RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (20 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "0002-1200-48",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-48)  / 100 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "00002-1200-48",
      "ProductNDC": "0002-1200",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amyvid",
      "NonProprietaryName": "Florbetapir F 18",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20120601",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA202008",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "FLORBETAPIR F-18",
      "StrengthNumber": "51",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230522",
      "SamplePackage": "N",
      "IndicationAndUsage": "AMYVID is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: : 1 Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline , 2 Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products .",
      "Description": "AMYVID (florbetapir F 18 injection) is a radioactive diagnostic drug for intravenous use. Chemically, florbetapir F 18 is (E)-4-(2-(6-(2-(2-(2[18F] fluoroethoxy)ethoxy)ethoxy)pyridine-3-yl)vinyl)-N-methylbenzamine. The molecular weight is 359 and the structural formula is:. AMYVID is a sterile, non-pyrogenic clear, colorless solution. Each mL contains 0.1 mcg to 19 mcg of florbetapir and 500 MBq to 1,900 MBq (13.5 mCi to 51 mCi) of florbetapir F 18 at EOS and the following inactive ingredients: 4.5 mg sodium ascorbate and 0.1 mL dehydrated alcohol in 0.9% sodium chloride injection. The pH of the solution is between 5.5 and 8.0."
    },
    {
      "NDCCode": "64942-1200-2",
      "PackageDescription": "1 CONTAINER in 1 CARTON (64942-1200-2)  > 48 g in 1 CONTAINER (64942-1200-1)",
      "NDC11Code": "64942-1200-02",
      "ProductNDC": "64942-1200",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Degree",
      "ProprietaryNameSuffix": "Clinical Protection Motion Sense Cotton Fresh Antiperspirant And Deodorant",
      "NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111101",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Conopco Inc. d/b/a Unilever",
      "SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
      "StrengthNumber": "20",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "0002-1200-10",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-10)  > 10 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "00002-1200-10",
      "ProductNDC": "0002-1200",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amyvid",
      "NonProprietaryName": "Florbetapir F 18",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20120601",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA202008",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "FLORBETAPIR F-18",
      "StrengthNumber": "51",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Radioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "0002-1200-30",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-30)  > 30 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "00002-1200-30",
      "ProductNDC": "0002-1200",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amyvid",
      "NonProprietaryName": "Florbetapir F 18",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20120601",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA202008",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "FLORBETAPIR F-18",
      "StrengthNumber": "51",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20120601",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0002-1200-50",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-50)  / 50 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "00002-1200-50",
      "ProductNDC": "0002-1200",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amyvid",
      "NonProprietaryName": "Florbetapir F 18",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20120601",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA202008",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "FLORBETAPIR F-18",
      "StrengthNumber": "51",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120601",
      "SamplePackage": "N",
      "IndicationAndUsage": "AMYVID is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: : 1 Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline , 2 Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products .",
      "Description": "AMYVID (florbetapir F 18 injection) is a radioactive diagnostic drug for intravenous use. Chemically, florbetapir F 18 is (E)-4-(2-(6-(2-(2-(2[18F] fluoroethoxy)ethoxy)ethoxy)pyridine-3-yl)vinyl)-N-methylbenzamine. The molecular weight is 359 and the structural formula is:. AMYVID is a sterile, non-pyrogenic clear, colorless solution. Each mL contains 0.1 mcg to 19 mcg of florbetapir and 500 MBq to 1,900 MBq (13.5 mCi to 51 mCi) of florbetapir F 18 at EOS and the following inactive ingredients: 4.5 mg sodium ascorbate and 0.1 mL dehydrated alcohol in 0.9% sodium chloride injection. The pH of the solution is between 5.5 and 8.0."
    },
    {
      "NDCCode": "37662-0002-2",
      "PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-0002-2) ",
      "NDC11Code": "37662-0002-02",
      "ProductNDC": "37662-0002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Beryllium Nitricum",
      "NonProprietaryName": "Beryllium Nitricum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220512",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "BERYLLIUM NITRATE",
      "StrengthNumber": "12",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220512",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52124-1200-1",
      "PackageDescription": "1 KIT in 1 KIT (52124-1200-1)  *  .5 g in 1 TUBE (52124-0003-1)  *  2 TABLET in 1 PACKET (52124-0009-1)  *  2 TABLET, FILM COATED in 1 PACKET (47682-175-46)  *  .8 mL in 1 PACKAGE (52124-0001-1)  *  .5 mL in 1 PACKAGE (52124-0002-1)",
      "NDC11Code": "52124-1200-01",
      "ProductNDC": "52124-1200",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Genuine First Aid - Home First Aid",
      "NonProprietaryName": "Benzalkonium Chloride, Ibuprofen, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Acetaminophen",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20110111",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Genuine First Aid, LLC",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Uses   for the temporary relief of minor aches and pains associated with headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever."
    },
    {
      "NDCCode": "0002-1220-48",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-48)  / 100 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "00002-1220-48",
      "ProductNDC": "0002-1220",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tauvid",
      "NonProprietaryName": "Flortaucipir F-18",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20220701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212123",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "FLORTAUCIPIR F-18",
      "StrengthNumber": "100",
      "StrengthUnit": "mCi/mL",
      "Status": "Active",
      "LastUpdate": "2026-01-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20221025",
      "SamplePackage": "N",
      "IndicationAndUsage": "TAUVID is indicated for use with positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD).",
      "Description": "TAUVID contains flortaucipir fluorine 18 (F 18). Chemically, flortaucipir F 18 is 7-(6-[F-18]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole. The molecular weight is 262.27, the molecular formula is C16H10[18F]N3, and the structural formula is:. TAUVID is a sterile, non-pyrogenic solution for intravenous injection. The clear, colorless solution free of visible particulate matter is supplied ready to use, and each milliliter contains up to 2 micrograms of flortaucipir and 300 to 3,700 MBq (8.1 to 100 mCi) flortaucipir F 18 at end of synthesis, 1.5 mg of L-cysteine hydrochloride monohydrate USP, 2.1 mg of dibasic sodium phosphate anhydrous USP, up to 55 of micrograms hydrogen chloride and 0.1 mL dehydrated alcohol in 0.9% sodium chloride injection USP. The pH of the solution is between 5.5 and 7.5."
    },
    {
      "NDCCode": "42608-0002-1",
      "PackageDescription": "48 BOTTLE in 1 CARTON (42608-0002-1)  > 30 CAPSULE in 1 BOTTLE",
      "NDC11Code": "42608-0002-01",
      "ProductNDC": "42608-0002",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Paricalcitol",
      "DosageFormName": "CAPSULE",
      "StartMarketingDate": "20151022",
      "EndMarketingDate": "20180130",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Catalent U.K. Packaging Limited",
      "SubstanceName": "PARICALCITOL",
      "StrengthNumber": "1",
      "StrengthUnit": "ug/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20180130"
    },
    {
      "NDCCode": "47682-002-48",
      "PackageDescription": "125 PACKET in 1 BOX (47682-002-48)  / 2 TABLET in 1 PACKET (47682-002-99) ",
      "NDC11Code": "47682-0002-48",
      "ProductNDC": "47682-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Green Guard Advanced Sinus Relief",
      "NonProprietaryName": "Acetaminophen, Phenylephrine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081230",
      "EndMarketingDate": "20240701",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Unifirst First Aid Corporation",
      "SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "500; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20081230",
      "EndMarketingDatePackage": "20240701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. temporarily relieves these common cold/flu symptoms: 1 nasal congestion, 2 headache, 3 minor aches and pains, 4 stuffy nose, 5 sinus congestion and pressure."
