RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "82086-003-77",
      "PackageDescription": "113 g in 1 TUBE (82086-003-77) ",
      "NDC11Code": "82086-0003-77",
      "ProductNDC": "82086-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Maui Island Secret Browning Creme Broad Spectrum Sunscreen Spf 5",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260120",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Formula 7venz L.L.C.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "3",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2026-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260120",
      "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 aging caused by the sun."
    },
    {
      "NDCCode": "63941-003-77",
      "PackageDescription": "500 mL in 1 BOTTLE, PLASTIC (63941-003-77) ",
      "NDC11Code": "63941-0003-77",
      "ProductNDC": "63941-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antiseptic",
      "NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950609",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Valu Merchandisers Company",
      "SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
      "StrengthNumber": ".92; .42; .6; .64",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-02-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19950609",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps control plaque that leads to gingivitis."
    },
    {
      "NDCCode": "72578-003-77",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (72578-003-77)  > 10 TABLET in 1 BLISTER PACK (72578-003-30) ",
      "NDC11Code": "72578-0003-77",
      "ProductNDC": "72578-003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Memantine Hydrochloride",
      "NonProprietaryName": "Memantine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090961",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "MEMANTINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-10-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).",
      "Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist.  The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP is a white crystalline powder, soluble in water and in methanol, practically insoluble in acetone. Each memantine hydrochloride tablet, USP intended for oral administration contains 5 mg or 10 mg of memantine hydrochloride. In addition, each film-coated tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, povidone, talc and titanium dioxide."
    },
    {
      "NDCCode": "78927-003-01",
      "PackageDescription": "77 g in 1 BAG (78927-003-01) ",
      "NDC11Code": "78927-0003-01",
      "ProductNDC": "78927-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Multi-purpose Antibacterial Wet Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200613",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "NUVOMED,INC.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".13",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200613",
      "SamplePackage": "N",
      "IndicationAndUsage": "Decreases bacteria on skin."
    },
    {
      "NDCCode": "79531-003-01",
      "PackageDescription": "77 g in 1 BAG (79531-003-01) ",
      "NDC11Code": "79531-0003-01",
      "ProductNDC": "79531-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Multi-purpose Antibacterial Wet Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200711",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Supreme Premium Products,Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".13",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200711",
      "SamplePackage": "N",
      "IndicationAndUsage": "Decreases bacteria on skin."
    },
    {
      "NDCCode": "13733-003-01",
      "PackageDescription": "50 mL in 1 CARTON (13733-003-01)",
      "NDC11Code": "13733-0003-01",
      "ProductNDC": "13733-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Missha M Shiny Bb",
      "ProprietaryNameSuffix": "Spf27",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20080416",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "ABLE C&C CO., LTD.",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "3.77",
      "StrengthUnit": "mL/50mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "Description": "Directions: After applying B.B Boomer, apply an appropriate amount evenly over the face. Highlight T-zone and underneath eye area to accentuate facial contour.Caution: For external use only. Do not swallow. Keep out of reach of children. Avoid contact with eyes."
    },
    {
      "NDCCode": "70618-003-02",
      "PackageDescription": "1 CONTAINER in 1 CARTON (70618-003-02)  > 40 mL in 1 CONTAINER (70618-003-01) ",
      "NDC11Code": "70618-0003-02",
      "ProductNDC": "70618-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Be Beautiful Makeup Base",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, Octisalate, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160408",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "THANK YOU FARMER CO., LTD.",
      "SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "2.4; .8; 1.61; .77",
      "StrengthUnit": "mg/40mL; mg/40mL; mg/40mL; mg/40mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20160408",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "76159-003-00",
      "PackageDescription": "1 TUBE in 1 CARTON (76159-003-00)  / 45 mL in 1 TUBE",
      "NDC11Code": "76159-0003-00",
      "ProductNDC": "76159-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "3lab Perfect Bb Spf 40 Broad Spectrum 03",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130110",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "3LAB, Inc",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "77.2",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2023-12-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20171219",
      "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": "79972-003-10",
      "PackageDescription": "300 mL in 1 BOTTLE, PLASTIC (79972-003-10) ",
      "NDC11Code": "79972-0003-10",
      "ProductNDC": "79972-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Be Clean Antiseptic Hand Gel",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200710",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Maria Nila Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "77",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200710",
      "SamplePackage": "N",
      "IndicationAndUsage": "USES(S): Hand sanitizer to help reduce bacteria that potentially can cause disease."
    },
    {
      "NDCCode": "82086-001-08",
      "PackageDescription": "236 mL in 1 BOTTLE (82086-001-08) ",
      "NDC11Code": "82086-0001-08",
      "ProductNDC": "82086-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Maui Island Secret Browning Creme Broad Spectrum Spf 5 Sunscreen",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200702",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Formula 7venz L.L.C.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "7",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200702",
      "SamplePackage": "N",
      "IndicationAndUsage": "  Helps prevent sunburn."
    },
    {
      "NDCCode": "82086-002-34",
      "PackageDescription": "100 mL in 1 TUBE (82086-002-34) ",
      "NDC11Code": "82086-0002-34",
      "ProductNDC": "82086-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Red Gecko Broad Spectrum Spf 30 Sunscreen",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200702",
      "EndMarketingDate": "20260430",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Formula 7venz L.L.C.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "18",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200702",
      "EndMarketingDatePackage": "20260430",
      "SamplePackage": "N",
      "IndicationAndUsage": "  Helps prevent sunburn.   If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "82086-004-76",
      "PackageDescription": "85 g in 1 TUBE (82086-004-76) ",
      "NDC11Code": "82086-0004-76",
      "ProductNDC": "82086-004",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Red Gecko Broad Spectrum Spf 30 Sunscreen",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260120",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Formula 7venz L.L.C.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "14.6",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2026-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260120",
      "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 aging caused by the sun."
    },
    {
      "NDCCode": "0002-5123-77",
      "PackageDescription": "90 BLISTER PACK in 1 CARTON (0002-5123-77)  > 1 TABLET, FILM COATED in 1 BLISTER PACK (0002-5123-01) ",
      "NDC11Code": "00002-5123-77",
      "ProductNDC": "0002-5123",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Effient",
      "NonProprietaryName": "Prasugrel Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090710",
      "EndMarketingDate": "20220331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022307",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "PRASUGREL HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20120301",
      "EndMarketingDatePackage": "20220228",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0006-3025-00",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3025-00)  / 40 mL in 1 VIAL, SINGLE-DOSE (0006-3025-01) ",
      "NDC11Code": "00006-3025-00",
      "ProductNDC": "0006-3025",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zinplava",
      "NonProprietaryName": "Bezlotoxumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20161021",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761046",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "BEZLOTOXUMAB",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-10-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161021",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZINPLAVA is indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence.",
      "Description": "Bezlotoxumab is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects. Bezlotoxumab is an IgG1 immunoglobulin with an approximate molecular weight of 148.2 kDa. ZINPLAVA (bezlotoxumab) Injection is a sterile, preservative-free, clear to moderately opalescent, colorless to pale yellow solution that requires dilution for intravenous infusion. The product is provided in a 50 mL vial that contains 1000 mg of bezlotoxumab in 40 mL of solution. Each mL of solution contains bezlotoxumab (25 mg), citric acid monohydrate (0.8 mg), diethylenetriaminepentaacetic acid (0.0078 mg), polysorbate 80 (0.25 mg), sodium chloride (8.77 mg), sodium citrate dihydrate (4.75 mg), and Water for Injection, USP. The vial may contain sodium hydroxide to adjust the pH to 6.0."
