RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (37 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "43596-0078-2",
      "PackageDescription": "1 TUBE in 1 BOX (43596-0078-2)  > 25 g in 1 TUBE (43596-0078-1) ",
      "NDC11Code": "43596-0078-02",
      "ProductNDC": "43596-0078",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cy Bb Facial Hidratante Con Color Fps 25 Multibeneficios",
      "NonProprietaryName": "Octinoxate And Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20171201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": ".07; .084",
      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "0006-0078-28",
      "PackageDescription": "2 BOTTLE in 1 CARTON (0006-0078-28)  / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-14) ",
      "NDC11Code": "00006-0078-28",
      "ProductNDC": "0006-0078",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Janumet",
      "ProprietaryNameSuffix": "Xr",
      "NonProprietaryName": "Sitagliptin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120202",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA202270",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "50; 500",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120202",
      "SamplePackage": "Y",
      "IndicationAndUsage": "JANUMET® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "JANUMET XR tablets for oral use contain two antihyperglycemic medications: sitagliptin and metformin extended-release."
    },
    {
      "NDCCode": "0078-0149-23",
      "PackageDescription": "2 mL in 1 VIAL (0078-0149-23)",
      "NDC11Code": "00078-0149-23",
      "ProductNDC": "0078-0149",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Miacalcin",
      "NonProprietaryName": "Calcitonin Salmon",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "19860703",
      "EndMarketingDate": "20170228",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017808",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "CALCITONIN SALMON",
      "StrengthNumber": "200",
      "StrengthUnit": "[iU]/mL",
      "Pharm_Classes": "Calcitonin [Chemical/Ingredient],Calcitonin [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-03-03"
    },
    {
      "NDCCode": "0078-0340-61",
      "PackageDescription": "1 KIT in 1 KIT (0078-0340-61)  *  2.5 mL in 1 SYRINGE *  .75 mL in 1 PACKET *  5 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "00078-0340-61",
      "ProductNDC": "0078-0340",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sandostatin Lar Depot",
      "NonProprietaryName": "Octreotide Acetate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19881101",
      "EndMarketingDate": "20170430",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021008",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2017-05-02"
    },
    {
      "NDCCode": "0078-0341-61",
      "PackageDescription": "1 KIT in 1 KIT (0078-0341-61)  *  5 mL in 1 VIAL, SINGLE-USE *  2.5 mL in 1 SYRINGE *  .75 mL in 1 PACKET",
      "NDC11Code": "00078-0341-61",
      "ProductNDC": "0078-0341",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sandostatin Lar Depot",
      "NonProprietaryName": "Octreotide Acetate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19881101",
      "EndMarketingDate": "20170831",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021008",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2017-09-01"
    },
    {
      "NDCCode": "0078-0342-61",
      "PackageDescription": "1 KIT in 1 KIT (0078-0342-61)  *  .75 mL in 1 PACKET *  5 mL in 1 VIAL, SINGLE-USE *  2.5 mL in 1 SYRINGE",
      "NDC11Code": "00078-0342-61",
      "ProductNDC": "0078-0342",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sandostatin Lar Depot",
      "NonProprietaryName": "Octreotide Acetate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19881101",
      "EndMarketingDate": "20170831",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021008",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2017-09-01"
    },
    {
      "NDCCode": "0078-0393-61",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0078-0393-61)  / 2.5 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "00078-0393-61",
      "ProductNDC": "0078-0393",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simulect",
      "NonProprietaryName": "Basiliximab",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19980512",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103764",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "BASILIXIMAB",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/2.5mL",
      "Pharm_Classes": "Interleukin 2 Receptor Antagonists [MoA], Interleukin 2 Receptor-directed Antibody Interactions [MoA], Interleukin-2 Receptor Blocking Antibody [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19980512",
      "SamplePackage": "N",
      "IndicationAndUsage": "Simulect® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.",
      "Description": "Basiliximab is a chimeric (murine/human) monoclonal antibody (IgG1к), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor α-chain (IL-2Rα, also known as CD25 antigen) on the surface of activated T-lymphocytes. Based on the amino acid sequence, the calculated molecular weight of the protein is 144 kilodaltons. It is a glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2Rα. Simulect® (basiliximab) for injection is a sterile, preservative-free lyophilisate, which is available in single-dose vials and is available in 10 mg and 20 mg strengths for intravenous administration after reconstitution. Each 10-mg vial contains 10 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.50 mg), glycine (20.3 mg), mannitol (40.6 mg), monobasic potassium phosphate (3.66 mg), sodium chloride (0.82 mg), and sucrose (10.1 mg) to be reconstituted in 2.5 mL of Sterile Water for Injection, USP. Each 20-mg vial contains 20 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.99 mg), glycine (40.1 mg), mannitol (80.1 mg), monobasic potassium phosphate (7.22 mg), sodium chloride (1.61 mg), and sucrose (20 mg) to be reconstituted in 5 mL of Sterile Water for Injection, USP."