    },
    {
      "NDCCode": "59579-002-48",
      "PackageDescription": "18 L in 1 DEWAR (59579-002-48) ",
      "NDC11Code": "59579-0002-48",
      "ProductNDC": "59579-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrogen",
      "NonProprietaryName": "Nitrogen",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20071001",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205850",
      "LabelerName": "Linde Gas & Equipment Inc.",
      "SubstanceName": "NITROGEN",
      "StrengthNumber": "990",
      "StrengthUnit": "mL/L",
      "Status": "Active",
      "LastUpdate": "2026-04-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200109",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73097-002-48",
      "PackageDescription": "24 POUCH in 1 CARTON (73097-002-48)  > 2 TABLET, EFFERVESCENT in 1 POUCH",
      "NDC11Code": "73097-0002-48",
      "ProductNDC": "73097-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alka Seltzer Plus Cold",
      "NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190701",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Savings Distributors LLC",
      "SubstanceName": "ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE",
      "StrengthNumber": "325; 2; 7.8",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190701",
      "SamplePackage": "N",
      "IndicationAndUsage": " temporarily relieves these symptoms due to a cold:  minor aches and pains  headache  runny nose  nasal and sinus congestion  sneezing  sore throat  temporarily reduces fever."
    },
    {
      "NDCCode": "73905-002-48",
      "PackageDescription": "80 mL in 1 BOTTLE (73905-002-48) ",
      "NDC11Code": "73905-0002-48",
      "ProductNDC": "73905-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "75% Alcohol Disnfectant",
      "NonProprietaryName": "75% Alcohol Disnfectant",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "EndMarketingDate": "20240423",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200331",
      "EndMarketingDatePackage": "20240423",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "77714-002-48",
      "PackageDescription": "148 mL in 1 BOTTLE (77714-002-48) ",
      "NDC11Code": "77714-0002-48",
      "ProductNDC": "77714-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bull Frog Spf 50",
      "NonProprietaryName": "Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 10.00%",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210808",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Bullfrog Brands, LLC",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "3; 15; 5; 10",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
      "Status": "Active",
      "LastUpdate": "2023-11-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210808",
      "SamplePackage": "N",
      "IndicationAndUsage": " helps prevent sunburn  if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "78505-002-48",
      "PackageDescription": "140 POUCH in 1 BOTTLE (78505-002-48)  > 3.5 g in 1 POUCH",
      "NDC11Code": "78505-0002-48",
      "ProductNDC": "78505-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Disinfectant Wipes",
      "NonProprietaryName": "Disinfectant Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200529",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "JINHUA CHANG GONG CLEANING UTENSILS CO.,LTD",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200610",
      "SamplePackage": "N",
      "IndicationAndUsage": "For Hand Sanitizing."
    },
    {
      "NDCCode": "84165-002-48",
      "PackageDescription": "48 BAG in 1 BOX (84165-002-48)  / 21 g in 1 BAG (84165-002-01) ",
      "NDC11Code": "84165-0002-48",
      "ProductNDC": "84165-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lidocaine Pain Relief Gel-patch",
      "NonProprietaryName": "Lidocaine",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250328",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Guangzhou Zhupuyou E-commerce Co., Ltd",
      "SubstanceName": "LIDOCAINE",
      "StrengthNumber": ".04",
      "StrengthUnit": "g/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250328",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,elbows."
    },
    {
      "NDCCode": "49035-284-48",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (49035-284-48)  / 48 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "49035-0284-48",
      "ProductNDC": "49035-284",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Equate Mucus Relief",
      "NonProprietaryName": "Guaifenesin",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240409",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209215",
      "LabelerName": "Wal-Mart Stores, Inc.",
      "SubstanceName": "GUAIFENESIN",
      "StrengthNumber": "1200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
      "Status": "Active",
      "LastUpdate": "2024-04-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240409",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
    },
    {
      "NDCCode": "51662-1200-1",
      "PackageDescription": "129 mL in 1 TUBE (51662-1200-1) ",
      "NDC11Code": "51662-1200-01",
      "ProductNDC": "51662-1200",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Activated Charcoal",
      "NonProprietaryName": "Activated Charcoal",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181222",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "ACTIVATED CHARCOAL",
      "StrengthNumber": "208",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20181222",
      "SamplePackage": "N",
      "IndicationAndUsage": "Actidose® with Sorbitol and Actidose®-Aqua should be used in a supervised medical facility or under the direction of a physician or poison control center. Actidose® with Sorbitol and Actidose®-Aqua are indicated in the management of many types of poisoning emergencies when a toxin has been ingested or when indicated for a limited number of systemic poisonings resulting from parenteral overdosage or when the toxin has been totally absorbed. If physiologic conditions are optimal, activated charcoal most effectively adsorbs toxins with a molecular weight of 100 - 1,000 Daltons (AMU’s).1 Activated charcoal may not be as effective in adsorbing low molecular weight substances such as aliphatic alcohols (methanol, isopropanol, ethanol, etc.) metals (iron, lead, mercury, etc.) and elements such as lithium.2. Two animal studies have demonstrated that very toxic and low molecular weight cyanide compounds are adsorbed by activated charcoal.21,22 The use of activated charcoal in toxic emergencies involving these substances is not contraindicated. Many poisonings involve multiple substances, therefore, Actidose® with Sorbitol and Actidose®-Aqua may be effective in adsorbing some or all of the ingested toxins. Adsorption of a toxin by activated charcoal can occur anywhere in the gastrointestinal tract. However, to use Actidose® with Sorbitol or Actidose®-Aqua most effectively it is important to administer it as soon as possible to the victim of an ingested exposure. The longer the delay between the ingestion of the toxin and administration of activated charcoal, the less effective it will be. If syrup of ipecac is being used to produce emesis, administration of Actidose® with Sorbitol or Actidose®-Aqua is customarily delayed until 30 – 60 minutes after conclusion of emesis. In a study which used syrup of ipecac, 60 ml, activated charcoal did not interfere with the emetic effect of syrup of ipecac.23. If gastric lavage is being used to facilitate stomach evacuation a single dose of activated charcoal can be administered in the early stages of gastric lavage. If this technique is utilized, Actidose®-Aqua, which does not contain sorbitol, should be used. Upon completion of gastric lavage Actidose® with Sorbitol can be instilled via the lavage tube. The only disadvantage to the use of activated charcoal in this fashion is that the gastric lavage returns will be black, thus making it difficult to evaluate what the patient ingested by visual examination. The primary advantage of this therapy is that activated charcoal can be administered early to the patient. The convenient packaging of Actidose® with Sorbitol and Actidose®-Aqua (except the 15gm/72ml size) in a squeeze bottle with a tapered nozzle expedites emergency treatment, allowing attachment to a gastric lavage tube and administration of contents. The most common application of activated charcoal is in acute toxic exposures where Actidose® with Sorbitol and Actidose®-Aqua can adsorb toxins thereby preventing their absorption. Activated charcoal can also be used in some toxic emergencies when absorption is complete or exposure was via a parenteral route. This application usually involves repetitive or multiple doses of activated charcoal. Multiple doses of activated charcoal may be useful in adsorbing toxins which undergo enterohepatic circulation.13 Drugs which are subject to biliary secretion such as digitoxin are constantly secreted into the gastrointestinal tract and are reabsorbed resulting in prolonged toxicity. Frequent doses of activated charcoal can adsorb those toxins thereby preventing their reabsorption and enhancing toxin elimination through the gastrointestinal