    },
    {
      "NDCCode": "0006-3822-10",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0006-3822-10)  / 10.8 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "00006-3822-10",
      "ProductNDC": "0006-3822",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cancidas",
      "NonProprietaryName": "Caspofungin Acetate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20010126",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021227",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "CASPOFUNGIN ACETATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20010126",
      "SamplePackage": "N",
      "IndicationAndUsage": "CANCIDAS is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: 1 Empirical therapy for presumed fungal infections in febrile, neutropenic patients. (1), 2 Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. (1), 3 Treatment of esophageal candidiasis. (1), 4 Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. (1).",
      "Description": "CANCIDAS is a sterile, lyophilized product for intravenous (IV) infusion that contains a semisynthetic lipopeptide (echinocandin) compound synthesized from a fermentation product of Glarea lozoyensis. CANCIDAS is an echinocandin antifungal that inhibits the synthesis of β (1,3)-D-glucan, an integral component of the fungal cell wall. CANCIDAS (caspofungin acetate) is 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N2-(10,12-dimethyl-1-oxotetradecyl)-4-hydroxy-L-ornithine]-5-[(3R)-3-hydroxy-L-ornithine] pneumocandin B0 diacetate (salt). CANCIDAS 50 mg contains 50 mg of caspofungin equivalent to 55.5 mg of caspofungin acetate. CANCIDAS 50 mg also contains: 39 mg sucrose, 26 mg mannitol, 2 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. CANCIDAS 70 mg contains 70 mg of caspofungin equivalent to 77.7 mg of caspofungin acetate. CANCIDAS 70 mg also contains 54 mg sucrose, 36 mg mannitol, 2.7 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water and methanol, and slightly soluble in ethanol. The pH of a saturated aqueous solution of caspofungin acetate is approximately 6.6. The empirical formula is C52H88N10O15∙2C2H4O2 and the formula weight is 1213.42. The structural formula is."
    },
    {
      "NDCCode": "0006-3823-10",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0006-3823-10)  / 10.8 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "00006-3823-10",
      "ProductNDC": "0006-3823",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cancidas",
      "NonProprietaryName": "Caspofungin Acetate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20010126",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021227",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "CASPOFUNGIN ACETATE",
      "StrengthNumber": "7",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20010126",
      "SamplePackage": "N",
      "IndicationAndUsage": "CANCIDAS is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: 1 Empirical therapy for presumed fungal infections in febrile, neutropenic patients. (1), 2 Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. (1), 3 Treatment of esophageal candidiasis. (1), 4 Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. (1).",
      "Description": "CANCIDAS is a sterile, lyophilized product for intravenous (IV) infusion that contains a semisynthetic lipopeptide (echinocandin) compound synthesized from a fermentation product of Glarea lozoyensis. CANCIDAS is an echinocandin antifungal that inhibits the synthesis of β (1,3)-D-glucan, an integral component of the fungal cell wall. CANCIDAS (caspofungin acetate) is 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N2-(10,12-dimethyl-1-oxotetradecyl)-4-hydroxy-L-ornithine]-5-[(3R)-3-hydroxy-L-ornithine] pneumocandin B0 diacetate (salt). CANCIDAS 50 mg contains 50 mg of caspofungin equivalent to 55.5 mg of caspofungin acetate. CANCIDAS 50 mg also contains: 39 mg sucrose, 26 mg mannitol, 2 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. CANCIDAS 70 mg contains 70 mg of caspofungin equivalent to 77.7 mg of caspofungin acetate. CANCIDAS 70 mg also contains 54 mg sucrose, 36 mg mannitol, 2.7 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water and methanol, and slightly soluble in ethanol. The pH of a saturated aqueous solution of caspofungin acetate is approximately 6.6. The empirical formula is C52H88N10O15∙2C2H4O2 and the formula weight is 1213.42. The structural formula is."
    },
    {
      "NDCCode": "0019-1323-77",
      "PackageDescription": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-77)  / 50 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "00019-1323-77",
      "ProductNDC": "0019-1323",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Optiray",
      "ProprietaryNameSuffix": "320",
      "NonProprietaryName": "Ioversol",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRA-ARTERIAL; INTRAVENOUS",
      "StartMarketingDate": "20120304",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019710",
      "LabelerName": "Liebel-Flarsheim Company LLC",
      "SubstanceName": "IOVERSOL",
      "StrengthNumber": "678",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-06-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120304",
      "SamplePackage": "N",
      "IndicationAndUsage": "OPTIRAY is indicated for."
    },
    {
      "NDCCode": "0019-1333-77",
      "PackageDescription": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-77)  / 50 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "00019-1333-77",
      "ProductNDC": "0019-1333",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Optiray",
      "ProprietaryNameSuffix": "350",
      "NonProprietaryName": "Ioversol",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRA-ARTERIAL; INTRAVENOUS",
      "StartMarketingDate": "20120304",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019710",
      "LabelerName": "Liebel-Flarsheim Company LLC",
      "SubstanceName": "IOVERSOL",
      "StrengthNumber": "741",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-06-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120304",
      "SamplePackage": "N",
      "IndicationAndUsage": "OPTIRAY is indicated for."
    },
    {
      "NDCCode": "0025-2732-31",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2732-31) ",
      "NDC11Code": "00025-2732-31",
      "ProductNDC": "0025-2732",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Norpace Cr",
      "NonProprietaryName": "Disopyramide Phosphate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19820720",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018655",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "DISOPYRAMIDE PHOSPHATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19820720",
      "SamplePackage": "N",
      "IndicationAndUsage": "Norpace and Norpace CR are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace CR should not be used initially if rapid establishment of disopyramide plasma levels is desired. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.",
      "Description": "Norpace (disopyramide phosphate) is an antiarrhythmic drug available for oral administration in immediate-release and controlled-release capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of Norpace is. Norpace is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/ml. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2. Norpace is a racemic mixture of d- and l- isomers. This drug is not chemically related to other antiarrhythmic drugs. Norpace CR (controlled-release) capsules are designed to afford a gradual and consistent release of disopyramide. Thus, for maintenance therapy, Norpace CR provides the benefit of less-frequent dosing (every 12 hours) as compared with the every-6-hour dosage schedule of immediate-release Norpace capsules. Inactive ingredients of Norpace include corn starch, edible ink, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, lactose, talc, and titanium dioxide; the 150-mg capsule also contains FD&C Blue No. 1. Inactive ingredients of Norpace CR include corn starch, D&C Yellow No. 10, edible ink, ethylcellulose, FD&C Blue No. 1, gelatin, shellac, sucrose, talc, and titanium dioxide; the 150-mg capsule also contains FD&C Red No. 3 and FD&C Yellow No. 6."
