIC ACID",
      "StrengthNumber": "45",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-11-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20220411",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73377-168-03",
      "PackageDescription": "480 g in 1 JAR (73377-168-03) ",
      "NDC11Code": "73377-0168-03",
      "ProductNDC": "73377-168",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Cyclobenzaprine Hudrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20220520",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "AX Pharmaceutical Corp",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2025-10-29",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "23-APR-25"
    },
    {
      "NDCCode": "76420-168-03",
      "PackageDescription": "3 g in 1 JAR (76420-168-03)",
      "NDC11Code": "76420-0168-03",
      "ProductNDC": "76420-168",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20150531",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "76891-168-03",
      "PackageDescription": "3 BOTTLE, SPRAY in 1 CARTON (76891-168-03)  / 30 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "76891-0168-03",
      "ProductNDC": "76891-168",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Scent Theory Hand Sanitizers",
      "ProprietaryNameSuffix": "Cherry Pop, Ocean Splash, Juicy Pear",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260216",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Scent Theory Products LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2026-02-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260216",
      "SamplePackage": "N",
      "IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "83589-168-03",
      "PackageDescription": "1 g in 1 BOTTLE (83589-168-03) ",
      "NDC11Code": "83589-0168-03",
      "ProductNDC": "83589-168",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Semax Acetate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20260304",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Nanjing Chengong Pharmaceutical Co., Ltd.",
      "SubstanceName": "SEMAX",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "04-MAR-26"
    }
  ]
}
                    
{"NDC":[{"NDCCode":"84010-168-03","ProprietaryName":"Qsoowis Wart Removal","NonProprietaryName":"Salicylic Acid 17% Wart Removal"},{"NDCCode":"84010-168-01","ProprietaryName":"Qsoowis Wart Removal","NonProprietaryName":"Salicylic Acid 17% Wart Removal"},{"NDCCode":"84010-168-02","ProprietaryName":"Qsoowis Wart Removal","NonProprietaryName":"Salicylic Acid 17% Wart Removal"},{"NDCCode":"84010-018-03","ProprietaryName":"Baodao Tattoo Numbing","NonProprietaryName":"Lidocaine 5% Tattoo Numbing"},{"NDCCode":"84010-029-03","ProprietaryName":"Nekvnro Fungal Nail","NonProprietaryName":"Tolnaftate 1% Fungal Nail"},{"NDCCode":"84010-030-03","ProprietaryName":"Nekvnro Clotrimazole","NonProprietaryName":"Clotrimazole1%, Miconazole1%clotrimazole"},{"NDCCode":"84010-037-03","ProprietaryName":"Qiuningtang Hemorrhoid","NonProprietaryName":"Lidocaine 4%, Phenylephrine Hcl 0.25%, Hemorrhoid"},{"NDCCode":"84010-040-03","ProprietaryName":"Healmusz Wart Remover","NonProprietaryName":"Salicylic Acid Wart Remover"},{"NDCCode":"84010-045-03","ProprietaryName":"Mrkayll Tattoo Numbing","NonProprietaryName":"Lidocaine5% Tattoo Numbing"},{"NDCCode":"84010-105-03","ProprietaryName":"Natuheal Wart Remover","NonProprietaryName":"Salicylic Acid 17% Wart Remover"},{"NDCCode":"84010-155-03","ProprietaryName":"Johohula Common And Plantar Wart Remover","NonProprietaryName":"Salicylic Acid 17% Common And Plantar Wart Remover"},{"NDCCode":"84010-166-03","ProprietaryName":"Elsatimy Multi-purpose Treatment","NonProprietaryName":"Tolnaftate 1% Multi-purpose Treatment"},{"NDCCode":"84010-237-03","ProprietaryName":"Jovynex Women Estriol","NonProprietaryName":"Micronized Estriol 0.1% Women Estriol"},{"NDCCode":"84010-238-03","ProprietaryName":"Patloom Quit Smoking Nicotine Patches","NonProprietaryName":"Nicotine14% Quit Smoking Nicotine Patches"},{"NDCCode":"84010-239-03","ProprietaryName":"Patloom Quit Smoking Nicotine Patches","NonProprietaryName":"Nicotine7% Quit Smoking Nicotine Patches"},{"NDCCode":"10825-002-03","ProprietaryName":"Oxygen","NonProprietaryName":"Oxygen"},{"NDCCode":"11534-168-03","ProprietaryName":"Benztropine Mesylate","NonProprietaryName":"Benztropine Mesylate"},{"NDCCode":"55289-168-03","ProprietaryName":"Famciclovir","NonProprietaryName":"Famciclovir"},{"NDCCode":"63304-168-03","ProprietaryName":"Sertraline Hydrochloride","NonProprietaryName":"Sertraline Hydrochloride"},{"NDCCode":"63545-168-03","ProprietaryName":"Arsenicum Album","NonProprietaryName":"Arsenicum Album"},{"NDCCode":"65841-046-03","ProprietaryName":"Ribavirin","NonProprietaryName":"Ribavirin"},{"NDCCode":"65841-260-03","ProprietaryName":"Ribavirin","NonProprietaryName":"Ribavirin"},{"NDCCode":"68382-046-03","ProprietaryName":"Ribavirin","NonProprietaryName":"Ribavirin"},{"NDCCode":"68382-260-03","ProprietaryName":"Ribavirin","NonProprietaryName":"Ribavirin"},{"NDCCode":"69339-168-03","ProprietaryName":"Gefitinib","NonProprietaryName":"Gefitinib"},{"NDCCode":"70436-168-03","ProprietaryName":"Fenofibric Acid","NonProprietaryName":"Fenofibric Acid"},{"NDCCode":"73377-168-03","NonProprietaryName":"Cyclobenzaprine Hudrochloride"},{"NDCCode":"76420-168-03","NonProprietaryName":"Cyclobenzaprine Hydrochloride"},{"NDCCode":"76891-168-03","ProprietaryName":"Scent Theory Hand Sanitizers","NonProprietaryName":"Alcohol"},{"NDCCode":"83589-168-03","NonProprietaryName":"Semax Acetate"}]}
                    