tract. Multiple dose activated charcoal is also used in what is termed gastrointestinal dialysis.14 There are only a limited number of toxins which may be eliminated by this method. Clinical judgement and the toxin’s pharmacokinetic parameters must be considered to determine the applicability of this treatment which is not universally applicable.24 The toxin passively diffuses along a concentration gradient between blood which is perfusing the gastrointestinal tract and the luminal fluids. The multiple doses of activated charcoal adsorb the toxin thereby preventing its reabsorption further maximizing the concentration gradient which permits diffusion of even more toxin into the gastric lumen. Compounds most effectively transferred by this mechanism are lipophilic, uncharged and not excessively bound to proteins. Phenobarbital and theophylline are examples of toxins which can be eliminated more rapidly by this method.15,16. Actidose® with Sorbitol should not be used in each dose of the multiple dose activated charcoal regimen unless it is necessary to produce catharsis. Actidose® with Sorbitol contains sorbitol which may produce excessive catharsis and resultant fluid and electrolyte problems if used at each dosing interval (see Precautions).9,25 Actidose®-Aqua should be used at dosage intervals when Actidose® with Sorbitol is not being used. CATHARTICS SHOULD BE USED CAUTIOUSLY AND ONLY INTERMITTENTLY DURING MULTIPLE DOSE ACTIVATED CHARCOAL THERAPY. If catharsis of activated charcoal does not occur following the use of Actidose® with Sorbitol within 4 - 8 hours, an additional sorbitol dose of 1.5 gm/kg may be administered. Or, if desired, a saline cathartic such as magnesium citrate may be used if the patient’s renal function is not impaired. Actidose® with Sorbitol and Actidose®-Aqua are formulated in palatable vehicles which eliminate the need to add additional taste or consistency enhancers. The use of supplementary chemicals, syrups, or dairy products should be avoided since their addition may compromise the adsorptive capacity of Actidose® with Sorbitol and Actidose®-Aqua.",
      "Description": "Actidose® with Sorbitol: Actidose® with Sorbitol, ready-to-use activated charcoal suspension with sorbitol, contains 25 gm or 50 gm of activated charcoal, and 48 gm or 96 gm of sorbitol, respectively, in an aqueous suspension with a unique preservative system. Each milliliter contains 208 mg (0.208 gm) of activated charcoal and 400 mg (0.400 gm) of sorbitol. Sorbitol reduces the gritty sensation associated with activated charcoal, imparts a sweet taste which enhances patient compliance, and usually produces a cathartic effect. Actidose®-Aqua: Actidose®-Aqua, ready-to-use activated charcoal suspension, contains 15 gm, 25 gm or 50 gm of activated charcoal in an aqueous suspension with a unique preservative system. Each milliliter contains 208 mg (0.208 gm) of activated charcoal."
    },
    {
      "NDCCode": "53041-191-48",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (53041-191-48)  / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "53041-0191-48",
      "ProductNDC": "53041-191",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mucus Relief Maximum Strength 1200 Mg",
      "NonProprietaryName": "Guaifenesin",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200624",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209215",
      "LabelerName": "Guardian Drug Company",
      "SubstanceName": "GUAIFENESIN",
      "StrengthNumber": "1200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
      "Status": "Active",
      "LastUpdate": "2024-05-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200624",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
    },
    {
      "NDCCode": "63824-023-48",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (63824-023-48)  / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "63824-0023-48",
      "ProductNDC": "63824-023",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mucinex",
      "ProprietaryNameSuffix": "Maximum Strength",
      "NonProprietaryName": "Guaifenesin",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120626",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021282",
      "LabelerName": "Reckitt Benckiser LLC",
      "SubstanceName": "GUAIFENESIN",
      "StrengthNumber": "1200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
      "Status": "Active",
      "LastUpdate": "2026-05-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120626",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
    },
    {
      "NDCCode": "63824-072-48",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (63824-072-48)  / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "63824-0072-48",
      "ProductNDC": "63824-072",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mucinex Dm",
      "ProprietaryNameSuffix": "Maximum Strength",
      "NonProprietaryName": "Guaifenesin And Dextromethorphan Hydrobromide",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120626",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021620",
      "LabelerName": "Reckitt Benckiser LLC",
      "SubstanceName": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE",
      "StrengthNumber": "1200; 60",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-05-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120626",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep."
    },
    {
      "NDCCode": "68196-325-04",
      "PackageDescription": "1 BOTTLE in 1 CARTON (68196-325-04)  > 48 TABLET, EXTENDED RELEASE in 1 BOTTLE",
      "NDC11Code": "68196-0325-04",
      "ProductNDC": "68196-325",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Members Mark Mucus Relief Er",
      "NonProprietaryName": "Guaifenesin",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160901",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091009",
      "LabelerName": "Sam's West Inc",
      "SubstanceName": "GUAIFENESIN",
      "StrengthNumber": "1200",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-22",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "68196-735-04",
      "PackageDescription": "1 BOTTLE in 1 CARTON (68196-735-04)  > 48 TABLET, EXTENDED RELEASE in 1 BOTTLE",
      "NDC11Code": "68196-0735-04",
      "ProductNDC": "68196-735",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Members Mark Mucus Relief Dm",
      "NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160901",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091070",
      "LabelerName": "Sam's West Inc",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
      "StrengthNumber": "60; 1200",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-22",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "69263-022-15",
      "PackageDescription": "5 POUCH in 1 CARTON (69263-022-15)  > 3 PATCH in 1 POUCH > 1200 mg in 1 PATCH",
      "NDC11Code": "69263-0022-15",
      "ProductNDC": "69263-022",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atendia",
      "NonProprietaryName": "Menthol And Lidocaine",
      "DosageFormName": "PATCH",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20140401",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "OakLock, LLC",
      "SubstanceName": "LIDOCAINE; MENTHOL",
      "StrengthNumber": "48; 36",
      "StrengthUnit": "mg/1200mg; mg/1200mg",
      "Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2015-09-04"
    },
    {
      "NDCCode": "20482-002-10",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (20482-002-10)  > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY",
      "NDC11Code": "20482-0002-10",
      "ProductNDC": "20482-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Subsys",
      "NonProprietaryName": "Fentanyl",
      "DosageFormName": "SPRAY",
      "RouteName": "SUBLINGUAL",
      "StartMarketingDate": "20120313",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA202788",
      "LabelerName": "Insys Therapeutics, Inc.",
      "SubstanceName": "FENTANYL",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20120313",
      "SamplePackage": "N",
      "IndicationAndUsage": "SUBSYS is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking SUBSYS. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency room [see Contraindications ( 4)]. , 3 As part of the Transmucosal Immediate-Release Fentanyl (TIRF) REMS ACCESS Program, SUBSYS may be dispensed only to outpatients enrolled in the program. [see Warnings and Precautions ( 5.7)] . For inpatient administration of SUBSYS, patient enrollment is not required. .",
      "Description": "SUBSYS (fentanyl sublingual spray) is an opioid agonist, available as a sublingual spray designed to deliver doses of 100, 200, 400, 600, 800, 1200 and 1600 mcg of fentanyl. The chemical name of fentanyl is N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide. Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 860:1) that is freely soluble in ethanol and methanol and practically insoluble in water (1:40). The molecular weight of the free base is 336.47. The pKa is 8.4. The inactive ingredients in SUBSYS include: dehydrated alcohol 63.6% (V/V), purified water, propylene glycol, xylitol, and L-menthol."
