RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (22 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "72308-037-00",
      "PackageDescription": "80 PATCH in 1 PACKET (72308-037-00)  / 3.2 g in 1 PATCH",
      "NDC11Code": "72308-0037-00",
      "ProductNDC": "72308-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Visibly Clean Antibacterial Wet Wipes Strawberry Tart",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200915",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Flex Beauty Labs LLC",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200915",
      "SamplePackage": "N",
      "IndicationAndUsage": "to reduce bacteria on the skin."
    },
    {
      "NDCCode": "72308-036-00",
      "PackageDescription": "80 PATCH in 1 PACKET (72308-036-00)  / 3.2 g in 1 PATCH",
      "NDC11Code": "72308-0036-00",
      "ProductNDC": "72308-036",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Visibly Clean Antibacterial Wet Wipes Blue Sage Lime",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200915",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Flex Beauty Labs LLC",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200915",
      "SamplePackage": "N",
      "IndicationAndUsage": "to reduce bacteria on the skin."
    },
    {
      "NDCCode": "72308-038-00",
      "PackageDescription": "80 PATCH in 1 PACKET (72308-038-00)  / 3.2 g in 1 PATCH",
      "NDC11Code": "72308-0038-00",
      "ProductNDC": "72308-038",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Visibly Clean Antibacterial Wet Wipes Fresh Lemonade",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200915",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Flex Beauty Labs LLC",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200915",
      "SamplePackage": "N",
      "IndicationAndUsage": "to reduce bacteria on the skin."
    },
    {
      "NDCCode": "12022-037-00",
      "PackageDescription": "74 mL in 1 BOTTLE, DISPENSING (12022-037-00) ",
      "NDC11Code": "12022-0037-00",
      "ProductNDC": "12022-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "White Rose Liquid Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200331",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "J. Strickland and Co.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".8",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "21695-037-00",
      "PackageDescription": "100 TABLET in 1 BOTTLE (21695-037-00)",
      "NDC11Code": "21695-0037-00",
      "ProductNDC": "21695-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078218",
      "LabelerName": "Rebel Distributors",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C20H21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets 10 mg contain the following inactive ingredients: croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, and titanium dioxide."
    },
    {
      "NDCCode": "42893-037-00",
      "PackageDescription": "1 TUBE in 1 CARTON (42893-037-00)  / 35 g in 1 TUBE",
      "NDC11Code": "42893-0037-00",
      "ProductNDC": "42893-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum Spf 15 Nude",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240424",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Chantecaille Beaute Inc",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "96.075",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2024-04-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240424",
      "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": "47049-037-00",
      "PackageDescription": "400 BLISTER PACK in 1 CASE (47049-037-00)  / 14 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "47049-0037-00",
      "ProductNDC": "47049-037",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Nirogacestat",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20240404",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon France S.A.S",
      "SubstanceName": "NIROGACESTAT",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2024-04-12",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "04-APR-24"
    },
    {
      "NDCCode": "47848-037-00",
      "PackageDescription": "1 kg in 1 CARTON (47848-037-00)",
      "NDC11Code": "47848-0037-00",
      "ProductNDC": "47848-037",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Irinotecan Hydrochloride Trihyd",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20100421",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Teva Czech Industries s.r.o.",
      "SubstanceName": "IRINOTECAN HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "53747-037-00",
      "PackageDescription": "1 BAG in 1 DRUM (53747-037-00)  / 80 kg in 1 BAG",
      "NDC11Code": "53747-0037-00",
      "ProductNDC": "53747-037",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Labetalol Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170329",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Unichem Laboratories Limited, India",
      "SubstanceName": "LABETALOL HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-12-12",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "29-MAR-17"
    },
    {
      "NDCCode": "58479-037-00",
      "PackageDescription": "96 g in 1 CAN (58479-037-00)",
      "NDC11Code": "58479-0037-00",
      "ProductNDC": "58479-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kids Sport Natural Mineral Sunscreen Broad Spectrum",
      "ProprietaryNameSuffix": "Spf 30",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "AEROSOL, SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160118",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Crossing Cultures LLC dba Goddess Garden",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "6.4; 6",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "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": "58877-037-00",
      "PackageDescription": "5 kg in 1 BOTTLE (58877-037-00)",
      "NDC11Code": "58877-0037-00",
      "ProductNDC": "58877-037",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Misoprostol",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20140901",
      "EndMarketingDate": "20160106",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Xiamen Origin Biotech Co., Ltd",
      "SubstanceName": "MISOPROSTOL",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20160106"
    },
    {
      "NDCCode": "61594-037-00",
      "PackageDescription": "8 POUCH in 1 CARTON (61594-037-00)  / 18 g in 1 POUCH",
      "NDC11Code": "61594-0037-00",
      "ProductNDC": "61594-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Theraworx Protect Advanced Hygiene With Skin Protectant Fragrance Free",
      "NonProprietaryName": "Allantoin",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240701",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "AVADIM HOLDINGS, INC.",
      "SubstanceName": "ALLANTOIN",
      "StrengthNumber": "6.5",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240701",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily protects minor:. cuts . scrapes. burns. temporarily protects chapped or cracked skin."