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>84010-168-03</NDCCode>
    <PackageDescription>3 TUBE in 1 BOX (84010-168-03)  / 8 mL in 1 TUBE</PackageDescription>
    <NDC11Code>84010-0168-03</NDC11Code>
    <ProductNDC>84010-168</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Qsoowis Wart Removal</ProprietaryName>
    <NonProprietaryName>Salicylic Acid 17% Wart Removal</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250806</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M028</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the removal of common warts and plantar warts.Common warts have a rough"cauliflower-like" surface and are easily recognizable.Plantar warts are located only on the soles of the feet, tender to touch, with an interrupted footprint pattern.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84010-168-01</NDCCode>
    <PackageDescription>3 TUBE in 1 BOX (84010-168-01)  / 4 mL in 1 TUBE</PackageDescription>
    <NDC11Code>84010-0168-01</NDC11Code>
    <ProductNDC>84010-168</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Qsoowis Wart Removal</ProprietaryName>
    <NonProprietaryName>Salicylic Acid 17% Wart Removal</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250806</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M028</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the removal of common warts and plantar warts.Common warts have a rough"cauliflower-like" surface and are easily recognizable.Plantar warts are located only on the soles of the feet, tender to touch, with an interrupted footprint pattern.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84010-168-02</NDCCode>
    <PackageDescription>3 TUBE in 1 BOX (84010-168-02)  / 6 mL in 1 TUBE</PackageDescription>
    <NDC11Code>84010-0168-02</NDC11Code>
    <ProductNDC>84010-168</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Qsoowis Wart Removal</ProprietaryName>
    <NonProprietaryName>Salicylic Acid 17% Wart Removal</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250806</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M028</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the removal of common warts and plantar warts.Common warts have a rough"cauliflower-like" surface and are easily recognizable.Plantar warts are located only on the soles of the feet, tender to touch, with an interrupted footprint pattern.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84010-018-03</NDCCode>
    <PackageDescription>30 g in 1 BOTTLE (84010-018-03) </PackageDescription>
    <NDC11Code>84010-0018-03</NDC11Code>
    <ProductNDC>84010-018</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Baodao Tattoo Numbing</ProprietaryName>
    <NonProprietaryName>Lidocaine 5% Tattoo Numbing</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20240711</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240711</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of local discomfort, itching, pain, soreness, or burning related to the tattoo process.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84010-029-03</NDCCode>
    <PackageDescription>42.5 g in 1 TUBE (84010-029-03) </PackageDescription>
    <NDC11Code>84010-0029-03</NDC11Code>
    <ProductNDC>84010-029</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nekvnro Fungal Nail</ProprietaryName>
    <NonProprietaryName>Tolnaftate 1% Fungal Nail</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240911</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>TOLNAFTATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240911</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>●Proven effective in the treatment of most athlete's foot (tinea pedis)and ringworm(tinea corporis). ● Helps prevent most athlete's foot with daily use. ● For effective relief of itching, burning and cracking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84010-030-03</NDCCode>
    <PackageDescription>42.5 g in 1 TUBE (84010-030-03) </PackageDescription>
    <NDC11Code>84010-0030-03</NDC11Code>
    <ProductNDC>84010-030</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nekvnro Clotrimazole</ProprietaryName>
    <NonProprietaryName>Clotrimazole1%, Miconazole1%clotrimazole</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240913</StartMarketingDate>