    },
    {
      "NDCCode": "20482-002-30",
      "PackageDescription": "30 BLISTER PACK in 1 CARTON (20482-002-30)  > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY",
      "NDC11Code": "20482-0002-30",
      "ProductNDC": "20482-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Subsys",
      "NonProprietaryName": "Fentanyl",
      "DosageFormName": "SPRAY",
      "RouteName": "SUBLINGUAL",
      "StartMarketingDate": "20120313",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA202788",
      "LabelerName": "Insys Therapeutics, Inc.",
      "SubstanceName": "FENTANYL",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20120313",
      "SamplePackage": "N",
      "IndicationAndUsage": "SUBSYS is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking SUBSYS. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency room [see Contraindications ( 4)]. , 3 As part of the Transmucosal Immediate-Release Fentanyl (TIRF) REMS ACCESS Program, SUBSYS may be dispensed only to outpatients enrolled in the program. [see Warnings and Precautions ( 5.7)] . For inpatient administration of SUBSYS, patient enrollment is not required. .",
      "Description": "SUBSYS (fentanyl sublingual spray) is an opioid agonist, available as a sublingual spray designed to deliver doses of 100, 200, 400, 600, 800, 1200 and 1600 mcg of fentanyl. The chemical name of fentanyl is N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide. Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 860:1) that is freely soluble in ethanol and methanol and practically insoluble in water (1:40). The molecular weight of the free base is 336.47. The pKa is 8.4. The inactive ingredients in SUBSYS include: dehydrated alcohol 63.6% (V/V), purified water, propylene glycol, xylitol, and L-menthol."
    },
    {
      "NDCCode": "51042-002-09",
      "PackageDescription": "1200 mL in 1 BOTTLE, PLASTIC (51042-002-09) ",
      "NDC11Code": "51042-0002-09",
      "ProductNDC": "51042-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "First Mark Ultra Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210521",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Performance Food Group",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "60",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210521",
      "SamplePackage": "N",
      "IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "55695-002-00",
      "PackageDescription": "15 mL in 1 BOTTLE (55695-002-00) ",
      "NDC11Code": "55695-0002-00",
      "ProductNDC": "55695-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azithromycin",
      "NonProprietaryName": "Azithromycin",
      "DosageFormName": "POWDER, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065246",
      "LabelerName": "STATE HEALTH SERVICES, TEXAS DEPARTMENT OF",
      "SubstanceName": "AZITHROMYCIN MONOHYDRATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
      "Status": "Active",
      "LastUpdate": "2024-03-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20101228",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for oral suspension USP and other antibacterial drugs, azithromycin for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Azithromycin for oral suspension USP is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
      "Description": "Azithromycin for oral suspension USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2R,3S,4R,5R,8R, 10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α- L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3- (dimethylamino)-β- D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C 38H 72N 2O 12 M.W. 749.0. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12H 2O and a molecular weight of 767.0. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: ammonio methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP."
    },
    {
      "NDCCode": "57896-002-12",
      "PackageDescription": "355 mL in 1 BOTTLE (57896-002-12) ",
      "NDC11Code": "57896-0002-12",
      "ProductNDC": "57896-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Milk Of Magnesia Original",
      "NonProprietaryName": "Magnesium Hydroxide",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210301",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "Geri-Care Pharmaceuticals, Corp",
      "SubstanceName": "MAGNESIUM HYDROXIDE",
      "StrengthNumber": "1200",
      "StrengthUnit": "mg/15mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210301",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves occasional constipation (irregularity). usually produces bowel movement in 1/2 to 6 hours."
    },
    {
      "NDCCode": "69821-002-13",
      "PackageDescription": "1200 POUCH in 1 BAG (69821-002-13)  > 1.7 g in 1 POUCH",
      "NDC11Code": "69821-0002-13",
      "ProductNDC": "69821-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Wet Wipes",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "SWAB",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200420",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Zhejiang Qimei Commodity Co.,Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200420",
      "SamplePackage": "N",
      "IndicationAndUsage": "■ For hand washing to dec rease bacteria on the skin. Recommended for repeated use."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"0002-1200-48","ProprietaryName":"Amyvid","NonProprietaryName":"Florbetapir F 18"},{"NDCCode":"64942-1200-2","ProprietaryName":"Degree","NonProprietaryName":"Aluminum Zirconium Tetrachlorohydrex Gly"},{"NDCCode":"0002-1200-10","ProprietaryName":"Amyvid","NonProprietaryName":"Florbetapir F 18"},{"NDCCode":"0002-1200-30","ProprietaryName":"Amyvid","NonProprietaryName":"Florbetapir F 18"},{"NDCCode":"0002-1200-50","ProprietaryName":"Amyvid","NonProprietaryName":"Florbetapir F 18"},{"NDCCode":"37662-0002-2","ProprietaryName":"Beryllium Nitricum","NonProprietaryName":"Beryllium Nitricum"},{"NDCCode":"52124-1200-1","ProprietaryName":"Genuine First Aid - Home First Aid","NonProprietaryName":"Benzalkonium Chloride, Ibuprofen, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Acetaminophen"},{"NDCCode":"0002-1220-48","ProprietaryName":"Tauvid","NonProprietaryName":"Flortaucipir F-18"},{"NDCCode":"42608-0002-1","NonProprietaryName":"Paricalcitol"},{"NDCCode":"47682-002-48","ProprietaryName":"Green Guard Advanced Sinus Relief","NonProprietaryName":"Acetaminophen, Phenylephrine Hydrochloride"},{"NDCCode":"59579-002-48","ProprietaryName":"Nitrogen","NonProprietaryName":"Nitrogen"},{"NDCCode":"73097-002-48","ProprietaryName":"Alka Seltzer Plus Cold","NonProprietaryName":"Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate"},{"NDCCode":"73905-002-48","ProprietaryName":"75% Alcohol Disnfectant","NonProprietaryName":"75% Alcohol Disnfectant"},{"NDCCode":"77714-002-48","ProprietaryName":"Bull Frog Spf 50","NonProprietaryName":"Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 10.00%"},{"NDCCode":"78505-002-48","ProprietaryName":"Disinfectant Wipes","NonProprietaryName":"Disinfectant Wipes"},{"NDCCode":"84165-002-48","ProprietaryName":"Lidocaine Pain Relief Gel-patch","NonProprietaryName":"Lidocaine"},{"NDCCode":"49035-284-48","ProprietaryName":"Equate Mucus Relief","NonProprietaryName":"Guaifenesin"},{"NDCCode":"51662-1200-1","ProprietaryName":"Activated Charcoal","NonProprietaryName":"Activated Charcoal"},{"NDCCode":"53041-191-48","ProprietaryName":"Mucus Relief Maximum Strength 1200 Mg","NonProprietaryName":"Guaifenesin"},{"NDCCode":"63824-023-48","ProprietaryName":"Mucinex","NonProprietaryName":"Guaifenesin"},{"NDCCode":"63824-072-48","ProprietaryName":"Mucinex Dm","NonProprietaryName":"Guaifenesin And Dextromethorphan Hydrobromide"},{"NDCCode":"68196-325-04","ProprietaryName":"Members Mark Mucus Relief Er","NonProprietaryName":"Guaifenesin"},{"NDCCode":"68196-735-04","ProprietaryName":"Members Mark Mucus Relief Dm","NonProprietaryName":"Dextromethorphan Hbr, Guaifenesin"},{"NDCCode":"69263-022-15","ProprietaryName":"Atendia","NonProprietaryName":"Menthol And Lidocaine"},{"NDCCode":"20482-002-10","ProprietaryName":"Subsys","NonProprietaryName":"Fentanyl"},{"NDCCode":"20482-002-30","ProprietaryName":"Subsys","NonProprietaryName":"Fentanyl"},{"NDCCode":"51042-002-09","ProprietaryName":"First Mark Ultra Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"55695-002-00","ProprietaryName":"Azithromycin","NonProprietaryName":"Azithromycin"},{"NDCCode":"57896-002-12","ProprietaryName":"Milk Of Magnesia Original","NonProprietaryName":"Magnesium Hydroxide"},{"NDCCode":"69821-002-13","ProprietaryName":"Wet Wipes","NonProprietaryName":"Ethyl Alcohol"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>0002-1200-48</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-48)  / 100 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>00002-1200-48</NDC11Code>
    <ProductNDC>0002-1200</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amyvid</ProprietaryName>
    <NonProprietaryName>Florbetapir F 18</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20120601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA202008</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>FLORBETAPIR F-18</SubstanceName>