    },
    {
      "NDCCode": "0078-0429-57",
      "PackageDescription": "2 TUBE in 1 CARTON (0078-0429-57)  > 10 g in 1 TUBE",
      "NDC11Code": "00078-0429-57",
      "ProductNDC": "0078-0429",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Genteal",
      "ProprietaryNameSuffix": "Severe",
      "NonProprietaryName": "Hypromellose",
      "DosageFormName": "GEL",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20090914",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part349",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "HYPROMELLOSE 2910 (4000 MPA.S)",
      "StrengthNumber": ".003",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20090914",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0078-0474-61",
      "PackageDescription": "1 KIT in 1 BLISTER PACK (0078-0474-61)  *  2 mL in 1 VIAL *  2 mL in 1 AMPULE",
      "NDC11Code": "00078-0474-61",
      "ProductNDC": "0078-0474",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Miochol E",
      "NonProprietaryName": "Acetylcholine Chloride",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19930922",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020213",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2014-11-21"
    },
    {
      "NDCCode": "0078-0476-41",
      "PackageDescription": "2 BOTTLE, DROPPER in 1 CARTON (0078-0476-41)  > 5 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "00078-0476-41",
      "ProductNDC": "0078-0476",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zaditor",
      "ProprietaryNameSuffix": "Antihistamine Eye Drops",
      "NonProprietaryName": "Ketotifen Fumarate",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20090922",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021066",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "KETOTIFEN FUMARATE",
      "StrengthNumber": ".345",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-11-18"
    },
    {
      "NDCCode": "0078-0569-12",
      "PackageDescription": "15 BLISTER PACK in 1 CARTON (0078-0569-12)  / 1 KIT in 1 BLISTER PACK (0078-0569-61)  *  3 mL in 1 VIAL, SINGLE-USE *  1.2 mL in 1 SYRINGE",
      "NDC11Code": "00078-0569-12",
      "ProductNDC": "0078-0569",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Extavia",
      "NonProprietaryName": "Interferon Beta-1b",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20090814",
      "EndMarketingDate": "20240531",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125290",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20090814",
      "EndMarketingDatePackage": "20240531",
      "SamplePackage": "N",
      "IndicationAndUsage": "EXTAVIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
      "Description": "Interferon beta-1b is a purified, sterile, lyophilized protein product produced by recombinant DNA techniques. Interferon beta-1b is manufactured by bacterial fermentation of a strain of Escherichia coli that bears a genetically engineered plasmid containing the gene for human interferon betaser17. The native gene was obtained from human fibroblasts and altered in a way that substitutes serine for the cysteine residue found at position 17. Interferon beta-1b has 165 amino acids and an approximate molecular weight of 18,500 daltons. It does not include the carbohydrate side chains found in the natural material. The specific activity of EXTAVIA is approximately 32 million international units (IU)/mg interferon beta-1b. Each vial contains 0.3 mg of interferon beta-1b. The unit measurement is derived by comparing the antiviral activity of the product to the World Health Organization (WHO) reference standard of recombinant human interferon beta. Mannitol, USP and albumin (human), USP (15 mg each/vial) are added as stabilizers. EXTAVIA (interferon beta-1b) for injection is a sterile, preservative-free, white to off-white lyophilized powder, for subcutaneous injection after reconstitution with the diluent supplied (0.54% sodium chloride solution, USP). Each vial contains albumin (human), USP (15 mg), and mannitol, USP (15 mg)."
    },
    {
      "NDCCode": "0078-0639-41",
      "PackageDescription": "2 mL in 1 CARTON (0078-0639-41) ",
      "NDC11Code": "00078-0639-41",
      "ProductNDC": "0078-0639",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cosentyx",
      "NonProprietaryName": "Secukinumab",
      "DosageFormName": "INJECTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20150121",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125504",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "SECUKINUMAB",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150121",
      "SamplePackage": "N",
      "IndicationAndUsage": "COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).",
      "Description": "Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8."
    },
    {
      "NDCCode": "0078-0639-98",
      "PackageDescription": "2 mL in 1 CARTON (0078-0639-98) ",
      "NDC11Code": "00078-0639-98",
      "ProductNDC": "0078-0639",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cosentyx",
      "NonProprietaryName": "Secukinumab",
      "DosageFormName": "INJECTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20150121",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125504",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "SECUKINUMAB",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150121",
      "SamplePackage": "N",
      "IndicationAndUsage": "COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).",
      "Description": "Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8."