    <EndMarketingDate>20250911</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>CLOTRIMAZOLE; MICONAZOLE</SubstanceName>
    <StrengthNumber>1; 1</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azole Antifungal [EPC], Azoles [CS], Azoles [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240913</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250911</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>84010-037-03</NDCCode>
    <PackageDescription>42.5 g in 1 TUBE (84010-037-03) </PackageDescription>
    <NDC11Code>84010-0037-03</NDC11Code>
    <ProductNDC>84010-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Qiuningtang Hemorrhoid</ProprietaryName>
    <NonProprietaryName>Lidocaine 4%, Phenylephrine Hcl 0.25%, Hemorrhoid</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241017</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4; .25</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241017</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily shrinks hemorrhoidal tissue,for the temporary relief of pain,soreness,or burning,and helps relieve the local it ching and discomfort associated with hemorrhoids.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84010-040-03</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE (84010-040-03) </PackageDescription>
    <NDC11Code>84010-0040-03</NDC11Code>
    <ProductNDC>84010-040</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Healmusz Wart Remover</ProprietaryName>
    <NonProprietaryName>Salicylic Acid Wart Remover</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241025</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M028</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241025</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>84010-045-03</NDCCode>
    <PackageDescription>60 g in 1 TUBE (84010-045-03) </PackageDescription>
    <NDC11Code>84010-0045-03</NDC11Code>
    <ProductNDC>84010-045</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mrkayll Tattoo Numbing</ProprietaryName>
    <NonProprietaryName>Lidocaine5% Tattoo Numbing</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241119</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of local discomfort, itching, pain, soreness, or burning related to the tattoo process.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84010-105-03</NDCCode>
    <PackageDescription>4 TUBE in 1 BOX (84010-105-03)  / 4 mL in 1 TUBE</PackageDescription>
    <NDC11Code>84010-0105-03</NDC11Code>
    <ProductNDC>84010-105</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Natuheal Wart Remover</ProprietaryName>
    <NonProprietaryName>Salicylic Acid 17% Wart Remover</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250506</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M028</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the removal of common warts and plantar warts.Common warts have a rough"cauliflower-like" surface and are easily recognizable.Plantar warts are located only on the soles of the feet, tender to touch, with an interrupted footprint pattern.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84010-155-03</NDCCode>
    <PackageDescription>15 mL in 1 BOTTLE (84010-155-03) </PackageDescription>
    <NDC11Code>84010-0155-03</NDC11Code>
    <ProductNDC>84010-155</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Johohula Common And Plantar Wart Remover</ProprietaryName>
    <NonProprietaryName>Salicylic Acid 17% Common And Plantar Wart Remover</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250717</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M028</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250717</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■For the removal of common andplantar warts.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84010-166-03</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE (84010-166-03) </PackageDescription>
    <NDC11Code>84010-0166-03</NDC11Code>
    <ProductNDC>84010-166</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Elsatimy Multi-purpose Treatment</ProprietaryName>
    <NonProprietaryName>Tolnaftate 1% Multi-purpose Treatment</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250729</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>TOLNAFTATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250729</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For most Nail Fungus,Relieves itching, sorenes,discoloration, thickening, splitting and nai brittleness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84010-237-03</NDCCode>
    <PackageDescription>100 g in 1 BOTTLE (84010-237-03) </PackageDescription>
    <NDC11Code>84010-0237-03</NDC11Code>
    <ProductNDC>84010-237</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Jovynex Women Estriol</ProprietaryName>