    <StrengthNumber>51</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Pharm_Classes>Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230522</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>AMYVID is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: : 1 Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline , 2 Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products .</IndicationAndUsage>
    <Description>AMYVID (florbetapir F 18 injection) is a radioactive diagnostic drug for intravenous use. Chemically, florbetapir F 18 is (E)-4-(2-(6-(2-(2-(2[18F] fluoroethoxy)ethoxy)ethoxy)pyridine-3-yl)vinyl)-N-methylbenzamine. The molecular weight is 359 and the structural formula is:. AMYVID is a sterile, non-pyrogenic clear, colorless solution. Each mL contains 0.1 mcg to 19 mcg of florbetapir and 500 MBq to 1,900 MBq (13.5 mCi to 51 mCi) of florbetapir F 18 at EOS and the following inactive ingredients: 4.5 mg sodium ascorbate and 0.1 mL dehydrated alcohol in 0.9% sodium chloride injection. The pH of the solution is between 5.5 and 8.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>64942-1200-2</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (64942-1200-2)  &gt; 48 g in 1 CONTAINER (64942-1200-1)</PackageDescription>
    <NDC11Code>64942-1200-02</NDC11Code>
    <ProductNDC>64942-1200</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Degree</ProprietaryName>
    <ProprietaryNameSuffix>Clinical Protection Motion Sense Cotton Fresh Antiperspirant And Deodorant</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Conopco Inc. d/b/a Unilever</LabelerName>
    <SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0002-1200-10</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-10)  &gt; 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>00002-1200-10</NDC11Code>
    <ProductNDC>0002-1200</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amyvid</ProprietaryName>
    <NonProprietaryName>Florbetapir F 18</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20120601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA202008</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>FLORBETAPIR F-18</SubstanceName>
    <StrengthNumber>51</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Pharm_Classes>Radioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0002-1200-30</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-30)  &gt; 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>00002-1200-30</NDC11Code>
    <ProductNDC>0002-1200</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amyvid</ProprietaryName>
    <NonProprietaryName>Florbetapir F 18</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20120601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA202008</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>FLORBETAPIR F-18</SubstanceName>
    <StrengthNumber>51</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Pharm_Classes>Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0002-1200-50</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-50)  / 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>00002-1200-50</NDC11Code>
    <ProductNDC>0002-1200</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amyvid</ProprietaryName>
    <NonProprietaryName>Florbetapir F 18</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20120601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA202008</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>FLORBETAPIR F-18</SubstanceName>
    <StrengthNumber>51</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Pharm_Classes>Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>AMYVID is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: : 1 Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline , 2 Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products .</IndicationAndUsage>
    <Description>AMYVID (florbetapir F 18 injection) is a radioactive diagnostic drug for intravenous use. Chemically, florbetapir F 18 is (E)-4-(2-(6-(2-(2-(2[18F] fluoroethoxy)ethoxy)ethoxy)pyridine-3-yl)vinyl)-N-methylbenzamine. The molecular weight is 359 and the structural formula is:. AMYVID is a sterile, non-pyrogenic clear, colorless solution. Each mL contains 0.1 mcg to 19 mcg of florbetapir and 500 MBq to 1,900 MBq (13.5 mCi to 51 mCi) of florbetapir F 18 at EOS and the following inactive ingredients: 4.5 mg sodium ascorbate and 0.1 mL dehydrated alcohol in 0.9% sodium chloride injection. The pH of the solution is between 5.5 and 8.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>37662-0002-2</NDCCode>
    <PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (37662-0002-2) </PackageDescription>
    <NDC11Code>37662-0002-02</NDC11Code>
    <ProductNDC>37662-0002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Beryllium Nitricum</ProprietaryName>
    <NonProprietaryName>Beryllium Nitricum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220512</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>BERYLLIUM NITRATE</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220512</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52124-1200-1</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (52124-1200-1)  *  .5 g in 1 TUBE (52124-0003-1)  *  2 TABLET in 1 PACKET (52124-0009-1)  *  2 TABLET, FILM COATED in 1 PACKET (47682-175-46)  *  .8 mL in 1 PACKAGE (52124-0001-1)  *  .5 mL in 1 PACKAGE (52124-0002-1)</PackageDescription>
    <NDC11Code>52124-1200-01</NDC11Code>
    <ProductNDC>52124-1200</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Genuine First Aid - Home First Aid</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride, Ibuprofen, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Acetaminophen</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20110111</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Genuine First Aid, LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses   for the temporary relief of minor aches and pains associated with headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0002-1220-48</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-48)  / 100 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>00002-1220-48</NDC11Code>
    <ProductNDC>0002-1220</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tauvid</ProprietaryName>
    <NonProprietaryName>Flortaucipir F-18</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220701</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212123</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>FLORTAUCIPIR F-18</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221025</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TAUVID is indicated for use with positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD).</IndicationAndUsage>
    <Description>TAUVID contains flortaucipir fluorine 18 (F 18). Chemically, flortaucipir F 18 is 7-(6-[F-18]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole. The molecular weight is 262.27, the molecular formula is C16H10[18F]N3, and the structural formula is:. TAUVID is a sterile, non-pyrogenic solution for intravenous injection. The clear, colorless solution free of visible particulate matter is supplied ready to use, and each milliliter contains up to 2 micrograms of flortaucipir and 300 to 3,700 MBq (8.1 to 100 mCi) flortaucipir F 18 at end of synthesis, 1.5 mg of L-cysteine hydrochloride monohydrate USP, 2.1 mg of dibasic sodium phosphate anhydrous USP, up to 55 of micrograms hydrogen chloride and 0.1 mL dehydrated alcohol in 0.9% sodium chloride injection USP. The pH of the solution is between 5.5 and 7.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>42608-0002-1</NDCCode>
    <PackageDescription>48 BOTTLE in 1 CARTON (42608-0002-1)  &gt; 30 CAPSULE in 1 BOTTLE</PackageDescription>
    <NDC11Code>42608-0002-01</NDC11Code>
    <ProductNDC>42608-0002</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Paricalcitol</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20151022</StartMarketingDate>
    <EndMarketingDate>20180130</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Catalent U.K. Packaging Limited</LabelerName>
    <SubstanceName>PARICALCITOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20180130</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>47682-002-48</NDCCode>
    <PackageDescription>125 PACKET in 1 BOX (47682-002-48)  / 2 TABLET in 1 PACKET (47682-002-99) </PackageDescription>
    <NDC11Code>47682-0002-48</NDC11Code>
    <ProductNDC>47682-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Green Guard Advanced Sinus Relief</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081230</StartMarketingDate>
    <EndMarketingDate>20240701</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Unifirst First Aid Corporation</LabelerName>
    <SubstanceName>ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20081230</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240701</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. temporarily relieves these common cold/flu symptoms: 1 nasal congestion, 2 headache, 3 minor aches and pains, 4 stuffy nose, 5 sinus congestion and pressure.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59579-002-48</NDCCode>