    },
    {
      "NDCCode": "0078-0641-81",
      "PackageDescription": "1 KIT in 1 KIT (0078-0641-81)  *  6 mL in 1 VIAL, SINGLE-USE (0078-0762-61)  *  2 mL in 1 SYRINGE",
      "NDC11Code": "00078-0641-81",
      "ProductNDC": "0078-0641",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Signifor Lar",
      "NonProprietaryName": "Pasireotide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20141215",
      "EndMarketingDate": "20220930",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA203255",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2022-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20141215",
      "EndMarketingDatePackage": "20220930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0078-0642-81",
      "PackageDescription": "1 KIT in 1 KIT (0078-0642-81)  *  2 mL in 1 SYRINGE *  6 mL in 1 VIAL, SINGLE-USE (0078-0776-61) ",
      "NDC11Code": "00078-0642-81",
      "ProductNDC": "0078-0642",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Signifor Lar",
      "NonProprietaryName": "Pasireotide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20141215",
      "EndMarketingDate": "20220930",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA203255",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2022-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20141215",
      "EndMarketingDatePackage": "20220930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0078-0643-81",
      "PackageDescription": "1 KIT in 1 KIT (0078-0643-81)  *  6 mL in 1 VIAL, SINGLE-USE (0078-0783-61)  *  2 mL in 1 SYRINGE",
      "NDC11Code": "00078-0643-81",
      "ProductNDC": "0078-0643",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Signifor Lar",
      "NonProprietaryName": "Pasireotide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20141215",
      "EndMarketingDate": "20220930",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA203255",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2022-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20141215",
      "EndMarketingDatePackage": "20220930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0078-0646-81",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 KIT (0078-0646-81)  > 1 KIT in 1 VIAL, SINGLE-USE (0078-0646-61)  *  6 mL in 1 VIAL, SINGLE-USE *  2 mL in 1 SYRINGE",
      "NDC11Code": "00078-0646-81",
      "ProductNDC": "0078-0646",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sandostatin Lar Depot",
      "NonProprietaryName": "Octreotide Acetate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20150201",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021008",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231",
      "StartMarketingDatePackage": "20150201",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0078-0647-81",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 KIT (0078-0647-81)  > 1 KIT in 1 VIAL, SINGLE-USE (0078-0647-61)  *  6 mL in 1 VIAL, SINGLE-USE *  2 mL in 1 SYRINGE",
      "NDC11Code": "00078-0647-81",
      "ProductNDC": "0078-0647",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sandostatin Lar Depot",
      "NonProprietaryName": "Octreotide Acetate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20150201",
      "EndMarketingDate": "20190630",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021008",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2019-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150201",
      "EndMarketingDatePackage": "20190630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0078-0648-81",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 KIT (0078-0648-81)  > 1 KIT in 1 VIAL, SINGLE-USE (0078-0648-61)  *  6 mL in 1 VIAL, SINGLE-USE *  2 mL in 1 SYRINGE",
      "NDC11Code": "00078-0648-81",
      "ProductNDC": "0078-0648",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sandostatin Lar Depot",
      "NonProprietaryName": "Octreotide Acetate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20150201",
      "EndMarketingDate": "20190331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021008",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150201",
      "EndMarketingDatePackage": "20190331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0078-0698-19",
      "PackageDescription": "4 CARTON in 1 CARTON (0078-0698-19)  / 14 BLISTER PACK in 1 CARTON (0078-0698-51)  / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02) ",
      "NDC11Code": "00078-0698-19",
      "ProductNDC": "0078-0698",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rydapt",
      "NonProprietaryName": "Rydapt",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170428",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA207997",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "MIDOSTAURIN",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170428",
      "SamplePackage": "N",
      "IndicationAndUsage": "RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: 1 Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. (1.1)Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML., 2 Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2).",
      "Description": "Midostaurin is a kinase inhibitor for oral use. The molecular formula for midostaurin is C35H30N4O4. The molecular weight is 570.65 g/mol. The chemical name of midostaurin is Benzamide, N-[(9S,10R,11R,13R)-2,3,10,11,12,13-hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3′,2′,1′-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl]-N-methyl-. The chemical structure of midostaurin is shown below. RYDAPT is supplied as a soft capsule containing 25 mg of midostaurin. The capsule contains carmine, corn oil mono-di-triglycerides, dehydrated alcohol, ferric oxide red, ferric oxide yellow, gelatin, glycerin 85%, hypromellose 2910, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, propylene glycol, purified water, titanium dioxide, and vitamin E."
    },
    {
      "NDCCode": "0078-0698-99",
      "PackageDescription": "2 CARTON in 1 CARTON (0078-0698-99)  / 14 BLISTER PACK in 1 CARTON (0078-0698-51)  / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02) ",
      "NDC11Code": "00078-0698-99",
      "ProductNDC": "0078-0698",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rydapt",
      "NonProprietaryName": "Rydapt",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170428",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA207997",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "MIDOSTAURIN",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170428",
      "SamplePackage": "N",
      "IndicationAndUsage": "RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: 1 Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. (1.1)Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML., 2 Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2).",
      "Description": "Midostaurin is a kinase inhibitor for oral use. The molecular formula for midostaurin is C35H30N4O4. The molecular weight is 570.65 g/mol. The chemical name of midostaurin is Benzamide, N-[(9S,10R,11R,13R)-2,3,10,11,12,13-hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3′,2′,1′-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl]-N-methyl-. The chemical structure of midostaurin is shown below. RYDAPT is supplied as a soft capsule containing 25 mg of midostaurin. The capsule contains carmine, corn oil mono-di-triglycerides, dehydrated alcohol, ferric oxide red, ferric oxide yellow, gelatin, glycerin 85%, hypromellose 2910, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, propylene glycol, purified water, titanium dioxide, and vitamin E."
    },
    {
      "NDCCode": "0078-0708-02",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (0078-0708-02)  / 28 TABLET in 1 BLISTER PACK (0078-0708-51) ",
      "NDC11Code": "00078-0708-02",
      "ProductNDC": "0078-0708",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Piqray",
      "NonProprietaryName": "Alpelisib",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190524",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212526",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "ALPELISIB",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190524",
      "SamplePackage": "N",
      "IndicationAndUsage": "PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.",
      "Description": "PIQRAY (alpelisib) is a kinase inhibitor. The chemical name of alpelisib is (2S)-N1-[4-Methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-1,2-pyrrolidinedicarboxamide. Alpelisib is a white to almost white powder. The molecular formula for alpelisib is C19H22F3N5O2S and the relative molecular mass is 441.47 g/mol. The chemical structure of alpelisib is shown below. PIQRAY film-coated tablets are supplied for oral administration with three strengths that contain 50 mg, 150 mg and 200 mg of alpelisib. The tablets also contain hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. The film-coating contains hypromellose, iron oxide black, iron oxide red, macrogol/polyethylene glycol (PEG) 4000, talc, and titanium dioxide."