    },
    {
      "NDCCode": "61755-037-05",
      "PackageDescription": "1 KIT in 1 DOSE PACK (61755-037-05)  *  1 VIAL, GLASS in 1 CARTON (61755-024-01)  > 11.1 mL in 1 VIAL, GLASS (61755-024-00)  *  1 VIAL, GLASS in 1 CARTON (61755-027-01)  > 2.5 mL in 1 VIAL, GLASS (61755-027-00) ",
      "NDC11Code": "61755-0037-05",
      "ProductNDC": "61755-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Regen-cov",
      "NonProprietaryName": "Casirivimab And Imdevimab",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20210207",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Regeneron Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210207",
      "SamplePackage": "N",
      "IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
      "Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
    },
    {
      "NDCCode": "63379-037-00",
      "PackageDescription": "28 POWDER, METERED in 1 INHALER (63379-037-00) ",
      "NDC11Code": "63379-0037-00",
      "ProductNDC": "63379-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Serevent",
      "ProprietaryNameSuffix": "Diskus",
      "NonProprietaryName": "Salmeterol Xinafoate",
      "DosageFormName": "POWDER, METERED",
      "RouteName": "ORAL; RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19971201",
      "MarketingCategoryName": "APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT",
      "ApplicationNumber": "NDA020692",
      "LabelerName": "Glaxo Operations UK Ltd",
      "SubstanceName": "SALMETEROL XINAFOATE",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "63552-037-00",
      "PackageDescription": "143 VIAL in 1 TRAY (63552-037-00)  / 15 mL in 1 VIAL",
      "NDC11Code": "63552-0037-00",
      "ProductNDC": "63552-037",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Trastuzumab",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "StartMarketingDate": "20170210",
      "EndMarketingDate": "20270831",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Manufacturing Services LLC",
      "SubstanceName": "TRASTUZUMAB",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/7.4mL",
      "Status": "Unfinished",
      "LastUpdate": "2026-05-06",
      "StartMarketingDatePackage": "10-FEB-17",
      "EndMarketingDatePackage": "31-AUG-27"
    },
    {
      "NDCCode": "65862-037-00",
      "PackageDescription": "100 TABLET in 1 BOTTLE (65862-037-00) ",
      "NDC11Code": "65862-0037-00",
      "ProductNDC": "65862-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisinopril",
      "NonProprietaryName": "Lisinopril",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077622",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "LISINOPRIL",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20060222",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
      "Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O52H2O and its structural formula is:. Lisinopril USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: 2.5 mg tablets – dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize).   5 mg tablets – dibasic calcium phosphate, ferric oxide red, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize). 10 mg, 20 mg, 30 mg, and 40 mg tablets - dibasic calcium phosphate, ferric oxide yellow, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize)."
    },
    {
      "NDCCode": "72888-037-00",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (72888-037-00) ",
      "NDC11Code": "72888-0037-00",
      "ProductNDC": "72888-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carvedilol",
      "NonProprietaryName": "Carvedilol",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210729",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078165",
      "LabelerName": "Advagen Pharma Ltd",
      "SubstanceName": "CARVEDILOL",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210729",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure ( 1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients ( 1.2) , 3 hypertension ( 1.3) .",
      "Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure:. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125mg, 6.25-mg, 12.5-mg, and 25-mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5)."
    },
    {
      "NDCCode": "73656-036-00",
      "PackageDescription": "1 KIT in 1 KIT (73656-036-00)  *  1 TUBE in 1 BOX (73656-037-00)  / 150 g in 1 TUBE",
      "NDC11Code": "73656-0036-00",
      "ProductNDC": "73656-036",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Optimax Professional Whitening Anticavity Fluoride",
      "NonProprietaryName": "Sodium Monofluorophosphate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20251208",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "WHITE GLO USA INC",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251208",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps protect against cavities."
    },
    {
      "NDCCode": "73656-038-00",
      "PackageDescription": "1 KIT in 1 KIT (73656-038-00)  *  1 TUBE in 1 BOX (73656-037-00)  / 150 g in 1 TUBE",
      "NDC11Code": "73656-0038-00",
      "ProductNDC": "73656-038",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Optimax Professional Whitening Anticavity Fluoride",
      "NonProprietaryName": "Sodium Monofluorophosphate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20251208",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "WHITE GLO USA INC",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251208",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps protect against cavities."
    },
    {
      "NDCCode": "78691-037-00",
      "PackageDescription": "30 mL in 1 BOTTLE, SPRAY (78691-037-00) ",
      "NDC11Code": "78691-0037-00",
      "ProductNDC": "78691-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Biopure Hand Sanitizer Spray-coastal Glow",
      "NonProprietaryName": "Hand Sanitizer Spray",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260115",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Quest USA Corp",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "16",
      "StrengthUnit": "g/30mL",
      "Status": "Active",
      "LastUpdate": "2026-01-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "82920-037-00",
      "PackageDescription": "13 kg in 1 DRUM (82920-037-00) ",
      "NDC11Code": "82920-0037-00",
      "ProductNDC": "82920-037",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Sunitinib Malate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230927",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SHILPA PHARMA LIFESCIENCES LIMITED",
      "SubstanceName": "SUNITINIB MALATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-09-28",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "27-SEP-23"
    },
    {
      "NDCCode": "83008-037-00",
      "PackageDescription": "1 TUBE in 1 CARTON (83008-037-00)  / 100 g in 1 TUBE",
      "NDC11Code": "83008-0037-00",
      "ProductNDC": "83008-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230804",
      "EndMarketingDate": "20270430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209903",
      "LabelerName": "Quality Care Products, LLC",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230804",
      "EndMarketingDatePackage": "20270430",
      "SamplePackage": "N",
      "Description": "Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) for topical use only. The chemical name is 2-[(2,6-dichlorophenyl) amino]benzene-acetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2, and it has the following chemical structure. It contains the active ingredient, diclofenac sodium, USP in an opaque, white gel base. Diclofenac sodium, USP is a white to off-white, amorphous, crystalline powder. Diclofenac sodium is a benzeneacetic acid derivative. The inactive ingredients in diclofenac sodium topical gel include: carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution."