    },
    {
      "NDCCode": "0025-2742-31",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2742-31) ",
      "NDC11Code": "00025-2742-31",
      "ProductNDC": "0025-2742",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Norpace Cr",
      "NonProprietaryName": "Disopyramide Phosphate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19820720",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018655",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "DISOPYRAMIDE PHOSPHATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19820720",
      "SamplePackage": "N",
      "IndicationAndUsage": "Norpace and Norpace CR are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace CR should not be used initially if rapid establishment of disopyramide plasma levels is desired. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.",
      "Description": "Norpace (disopyramide phosphate) is an antiarrhythmic drug available for oral administration in immediate-release and controlled-release capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of Norpace is. Norpace is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/ml. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2. Norpace is a racemic mixture of d- and l- isomers. This drug is not chemically related to other antiarrhythmic drugs. Norpace CR (controlled-release) capsules are designed to afford a gradual and consistent release of disopyramide. Thus, for maintenance therapy, Norpace CR provides the benefit of less-frequent dosing (every 12 hours) as compared with the every-6-hour dosage schedule of immediate-release Norpace capsules. Inactive ingredients of Norpace include corn starch, edible ink, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, lactose, talc, and titanium dioxide; the 150-mg capsule also contains FD&C Blue No. 1. Inactive ingredients of Norpace CR include corn starch, D&C Yellow No. 10, edible ink, ethylcellulose, FD&C Blue No. 1, gelatin, shellac, sucrose, talc, and titanium dioxide; the 150-mg capsule also contains FD&C Red No. 3 and FD&C Yellow No. 6."
    },
    {
      "NDCCode": "0025-2752-31",
      "PackageDescription": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (0025-2752-31) ",
      "NDC11Code": "00025-2752-31",
      "ProductNDC": "0025-2752",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Norpace",
      "NonProprietaryName": "Disopyramide Phosphate",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19770901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017447",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "DISOPYRAMIDE PHOSPHATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19770901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Norpace and Norpace CR are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace CR should not be used initially if rapid establishment of disopyramide plasma levels is desired. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.",
      "Description": "Norpace (disopyramide phosphate) is an antiarrhythmic drug available for oral administration in immediate-release and controlled-release capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of Norpace is. Norpace is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/ml. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2. Norpace is a racemic mixture of d- and l- isomers. This drug is not chemically related to other antiarrhythmic drugs. Norpace CR (controlled-release) capsules are designed to afford a gradual and consistent release of disopyramide. Thus, for maintenance therapy, Norpace CR provides the benefit of less-frequent dosing (every 12 hours) as compared with the every-6-hour dosage schedule of immediate-release Norpace capsules. Inactive ingredients of Norpace include corn starch, edible ink, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, lactose, talc, and titanium dioxide; the 150-mg capsule also contains FD&C Blue No. 1. Inactive ingredients of Norpace CR include corn starch, D&C Yellow No. 10, edible ink, ethylcellulose, FD&C Blue No. 1, gelatin, shellac, sucrose, talc, and titanium dioxide; the 150-mg capsule also contains FD&C Red No. 3 and FD&C Yellow No. 6."
    },
    {
      "NDCCode": "0025-2762-31",
      "PackageDescription": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (0025-2762-31) ",
      "NDC11Code": "00025-2762-31",
      "ProductNDC": "0025-2762",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Norpace",
      "NonProprietaryName": "Disopyramide Phosphate",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19770901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017447",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "DISOPYRAMIDE PHOSPHATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19770901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Norpace and Norpace CR are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace CR should not be used initially if rapid establishment of disopyramide plasma levels is desired. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.",
      "Description": "Norpace (disopyramide phosphate) is an antiarrhythmic drug available for oral administration in immediate-release and controlled-release capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of Norpace is. Norpace is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/ml. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2. Norpace is a racemic mixture of d- and l- isomers. This drug is not chemically related to other antiarrhythmic drugs. Norpace CR (controlled-release) capsules are designed to afford a gradual and consistent release of disopyramide. Thus, for maintenance therapy, Norpace CR provides the benefit of less-frequent dosing (every 12 hours) as compared with the every-6-hour dosage schedule of immediate-release Norpace capsules. Inactive ingredients of Norpace include corn starch, edible ink, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, lactose, talc, and titanium dioxide; the 150-mg capsule also contains FD&C Blue No. 1. Inactive ingredients of Norpace CR include corn starch, D&C Yellow No. 10, edible ink, ethylcellulose, FD&C Blue No. 1, gelatin, shellac, sucrose, talc, and titanium dioxide; the 150-mg capsule also contains FD&C Red No. 3 and FD&C Yellow No. 6."
    },
    {
      "NDCCode": "0054-0906-23",
      "PackageDescription": "120 TABLET in 1 BOTTLE (0054-0906-23) ",
      "NDC11Code": "00054-0906-23",
      "ProductNDC": "0054-0906",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sapropterin Dihydrochloride",
      "NonProprietaryName": "Sapropterin Dihydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251023",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218797",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "SAPROPTERIN DIHYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251023",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sapropterin dihydrochloride tablets are indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride tablets are to be used in conjunction with a Phe- restricted diet.",
      "Description": "Sapropterin dihydrochloride is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in sapropterin dihydrochloride tablets, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is an off-white to light yellow powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6[(3R,2S)-dihydroxypropyl]-4-oxo-5,6,7,8-. tetrahydropteridine dihydrochloride and the molecular formula is C9H15N5O3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. Sapropterin dihydrochloride is supplied as tablets containing 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin base). Tablets are off white to light yellow, mottled, round shaped tablets debossed with “ZS” on one side and plain on other side. Each tablet contains the following inactive ingredients: Ascorbic acid, crospovidone, anhydrous dibasic calcium phosphate, mannitol, riboflavin, and sodium stearyl fumarate."
    },
    {
      "NDCCode": "0065-1509-77",
      "PackageDescription": "3 BOTTLE, DROPPER in 1 CARTON (0065-1509-77)  / 10 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "00065-1509-77",
      "ProductNDC": "0065-1509",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Systane Complete Pf",
      "NonProprietaryName": "Propylene Glycol",
      "DosageFormName": "EMULSION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20220118",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M018",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "PROPYLENE GLYCOL",
      "StrengthNumber": ".06",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230601",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of burning and irritation due to dryness of the eye. for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun . for use as a protectant against further irritation or to relieve dryness of the eye. for use as a lubricant to prevent further irritation or to relieve dryness of the eye."