    },
    {
      "NDCCode": "0078-0715-02",
      "PackageDescription": "2 KIT in 1 CARTON (0078-0715-02)  / 1 KIT in 1 KIT (0078-0715-61)  *  14 TABLET in 1 BLISTER PACK *  14 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00078-0715-02",
      "ProductNDC": "0078-0715",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Piqray",
      "NonProprietaryName": "Alpelisib",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20190524",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212526",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190524",
      "SamplePackage": "N",
      "IndicationAndUsage": "PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.",
      "Description": "PIQRAY (alpelisib) is a kinase inhibitor. The chemical name of alpelisib is (2S)-N1-[4-Methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-1,2-pyrrolidinedicarboxamide. Alpelisib is a white to almost white powder. The molecular formula for alpelisib is C19H22F3N5O2S and the relative molecular mass is 441.47 g/mol. The chemical structure of alpelisib is shown below. PIQRAY film-coated tablets are supplied for oral administration with three strengths that contain 50 mg, 150 mg and 200 mg of alpelisib. The tablets also contain hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. The film-coating contains hypromellose, iron oxide black, iron oxide red, macrogol/polyethylene glycol (PEG) 4000, talc, and titanium dioxide."
    },
    {
      "NDCCode": "0078-0741-81",
      "PackageDescription": "1 KIT in 1 KIT (0078-0741-81)  *  6 mL in 1 VIAL, SINGLE-USE (0078-0769-61)  *  2 mL in 1 SYRINGE",
      "NDC11Code": "00078-0741-81",
      "ProductNDC": "0078-0741",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Signifor Lar",
      "NonProprietaryName": "Pasireotide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20141215",
      "EndMarketingDate": "20220930",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA203255",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2022-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180629",
      "EndMarketingDatePackage": "20220930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0078-0748-81",
      "PackageDescription": "1 KIT in 1 KIT (0078-0748-81)  *  6 mL in 1 VIAL, SINGLE-USE (0078-0755-61)  *  2 mL in 1 SYRINGE",
      "NDC11Code": "00078-0748-81",
      "ProductNDC": "0078-0748",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Signifor Lar",
      "NonProprietaryName": "Pasireotide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20141215",
      "EndMarketingDate": "20220930",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA203255",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2022-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180629",
      "EndMarketingDatePackage": "20220930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0078-0811-81",
      "PackageDescription": "1 KIT in 1 KIT (0078-0811-81)  *  6 mL in 1 VIAL (0078-0790-61)  *  2 mL in 1 SYRINGE",
      "NDC11Code": "00078-0811-81",
      "ProductNDC": "0078-0811",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sandostatin Lar Depot",
      "NonProprietaryName": "Octreotide Acetate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160722",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021008",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160722",
      "SamplePackage": "N",
      "IndicationAndUsage": "SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.",
      "Description": "Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)]. The molecular weight of octreotide is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is. SANDOSTATIN LAR DEPOT is available in a single-dose vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability. SANDOSTATIN LAR DEPOT is available as: sterile 6-mL single-dose vials in 3 strengths delivering 10 mg, 20 mg, or 30 mg octreotide-free peptide. Each single-dose vial of SANDOSTATIN LAR DEPOT delivers."
    },
    {
      "NDCCode": "0078-0818-81",
      "PackageDescription": "1 KIT in 1 KIT (0078-0818-81)  *  6 mL in 1 VIAL (0078-0797-61)  *  2 mL in 1 SYRINGE",
      "NDC11Code": "00078-0818-81",
      "ProductNDC": "0078-0818",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sandostatin Lar Depot",
      "NonProprietaryName": "Octreotide Acetate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160722",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021008",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160722",
      "SamplePackage": "N",
      "IndicationAndUsage": "SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.",
      "Description": "Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)]. The molecular weight of octreotide is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is. SANDOSTATIN LAR DEPOT is available in a single-dose vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability. SANDOSTATIN LAR DEPOT is available as: sterile 6-mL single-dose vials in 3 strengths delivering 10 mg, 20 mg, or 30 mg octreotide-free peptide. Each single-dose vial of SANDOSTATIN LAR DEPOT delivers."
    },
    {
      "NDCCode": "0078-0825-81",
      "PackageDescription": "1 KIT in 1 KIT (0078-0825-81)  *  2 mL in 1 SYRINGE *  6 mL in 1 VIAL (0078-0804-61) ",
      "NDC11Code": "00078-0825-81",
      "ProductNDC": "0078-0825",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sandostatin Lar Depot",
      "NonProprietaryName": "Octreotide Acetate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160722",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021008",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160722",
      "SamplePackage": "N",
      "IndicationAndUsage": "SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.",
      "Description": "Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)]. The molecular weight of octreotide is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is. SANDOSTATIN LAR DEPOT is available in a single-dose vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability. SANDOSTATIN LAR DEPOT is available as: sterile 6-mL single-dose vials in 3 strengths delivering 10 mg, 20 mg, or 30 mg octreotide-free peptide. Each single-dose vial of SANDOSTATIN LAR DEPOT delivers."