    },
    {
      "NDCCode": "84003-037-00",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (84003-037-00)  / 27 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "84003-0037-00",
      "ProductNDC": "84003-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dolce And Gabbana Everlast Foundation Spf 20 37w Deep",
      "NonProprietaryName": "Octisalate, Octocrylene, Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Dolce & Gabbana Beauty S.R.L",
      "SubstanceName": "OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "35; 50; 5; 18.8",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn . If uses directed with others sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
    },
    {
      "NDCCode": "85179-037-00",
      "PackageDescription": "45 mL in 1 BOTTLE (85179-037-00) ",
      "NDC11Code": "85179-0037-00",
      "ProductNDC": "85179-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Amora Hand Sanitizer Cherry",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251117",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "I World LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2026-05-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251117",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand-washing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "0264-2205-00",
      "PackageDescription": "16 CONTAINER in 1 CASE (0264-2205-00)  / 1000 mL in 1 CONTAINER",
      "NDC11Code": "00264-2205-00",
      "ProductNDC": "0264-2205",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Physiolyte",
      "NonProprietaryName": "Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "19840608",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019024",
      "LabelerName": "B. Braun Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": ".53; .5; .37; .037; .03",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2023-09-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19840608",
      "SamplePackage": "N",
      "IndicationAndUsage": "Physiolyte (A Physiological Irrigating Solution) is indicated for all general irrigation, washing, and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.",
      "Description": "Physiolyte is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing, and rinsing purposes. Each 100 mL contains:Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 gSodium Acetate Trihydrate USP 0.37 g; Potassium ChlorideUSP 0.037 g; Magnesium Chloride Hexahydrate USP 0.03 gWater for Injection USP qsGlacial Acetic Acid USP has been added to adjust the pH. pH: 6.8 (6.3–7.3)Calculated Osmolarity: The solution is isotonic (295 mOsmol/liter). Concentration of Electrolytes (mEq/liter): Sodium 140Potassium 5; Magnesium 3; Chloride 98; Acetate (CH3COO−) 27Gluconate (HOCH2(CHOH)4COO−) 23. It contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Physiolyte may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. The formulas of the active ingredients are. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. Not made with natural rubber latex, PVC or DEHP."
    },
    {
      "NDCCode": "0264-7703-00",
      "PackageDescription": "12 CONTAINER in 1 CASE (0264-7703-00)  > 1000 mL in 1 CONTAINER",
      "NDC11Code": "00264-7703-00",
      "ProductNDC": "0264-7703",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Isolyte S",
      "NonProprietaryName": "Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19890929",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019711",
      "LabelerName": "B. Braun Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": ".53; .5; .37; .037; .03",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2020-05-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19890929",
      "SamplePackage": "N",
      "IndicationAndUsage": "This solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration, and as an alkalinizing agent.",
      "Description": "Each 100 mL of Isolyte® S (Multi-Electrolyte Injection) contains:Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 gSodium Acetate Trihydrate USP 0.37 g; Potassium Chloride USP 0.037 gMagnesium Chloride Hexahydrate USP 0.03 gWater for Injection USP qs. pH adjusted with Glacial Acetic Acid USPpH: 6.7 (6.3–7.3)Calculated Osmolarity: 295 mOsmol/liter. Concentration of Electrolytes (mEq/liter): Sodium 140; Potassium 5Magnesium 3; Chloride 98; Acetate (CH3COO−) 27Gluconate (HOCH2(CHOH)4COO−) 23. Isolyte® S is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container."
    },
    {
      "NDCCode": "0264-7704-00",
      "PackageDescription": "12 CONTAINER in 1 CASE (0264-7704-00)  > 1000 mL in 1 CONTAINER",
      "NDC11Code": "00264-7704-00",
      "ProductNDC": "0264-7704",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Isolyte S In Dextrose",
      "NonProprietaryName": "Hydrous Dextrose, Sodium Chloride, Sodium Gluconate, Sodium Acetate Trihydrate, Potassium Chloride And Magnesium Chloride Hexahydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19930809",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA019843",
      "LabelerName": "B. Braun Medical Inc.",
      "SubstanceName": "DEXTROSE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "5; .53; .5; .37; .037; .03",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-13",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0264-7707-00",
      "PackageDescription": "12 CONTAINER in 1 CASE (0264-7707-00)  / 1000 mL in 1 CONTAINER",
      "NDC11Code": "00264-7707-00",
      "ProductNDC": "0264-7707",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Isolyte S Ph 7.4",
      "NonProprietaryName": "Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19890929",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019696",
      "LabelerName": "B. Braun Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC",
      "StrengthNumber": ".53; .5; .37; .037; .03; .012; .00082",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2023-10-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19890929",
      "SamplePackage": "N",
      "IndicationAndUsage": "This solution is indicated for use in adults as a source of electrolytes and water for hydration, and as an alkalinizing agent.",
      "Description": "Each 100 mL of Isolyte® S pH 7.4 (Multi-Electrolyte Injection) contains: Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 gSodium Acetate Trihydrate USP 0.37 g; Potassium Chloride USP 0.037 gMagnesium Chloride Hexahydrate USP 0.03 g Dibasic Sodium Phosphate Heptahydrate USP 0.012 g Monobasic Potassium Phosphate NF 0.00082 g; Water for Injection USP qs pH may be adjusted with Glacial Acetic Acid USP or Sodium Hydroxide NF pH: 7.4 (7.0–7.8)    Calculated Osmolarity: 295 mOsmol/liter Concentration of Electrolytes (mEq/liter): Sodium 141; Potassium 5Magnesium 3; Chloride 98; 0.5 mmole P/literPhosphate (HPO) 1; Acetate (CH3COO–) 27 Gluconate (HOCH2(CHOH)4COO–) 23. Isolyte® S pH 7.4 is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration. The formulas of the active ingredients are. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container."