    <NonProprietaryName>Micronized Estriol 0.1% Women Estriol</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251222</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>ESTRIOL</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>·Provides temporary relief from intimate dryness and discomfort.·Moisturizes and soothes the intimate area.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84010-238-03</NDCCode>
    <PackageDescription>42 PATCH in 1 BOX (84010-238-03) </PackageDescription>
    <NDC11Code>84010-0238-03</NDC11Code>
    <ProductNDC>84010-238</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Patloom Quit Smoking Nicotine Patches</ProprietaryName>
    <NonProprietaryName>Nicotine14% Quit Smoking Nicotine Patches</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251224</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>14</StrengthNumber>
    <StrengthUnit>mg/1001</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms,including nicotine craving,associated with quitting smoking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84010-239-03</NDCCode>
    <PackageDescription>42 PATCH in 1 BOX (84010-239-03) </PackageDescription>
    <NDC11Code>84010-0239-03</NDC11Code>
    <ProductNDC>84010-239</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Patloom Quit Smoking Nicotine Patches</ProprietaryName>
    <NonProprietaryName>Nicotine7% Quit Smoking Nicotine Patches</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251224</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Jiangxi Hemei Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>7</StrengthNumber>
    <StrengthUnit>mg/1001</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms,including nicotine craving,associated with quitting smoking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10825-002-03</NDCCode>
    <PackageDescription>168 L in 1 DEWAR (10825-002-03)</PackageDescription>
    <NDC11Code>10825-0002-03</NDC11Code>
    <ProductNDC>10825-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen</ProprietaryName>
    <NonProprietaryName>Oxygen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19740101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Northern Welding Supply</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>11534-168-03</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (11534-168-03)</PackageDescription>
    <NDC11Code>11534-0168-03</NDC11Code>
    <ProductNDC>11534-168</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benztropine Mesylate</ProprietaryName>
    <NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204713</ApplicationNumber>
    <LabelerName>SUNRISE PHARMACEUTICAL, INC</LabelerName>
    <SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-07</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55289-168-03</NDCCode>
    <PackageDescription>3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-168-03) </PackageDescription>
    <NDC11Code>55289-0168-03</NDC11Code>
    <ProductNDC>55289-168</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Famciclovir</ProprietaryName>
    <NonProprietaryName>Famciclovir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070905</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077487</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FAMCICLOVIR</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110414</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Famciclovir tablets, a prodrug of penciclovir, are a deoxynucleoside analog DNA polymerase inhibitor indicated for. Immunocompetent Adult Patients( 1.1) : 1 Herpes labialis (cold sores) Treatment of recurrent episodes, 2 Genital herpes Treatment of recurrent episodesSuppressive therapy of recurrent episodes, 3 Herpes zoster (shingles).</IndicationAndUsage>
    <Description>Famciclovir Tablets, USP contain famciclovir, USP, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir, USP is known as 2-[2-(2-amino-9 H-purin-9-yl)ethyl]-1,3-propanediol diacetate. It is a synthetic acyclic guanine derivative and has the following structure:. C 14H 19N 5O 4M.W. 321.3. Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P= 1.09 and octanol/phosphate buffer (pH 7.4) P= 2.08. Each white, film-coated tablet contains famciclovir, USP. The 125 mg and 250 mg tablets are round; the 500 mg tablets are capsule-shaped. Inactive ingredients consist of croscarmellose sodium, hydroxypropyl cellulose, hypromellose, polydextrose, polyethylene glycol, silicified microcrystalline cellulose, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide, and triacetin. Product meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-168-03</NDCCode>
    <PackageDescription>10 TABLET, COATED in 1 BOTTLE (63304-168-03)</PackageDescription>
    <NDC11Code>63304-0168-03</NDC11Code>