    },
    {
      "NDCCode": "0078-0904-98",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0078-0904-98)  > 2.5 mL in 1 BOTTLE",
      "NDC11Code": "00078-0904-98",
      "ProductNDC": "0078-0904",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simbrinza",
      "NonProprietaryName": "Brinzolamide/brimonidine Tartrate",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20130501",
      "EndMarketingDate": "20230228",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204251",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "BRIMONIDINE TARTRATE; BRINZOLAMIDE",
      "StrengthNumber": "2; 10",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], alpha-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-03-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200804",
      "EndMarketingDatePackage": "20230228",
      "SamplePackage": "Y"
    },
    {
      "NDCCode": "0078-0911-12",
      "PackageDescription": "12 POUCH in 1 CARTON (0078-0911-12)  / 5 AMPULE in 1 POUCH (0078-0911-05)  / .2 mL in 1 AMPULE",
      "NDC11Code": "00078-0911-12",
      "ProductNDC": "0078-0911",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Xiidra",
      "NonProprietaryName": "Lifitegrast",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20160711",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA208073",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "LIFITEGRAST",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Lymphocyte Function-Associated Antigen-1 Antagonist [EPC], Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-08-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200604",
      "EndMarketingDatePackage": "20270601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Xiidra ®(lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED).",
      "Description": "The chemical name for lifitegrast is (S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoic acid. The molecular formula of lifitegrast is C 29H 24Cl 2N 2O 7S and its molecular weight is 615.5 g/mol. The structural formula of lifitegrast is:. *Chiral center. Lifitegrast is a white to off-white powder, which is soluble in water. Xiidra (lifitegrast ophthalmic solution) 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist supplied as a sterile, clear, colorless to slightly brownish-yellow colored, isotonic solution of lifitegrast with a pH of 7.0-8.0, and an osmolality range of 200-330 mOsmol/kg. Xiidra contains Active:lifitegrast 50 mg/mL; Inactives: sodium chloride, sodium phosphate dibasic anhydrous, sodium thiosulfate pentahydrate, and water for injection. Sodium hydroxide and/or hydrochloric acid (to adjust pH)."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"43596-0078-2","ProprietaryName":"Cy Bb Facial Hidratante Con Color Fps 25 Multibeneficios","NonProprietaryName":"Octinoxate And Zinc Oxide"},{"NDCCode":"0006-0078-28","ProprietaryName":"Janumet","NonProprietaryName":"Sitagliptin And Metformin Hydrochloride"},{"NDCCode":"0078-0149-23","ProprietaryName":"Miacalcin","NonProprietaryName":"Calcitonin Salmon"},{"NDCCode":"0078-0340-61","ProprietaryName":"Sandostatin Lar Depot","NonProprietaryName":"Octreotide Acetate"},{"NDCCode":"0078-0341-61","ProprietaryName":"Sandostatin Lar Depot","NonProprietaryName":"Octreotide Acetate"},{"NDCCode":"0078-0342-61","ProprietaryName":"Sandostatin Lar Depot","NonProprietaryName":"Octreotide Acetate"},{"NDCCode":"0078-0393-61","ProprietaryName":"Simulect","NonProprietaryName":"Basiliximab"},{"NDCCode":"0078-0429-57","ProprietaryName":"Genteal","NonProprietaryName":"Hypromellose"},{"NDCCode":"0078-0474-61","ProprietaryName":"Miochol E","NonProprietaryName":"Acetylcholine Chloride"},{"NDCCode":"0078-0476-41","ProprietaryName":"Zaditor","NonProprietaryName":"Ketotifen Fumarate"},{"NDCCode":"0078-0569-12","ProprietaryName":"Extavia","NonProprietaryName":"Interferon Beta-1b"},{"NDCCode":"0078-0639-41","ProprietaryName":"Cosentyx","NonProprietaryName":"Secukinumab"},{"NDCCode":"0078-0639-98","ProprietaryName":"Cosentyx","NonProprietaryName":"Secukinumab"},{"NDCCode":"0078-0641-81","ProprietaryName":"Signifor Lar","NonProprietaryName":"Pasireotide"},{"NDCCode":"0078-0642-81","ProprietaryName":"Signifor Lar","NonProprietaryName":"Pasireotide"},{"NDCCode":"0078-0643-81","ProprietaryName":"Signifor Lar","NonProprietaryName":"Pasireotide"},{"NDCCode":"0078-0646-81","ProprietaryName":"Sandostatin Lar Depot","NonProprietaryName":"Octreotide Acetate"},{"NDCCode":"0078-0647-81","ProprietaryName":"Sandostatin Lar Depot","NonProprietaryName":"Octreotide Acetate"},{"NDCCode":"0078-0648-81","ProprietaryName":"Sandostatin Lar Depot","NonProprietaryName":"Octreotide Acetate"},{"NDCCode":"0078-0698-19","ProprietaryName":"Rydapt","NonProprietaryName":"Rydapt"},{"NDCCode":"0078-0698-99","ProprietaryName":"Rydapt","NonProprietaryName":"Rydapt"},{"NDCCode":"0078-0708-02","ProprietaryName":"Piqray","NonProprietaryName":"Alpelisib"},{"NDCCode":"0078-0715-02","ProprietaryName":"Piqray","NonProprietaryName":"Alpelisib"},{"NDCCode":"0078-0741-81","ProprietaryName":"Signifor Lar","NonProprietaryName":"Pasireotide"},{"NDCCode":"0078-0748-81","ProprietaryName":"Signifor Lar","NonProprietaryName":"Pasireotide"},{"NDCCode":"0078-0811-81","ProprietaryName":"Sandostatin Lar Depot","NonProprietaryName":"Octreotide Acetate"},{"NDCCode":"0078-0818-81","ProprietaryName":"Sandostatin Lar Depot","NonProprietaryName":"Octreotide Acetate"},{"NDCCode":"0078-0825-81","ProprietaryName":"Sandostatin Lar Depot","NonProprietaryName":"Octreotide Acetate"},{"NDCCode":"0078-0904-98","ProprietaryName":"Simbrinza","NonProprietaryName":"Brinzolamide/brimonidine Tartrate"},{"NDCCode":"0078-0911-12","ProprietaryName":"Xiidra","NonProprietaryName":"Lifitegrast"}]}
                    

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    <NDCCode>43596-0078-2</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (43596-0078-2)  &gt; 25 g in 1 TUBE (43596-0078-1) </PackageDescription>
    <NDC11Code>43596-0078-02</NDC11Code>
    <ProductNDC>43596-0078</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cy Bb Facial Hidratante Con Color Fps 25 Multibeneficios</ProprietaryName>
    <NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20171201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.07; .084</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0006-0078-28</NDCCode>
    <PackageDescription>2 BOTTLE in 1 CARTON (0006-0078-28)  / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-14) </PackageDescription>
    <NDC11Code>00006-0078-28</NDC11Code>
    <ProductNDC>0006-0078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Janumet</ProprietaryName>
    <ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