    },
    {
      "NDCCode": "0264-9872-00",
      "PackageDescription": "12 CONTAINER in 1 CASE (0264-9872-00)  / 1000 mL in 1 CONTAINER",
      "NDC11Code": "00264-9872-00",
      "ProductNDC": "0264-9872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Heparin Sodium In Sodium Chloride",
      "NonProprietaryName": "Heparin Sodium In Sodium Chloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19920720",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019953",
      "LabelerName": "B. Braun Medical Inc.",
      "SubstanceName": "HEPARIN SODIUM",
      "StrengthNumber": "200",
      "StrengthUnit": "[USP'U]/100mL",
      "Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Heparin Sodium in 0.9% Sodium Chloride Injection at the concentration of 2 USP units/mL is indicated as an anticoagulant to maintain catheter patency.",
      "Description": "Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. It is composed of polymers of alternating derivations of  alpha-L-iduronic acid 2-sulfate (1),  2-deoxy-2-sulfamino-alpha-D-glucose 6-sulfate (2),  beta-D-glucuronic acid (3),  2-acetamido-2-deoxy-alpha-D-glucose (4), and alpha-L-iduronic acid (5). Structure of Heparin Sodium (representative subunits). Heparin Sodium in 0.9% Sodium Chloride Injection is a sterile, single-dose, clear, nonpyrogenic solution prepared from Heparin Sodium USP (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) in 0.9% Sodium Chloride Injection. It is to be administered by intravenous injection. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Each 100 mL contains 200 USP Units Heparin Sodium, 0.43 g Dibasic Sodium Phosphate7H2O USP and 0.037 g Citric Acid Anhydrous USP as a buffer system, 0.9 g Sodium Chloride USP, and Water for Injection USP qs. pH: 7.0 (6.8-7.2); Calculated Osmolarity:  360 mOsmol/liter. Concentration of Electrolytes (mEq/liter):  Sodium 186; Chloride 154; Phosphate (HPO) 32; Citrate 6. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The plastic container is not made with natural rubber latex, PVC or DEHP. The closure system has two ports; the one for the administration set has a tamper evident plastic protector."
    },
    {
      "NDCCode": "72308-001-01",
      "PackageDescription": "295 mL in 1 BOTTLE, PLASTIC (72308-001-01) ",
      "NDC11Code": "72308-0001-01",
      "ProductNDC": "72308-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Advanced Hand Sanitizer",
      "NonProprietaryName": "Hand Sanitizer",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170802",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Flex Beauty Labs, LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180507",
      "SamplePackage": "N",
      "IndicationAndUsage": "Place enough Product in your palm to thoroughtly spread on both hands and rub into the skin until dry. . Children under 6 years of age should be supervised when using this product."
    }
  ]
}
                    

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<NDCList>
  <NDC>
    <NDCCode>72308-037-00</NDCCode>
    <PackageDescription>80 PATCH in 1 PACKET (72308-037-00)  / 3.2 g in 1 PATCH</PackageDescription>
    <NDC11Code>72308-0037-00</NDC11Code>
    <ProductNDC>72308-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Visibly Clean Antibacterial Wet Wipes Strawberry Tart</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200915</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Flex Beauty Labs LLC</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>to reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72308-036-00</NDCCode>
    <PackageDescription>80 PATCH in 1 PACKET (72308-036-00)  / 3.2 g in 1 PATCH</PackageDescription>
    <NDC11Code>72308-0036-00</NDC11Code>
    <ProductNDC>72308-036</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Visibly Clean Antibacterial Wet Wipes Blue Sage Lime</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200915</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Flex Beauty Labs LLC</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>to reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72308-038-00</NDCCode>
    <PackageDescription>80 PATCH in 1 PACKET (72308-038-00)  / 3.2 g in 1 PATCH</PackageDescription>
    <NDC11Code>72308-0038-00</NDC11Code>
    <ProductNDC>72308-038</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Visibly Clean Antibacterial Wet Wipes Fresh Lemonade</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
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    <StartMarketingDate>20200915</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Flex Beauty Labs LLC</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>to reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>12022-037-00</NDCCode>
    <PackageDescription>74 mL in 1 BOTTLE, DISPENSING (12022-037-00) </PackageDescription>
    <NDC11Code>12022-0037-00</NDC11Code>
    <ProductNDC>12022-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>White Rose Liquid Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200331</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>J. Strickland and Co.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.8</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>21695-037-00</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (21695-037-00)</PackageDescription>
    <NDC11Code>21695-0037-00</NDC11Code>
    <ProductNDC>21695-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100218</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078218</ApplicationNumber>
    <LabelerName>Rebel Distributors</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C20H21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets 10 mg contain the following inactive ingredients: croscarmellose sodium, D&amp;C Yellow #10 aluminum lake, FD&amp;C Blue #2 aluminum lake, FD&amp;C Yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42893-037-00</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (42893-037-00)  / 35 g in 1 TUBE</PackageDescription>
    <NDC11Code>42893-0037-00</NDC11Code>
    <ProductNDC>42893-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum Spf 15 Nude</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240424</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Chantecaille Beaute Inc</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>96.075</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-04-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240424</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>47049-037-00</NDCCode>