    <PackageDescription>18 L in 1 DEWAR (59579-002-48) </PackageDescription>
    <NDC11Code>59579-0002-48</NDC11Code>
    <ProductNDC>59579-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrogen</ProprietaryName>
    <NonProprietaryName>Nitrogen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20071001</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205850</ApplicationNumber>
    <LabelerName>Linde Gas &amp; Equipment Inc.</LabelerName>
    <SubstanceName>NITROGEN</SubstanceName>
    <StrengthNumber>990</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>73097-002-48</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (73097-002-48)  &gt; 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
    <NDC11Code>73097-0002-48</NDC11Code>
    <ProductNDC>73097-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alka Seltzer Plus Cold</ProprietaryName>
    <NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName>
    <DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Savings Distributors LLC</LabelerName>
    <SubstanceName>ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE</SubstanceName>
    <StrengthNumber>325; 2; 7.8</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> temporarily relieves these symptoms due to a cold:  minor aches and pains  headache  runny nose  nasal and sinus congestion  sneezing  sore throat  temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73905-002-48</NDCCode>
    <PackageDescription>80 mL in 1 BOTTLE (73905-002-48) </PackageDescription>
    <NDC11Code>73905-0002-48</NDC11Code>
    <ProductNDC>73905-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>75% Alcohol Disnfectant</ProprietaryName>
    <NonProprietaryName>75% Alcohol Disnfectant</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <EndMarketingDate>20240423</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200331</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240423</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>77714-002-48</NDCCode>
    <PackageDescription>148 mL in 1 BOTTLE (77714-002-48) </PackageDescription>
    <NDC11Code>77714-0002-48</NDC11Code>
    <ProductNDC>77714-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bull Frog Spf 50</ProprietaryName>
    <NonProprietaryName>Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 10.00%</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210808</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Bullfrog Brands, LLC</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>3; 15; 5; 10</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-11-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210808</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> helps prevent sunburn  if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>78505-002-48</NDCCode>
    <PackageDescription>140 POUCH in 1 BOTTLE (78505-002-48)  &gt; 3.5 g in 1 POUCH</PackageDescription>
    <NDC11Code>78505-0002-48</NDC11Code>
    <ProductNDC>78505-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Disinfectant Wipes</ProprietaryName>
    <NonProprietaryName>Disinfectant Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200529</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>JINHUA CHANG GONG CLEANING UTENSILS CO.,LTD</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For Hand Sanitizing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84165-002-48</NDCCode>
    <PackageDescription>48 BAG in 1 BOX (84165-002-48)  / 21 g in 1 BAG (84165-002-01) </PackageDescription>
    <NDC11Code>84165-0002-48</NDC11Code>
    <ProductNDC>84165-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Pain Relief Gel-patch</ProprietaryName>
    <NonProprietaryName>Lidocaine</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250328</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Guangzhou Zhupuyou E-commerce Co., Ltd</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>.04</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,elbows.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49035-284-48</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (49035-284-48)  / 48 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>49035-0284-48</NDC11Code>
    <ProductNDC>49035-284</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Equate Mucus Relief</ProprietaryName>
    <NonProprietaryName>Guaifenesin</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240409</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209215</ApplicationNumber>
    <LabelerName>Wal-Mart Stores, Inc.</LabelerName>
    <SubstanceName>GUAIFENESIN</SubstanceName>
    <StrengthNumber>1200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51662-1200-1</NDCCode>
    <PackageDescription>129 mL in 1 TUBE (51662-1200-1) </PackageDescription>
    <NDC11Code>51662-1200-01</NDC11Code>
    <ProductNDC>51662-1200</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Activated Charcoal</ProprietaryName>
    <NonProprietaryName>Activated Charcoal</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181222</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
    <SubstanceName>ACTIVATED CHARCOAL</SubstanceName>
    <StrengthNumber>208</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Actidose® with Sorbitol and Actidose®-Aqua should be used in a supervised medical facility or under the direction of a physician or poison control center. Actidose® with Sorbitol and Actidose®-Aqua are indicated in the management of many types of poisoning emergencies when a toxin has been ingested or when indicated for a limited number of systemic poisonings resulting from parenteral overdosage or when the toxin has been totally absorbed. If physiologic conditions are optimal, activated charcoal most effectively adsorbs toxins with a molecular weight of 100 - 1,000 Daltons (AMU’s).1 Activated charcoal may not be as effective in adsorbing low molecular weight substances such as aliphatic alcohols (methanol, isopropanol, ethanol, etc.) metals (iron, lead, mercury, etc.) and elements such as lithium.2. Two animal studies have demonstrated that very toxic and low molecular weight cyanide compounds are adsorbed by activated charcoal.21,22 The use of activated charcoal in toxic emergencies involving these substances is not contraindicated. Many poisonings involve multiple substances, therefore, Actidose® with Sorbitol and Actidose®-Aqua may be effective in adsorbing some or all of the ingested toxins. Adsorption of a toxin by activated charcoal can occur anywhere in the gastrointestinal tract. However, to use Actidose® with Sorbitol or Actidose®-Aqua most effectively it is important to administer it as soon as possible to the victim of an ingested exposure. The longer the delay between the ingestion of the toxin and administration of activated charcoal, the less effective it will be. If syrup of ipecac is being used to produce emesis, administration of Actidose® with Sorbitol or Actidose®-Aqua is customarily delayed until 30 – 60 minutes after conclusion of emesis. In a study which used syrup of ipecac, 60 ml, activated charcoal did not interfere with the emetic effect of syrup of ipecac.23. If gastric lavage is being used to facilitate stomach evacuation a single dose of activated charcoal can be administered in the early stages of gastric lavage. If this technique is utilized, Actidose®-Aqua, which does not contain sorbitol, should be used. Upon completion of gastric lavage Actidose® with Sorbitol can be instilled via the lavage tube. The only disadvantage to the use of activated charcoal in this fashion is that the gastric lavage returns will be black, thus making it difficult to evaluate what the patient ingested by visual examination. The primary advantage of this therapy is that activated charcoal can be administered early to the patient. The convenient packaging of Actidose® with Sorbitol and Actidose®-Aqua (except the 15gm/72ml size) in a squeeze bottle with a tapered nozzle expedites emergency treatment, allowing attachment to a gastric lavage tube and administration of contents. The most common application of activated charcoal is in acute toxic exposures where Actidose® with Sorbitol and Actidose®-Aqua can adsorb toxins thereby preventing their absorption. Activated charcoal can also be used in some toxic emergencies when absorption is complete or exposure was via a parenteral route. This application usually involves repetitive or multiple doses of activated charcoal. Multiple doses of activated charcoal may be useful in adsorbing toxins which undergo enterohepatic circulation.13 Drugs which are subject to biliary secretion such as digitoxin are constantly secreted into the gastrointestinal tract and are reabsorbed resulting in prolonged toxicity. Frequent doses of activated charcoal can adsorb those toxins thereby preventing their reabsorption and enhancing toxin elimination through the gastrointestinal tract. Multiple dose activated charcoal is also used in what is termed gastrointestinal dialysis.14 There are only a limited number of toxins which may be eliminated by this method. Clinical judgement and the toxin’s pharmacokinetic parameters must be considered