    <ProductNDC>63304-168</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077977</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Major Depressive Disorder–Sertraline hydrochloride tablets are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder–Sertraline hydrochloride tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder–Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of sertraline hydrochloride was established in three 10 to 12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)–Sertraline hydrochloride is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-III-R/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride tablets are indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).</IndicationAndUsage>
    <Description>Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The molecular formula C17H17NCl2HCl is represented by the following molecular structure. Sertraline hydrochloride is a white to off-white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50, 100, 150, and 200 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>63545-168-03</NDCCode>
    <PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (63545-168-03) </PackageDescription>
    <NDC11Code>63545-0168-03</NDC11Code>
    <ProductNDC>63545-168</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Arsenicum Album</ProprietaryName>
    <NonProprietaryName>Arsenicum Album</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210323</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
    <SubstanceName>ARSENIC TRIOXIDE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-03-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210323</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65841-046-03</NDCCode>
    <PackageDescription>168 TABLET, FILM COATED in 1 BOTTLE (65841-046-03) </PackageDescription>
    <NDC11Code>65841-0046-03</NDC11Code>
    <ProductNDC>65841-046</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ribavirin</ProprietaryName>
    <NonProprietaryName>Ribavirin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20051205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077094</ApplicationNumber>
    <LabelerName>Zydus Lifesciences Limited</LabelerName>
    <SubstanceName>RIBAVIRIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20051205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65841-260-03</NDCCode>
    <PackageDescription>168 CAPSULE in 1 BOTTLE (65841-260-03) </PackageDescription>
    <NDC11Code>65841-0260-03</NDC11Code>
    <ProductNDC>65841-260</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ribavirin</ProprietaryName>
    <NonProprietaryName>Ribavirin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077224</ApplicationNumber>
    <LabelerName>Zydus Lifesciences Limited</LabelerName>
    <SubstanceName>RIBAVIRIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68382-046-03</NDCCode>
    <PackageDescription>168 TABLET, FILM COATED in 1 BOTTLE (68382-046-03) </PackageDescription>
    <NDC11Code>68382-0046-03</NDC11Code>
    <ProductNDC>68382-046</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ribavirin</ProprietaryName>
    <NonProprietaryName>Ribavirin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20051205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077094</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>RIBAVIRIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20051205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ribavirin is a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with peginterferon alfa-2a in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients coinfected with HIV (1).</IndicationAndUsage>
    <Description>Ribavirin is a nucleoside analogue with antiviral activity. The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula. The molecular formula of ribavirin is C8H12N4O5 and the molecular weight is 244.2. Ribavirin, USP is white, crystalline powder. It is freely soluble in water and slightly soluble in dehydrated alcohol. Each film-coated ribavirin tablet intended for oral administration contains 200 mg or 400 mg or 500 mg or 600 mg of ribavirin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, talc and titanium dioxide. Organic test number pending in the USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-260-03</NDCCode>
    <PackageDescription>168 CAPSULE in 1 BOTTLE (68382-260-03) </PackageDescription>
    <NDC11Code>68382-0260-03</NDC11Code>
    <ProductNDC>68382-260</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ribavirin</ProprietaryName>
    <NonProprietaryName>Ribavirin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077224</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>RIBAVIRIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ribavirin is a nucleoside analogue indicated in combination with interferon alfa- 2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease.  (1.1). Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.</IndicationAndUsage>