    <PackageDescription>400 BLISTER PACK in 1 CASE (47049-037-00)  / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>47049-0037-00</NDC11Code>
    <ProductNDC>47049-037</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Nirogacestat</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20240404</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon France S.A.S</LabelerName>
    <SubstanceName>NIROGACESTAT</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-04-12</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>04-APR-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>47848-037-00</NDCCode>
    <PackageDescription>1 kg in 1 CARTON (47848-037-00)</PackageDescription>
    <NDC11Code>47848-0037-00</NDC11Code>
    <ProductNDC>47848-037</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Irinotecan Hydrochloride Trihyd</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20100421</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Teva Czech Industries s.r.o.</LabelerName>
    <SubstanceName>IRINOTECAN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>53747-037-00</NDCCode>
    <PackageDescription>1 BAG in 1 DRUM (53747-037-00)  / 80 kg in 1 BAG</PackageDescription>
    <NDC11Code>53747-0037-00</NDC11Code>
    <ProductNDC>53747-037</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170329</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Unichem Laboratories Limited, India</LabelerName>
    <SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-12-12</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>29-MAR-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>58479-037-00</NDCCode>
    <PackageDescription>96 g in 1 CAN (58479-037-00)</PackageDescription>
    <NDC11Code>58479-0037-00</NDC11Code>
    <ProductNDC>58479-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kids Sport Natural Mineral Sunscreen Broad Spectrum</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>AEROSOL, SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160118</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Crossing Cultures LLC dba Goddess Garden</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>6.4; 6</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <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>58877-037-00</NDCCode>
    <PackageDescription>5 kg in 1 BOTTLE (58877-037-00)</PackageDescription>
    <NDC11Code>58877-0037-00</NDC11Code>
    <ProductNDC>58877-037</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Misoprostol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140901</StartMarketingDate>
    <EndMarketingDate>20160106</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Xiamen Origin Biotech Co., Ltd</LabelerName>
    <SubstanceName>MISOPROSTOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20160106</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>61594-037-00</NDCCode>
    <PackageDescription>8 POUCH in 1 CARTON (61594-037-00)  / 18 g in 1 POUCH</PackageDescription>
    <NDC11Code>61594-0037-00</NDC11Code>
    <ProductNDC>61594-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Theraworx Protect Advanced Hygiene With Skin Protectant Fragrance Free</ProprietaryName>
    <NonProprietaryName>Allantoin</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>AVADIM HOLDINGS, INC.</LabelerName>
    <SubstanceName>ALLANTOIN</SubstanceName>
    <StrengthNumber>6.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily protects minor:. cuts . scrapes. burns. temporarily protects chapped or cracked skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61755-037-05</NDCCode>
    <PackageDescription>1 KIT in 1 DOSE PACK (61755-037-05)  *  1 VIAL, GLASS in 1 CARTON (61755-024-01)  &gt; 11.1 mL in 1 VIAL, GLASS (61755-024-00)  *  1 VIAL, GLASS in 1 CARTON (61755-027-01)  &gt; 2.5 mL in 1 VIAL, GLASS (61755-027-00) </PackageDescription>
    <NDC11Code>61755-0037-05</NDC11Code>
    <ProductNDC>61755-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Regen-cov</ProprietaryName>
    <NonProprietaryName>Casirivimab And Imdevimab</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20210207</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210207</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
    <Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>63379-037-00</NDCCode>
    <PackageDescription>28 POWDER, METERED in 1 INHALER (63379-037-00) </PackageDescription>
    <NDC11Code>63379-0037-00</NDC11Code>
    <ProductNDC>63379-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Serevent</ProprietaryName>
    <ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
    <NonProprietaryName>Salmeterol Xinafoate</NonProprietaryName>
    <DosageFormName>POWDER, METERED</DosageFormName>
    <RouteName>ORAL; RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19971201</StartMarketingDate>
    <MarketingCategoryName>APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT</MarketingCategoryName>
    <ApplicationNumber>NDA020692</ApplicationNumber>
    <LabelerName>Glaxo Operations UK Ltd</LabelerName>
    <SubstanceName>SALMETEROL XINAFOATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63552-037-00</NDCCode>
    <PackageDescription>143 VIAL in 1 TRAY (63552-037-00)  / 15 mL in 1 VIAL</PackageDescription>
    <NDC11Code>63552-0037-00</NDC11Code>
    <ProductNDC>63552-037</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Trastuzumab</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <StartMarketingDate>20170210</StartMarketingDate>
    <EndMarketingDate>20270831</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Manufacturing Services LLC</LabelerName>
    <SubstanceName>TRASTUZUMAB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/7.4mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-05-06</LastUpdate>
    <StartMarketingDatePackage>10-FEB-17</StartMarketingDatePackage>
    <EndMarketingDatePackage>31-AUG-27</EndMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>65862-037-00</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (65862-037-00) </PackageDescription>
    <NDC11Code>65862-0037-00</NDC11Code>
    <ProductNDC>65862-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisinopril</ProprietaryName>