    <NonProprietaryName>Sitagliptin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120202</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA202270</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50; 500</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120202</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>JANUMET® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>JANUMET XR tablets for oral use contain two antihyperglycemic medications: sitagliptin and metformin extended-release.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0149-23</NDCCode>
    <PackageDescription>2 mL in 1 VIAL (0078-0149-23)</PackageDescription>
    <NDC11Code>00078-0149-23</NDC11Code>
    <ProductNDC>0078-0149</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Miacalcin</ProprietaryName>
    <NonProprietaryName>Calcitonin Salmon</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19860703</StartMarketingDate>
    <EndMarketingDate>20170228</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017808</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>CALCITONIN SALMON</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Pharm_Classes>Calcitonin [Chemical/Ingredient],Calcitonin [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-03-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0078-0340-61</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0078-0340-61)  *  2.5 mL in 1 SYRINGE *  .75 mL in 1 PACKET *  5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>00078-0340-61</NDC11Code>
    <ProductNDC>0078-0340</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandostatin Lar Depot</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19881101</StartMarketingDate>
    <EndMarketingDate>20170430</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021008</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2017-05-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0078-0341-61</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0078-0341-61)  *  5 mL in 1 VIAL, SINGLE-USE *  2.5 mL in 1 SYRINGE *  .75 mL in 1 PACKET</PackageDescription>
    <NDC11Code>00078-0341-61</NDC11Code>
    <ProductNDC>0078-0341</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandostatin Lar Depot</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19881101</StartMarketingDate>
    <EndMarketingDate>20170831</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021008</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2017-09-01</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0078-0342-61</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0078-0342-61)  *  .75 mL in 1 PACKET *  5 mL in 1 VIAL, SINGLE-USE *  2.5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00078-0342-61</NDC11Code>
    <ProductNDC>0078-0342</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandostatin Lar Depot</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19881101</StartMarketingDate>
    <EndMarketingDate>20170831</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021008</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2017-09-01</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0078-0393-61</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0078-0393-61)  / 2.5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>00078-0393-61</NDC11Code>
    <ProductNDC>0078-0393</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simulect</ProprietaryName>
    <NonProprietaryName>Basiliximab</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19980512</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103764</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>BASILIXIMAB</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/2.5mL</StrengthUnit>
    <Pharm_Classes>Interleukin 2 Receptor Antagonists [MoA], Interleukin 2 Receptor-directed Antibody Interactions [MoA], Interleukin-2 Receptor Blocking Antibody [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980512</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simulect® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.</IndicationAndUsage>
    <Description>Basiliximab is a chimeric (murine/human) monoclonal antibody (IgG1к), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor α-chain (IL-2Rα, also known as CD25 antigen) on the surface of activated T-lymphocytes. Based on the amino acid sequence, the calculated molecular weight of the protein is 144 kilodaltons. It is a glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2Rα. Simulect® (basiliximab) for injection is a sterile, preservative-free lyophilisate, which is available in single-dose vials and is available in 10 mg and 20 mg strengths for intravenous administration after reconstitution. Each 10-mg vial contains 10 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.50 mg), glycine (20.3 mg), mannitol (40.6 mg), monobasic potassium phosphate (3.66 mg), sodium chloride (0.82 mg), and sucrose (10.1 mg) to be reconstituted in 2.5 mL of Sterile Water for Injection, USP. Each 20-mg vial contains 20 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.99 mg), glycine (40.1 mg), mannitol (80.1 mg), monobasic potassium phosphate (7.22 mg), sodium chloride (1.61 mg), and sucrose (20 mg) to be reconstituted in 5 mL of Sterile Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0429-57</NDCCode>
    <PackageDescription>2 TUBE in 1 CARTON (0078-0429-57)  &gt; 10 g in 1 TUBE</PackageDescription>
    <NDC11Code>00078-0429-57</NDC11Code>
    <ProductNDC>0078-0429</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Genteal</ProprietaryName>
    <ProprietaryNameSuffix>Severe</ProprietaryNameSuffix>
    <NonProprietaryName>Hypromellose</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20090914</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>HYPROMELLOSE 2910 (4000 MPA.S)</SubstanceName>
    <StrengthNumber>.003</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090914</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-0474-61</NDCCode>
    <PackageDescription>1 KIT in 1 BLISTER PACK (0078-0474-61)  *  2 mL in 1 VIAL *  2 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>00078-0474-61</NDC11Code>
    <ProductNDC>0078-0474</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Miochol E</ProprietaryName>
    <NonProprietaryName>Acetylcholine Chloride</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19930922</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020213</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2014-11-21</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0078-0476-41</NDCCode>
    <PackageDescription>2 BOTTLE, DROPPER in 1 CARTON (0078-0476-41)  &gt; 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00078-0476-41</NDC11Code>
    <ProductNDC>0078-0476</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zaditor</ProprietaryName>
    <ProprietaryNameSuffix>Antihistamine Eye Drops</ProprietaryNameSuffix>
    <NonProprietaryName>Ketotifen Fumarate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20090922</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021066</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>KETOTIFEN FUMARATE</SubstanceName>