    },
    {
      "NDCCode": "0067-2000-77",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0067-2000-77)  / 250 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "00067-2000-77",
      "ProductNDC": "0067-2000",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Excedrin",
      "ProprietaryNameSuffix": "Extra Strength Pain Reliever",
      "NonProprietaryName": "Acetaminophen, Aspirin (nsaid), And Caffeine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060927",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Haleon US Holdings LLC",
      "SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
      "StrengthNumber": "250; 250; 65",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
      "Status": "Active",
      "LastUpdate": "2024-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20060927",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves minor aches and pains due to:oheadache oa coldoarthritisomuscular achesotoothache opremenstrual & menstrual cramps."
    },
    {
      "NDCCode": "0067-2030-77",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0067-2030-77)  > 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00067-2030-77",
      "ProductNDC": "0067-2030",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Excedrin",
      "ProprietaryNameSuffix": "Extra Strength",
      "NonProprietaryName": "Acetaminophen, Aspirin (nsaid), And Caffeine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060927",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Novartis Consumer Health, Inc.",
      "SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
      "StrengthNumber": "250; 250; 65",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-04-04"
    },
    {
      "NDCCode": "0067-2037-77",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0067-2037-77)  > 250 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "00067-2037-77",
      "ProductNDC": "0067-2037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Excedrin",
      "ProprietaryNameSuffix": "Migraine",
      "NonProprietaryName": "Acetaminophen, Aspirin And Caffeine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100215",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020802",
      "LabelerName": "Novartis Consumer Health, Inc.",
      "SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
      "StrengthNumber": "250; 250; 65",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-27",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "0067-2039-77",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0067-2039-77)  / 250 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "00067-2039-77",
      "ProductNDC": "0067-2039",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Excedrin",
      "ProprietaryNameSuffix": "Migraine",
      "NonProprietaryName": "Acetaminophen, Aspirin (nsaid) And Caffeine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100215",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020802",
      "LabelerName": "Haleon US Holdings LLC",
      "SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
      "StrengthNumber": "250; 250; 65",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100215",
      "SamplePackage": "N",
      "IndicationAndUsage": "treats migraine."
    },
    {
      "NDCCode": "0067-2045-77",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0067-2045-77)  > 250 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "00067-2045-77",
      "ProductNDC": "0067-2045",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Excedrin",
      "ProprietaryNameSuffix": "Tension Headache",
      "NonProprietaryName": "Acetaminophine, Caffeine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20051031",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Novartis Consumer Health, Inc.",
      "SubstanceName": "ACETAMINOPHEN; CAFFEINE",
      "StrengthNumber": "500; 65",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-04-04"
    },
    {
      "NDCCode": "0067-6238-77",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0067-6238-77)  > 250 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "00067-6238-77",
      "ProductNDC": "0067-6238",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Excedrin",
      "ProprietaryNameSuffix": "Back And Body",
      "NonProprietaryName": "Acetaminophen, Aspirin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100215",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Novartis Consumer Health, Inc.",
      "SubstanceName": "ACETAMINOPHEN; ASPIRIN",
      "StrengthNumber": "250; 250",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-02-24"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"82086-003-77","ProprietaryName":"Maui Island Secret Browning Creme Broad Spectrum Sunscreen Spf 5","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"63941-003-77","ProprietaryName":"Antiseptic","NonProprietaryName":"Eucalyptol, Menthol, Methyl Salicylate, Thymol"},{"NDCCode":"72578-003-77","ProprietaryName":"Memantine Hydrochloride","NonProprietaryName":"Memantine Hydrochloride"},{"NDCCode":"78927-003-01","ProprietaryName":"Multi-purpose Antibacterial Wet Wipes","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"79531-003-01","ProprietaryName":"Multi-purpose Antibacterial Wet Wipes","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"13733-003-01","ProprietaryName":"Missha M Shiny Bb","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"70618-003-02","ProprietaryName":"Be Beautiful Makeup Base","NonProprietaryName":"Octinoxate, Titanium Dioxide, Octisalate, Zinc Oxide"},{"NDCCode":"76159-003-00","ProprietaryName":"3lab Perfect Bb Spf 40 Broad Spectrum 03","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"79972-003-10","ProprietaryName":"Be Clean Antiseptic Hand Gel","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"82086-001-08","ProprietaryName":"Maui Island Secret Browning Creme Broad Spectrum Spf 5 Sunscreen","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"82086-002-34","ProprietaryName":"Red Gecko Broad Spectrum Spf 30 Sunscreen","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"82086-004-76","ProprietaryName":"Red Gecko Broad Spectrum Spf 30 Sunscreen","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"0002-5123-77","ProprietaryName":"Effient","NonProprietaryName":"Prasugrel Hydrochloride"},{"NDCCode":"0006-3025-00","ProprietaryName":"Zinplava","NonProprietaryName":"Bezlotoxumab"},{"NDCCode":"0006-3822-10","ProprietaryName":"Cancidas","NonProprietaryName":"Caspofungin Acetate"},{"NDCCode":"0006-3823-10","ProprietaryName":"Cancidas","NonProprietaryName":"Caspofungin Acetate"},{"NDCCode":"0019-1323-77","ProprietaryName":"Optiray","NonProprietaryName":"Ioversol"},{"NDCCode":"0019-1333-77","ProprietaryName":"Optiray","NonProprietaryName":"Ioversol"},{"NDCCode":"0025-2732-31","ProprietaryName":"Norpace Cr","NonProprietaryName":"Disopyramide Phosphate"},{"NDCCode":"0025-2742-31","ProprietaryName":"Norpace Cr","NonProprietaryName":"Disopyramide Phosphate"},{"NDCCode":"0025-2752-31","ProprietaryName":"Norpace","NonProprietaryName":"Disopyramide Phosphate"},{"NDCCode":"0025-2762-31","ProprietaryName":"Norpace","NonProprietaryName":"Disopyramide Phosphate"},{"NDCCode":"0054-0906-23","ProprietaryName":"Sapropterin Dihydrochloride","NonProprietaryName":"Sapropterin Dihydrochloride"},{"NDCCode":"0065-1509-77","ProprietaryName":"Systane Complete Pf","NonProprietaryName":"Propylene Glycol"},{"NDCCode":"0067-2000-77","ProprietaryName":"Excedrin","NonProprietaryName":"Acetaminophen, Aspirin (nsaid), And Caffeine"},{"NDCCode":"0067-2030-77","ProprietaryName":"Excedrin","NonProprietaryName":"Acetaminophen, Aspirin (nsaid), And Caffeine"},{"NDCCode":"0067-2037-77","ProprietaryName":"Excedrin","NonProprietaryName":"Acetaminophen, Aspirin And Caffeine"},{"NDCCode":"0067-2039-77","ProprietaryName":"Excedrin","NonProprietaryName":"Acetaminophen, Aspirin (nsaid) And Caffeine"},{"NDCCode":"0067-2045-77","ProprietaryName":"Excedrin","NonProprietaryName":"Acetaminophine, Caffeine"},{"NDCCode":"0067-6238-77","ProprietaryName":"Excedrin","NonProprietaryName":"Acetaminophen, Aspirin"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>82086-003-77</NDCCode>
    <PackageDescription>113 g in 1 TUBE (82086-003-77) </PackageDescription>
    <NDC11Code>82086-0003-77</NDC11Code>
    <ProductNDC>82086-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Maui Island Secret Browning Creme Broad Spectrum Sunscreen Spf 5</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260120</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Formula 7venz L.L.C.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260120</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 aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63941-003-77</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE, PLASTIC (63941-003-77) </PackageDescription>
    <NDC11Code>63941-0003-77</NDC11Code>
    <ProductNDC>63941-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antiseptic</ProprietaryName>
    <NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName>