to determine the applicability of this treatment which is not universally applicable.24 The toxin passively diffuses along a concentration gradient between blood which is perfusing the gastrointestinal tract and the luminal fluids. The multiple doses of activated charcoal adsorb the toxin thereby preventing its reabsorption further maximizing the concentration gradient which permits diffusion of even more toxin into the gastric lumen. Compounds most effectively transferred by this mechanism are lipophilic, uncharged and not excessively bound to proteins. Phenobarbital and theophylline are examples of toxins which can be eliminated more rapidly by this method.15,16. Actidose® with Sorbitol should not be used in each dose of the multiple dose activated charcoal regimen unless it is necessary to produce catharsis. Actidose® with Sorbitol contains sorbitol which may produce excessive catharsis and resultant fluid and electrolyte problems if used at each dosing interval (see Precautions).9,25 Actidose®-Aqua should be used at dosage intervals when Actidose® with Sorbitol is not being used. CATHARTICS SHOULD BE USED CAUTIOUSLY AND ONLY INTERMITTENTLY DURING MULTIPLE DOSE ACTIVATED CHARCOAL THERAPY. If catharsis of activated charcoal does not occur following the use of Actidose® with Sorbitol within 4 - 8 hours, an additional sorbitol dose of 1.5 gm/kg may be administered. Or, if desired, a saline cathartic such as magnesium citrate may be used if the patient’s renal function is not impaired. Actidose® with Sorbitol and Actidose®-Aqua are formulated in palatable vehicles which eliminate the need to add additional taste or consistency enhancers. The use of supplementary chemicals, syrups, or dairy products should be avoided since their addition may compromise the adsorptive capacity of Actidose® with Sorbitol and Actidose®-Aqua.</IndicationAndUsage>
    <Description>Actidose® with Sorbitol: Actidose® with Sorbitol, ready-to-use activated charcoal suspension with sorbitol, contains 25 gm or 50 gm of activated charcoal, and 48 gm or 96 gm of sorbitol, respectively, in an aqueous suspension with a unique preservative system. Each milliliter contains 208 mg (0.208 gm) of activated charcoal and 400 mg (0.400 gm) of sorbitol. Sorbitol reduces the gritty sensation associated with activated charcoal, imparts a sweet taste which enhances patient compliance, and usually produces a cathartic effect. Actidose®-Aqua: Actidose®-Aqua, ready-to-use activated charcoal suspension, contains 15 gm, 25 gm or 50 gm of activated charcoal in an aqueous suspension with a unique preservative system. Each milliliter contains 208 mg (0.208 gm) of activated charcoal.</Description>
  </NDC>
  <NDC>
    <NDCCode>53041-191-48</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (53041-191-48)  / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>53041-0191-48</NDC11Code>
    <ProductNDC>53041-191</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mucus Relief Maximum Strength 1200 Mg</ProprietaryName>
    <NonProprietaryName>Guaifenesin</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200624</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209215</ApplicationNumber>
    <LabelerName>Guardian Drug Company</LabelerName>
    <SubstanceName>GUAIFENESIN</SubstanceName>
    <StrengthNumber>1200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200624</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63824-023-48</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (63824-023-48)  / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63824-0023-48</NDC11Code>
    <ProductNDC>63824-023</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mucinex</ProprietaryName>
    <ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Guaifenesin</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120626</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021282</ApplicationNumber>
    <LabelerName>Reckitt Benckiser LLC</LabelerName>
    <SubstanceName>GUAIFENESIN</SubstanceName>
    <StrengthNumber>1200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120626</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63824-072-48</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (63824-072-48)  / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63824-0072-48</NDC11Code>
    <ProductNDC>63824-072</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mucinex Dm</ProprietaryName>
    <ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Guaifenesin And Dextromethorphan Hydrobromide</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120626</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021620</ApplicationNumber>
    <LabelerName>Reckitt Benckiser LLC</LabelerName>
    <SubstanceName>GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>1200; 60</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120626</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68196-325-04</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (68196-325-04)  &gt; 48 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>68196-0325-04</NDC11Code>
    <ProductNDC>68196-325</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Members Mark Mucus Relief Er</ProprietaryName>
    <NonProprietaryName>Guaifenesin</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091009</ApplicationNumber>
    <LabelerName>Sam's West Inc</LabelerName>
    <SubstanceName>GUAIFENESIN</SubstanceName>
    <StrengthNumber>1200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-22</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>68196-735-04</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (68196-735-04)  &gt; 48 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>68196-0735-04</NDC11Code>
    <ProductNDC>68196-735</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Members Mark Mucus Relief Dm</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hbr, Guaifenesin</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091070</ApplicationNumber>
    <LabelerName>Sam's West Inc</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
    <StrengthNumber>60; 1200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-22</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>69263-022-15</NDCCode>
    <PackageDescription>5 POUCH in 1 CARTON (69263-022-15)  &gt; 3 PATCH in 1 POUCH &gt; 1200 mg in 1 PATCH</PackageDescription>
    <NDC11Code>69263-0022-15</NDC11Code>
    <ProductNDC>69263-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atendia</ProprietaryName>
    <NonProprietaryName>Menthol And Lidocaine</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20140401</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>OakLock, LLC</LabelerName>
    <SubstanceName>LIDOCAINE; MENTHOL</SubstanceName>
    <StrengthNumber>48; 36</StrengthNumber>
    <StrengthUnit>mg/1200mg; mg/1200mg</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-09-04</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>20482-002-10</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (20482-002-10)  &gt; 1 BOTTLE, SPRAY in 1 BLISTER PACK &gt; 1 SPRAY in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>20482-0002-10</NDC11Code>
    <ProductNDC>20482-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Subsys</ProprietaryName>
    <NonProprietaryName>Fentanyl</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>SUBLINGUAL</RouteName>
    <StartMarketingDate>20120313</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA202788</ApplicationNumber>
    <LabelerName>Insys Therapeutics, Inc.</LabelerName>
    <SubstanceName>FENTANYL</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SUBSYS is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking SUBSYS. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency room [see Contraindications ( 4)]. , 3 As part of the Transmucosal Immediate-Release Fentanyl (TIRF) REMS ACCESS Program, SUBSYS may be dispensed only to outpatients enrolled in the program. [see Warnings and Precautions ( 5.7)] . For inpatient administration of SUBSYS, patient enrollment is not required. .</IndicationAndUsage>
    <Description>SUBSYS (fentanyl sublingual spray) is an opioid agonist, available as a sublingual spray designed to deliver doses of 100, 200, 400, 600, 800, 1200 and 1600 mcg of fentanyl. The chemical name of fentanyl is N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide. Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 860:1) that is freely soluble in ethanol and methanol and practically insoluble in water (1:40). The molecular weight of the free base is 336.47. The pKa is 8.4. The inactive ingredients in SUBSYS include: dehydrated alcohol 63.6% (V/V), purified water, propylene glycol, xylitol, and L-menthol.</Description>
  </NDC>
  <NDC>
    <NDCCode>20482-002-30</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (20482-002-30)  &gt; 1 BOTTLE, SPRAY in 1 BLISTER PACK &gt; 1 SPRAY in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>20482-0002-30</NDC11Code>
    <ProductNDC>20482-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Subsys</ProprietaryName>
    <NonProprietaryName>Fentanyl</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>SUBLINGUAL</RouteName>