    <NonProprietaryName>Lisinopril</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077622</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>LISINOPRIL</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
    <Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O52H2O and its structural formula is:. Lisinopril USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: 2.5 mg tablets – dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize).   5 mg tablets – dibasic calcium phosphate, ferric oxide red, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize). 10 mg, 20 mg, 30 mg, and 40 mg tablets - dibasic calcium phosphate, ferric oxide yellow, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize).</Description>
  </NDC>
  <NDC>
    <NDCCode>72888-037-00</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (72888-037-00) </PackageDescription>
    <NDC11Code>72888-0037-00</NDC11Code>
    <ProductNDC>72888-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol</ProprietaryName>
    <NonProprietaryName>Carvedilol</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210729</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078165</ApplicationNumber>
    <LabelerName>Advagen Pharma Ltd</LabelerName>
    <SubstanceName>CARVEDILOL</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210729</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure ( 1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients ( 1.2) , 3 hypertension ( 1.3) .</IndicationAndUsage>
    <Description>Carvedilol is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure:. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125mg, 6.25-mg, 12.5-mg, and 25-mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5).</Description>
  </NDC>
  <NDC>
    <NDCCode>73656-036-00</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (73656-036-00)  *  1 TUBE in 1 BOX (73656-037-00)  / 150 g in 1 TUBE</PackageDescription>
    <NDC11Code>73656-0036-00</NDC11Code>
    <ProductNDC>73656-036</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Optimax Professional Whitening Anticavity Fluoride</ProprietaryName>
    <NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20251208</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>WHITE GLO USA INC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73656-038-00</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (73656-038-00)  *  1 TUBE in 1 BOX (73656-037-00)  / 150 g in 1 TUBE</PackageDescription>
    <NDC11Code>73656-0038-00</NDC11Code>
    <ProductNDC>73656-038</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Optimax Professional Whitening Anticavity Fluoride</ProprietaryName>
    <NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20251208</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>WHITE GLO USA INC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>78691-037-00</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, SPRAY (78691-037-00) </PackageDescription>
    <NDC11Code>78691-0037-00</NDC11Code>
    <ProductNDC>78691-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Biopure Hand Sanitizer Spray-coastal Glow</ProprietaryName>
    <NonProprietaryName>Hand Sanitizer Spray</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260115</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Quest USA Corp</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>g/30mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>82920-037-00</NDCCode>
    <PackageDescription>13 kg in 1 DRUM (82920-037-00) </PackageDescription>
    <NDC11Code>82920-0037-00</NDC11Code>
    <ProductNDC>82920-037</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Sunitinib Malate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230927</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SHILPA PHARMA LIFESCIENCES LIMITED</LabelerName>
    <SubstanceName>SUNITINIB MALATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-09-28</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>27-SEP-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>83008-037-00</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (83008-037-00)  / 100 g in 1 TUBE</PackageDescription>
    <NDC11Code>83008-0037-00</NDC11Code>
    <ProductNDC>83008-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230804</StartMarketingDate>
    <EndMarketingDate>20270430</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209903</ApplicationNumber>
    <LabelerName>Quality Care Products, LLC</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230804</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) for topical use only. The chemical name is 2-[(2,6-dichlorophenyl) amino]benzene-acetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2, and it has the following chemical structure. It contains the active ingredient, diclofenac sodium, USP in an opaque, white gel base. Diclofenac sodium, USP is a white to off-white, amorphous, crystalline powder. Diclofenac sodium is a benzeneacetic acid derivative. The inactive ingredients in diclofenac sodium topical gel include: carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>84003-037-00</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (84003-037-00)  / 27 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>84003-0037-00</NDC11Code>
    <ProductNDC>84003-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dolce And Gabbana Everlast Foundation Spf 20 37w Deep</ProprietaryName>
    <NonProprietaryName>Octisalate, Octocrylene, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Dolce &amp; Gabbana Beauty S.R.L</LabelerName>
    <SubstanceName>OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>35; 50; 5; 18.8</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn . If uses directed with others sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85179-037-00</NDCCode>
    <PackageDescription>45 mL in 1 BOTTLE (85179-037-00) </PackageDescription>
    <NDC11Code>85179-0037-00</NDC11Code>
    <ProductNDC>85179-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Amora Hand Sanitizer Cherry</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251117</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>I World LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand-washing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0264-2205-00</NDCCode>
    <PackageDescription>16 CONTAINER in 1 CASE (0264-2205-00)  / 1000 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-2205-00</NDC11Code>