    <DosageFormName>MOUTHWASH</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19950609</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Valu Merchandisers Company</LabelerName>
    <SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
    <StrengthNumber>.92; .42; .6; .64</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19950609</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps control plaque that leads to gingivitis.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72578-003-77</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (72578-003-77)  &gt; 10 TABLET in 1 BLISTER PACK (72578-003-30) </PackageDescription>
    <NDC11Code>72578-0003-77</NDC11Code>
    <ProductNDC>72578-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Memantine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190228</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090961</ApplicationNumber>
    <LabelerName>Viona Pharmaceuticals Inc</LabelerName>
    <SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).</IndicationAndUsage>
    <Description>Memantine hydrochloride is an orally active NMDA receptor antagonist.  The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP is a white crystalline powder, soluble in water and in methanol, practically insoluble in acetone. Each memantine hydrochloride tablet, USP intended for oral administration contains 5 mg or 10 mg of memantine hydrochloride. In addition, each film-coated tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, povidone, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>78927-003-01</NDCCode>
    <PackageDescription>77 g in 1 BAG (78927-003-01) </PackageDescription>
    <NDC11Code>78927-0003-01</NDC11Code>
    <ProductNDC>78927-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Multi-purpose Antibacterial Wet Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200613</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>NUVOMED,INC.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.13</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200613</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Decreases bacteria on skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>79531-003-01</NDCCode>
    <PackageDescription>77 g in 1 BAG (79531-003-01) </PackageDescription>
    <NDC11Code>79531-0003-01</NDC11Code>
    <ProductNDC>79531-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Multi-purpose Antibacterial Wet Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200711</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Supreme Premium Products,Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.13</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200711</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Decreases bacteria on skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13733-003-01</NDCCode>
    <PackageDescription>50 mL in 1 CARTON (13733-003-01)</PackageDescription>
    <NDC11Code>13733-0003-01</NDC11Code>
    <ProductNDC>13733-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Missha M Shiny Bb</ProprietaryName>
    <ProprietaryNameSuffix>Spf27</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20080416</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>ABLE C&amp;C CO., LTD.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>3.77</StrengthNumber>
    <StrengthUnit>mL/50mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <Description>Directions: After applying B.B Boomer, apply an appropriate amount evenly over the face. Highlight T-zone and underneath eye area to accentuate facial contour.Caution: For external use only. Do not swallow. Keep out of reach of children. Avoid contact with eyes.</Description>
  </NDC>
  <NDC>
    <NDCCode>70618-003-02</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (70618-003-02)  &gt; 40 mL in 1 CONTAINER (70618-003-01) </PackageDescription>
    <NDC11Code>70618-0003-02</NDC11Code>
    <ProductNDC>70618-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Be Beautiful Makeup Base</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, Octisalate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160408</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>THANK YOU FARMER CO., LTD.</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>2.4; .8; 1.61; .77</StrengthNumber>
    <StrengthUnit>mg/40mL; mg/40mL; mg/40mL; mg/40mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160408</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>76159-003-00</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (76159-003-00)  / 45 mL in 1 TUBE</PackageDescription>
    <NDC11Code>76159-0003-00</NDC11Code>
    <ProductNDC>76159-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>3lab Perfect Bb Spf 40 Broad Spectrum 03</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130110</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>3LAB, Inc</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>77.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-12-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171219</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>79972-003-10</NDCCode>
    <PackageDescription>300 mL in 1 BOTTLE, PLASTIC (79972-003-10) </PackageDescription>
    <NDC11Code>79972-0003-10</NDC11Code>
    <ProductNDC>79972-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Be Clean Antiseptic Hand Gel</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200710</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Maria Nila Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>77</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200710</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>USES(S): Hand sanitizer to help reduce bacteria that potentially can cause disease.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>82086-001-08</NDCCode>
    <PackageDescription>236 mL in 1 BOTTLE (82086-001-08) </PackageDescription>
    <NDC11Code>82086-0001-08</NDC11Code>
    <ProductNDC>82086-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Maui Island Secret Browning Creme Broad Spectrum Spf 5 Sunscreen</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200702</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Formula 7venz L.L.C.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>7</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200702</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>  Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>82086-002-34</NDCCode>
    <PackageDescription>100 mL in 1 TUBE (82086-002-34) </PackageDescription>
    <NDC11Code>82086-0002-34</NDC11Code>
    <ProductNDC>82086-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Red Gecko Broad Spectrum Spf 30 Sunscreen</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200702</StartMarketingDate>
    <EndMarketingDate>20260430</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Formula 7venz L.L.C.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>18</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200702</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>  Helps prevent sunburn.   If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>82086-004-76</NDCCode>
    <PackageDescription>85 g in 1 TUBE (82086-004-76) </PackageDescription>
    <NDC11Code>82086-0004-76</NDC11Code>
    <ProductNDC>82086-004</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Red Gecko Broad Spectrum Spf 30 Sunscreen</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260120</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Formula 7venz L.L.C.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>14.6</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260120</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 aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0002-5123-77</NDCCode>
    <PackageDescription>90 BLISTER PACK in 1 CARTON (0002-5123-77)  &gt; 1 TABLET, FILM COATED in 1 BLISTER PACK (0002-5123-01) </PackageDescription>
    <NDC11Code>00002-5123-77</NDC11Code>
    <ProductNDC>0002-5123</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Effient</ProprietaryName>
    <NonProprietaryName>Prasugrel Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090710</StartMarketingDate>
    <EndMarketingDate>20220331</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022307</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>PRASUGREL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120301</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0006-3025-00</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3025-00)  / 40 mL in 1 VIAL, SINGLE-DOSE (0006-3025-01) </PackageDescription>
    <NDC11Code>00006-3025-00</NDC11Code>
    <ProductNDC>0006-3025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zinplava</ProprietaryName>
    <NonProprietaryName>Bezlotoxumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20161021</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761046</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>BEZLOTOXUMAB</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZINPLAVA is indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence.</IndicationAndUsage>