    <StartMarketingDate>20120313</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA202788</ApplicationNumber>
    <LabelerName>Insys Therapeutics, Inc.</LabelerName>
    <SubstanceName>FENTANYL</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SUBSYS is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking SUBSYS. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency room [see Contraindications ( 4)]. , 3 As part of the Transmucosal Immediate-Release Fentanyl (TIRF) REMS ACCESS Program, SUBSYS may be dispensed only to outpatients enrolled in the program. [see Warnings and Precautions ( 5.7)] . For inpatient administration of SUBSYS, patient enrollment is not required. .</IndicationAndUsage>
    <Description>SUBSYS (fentanyl sublingual spray) is an opioid agonist, available as a sublingual spray designed to deliver doses of 100, 200, 400, 600, 800, 1200 and 1600 mcg of fentanyl. The chemical name of fentanyl is N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide. Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 860:1) that is freely soluble in ethanol and methanol and practically insoluble in water (1:40). The molecular weight of the free base is 336.47. The pKa is 8.4. The inactive ingredients in SUBSYS include: dehydrated alcohol 63.6% (V/V), purified water, propylene glycol, xylitol, and L-menthol.</Description>
  </NDC>
  <NDC>
    <NDCCode>51042-002-09</NDCCode>
    <PackageDescription>1200 mL in 1 BOTTLE, PLASTIC (51042-002-09) </PackageDescription>
    <NDC11Code>51042-0002-09</NDC11Code>
    <ProductNDC>51042-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>First Mark Ultra Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210521</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Performance Food Group</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210521</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55695-002-00</NDCCode>
    <PackageDescription>15 mL in 1 BOTTLE (55695-002-00) </PackageDescription>
    <NDC11Code>55695-0002-00</NDC11Code>
    <ProductNDC>55695-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azithromycin</ProprietaryName>
    <NonProprietaryName>Azithromycin</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101228</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065246</ApplicationNumber>
    <LabelerName>STATE HEALTH SERVICES, TEXAS DEPARTMENT OF</LabelerName>
    <SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for oral suspension USP and other antibacterial drugs, azithromycin for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Azithromycin for oral suspension USP is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
    <Description>Azithromycin for oral suspension USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2R,3S,4R,5R,8R, 10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α- L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3- (dimethylamino)-β- D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C 38H 72N 2O 12 M.W. 749.0. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12H 2O and a molecular weight of 767.0. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: ammonio methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&amp;C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>57896-002-12</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE (57896-002-12) </PackageDescription>
    <NDC11Code>57896-0002-12</NDC11Code>
    <ProductNDC>57896-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Milk Of Magnesia Original</ProprietaryName>
    <NonProprietaryName>Magnesium Hydroxide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>Geri-Care Pharmaceuticals, Corp</LabelerName>
    <SubstanceName>MAGNESIUM HYDROXIDE</SubstanceName>
    <StrengthNumber>1200</StrengthNumber>
    <StrengthUnit>mg/15mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves occasional constipation (irregularity). usually produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69821-002-13</NDCCode>
    <PackageDescription>1200 POUCH in 1 BAG (69821-002-13)  &gt; 1.7 g in 1 POUCH</PackageDescription>
    <NDC11Code>69821-0002-13</NDC11Code>
    <ProductNDC>69821-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Wet Wipes</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>SWAB</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200420</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Zhejiang Qimei Commodity Co.,Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ For hand washing to dec rease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0002-1200-48</NDCCode><ProprietaryName>Amyvid</ProprietaryName><NonProprietaryName>Florbetapir F 18</NonProprietaryName></NDC><NDC><NDCCode>64942-1200-2</NDCCode><ProprietaryName>Degree</ProprietaryName><NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName></NDC><NDC><NDCCode>0002-1200-10</NDCCode><ProprietaryName>Amyvid</ProprietaryName><NonProprietaryName>Florbetapir F 18</NonProprietaryName></NDC><NDC><NDCCode>0002-1200-30</NDCCode><ProprietaryName>Amyvid</ProprietaryName><NonProprietaryName>Florbetapir F 18</NonProprietaryName></NDC><NDC><NDCCode>0002-1200-50</NDCCode><ProprietaryName>Amyvid</ProprietaryName><NonProprietaryName>Florbetapir F 18</NonProprietaryName></NDC><NDC><NDCCode>37662-0002-2</NDCCode><ProprietaryName>Beryllium Nitricum</ProprietaryName><NonProprietaryName>Beryllium Nitricum</NonProprietaryName></NDC><NDC><NDCCode>52124-1200-1</NDCCode><ProprietaryName>Genuine First Aid - Home First Aid</ProprietaryName><NonProprietaryName>Benzalkonium Chloride, Ibuprofen, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>0002-1220-48</NDCCode><ProprietaryName>Tauvid</ProprietaryName><NonProprietaryName>Flortaucipir F-18</NonProprietaryName></NDC><NDC><NDCCode>42608-0002-1</NDCCode><NonProprietaryName>Paricalcitol</NonProprietaryName></NDC><NDC><NDCCode>47682-002-48</NDCCode><ProprietaryName>Green Guard Advanced Sinus Relief</ProprietaryName><NonProprietaryName>Acetaminophen, Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>59579-002-48</NDCCode><ProprietaryName>Nitrogen</ProprietaryName><NonProprietaryName>Nitrogen</NonProprietaryName></NDC><NDC><NDCCode>73097-002-48</NDCCode><ProprietaryName>Alka Seltzer Plus Cold</ProprietaryName><NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName></NDC><NDC><NDCCode>73905-002-48</NDCCode><ProprietaryName>75% Alcohol Disnfectant</ProprietaryName><NonProprietaryName>75% Alcohol Disnfectant</NonProprietaryName></NDC><NDC><NDCCode>77714-002-48</NDCCode><ProprietaryName>Bull Frog Spf 50</ProprietaryName><NonProprietaryName>Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 10.00%</NonProprietaryName></NDC><NDC><NDCCode>78505-002-48</NDCCode><ProprietaryName>Disinfectant Wipes</ProprietaryName><NonProprietaryName>Disinfectant Wipes</NonProprietaryName></NDC><NDC><NDCCode>84165-002-48</NDCCode><ProprietaryName>Lidocaine Pain Relief Gel-patch</ProprietaryName><NonProprietaryName>Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>49035-284-48</NDCCode><ProprietaryName>Equate Mucus Relief</ProprietaryName><NonProprietaryName>Guaifenesin</NonProprietaryName></NDC><NDC><NDCCode>51662-1200-1</NDCCode><ProprietaryName>Activated Charcoal</ProprietaryName><NonProprietaryName>Activated Charcoal</NonProprietaryName></NDC><NDC><NDCCode>53041-191-48</NDCCode><ProprietaryName>Mucus Relief Maximum Strength 1200 Mg</ProprietaryName><NonProprietaryName>Guaifenesin</NonProprietaryName></NDC><NDC><NDCCode>63824-023-48</NDCCode><ProprietaryName>Mucinex</ProprietaryName><NonProprietaryName>Guaifenesin</NonProprietaryName></NDC><NDC><NDCCode>63824-072-48</NDCCode><ProprietaryName>Mucinex Dm</ProprietaryName><NonProprietaryName>Guaifenesin And Dextromethorphan Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>68196-325-04</NDCCode><ProprietaryName>Members Mark Mucus Relief Er</ProprietaryName><NonProprietaryName>Guaifenesin</NonProprietaryName></NDC><NDC><NDCCode>68196-735-04</NDCCode><ProprietaryName>Members Mark Mucus Relief Dm</ProprietaryName><NonProprietaryName>Dextromethorphan Hbr, Guaifenesin</NonProprietaryName></NDC><NDC><NDCCode>69263-022-15</NDCCode><ProprietaryName>Atendia</ProprietaryName><NonProprietaryName>Menthol And Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>20482-002-10</NDCCode><ProprietaryName>Subsys</ProprietaryName><NonProprietaryName>Fentanyl</NonProprietaryName></NDC><NDC><NDCCode>20482-002-30</NDCCode><ProprietaryName>Subsys</ProprietaryName><NonProprietaryName>Fentanyl</NonProprietaryName></NDC><NDC><NDCCode>51042-002-09</NDCCode><ProprietaryName>First Mark Ultra Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>55695-002-00</NDCCode><ProprietaryName>Azithromycin</ProprietaryName><NonProprietaryName>Azithromycin</NonProprietaryName></NDC><NDC><NDCCode>57896-002-12</NDCCode><ProprietaryName>Milk Of Magnesia Original</ProprietaryName><NonProprietaryName>Magnesium Hydroxide</NonProprietaryName></NDC><NDC><NDCCode>69821-002-13</NDCCode><ProprietaryName>Wet Wipes</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
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      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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