    <ProductNDC>0264-2205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Physiolyte</ProprietaryName>
    <NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride</NonProprietaryName>
    <DosageFormName>IRRIGANT</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>19840608</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019024</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.53; .5; .37; .037; .03</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19840608</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Physiolyte (A Physiological Irrigating Solution) is indicated for all general irrigation, washing, and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.</IndicationAndUsage>
    <Description>Physiolyte is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing, and rinsing purposes. Each 100 mL contains:Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 gSodium Acetate Trihydrate USP 0.37 g; Potassium ChlorideUSP 0.037 g; Magnesium Chloride Hexahydrate USP 0.03 gWater for Injection USP qsGlacial Acetic Acid USP has been added to adjust the pH. pH: 6.8 (6.3–7.3)Calculated Osmolarity: The solution is isotonic (295 mOsmol/liter). Concentration of Electrolytes (mEq/liter): Sodium 140Potassium 5; Magnesium 3; Chloride 98; Acetate (CH3COO−) 27Gluconate (HOCH2(CHOH)4COO−) 23. It contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Physiolyte may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. The formulas of the active ingredients are. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. Not made with natural rubber latex, PVC or DEHP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-7703-00</NDCCode>
    <PackageDescription>12 CONTAINER in 1 CASE (0264-7703-00)  &gt; 1000 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-7703-00</NDC11Code>
    <ProductNDC>0264-7703</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isolyte S</ProprietaryName>
    <NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19890929</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019711</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.53; .5; .37; .037; .03</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19890929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration, and as an alkalinizing agent.</IndicationAndUsage>
    <Description>Each 100 mL of Isolyte® S (Multi-Electrolyte Injection) contains:Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 gSodium Acetate Trihydrate USP 0.37 g; Potassium Chloride USP 0.037 gMagnesium Chloride Hexahydrate USP 0.03 gWater for Injection USP qs. pH adjusted with Glacial Acetic Acid USPpH: 6.7 (6.3–7.3)Calculated Osmolarity: 295 mOsmol/liter. Concentration of Electrolytes (mEq/liter): Sodium 140; Potassium 5Magnesium 3; Chloride 98; Acetate (CH3COO−) 27Gluconate (HOCH2(CHOH)4COO−) 23. Isolyte® S is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-7704-00</NDCCode>
    <PackageDescription>12 CONTAINER in 1 CASE (0264-7704-00)  &gt; 1000 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-7704-00</NDC11Code>
    <ProductNDC>0264-7704</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isolyte S In Dextrose</ProprietaryName>
    <NonProprietaryName>Hydrous Dextrose, Sodium Chloride, Sodium Gluconate, Sodium Acetate Trihydrate, Potassium Chloride And Magnesium Chloride Hexahydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19930809</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA019843</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>DEXTROSE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
    <StrengthNumber>5; .53; .5; .37; .037; .03</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-04-13</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0264-7707-00</NDCCode>
    <PackageDescription>12 CONTAINER in 1 CASE (0264-7707-00)  / 1000 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-7707-00</NDC11Code>
    <ProductNDC>0264-7707</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isolyte S Ph 7.4</ProprietaryName>
    <NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19890929</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019696</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC</SubstanceName>
    <StrengthNumber>.53; .5; .37; .037; .03; .012; .00082</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-10-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19890929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This solution is indicated for use in adults as a source of electrolytes and water for hydration, and as an alkalinizing agent.</IndicationAndUsage>
    <Description>Each 100 mL of Isolyte® S pH 7.4 (Multi-Electrolyte Injection) contains: Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 gSodium Acetate Trihydrate USP 0.37 g; Potassium Chloride USP 0.037 gMagnesium Chloride Hexahydrate USP 0.03 g Dibasic Sodium Phosphate Heptahydrate USP 0.012 g Monobasic Potassium Phosphate NF 0.00082 g; Water for Injection USP qs pH may be adjusted with Glacial Acetic Acid USP or Sodium Hydroxide NF pH: 7.4 (7.0–7.8)    Calculated Osmolarity: 295 mOsmol/liter Concentration of Electrolytes (mEq/liter): Sodium 141; Potassium 5Magnesium 3; Chloride 98; 0.5 mmole P/literPhosphate (HPO) 1; Acetate (CH3COO–) 27 Gluconate (HOCH2(CHOH)4COO–) 23. Isolyte® S pH 7.4 is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration. The formulas of the active ingredients are. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-9872-00</NDCCode>
    <PackageDescription>12 CONTAINER in 1 CASE (0264-9872-00)  / 1000 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-9872-00</NDC11Code>
    <ProductNDC>0264-9872</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Heparin Sodium In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Heparin Sodium In Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19920720</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019953</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>HEPARIN SODIUM</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>[USP'U]/100mL</StrengthUnit>
    <Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Heparin Sodium in 0.9% Sodium Chloride Injection at the concentration of 2 USP units/mL is indicated as an anticoagulant to maintain catheter patency.</IndicationAndUsage>