    <Description>Bezlotoxumab is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects. Bezlotoxumab is an IgG1 immunoglobulin with an approximate molecular weight of 148.2 kDa. ZINPLAVA (bezlotoxumab) Injection is a sterile, preservative-free, clear to moderately opalescent, colorless to pale yellow solution that requires dilution for intravenous infusion. The product is provided in a 50 mL vial that contains 1000 mg of bezlotoxumab in 40 mL of solution. Each mL of solution contains bezlotoxumab (25 mg), citric acid monohydrate (0.8 mg), diethylenetriaminepentaacetic acid (0.0078 mg), polysorbate 80 (0.25 mg), sodium chloride (8.77 mg), sodium citrate dihydrate (4.75 mg), and Water for Injection, USP. The vial may contain sodium hydroxide to adjust the pH to 6.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-3822-10</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0006-3822-10)  / 10.8 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>00006-3822-10</NDC11Code>
    <ProductNDC>0006-3822</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cancidas</ProprietaryName>
    <NonProprietaryName>Caspofungin Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20010126</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021227</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>CASPOFUNGIN ACETATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Echinocandin Antifungal [EPC], Lipopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CANCIDAS is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: 1 Empirical therapy for presumed fungal infections in febrile, neutropenic patients. (1), 2 Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. (1), 3 Treatment of esophageal candidiasis. (1), 4 Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. (1).</IndicationAndUsage>
    <Description>CANCIDAS is a sterile, lyophilized product for intravenous (IV) infusion that contains a semisynthetic lipopeptide (echinocandin) compound synthesized from a fermentation product of Glarea lozoyensis. CANCIDAS is an echinocandin antifungal that inhibits the synthesis of β (1,3)-D-glucan, an integral component of the fungal cell wall. CANCIDAS (caspofungin acetate) is 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N2-(10,12-dimethyl-1-oxotetradecyl)-4-hydroxy-L-ornithine]-5-[(3R)-3-hydroxy-L-ornithine] pneumocandin B0 diacetate (salt). CANCIDAS 50 mg contains 50 mg of caspofungin equivalent to 55.5 mg of caspofungin acetate. CANCIDAS 50 mg also contains: 39 mg sucrose, 26 mg mannitol, 2 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. CANCIDAS 70 mg contains 70 mg of caspofungin equivalent to 77.7 mg of caspofungin acetate. CANCIDAS 70 mg also contains 54 mg sucrose, 36 mg mannitol, 2.7 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water and methanol, and slightly soluble in ethanol. The pH of a saturated aqueous solution of caspofungin acetate is approximately 6.6. The empirical formula is C52H88N10O15∙2C2H4O2 and the formula weight is 1213.42. The structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-3823-10</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0006-3823-10)  / 10.8 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>00006-3823-10</NDC11Code>
    <ProductNDC>0006-3823</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cancidas</ProprietaryName>
    <NonProprietaryName>Caspofungin Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20010126</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021227</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>CASPOFUNGIN ACETATE</SubstanceName>
    <StrengthNumber>7</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Echinocandin Antifungal [EPC], Lipopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CANCIDAS is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: 1 Empirical therapy for presumed fungal infections in febrile, neutropenic patients. (1), 2 Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. (1), 3 Treatment of esophageal candidiasis. (1), 4 Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. (1).</IndicationAndUsage>
    <Description>CANCIDAS is a sterile, lyophilized product for intravenous (IV) infusion that contains a semisynthetic lipopeptide (echinocandin) compound synthesized from a fermentation product of Glarea lozoyensis. CANCIDAS is an echinocandin antifungal that inhibits the synthesis of β (1,3)-D-glucan, an integral component of the fungal cell wall. CANCIDAS (caspofungin acetate) is 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N2-(10,12-dimethyl-1-oxotetradecyl)-4-hydroxy-L-ornithine]-5-[(3R)-3-hydroxy-L-ornithine] pneumocandin B0 diacetate (salt). CANCIDAS 50 mg contains 50 mg of caspofungin equivalent to 55.5 mg of caspofungin acetate. CANCIDAS 50 mg also contains: 39 mg sucrose, 26 mg mannitol, 2 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. CANCIDAS 70 mg contains 70 mg of caspofungin equivalent to 77.7 mg of caspofungin acetate. CANCIDAS 70 mg also contains 54 mg sucrose, 36 mg mannitol, 2.7 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water and methanol, and slightly soluble in ethanol. The pH of a saturated aqueous solution of caspofungin acetate is approximately 6.6. The empirical formula is C52H88N10O15∙2C2H4O2 and the formula weight is 1213.42. The structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>0019-1323-77</NDCCode>
    <PackageDescription>20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-77)  / 50 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>00019-1323-77</NDC11Code>
    <ProductNDC>0019-1323</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Optiray</ProprietaryName>
    <ProprietaryNameSuffix>320</ProprietaryNameSuffix>
    <NonProprietaryName>Ioversol</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRA-ARTERIAL; INTRAVENOUS</RouteName>
    <StartMarketingDate>20120304</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019710</ApplicationNumber>
    <LabelerName>Liebel-Flarsheim Company LLC</LabelerName>
    <SubstanceName>IOVERSOL</SubstanceName>
    <StrengthNumber>678</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120304</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OPTIRAY is indicated for.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0019-1333-77</NDCCode>
    <PackageDescription>20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-77)  / 50 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>00019-1333-77</NDC11Code>
    <ProductNDC>0019-1333</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Optiray</ProprietaryName>
    <ProprietaryNameSuffix>350</ProprietaryNameSuffix>
    <NonProprietaryName>Ioversol</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRA-ARTERIAL; INTRAVENOUS</RouteName>
    <StartMarketingDate>20120304</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019710</ApplicationNumber>
    <LabelerName>Liebel-Flarsheim Company LLC</LabelerName>
    <SubstanceName>IOVERSOL</SubstanceName>
    <StrengthNumber>741</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120304</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OPTIRAY is indicated for.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0025-2732-31</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2732-31) </PackageDescription>
    <NDC11Code>00025-2732-31</NDC11Code>
    <ProductNDC>0025-2732</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norpace Cr</ProprietaryName>
    <NonProprietaryName>Disopyramide Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19820720</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018655</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>DISOPYRAMIDE PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19820720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Norpace and Norpace CR are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace CR should not be used initially if rapid establishment of disopyramide plasma levels is desired. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.</IndicationAndUsage>
    <Description>Norpace (disopyramide phosphate) is an antiarrhythmic drug available for oral administration in immediate-release and controlled-release capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of Norpace is. Norpace is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/ml. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2. Norpace is a racemic mixture of d- and l- isomers. This drug is not chemically related to other antiarrhythmic drugs. Norpace CR (controlled-release) capsules are designed to afford a gradual and consistent release of disopyramide. Thus, for maintenance therapy, Norpace CR provides the benefit of less-frequent dosing (every 12 hours) as compared with the every-6-hour dosage schedule of immediate-release Norpace capsules. Inactive ingredients of Norpace include corn starch, edible ink, FD&amp;C Red No. 3, FD&amp;C Yellow No. 6, gelatin, lactose, talc, and titanium dioxide; the 150-mg capsule also contains FD&amp;C Blue No. 1. Inactive ingredients of Norpace CR include corn starch, D&amp;C Yellow No. 10, edible ink, ethylcellulose, FD&amp;C Blue No. 1, gelatin, shellac, sucrose, talc, and titanium dioxide; the 150-mg capsule also contains FD&amp;C Red No. 3 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>0025-2742-31</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2742-31) </PackageDescription>