    <StrengthNumber>.345</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-11-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0078-0569-12</NDCCode>
    <PackageDescription>15 BLISTER PACK in 1 CARTON (0078-0569-12)  / 1 KIT in 1 BLISTER PACK (0078-0569-61)  *  3 mL in 1 VIAL, SINGLE-USE *  1.2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00078-0569-12</NDC11Code>
    <ProductNDC>0078-0569</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Extavia</ProprietaryName>
    <NonProprietaryName>Interferon Beta-1b</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20090814</StartMarketingDate>
    <EndMarketingDate>20240531</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125290</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20090814</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>EXTAVIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>Interferon beta-1b is a purified, sterile, lyophilized protein product produced by recombinant DNA techniques. Interferon beta-1b is manufactured by bacterial fermentation of a strain of Escherichia coli that bears a genetically engineered plasmid containing the gene for human interferon betaser17. The native gene was obtained from human fibroblasts and altered in a way that substitutes serine for the cysteine residue found at position 17. Interferon beta-1b has 165 amino acids and an approximate molecular weight of 18,500 daltons. It does not include the carbohydrate side chains found in the natural material. The specific activity of EXTAVIA is approximately 32 million international units (IU)/mg interferon beta-1b. Each vial contains 0.3 mg of interferon beta-1b. The unit measurement is derived by comparing the antiviral activity of the product to the World Health Organization (WHO) reference standard of recombinant human interferon beta. Mannitol, USP and albumin (human), USP (15 mg each/vial) are added as stabilizers. EXTAVIA (interferon beta-1b) for injection is a sterile, preservative-free, white to off-white lyophilized powder, for subcutaneous injection after reconstitution with the diluent supplied (0.54% sodium chloride solution, USP). Each vial contains albumin (human), USP (15 mg), and mannitol, USP (15 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0639-41</NDCCode>
    <PackageDescription>2 mL in 1 CARTON (0078-0639-41) </PackageDescription>
    <NDC11Code>00078-0639-41</NDC11Code>
    <ProductNDC>0078-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cosentyx</ProprietaryName>
    <NonProprietaryName>Secukinumab</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150121</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125504</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>SECUKINUMAB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
    <Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0639-98</NDCCode>
    <PackageDescription>2 mL in 1 CARTON (0078-0639-98) </PackageDescription>
    <NDC11Code>00078-0639-98</NDC11Code>
    <ProductNDC>0078-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cosentyx</ProprietaryName>
    <NonProprietaryName>Secukinumab</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150121</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125504</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>SECUKINUMAB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
    <Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0641-81</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0078-0641-81)  *  6 mL in 1 VIAL, SINGLE-USE (0078-0762-61)  *  2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00078-0641-81</NDC11Code>
    <ProductNDC>0078-0641</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Signifor Lar</ProprietaryName>
    <NonProprietaryName>Pasireotide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20141215</StartMarketingDate>
    <EndMarketingDate>20220930</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA203255</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20141215</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-0642-81</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0078-0642-81)  *  2 mL in 1 SYRINGE *  6 mL in 1 VIAL, SINGLE-USE (0078-0776-61) </PackageDescription>
    <NDC11Code>00078-0642-81</NDC11Code>
    <ProductNDC>0078-0642</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Signifor Lar</ProprietaryName>
    <NonProprietaryName>Pasireotide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20141215</StartMarketingDate>
    <EndMarketingDate>20220930</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA203255</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20141215</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-0643-81</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0078-0643-81)  *  6 mL in 1 VIAL, SINGLE-USE (0078-0783-61)  *  2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00078-0643-81</NDC11Code>
    <ProductNDC>0078-0643</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Signifor Lar</ProprietaryName>
    <NonProprietaryName>Pasireotide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20141215</StartMarketingDate>
    <EndMarketingDate>20220930</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA203255</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20141215</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-0646-81</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 KIT (0078-0646-81)  &gt; 1 KIT in 1 VIAL, SINGLE-USE (0078-0646-61)  *  6 mL in 1 VIAL, SINGLE-USE *  2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00078-0646-81</NDC11Code>
    <ProductNDC>0078-0646</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandostatin Lar Depot</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20150201</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021008</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-0647-81</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 KIT (0078-0647-81)  &gt; 1 KIT in 1 VIAL, SINGLE-USE (0078-0647-61)  *  6 mL in 1 VIAL, SINGLE-USE *  2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00078-0647-81</NDC11Code>
    <ProductNDC>0078-0647</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandostatin Lar Depot</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20150201</StartMarketingDate>
    <EndMarketingDate>20190630</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021008</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2019-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150201</StartMarketingDatePackage>
    <EndMarketingDatePackage>20190630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-0648-81</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 KIT (0078-0648-81)  &gt; 1 KIT in 1 VIAL, SINGLE-USE (0078-0648-61)  *  6 mL in 1 VIAL, SINGLE-USE *  2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00078-0648-81</NDC11Code>