    <Description>Ribavirin is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see Figure 1). Figure 1: Structural Formula. Ribavirin, USP is a white, crystalline powder. It is freely soluble in water and slightly soluble in dehydrated alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21. Each ribavirin capsule, USP intended for oral administration contains 200 mg of ribavirin, USP in white, hard gelatin capsule shells. In addition, each capsule contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, and silicon dioxide. The capsule shell consists of gelatin and titanium dioxide. It may also contain sodium lauryl sulfate. The capsule is printed with black pharmaceutical ink.</Description>
  </NDC>
  <NDC>
    <NDCCode>69339-168-03</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69339-168-03) </PackageDescription>
    <NDC11Code>69339-0168-03</NDC11Code>
    <ProductNDC>69339-168</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gefitinib</ProprietaryName>
    <NonProprietaryName>Gefitinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230605</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212827</ApplicationNumber>
    <LabelerName>Natco Pharma USA LLC</LabelerName>
    <SubstanceName>GEFITINIB</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14)]. Limitation of Use: Safety and efficacy of gefitinib tablets have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [seeClinical Studies (14)].</IndicationAndUsage>
    <Description>Gefitinib is a kinase inhibitor. The chemical name of gefitinib is N-(3ʹ-Chloro-4ʹ-fluorophenyl)-7-methoxy-6-{3-(4- morpholinyl)proproxy}-4-quinazolinamine and the following structural formula. Gefitinib has the molecular formula C22H24ClFN4O3, a relative molecular mass of 446.9 daltons and is a White to off-white crystalline powder. Gefitinib is a free base. The molecule has pKa1 is 6.5 &amp; pKa2 is 6.9. Gefitinib can be defined as soluble at pH 1, but insoluble above pH 7, freely soluble in dimethylformamide and acetic acid, slightly soluble in methanol. Gefitinib tablets are available as brown film-coated tablets, containing 250 mg of gefitinib, for oral administration. The inactive ingredients of the tablet core of gefitinib tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, and sodium lauryl sulfate and magnesium stearate. Tablet coating contains: polyvinyl alcohol, polyethylene glycol/PEG, talc, titanium dioxide, yellow iron oxide and red iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-168-03</NDCCode>
    <PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70436-168-03) </PackageDescription>
    <NDC11Code>70436-0168-03</NDC11Code>
    <ProductNDC>70436-168</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibric Acid</ProprietaryName>
    <NonProprietaryName>Fenofibric Acid</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220411</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212562</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>FENOFIBRIC ACID</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220411</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>73377-168-03</NDCCode>
    <PackageDescription>480 g in 1 JAR (73377-168-03) </PackageDescription>
    <NDC11Code>73377-0168-03</NDC11Code>
    <ProductNDC>73377-168</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Cyclobenzaprine Hudrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20220520</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>AX Pharmaceutical Corp</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-10-29</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>23-APR-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>76420-168-03</NDCCode>
    <PackageDescription>3 g in 1 JAR (76420-168-03)</PackageDescription>
    <NDC11Code>76420-0168-03</NDC11Code>
    <ProductNDC>76420-168</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20150531</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>76891-168-03</NDCCode>
    <PackageDescription>3 BOTTLE, SPRAY in 1 CARTON (76891-168-03)  / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>76891-0168-03</NDC11Code>
    <ProductNDC>76891-168</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Scent Theory Hand Sanitizers</ProprietaryName>
    <ProprietaryNameSuffix>Cherry Pop, Ocean Splash, Juicy Pear</ProprietaryNameSuffix>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260216</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Scent Theory Products LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>83589-168-03</NDCCode>
    <PackageDescription>1 g in 1 BOTTLE (83589-168-03) </PackageDescription>
    <NDC11Code>83589-0168-03</NDC11Code>
    <ProductNDC>83589-168</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Semax Acetate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20260304</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Nanjing Chengong Pharmaceutical Co., Ltd.</LabelerName>