    <NDC11Code>00025-2742-31</NDC11Code>
    <ProductNDC>0025-2742</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norpace Cr</ProprietaryName>
    <NonProprietaryName>Disopyramide Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19820720</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018655</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>DISOPYRAMIDE PHOSPHATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19820720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Norpace and Norpace CR are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace CR should not be used initially if rapid establishment of disopyramide plasma levels is desired. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.</IndicationAndUsage>
    <Description>Norpace (disopyramide phosphate) is an antiarrhythmic drug available for oral administration in immediate-release and controlled-release capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of Norpace is. Norpace is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/ml. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2. Norpace is a racemic mixture of d- and l- isomers. This drug is not chemically related to other antiarrhythmic drugs. Norpace CR (controlled-release) capsules are designed to afford a gradual and consistent release of disopyramide. Thus, for maintenance therapy, Norpace CR provides the benefit of less-frequent dosing (every 12 hours) as compared with the every-6-hour dosage schedule of immediate-release Norpace capsules. Inactive ingredients of Norpace include corn starch, edible ink, FD&amp;C Red No. 3, FD&amp;C Yellow No. 6, gelatin, lactose, talc, and titanium dioxide; the 150-mg capsule also contains FD&amp;C Blue No. 1. Inactive ingredients of Norpace CR include corn starch, D&amp;C Yellow No. 10, edible ink, ethylcellulose, FD&amp;C Blue No. 1, gelatin, shellac, sucrose, talc, and titanium dioxide; the 150-mg capsule also contains FD&amp;C Red No. 3 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>0025-2752-31</NDCCode>
    <PackageDescription>100 CAPSULE, GELATIN COATED in 1 BOTTLE (0025-2752-31) </PackageDescription>
    <NDC11Code>00025-2752-31</NDC11Code>
    <ProductNDC>0025-2752</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norpace</ProprietaryName>
    <NonProprietaryName>Disopyramide Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19770901</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017447</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>DISOPYRAMIDE PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19770901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Norpace and Norpace CR are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace CR should not be used initially if rapid establishment of disopyramide plasma levels is desired. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.</IndicationAndUsage>
    <Description>Norpace (disopyramide phosphate) is an antiarrhythmic drug available for oral administration in immediate-release and controlled-release capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of Norpace is. Norpace is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/ml. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2. Norpace is a racemic mixture of d- and l- isomers. This drug is not chemically related to other antiarrhythmic drugs. Norpace CR (controlled-release) capsules are designed to afford a gradual and consistent release of disopyramide. Thus, for maintenance therapy, Norpace CR provides the benefit of less-frequent dosing (every 12 hours) as compared with the every-6-hour dosage schedule of immediate-release Norpace capsules. Inactive ingredients of Norpace include corn starch, edible ink, FD&amp;C Red No. 3, FD&amp;C Yellow No. 6, gelatin, lactose, talc, and titanium dioxide; the 150-mg capsule also contains FD&amp;C Blue No. 1. Inactive ingredients of Norpace CR include corn starch, D&amp;C Yellow No. 10, edible ink, ethylcellulose, FD&amp;C Blue No. 1, gelatin, shellac, sucrose, talc, and titanium dioxide; the 150-mg capsule also contains FD&amp;C Red No. 3 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>0025-2762-31</NDCCode>
    <PackageDescription>100 CAPSULE, GELATIN COATED in 1 BOTTLE (0025-2762-31) </PackageDescription>
    <NDC11Code>00025-2762-31</NDC11Code>
    <ProductNDC>0025-2762</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norpace</ProprietaryName>
    <NonProprietaryName>Disopyramide Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19770901</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017447</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>DISOPYRAMIDE PHOSPHATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19770901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Norpace and Norpace CR are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace CR should not be used initially if rapid establishment of disopyramide plasma levels is desired. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.</IndicationAndUsage>
    <Description>Norpace (disopyramide phosphate) is an antiarrhythmic drug available for oral administration in immediate-release and controlled-release capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of Norpace is. Norpace is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/ml. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2. Norpace is a racemic mixture of d- and l- isomers. This drug is not chemically related to other antiarrhythmic drugs. Norpace CR (controlled-release) capsules are designed to afford a gradual and consistent release of disopyramide. Thus, for maintenance therapy, Norpace CR provides the benefit of less-frequent dosing (every 12 hours) as compared with the every-6-hour dosage schedule of immediate-release Norpace capsules. Inactive ingredients of Norpace include corn starch, edible ink, FD&amp;C Red No. 3, FD&amp;C Yellow No. 6, gelatin, lactose, talc, and titanium dioxide; the 150-mg capsule also contains FD&amp;C Blue No. 1. Inactive ingredients of Norpace CR include corn starch, D&amp;C Yellow No. 10, edible ink, ethylcellulose, FD&amp;C Blue No. 1, gelatin, shellac, sucrose, talc, and titanium dioxide; the 150-mg capsule also contains FD&amp;C Red No. 3 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0906-23</NDCCode>
    <PackageDescription>120 TABLET in 1 BOTTLE (0054-0906-23) </PackageDescription>
    <NDC11Code>00054-0906-23</NDC11Code>
    <ProductNDC>0054-0906</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sapropterin Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Sapropterin Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251023</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218797</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>SAPROPTERIN DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251023</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sapropterin dihydrochloride tablets are indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride tablets are to be used in conjunction with a Phe- restricted diet.</IndicationAndUsage>
    <Description>Sapropterin dihydrochloride is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in sapropterin dihydrochloride tablets, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is an off-white to light yellow powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6[(3R,2S)-dihydroxypropyl]-4-oxo-5,6,7,8-. tetrahydropteridine dihydrochloride and the molecular formula is C9H15N5O3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. Sapropterin dihydrochloride is supplied as tablets containing 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin base). Tablets are off white to light yellow, mottled, round shaped tablets debossed with “ZS” on one side and plain on other side. Each tablet contains the following inactive ingredients: Ascorbic acid, crospovidone, anhydrous dibasic calcium phosphate, mannitol, riboflavin, and sodium stearyl fumarate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0065-1509-77</NDCCode>
    <PackageDescription>3 BOTTLE, DROPPER in 1 CARTON (0065-1509-77)  / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00065-1509-77</NDC11Code>
    <ProductNDC>0065-1509</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Systane Complete Pf</ProprietaryName>
    <NonProprietaryName>Propylene Glycol</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20220118</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M018</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>PROPYLENE GLYCOL</SubstanceName>
    <StrengthNumber>.06</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of burning and irritation due to dryness of the eye. for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun . for use as a protectant against further irritation or to relieve dryness of the eye. for use as a lubricant to prevent further irritation or to relieve dryness of the eye.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0067-2000-77</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0067-2000-77)  / 250 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>00067-2000-77</NDC11Code>