    <Description>Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. It is composed of polymers of alternating derivations of  alpha-L-iduronic acid 2-sulfate (1),  2-deoxy-2-sulfamino-alpha-D-glucose 6-sulfate (2),  beta-D-glucuronic acid (3),  2-acetamido-2-deoxy-alpha-D-glucose (4), and alpha-L-iduronic acid (5). Structure of Heparin Sodium (representative subunits). Heparin Sodium in 0.9% Sodium Chloride Injection is a sterile, single-dose, clear, nonpyrogenic solution prepared from Heparin Sodium USP (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) in 0.9% Sodium Chloride Injection. It is to be administered by intravenous injection. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Each 100 mL contains 200 USP Units Heparin Sodium, 0.43 g Dibasic Sodium Phosphate7H2O USP and 0.037 g Citric Acid Anhydrous USP as a buffer system, 0.9 g Sodium Chloride USP, and Water for Injection USP qs. pH: 7.0 (6.8-7.2); Calculated Osmolarity:  360 mOsmol/liter. Concentration of Electrolytes (mEq/liter):  Sodium 186; Chloride 154; Phosphate (HPO) 32; Citrate 6. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The plastic container is not made with natural rubber latex, PVC or DEHP. The closure system has two ports; the one for the administration set has a tamper evident plastic protector.</Description>
  </NDC>
  <NDC>
    <NDCCode>72308-001-01</NDCCode>
    <PackageDescription>295 mL in 1 BOTTLE, PLASTIC (72308-001-01) </PackageDescription>
    <NDC11Code>72308-0001-01</NDC11Code>
    <ProductNDC>72308-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Advanced Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Hand Sanitizer</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170802</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Flex Beauty Labs, LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180507</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Place enough Product in your palm to thoroughtly spread on both hands and rub into the skin until dry. . Children under 6 years of age should be supervised when using this product.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>72308-037-00</NDCCode><ProprietaryName>Visibly Clean Antibacterial Wet Wipes Strawberry Tart</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>72308-036-00</NDCCode><ProprietaryName>Visibly Clean Antibacterial Wet Wipes Blue Sage Lime</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>72308-038-00</NDCCode><ProprietaryName>Visibly Clean Antibacterial Wet Wipes Fresh Lemonade</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>12022-037-00</NDCCode><ProprietaryName>White Rose Liquid Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>21695-037-00</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42893-037-00</NDCCode><ProprietaryName>Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum Spf 15 Nude</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>47049-037-00</NDCCode><NonProprietaryName>Nirogacestat</NonProprietaryName></NDC><NDC><NDCCode>47848-037-00</NDCCode><NonProprietaryName>Irinotecan Hydrochloride Trihyd</NonProprietaryName></NDC><NDC><NDCCode>53747-037-00</NDCCode><NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>58479-037-00</NDCCode><ProprietaryName>Kids Sport Natural Mineral Sunscreen Broad Spectrum</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>58877-037-00</NDCCode><NonProprietaryName>Misoprostol</NonProprietaryName></NDC><NDC><NDCCode>61594-037-00</NDCCode><ProprietaryName>Theraworx Protect Advanced Hygiene With Skin Protectant Fragrance Free</ProprietaryName><NonProprietaryName>Allantoin</NonProprietaryName></NDC><NDC><NDCCode>61755-037-05</NDCCode><ProprietaryName>Regen-cov</ProprietaryName><NonProprietaryName>Casirivimab And Imdevimab</NonProprietaryName></NDC><NDC><NDCCode>63379-037-00</NDCCode><ProprietaryName>Serevent</ProprietaryName><NonProprietaryName>Salmeterol Xinafoate</NonProprietaryName></NDC><NDC><NDCCode>63552-037-00</NDCCode><NonProprietaryName>Trastuzumab</NonProprietaryName></NDC><NDC><NDCCode>65862-037-00</NDCCode><ProprietaryName>Lisinopril</ProprietaryName><NonProprietaryName>Lisinopril</NonProprietaryName></NDC><NDC><NDCCode>72888-037-00</NDCCode><ProprietaryName>Carvedilol</ProprietaryName><NonProprietaryName>Carvedilol</NonProprietaryName></NDC><NDC><NDCCode>73656-036-00</NDCCode><ProprietaryName>Optimax Professional Whitening Anticavity Fluoride</ProprietaryName><NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName></NDC><NDC><NDCCode>73656-038-00</NDCCode><ProprietaryName>Optimax Professional Whitening Anticavity Fluoride</ProprietaryName><NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName></NDC><NDC><NDCCode>78691-037-00</NDCCode><ProprietaryName>Biopure Hand Sanitizer Spray-coastal Glow</ProprietaryName><NonProprietaryName>Hand Sanitizer Spray</NonProprietaryName></NDC><NDC><NDCCode>82920-037-00</NDCCode><NonProprietaryName>Sunitinib Malate</NonProprietaryName></NDC><NDC><NDCCode>83008-037-00</NDCCode><ProprietaryName>Diclofenac Sodium</ProprietaryName><NonProprietaryName>Diclofenac Sodium</NonProprietaryName></NDC><NDC><NDCCode>84003-037-00</NDCCode><ProprietaryName>Dolce And Gabbana Everlast Foundation Spf 20 37w Deep</ProprietaryName><NonProprietaryName>Octisalate, Octocrylene, Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>85179-037-00</NDCCode><ProprietaryName>Amora Hand Sanitizer Cherry</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>0264-2205-00</NDCCode><ProprietaryName>Physiolyte</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0264-7703-00</NDCCode><ProprietaryName>Isolyte S</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0264-7704-00</NDCCode><ProprietaryName>Isolyte S In Dextrose</ProprietaryName><NonProprietaryName>Hydrous Dextrose, Sodium Chloride, Sodium Gluconate, Sodium Acetate Trihydrate, Potassium Chloride And Magnesium Chloride Hexahydrate</NonProprietaryName></NDC><NDC><NDCCode>0264-7707-00</NDCCode><ProprietaryName>Isolyte S Ph 7.4</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate</NonProprietaryName></NDC><NDC><NDCCode>0264-9872-00</NDCCode><ProprietaryName>Heparin Sodium In Sodium Chloride</ProprietaryName><NonProprietaryName>Heparin Sodium In Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>72308-001-01</NDCCode><ProprietaryName>Advanced Hand Sanitizer</ProprietaryName><NonProprietaryName>Hand Sanitizer</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",
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      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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