    <SubstanceName>SEMAX</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>04-MAR-26</StartMarketingDatePackage>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>84010-168-03</NDCCode><ProprietaryName>Qsoowis Wart Removal</ProprietaryName><NonProprietaryName>Salicylic Acid 17% Wart Removal</NonProprietaryName></NDC><NDC><NDCCode>84010-168-01</NDCCode><ProprietaryName>Qsoowis Wart Removal</ProprietaryName><NonProprietaryName>Salicylic Acid 17% Wart Removal</NonProprietaryName></NDC><NDC><NDCCode>84010-168-02</NDCCode><ProprietaryName>Qsoowis Wart Removal</ProprietaryName><NonProprietaryName>Salicylic Acid 17% Wart Removal</NonProprietaryName></NDC><NDC><NDCCode>84010-018-03</NDCCode><ProprietaryName>Baodao Tattoo Numbing</ProprietaryName><NonProprietaryName>Lidocaine 5% Tattoo Numbing</NonProprietaryName></NDC><NDC><NDCCode>84010-029-03</NDCCode><ProprietaryName>Nekvnro Fungal Nail</ProprietaryName><NonProprietaryName>Tolnaftate 1% Fungal Nail</NonProprietaryName></NDC><NDC><NDCCode>84010-030-03</NDCCode><ProprietaryName>Nekvnro Clotrimazole</ProprietaryName><NonProprietaryName>Clotrimazole1%, Miconazole1%clotrimazole</NonProprietaryName></NDC><NDC><NDCCode>84010-037-03</NDCCode><ProprietaryName>Qiuningtang Hemorrhoid</ProprietaryName><NonProprietaryName>Lidocaine 4%, Phenylephrine Hcl 0.25%, Hemorrhoid</NonProprietaryName></NDC><NDC><NDCCode>84010-040-03</NDCCode><ProprietaryName>Healmusz Wart Remover</ProprietaryName><NonProprietaryName>Salicylic Acid Wart Remover</NonProprietaryName></NDC><NDC><NDCCode>84010-045-03</NDCCode><ProprietaryName>Mrkayll Tattoo Numbing</ProprietaryName><NonProprietaryName>Lidocaine5% Tattoo Numbing</NonProprietaryName></NDC><NDC><NDCCode>84010-105-03</NDCCode><ProprietaryName>Natuheal Wart Remover</ProprietaryName><NonProprietaryName>Salicylic Acid 17% Wart Remover</NonProprietaryName></NDC><NDC><NDCCode>84010-155-03</NDCCode><ProprietaryName>Johohula Common And Plantar Wart Remover</ProprietaryName><NonProprietaryName>Salicylic Acid 17% Common And Plantar Wart Remover</NonProprietaryName></NDC><NDC><NDCCode>84010-166-03</NDCCode><ProprietaryName>Elsatimy Multi-purpose Treatment</ProprietaryName><NonProprietaryName>Tolnaftate 1% Multi-purpose Treatment</NonProprietaryName></NDC><NDC><NDCCode>84010-237-03</NDCCode><ProprietaryName>Jovynex Women Estriol</ProprietaryName><NonProprietaryName>Micronized Estriol 0.1% Women Estriol</NonProprietaryName></NDC><NDC><NDCCode>84010-238-03</NDCCode><ProprietaryName>Patloom Quit Smoking Nicotine Patches</ProprietaryName><NonProprietaryName>Nicotine14% Quit Smoking Nicotine Patches</NonProprietaryName></NDC><NDC><NDCCode>84010-239-03</NDCCode><ProprietaryName>Patloom Quit Smoking Nicotine Patches</ProprietaryName><NonProprietaryName>Nicotine7% Quit Smoking Nicotine Patches</NonProprietaryName></NDC><NDC><NDCCode>10825-002-03</NDCCode><ProprietaryName>Oxygen</ProprietaryName><NonProprietaryName>Oxygen</NonProprietaryName></NDC><NDC><NDCCode>11534-168-03</NDCCode><ProprietaryName>Benztropine Mesylate</ProprietaryName><NonProprietaryName>Benztropine Mesylate</NonProprietaryName></NDC><NDC><NDCCode>55289-168-03</NDCCode><ProprietaryName>Famciclovir</ProprietaryName><NonProprietaryName>Famciclovir</NonProprietaryName></NDC><NDC><NDCCode>63304-168-03</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>63545-168-03</NDCCode><ProprietaryName>Arsenicum Album</ProprietaryName><NonProprietaryName>Arsenicum Album</NonProprietaryName></NDC><NDC><NDCCode>65841-046-03</NDCCode><ProprietaryName>Ribavirin</ProprietaryName><NonProprietaryName>Ribavirin</NonProprietaryName></NDC><NDC><NDCCode>65841-260-03</NDCCode><ProprietaryName>Ribavirin</ProprietaryName><NonProprietaryName>Ribavirin</NonProprietaryName></NDC><NDC><NDCCode>68382-046-03</NDCCode><ProprietaryName>Ribavirin</ProprietaryName><NonProprietaryName>Ribavirin</NonProprietaryName></NDC><NDC><NDCCode>68382-260-03</NDCCode><ProprietaryName>Ribavirin</ProprietaryName><NonProprietaryName>Ribavirin</NonProprietaryName></NDC><NDC><NDCCode>69339-168-03</NDCCode><ProprietaryName>Gefitinib</ProprietaryName><NonProprietaryName>Gefitinib</NonProprietaryName></NDC><NDC><NDCCode>70436-168-03</NDCCode><ProprietaryName>Fenofibric Acid</ProprietaryName><NonProprietaryName>Fenofibric Acid</NonProprietaryName></NDC><NDC><NDCCode>73377-168-03</NDCCode><NonProprietaryName>Cyclobenzaprine Hudrochloride</NonProprietaryName></NDC><NDC><NDCCode>76420-168-03</NDCCode><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76891-168-03</NDCCode><ProprietaryName>Scent Theory Hand Sanitizers</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>83589-168-03</NDCCode><NonProprietaryName>Semax Acetate</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
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      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

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

How does it work

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

Full Text Search & DataLabs REST API

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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