    <ProductNDC>0067-2000</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Excedrin</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength Pain Reliever</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060927</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Haleon US Holdings LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
    <StrengthNumber>250; 250; 65</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060927</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to:oheadache oa coldoarthritisomuscular achesotoothache opremenstrual &amp; menstrual cramps.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0067-2030-77</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0067-2030-77)  &gt; 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>00067-2030-77</NDC11Code>
    <ProductNDC>0067-2030</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Excedrin</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060927</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Novartis Consumer Health, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
    <StrengthNumber>250; 250; 65</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-04-04</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0067-2037-77</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0067-2037-77)  &gt; 250 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>00067-2037-77</NDC11Code>
    <ProductNDC>0067-2037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Excedrin</ProprietaryName>
    <ProprietaryNameSuffix>Migraine</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen, Aspirin And Caffeine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100215</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020802</ApplicationNumber>
    <LabelerName>Novartis Consumer Health, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
    <StrengthNumber>250; 250; 65</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-27</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0067-2039-77</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0067-2039-77)  / 250 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>00067-2039-77</NDC11Code>
    <ProductNDC>0067-2039</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Excedrin</ProprietaryName>
    <ProprietaryNameSuffix>Migraine</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen, Aspirin (nsaid) And Caffeine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100215</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020802</ApplicationNumber>
    <LabelerName>Haleon US Holdings LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
    <StrengthNumber>250; 250; 65</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats migraine.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0067-2045-77</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0067-2045-77)  &gt; 250 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>00067-2045-77</NDC11Code>
    <ProductNDC>0067-2045</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Excedrin</ProprietaryName>
    <ProprietaryNameSuffix>Tension Headache</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophine, Caffeine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20051031</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Novartis Consumer Health, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; CAFFEINE</SubstanceName>
    <StrengthNumber>500; 65</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-04-04</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0067-6238-77</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0067-6238-77)  &gt; 250 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>00067-6238-77</NDC11Code>
    <ProductNDC>0067-6238</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Excedrin</ProprietaryName>
    <ProprietaryNameSuffix>Back And Body</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen, Aspirin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100215</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Novartis Consumer Health, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; ASPIRIN</SubstanceName>
    <StrengthNumber>250; 250</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-02-24</LastUpdate>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>82086-003-77</NDCCode><ProprietaryName>Maui Island Secret Browning Creme Broad Spectrum Sunscreen Spf 5</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>63941-003-77</NDCCode><ProprietaryName>Antiseptic</ProprietaryName><NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName></NDC><NDC><NDCCode>72578-003-77</NDCCode><ProprietaryName>Memantine Hydrochloride</ProprietaryName><NonProprietaryName>Memantine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>78927-003-01</NDCCode><ProprietaryName>Multi-purpose Antibacterial Wet Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>79531-003-01</NDCCode><ProprietaryName>Multi-purpose Antibacterial Wet Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>13733-003-01</NDCCode><ProprietaryName>Missha M Shiny Bb</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>70618-003-02</NDCCode><ProprietaryName>Be Beautiful Makeup Base</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, Octisalate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>76159-003-00</NDCCode><ProprietaryName>3lab Perfect Bb Spf 40 Broad Spectrum 03</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>79972-003-10</NDCCode><ProprietaryName>Be Clean Antiseptic Hand Gel</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>82086-001-08</NDCCode><ProprietaryName>Maui Island Secret Browning Creme Broad Spectrum Spf 5 Sunscreen</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>82086-002-34</NDCCode><ProprietaryName>Red Gecko Broad Spectrum Spf 30 Sunscreen</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>82086-004-76</NDCCode><ProprietaryName>Red Gecko Broad Spectrum Spf 30 Sunscreen</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>0002-5123-77</NDCCode><ProprietaryName>Effient</ProprietaryName><NonProprietaryName>Prasugrel Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0006-3025-00</NDCCode><ProprietaryName>Zinplava</ProprietaryName><NonProprietaryName>Bezlotoxumab</NonProprietaryName></NDC><NDC><NDCCode>0006-3822-10</NDCCode><ProprietaryName>Cancidas</ProprietaryName><NonProprietaryName>Caspofungin Acetate</NonProprietaryName></NDC><NDC><NDCCode>0006-3823-10</NDCCode><ProprietaryName>Cancidas</ProprietaryName><NonProprietaryName>Caspofungin Acetate</NonProprietaryName></NDC><NDC><NDCCode>0019-1323-77</NDCCode><ProprietaryName>Optiray</ProprietaryName><NonProprietaryName>Ioversol</NonProprietaryName></NDC><NDC><NDCCode>0019-1333-77</NDCCode><ProprietaryName>Optiray</ProprietaryName><NonProprietaryName>Ioversol</NonProprietaryName></NDC><NDC><NDCCode>0025-2732-31</NDCCode><ProprietaryName>Norpace Cr</ProprietaryName><NonProprietaryName>Disopyramide Phosphate</NonProprietaryName></NDC><NDC><NDCCode>0025-2742-31</NDCCode><ProprietaryName>Norpace Cr</ProprietaryName><NonProprietaryName>Disopyramide Phosphate</NonProprietaryName></NDC><NDC><NDCCode>0025-2752-31</NDCCode><ProprietaryName>Norpace</ProprietaryName><NonProprietaryName>Disopyramide Phosphate</NonProprietaryName></NDC><NDC><NDCCode>0025-2762-31</NDCCode><ProprietaryName>Norpace</ProprietaryName><NonProprietaryName>Disopyramide Phosphate</NonProprietaryName></NDC><NDC><NDCCode>0054-0906-23</NDCCode><ProprietaryName>Sapropterin Dihydrochloride</ProprietaryName><NonProprietaryName>Sapropterin Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0065-1509-77</NDCCode><ProprietaryName>Systane Complete Pf</ProprietaryName><NonProprietaryName>Propylene Glycol</NonProprietaryName></NDC><NDC><NDCCode>0067-2000-77</NDCCode><ProprietaryName>Excedrin</ProprietaryName><NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName></NDC><NDC><NDCCode>0067-2030-77</NDCCode><ProprietaryName>Excedrin</ProprietaryName><NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName></NDC><NDC><NDCCode>0067-2037-77</NDCCode><ProprietaryName>Excedrin</ProprietaryName><NonProprietaryName>Acetaminophen, Aspirin And Caffeine</NonProprietaryName></NDC><NDC><NDCCode>0067-2039-77</NDCCode><ProprietaryName>Excedrin</ProprietaryName><NonProprietaryName>Acetaminophen, Aspirin (nsaid) And Caffeine</NonProprietaryName></NDC><NDC><NDCCode>0067-2045-77</NDCCode><ProprietaryName>Excedrin</ProprietaryName><NonProprietaryName>Acetaminophine, Caffeine</NonProprietaryName></NDC><NDC><NDCCode>0067-6238-77</NDCCode><ProprietaryName>Excedrin</ProprietaryName><NonProprietaryName>Acetaminophen, Aspirin</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",
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      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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