    <ProductNDC>0078-0648</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandostatin Lar Depot</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20150201</StartMarketingDate>
    <EndMarketingDate>20190331</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021008</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2019-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150201</StartMarketingDatePackage>
    <EndMarketingDatePackage>20190331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-0698-19</NDCCode>
    <PackageDescription>4 CARTON in 1 CARTON (0078-0698-19)  / 14 BLISTER PACK in 1 CARTON (0078-0698-51)  / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02) </PackageDescription>
    <NDC11Code>00078-0698-19</NDC11Code>
    <ProductNDC>0078-0698</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rydapt</ProprietaryName>
    <NonProprietaryName>Rydapt</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170428</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207997</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>MIDOSTAURIN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170428</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: 1 Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. (1.1)Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML., 2 Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2).</IndicationAndUsage>
    <Description>Midostaurin is a kinase inhibitor for oral use. The molecular formula for midostaurin is C35H30N4O4. The molecular weight is 570.65 g/mol. The chemical name of midostaurin is Benzamide, N-[(9S,10R,11R,13R)-2,3,10,11,12,13-hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3′,2′,1′-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl]-N-methyl-. The chemical structure of midostaurin is shown below. RYDAPT is supplied as a soft capsule containing 25 mg of midostaurin. The capsule contains carmine, corn oil mono-di-triglycerides, dehydrated alcohol, ferric oxide red, ferric oxide yellow, gelatin, glycerin 85%, hypromellose 2910, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, propylene glycol, purified water, titanium dioxide, and vitamin E.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0698-99</NDCCode>
    <PackageDescription>2 CARTON in 1 CARTON (0078-0698-99)  / 14 BLISTER PACK in 1 CARTON (0078-0698-51)  / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02) </PackageDescription>
    <NDC11Code>00078-0698-99</NDC11Code>
    <ProductNDC>0078-0698</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rydapt</ProprietaryName>
    <NonProprietaryName>Rydapt</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170428</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207997</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>MIDOSTAURIN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170428</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: 1 Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. (1.1)Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML., 2 Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2).</IndicationAndUsage>
    <Description>Midostaurin is a kinase inhibitor for oral use. The molecular formula for midostaurin is C35H30N4O4. The molecular weight is 570.65 g/mol. The chemical name of midostaurin is Benzamide, N-[(9S,10R,11R,13R)-2,3,10,11,12,13-hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3′,2′,1′-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl]-N-methyl-. The chemical structure of midostaurin is shown below. RYDAPT is supplied as a soft capsule containing 25 mg of midostaurin. The capsule contains carmine, corn oil mono-di-triglycerides, dehydrated alcohol, ferric oxide red, ferric oxide yellow, gelatin, glycerin 85%, hypromellose 2910, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, propylene glycol, purified water, titanium dioxide, and vitamin E.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0708-02</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (0078-0708-02)  / 28 TABLET in 1 BLISTER PACK (0078-0708-51) </PackageDescription>
    <NDC11Code>00078-0708-02</NDC11Code>
    <ProductNDC>0078-0708</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Piqray</ProprietaryName>
    <NonProprietaryName>Alpelisib</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190524</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212526</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>ALPELISIB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.</IndicationAndUsage>
    <Description>PIQRAY (alpelisib) is a kinase inhibitor. The chemical name of alpelisib is (2S)-N1-[4-Methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-1,2-pyrrolidinedicarboxamide. Alpelisib is a white to almost white powder. The molecular formula for alpelisib is C19H22F3N5O2S and the relative molecular mass is 441.47 g/mol. The chemical structure of alpelisib is shown below. PIQRAY film-coated tablets are supplied for oral administration with three strengths that contain 50 mg, 150 mg and 200 mg of alpelisib. The tablets also contain hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. The film-coating contains hypromellose, iron oxide black, iron oxide red, macrogol/polyethylene glycol (PEG) 4000, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0715-02</NDCCode>
    <PackageDescription>2 KIT in 1 CARTON (0078-0715-02)  / 1 KIT in 1 KIT (0078-0715-61)  *  14 TABLET in 1 BLISTER PACK *  14 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00078-0715-02</NDC11Code>
    <ProductNDC>0078-0715</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Piqray</ProprietaryName>
    <NonProprietaryName>Alpelisib</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20190524</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212526</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.</IndicationAndUsage>
    <Description>PIQRAY (alpelisib) is a kinase inhibitor. The chemical name of alpelisib is (2S)-N1-[4-Methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-1,2-pyrrolidinedicarboxamide. Alpelisib is a white to almost white powder. The molecular formula for alpelisib is C19H22F3N5O2S and the relative molecular mass is 441.47 g/mol. The chemical structure of alpelisib is shown below. PIQRAY film-coated tablets are supplied for oral administration with three strengths that contain 50 mg, 150 mg and 200 mg of alpelisib. The tablets also contain hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. The film-coating contains hypromellose, iron oxide black, iron oxide red, macrogol/polyethylene glycol (PEG) 4000, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0741-81</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0078-0741-81)  *  6 mL in 1 VIAL, SINGLE-USE (0078-0769-61)  *  2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00078-0741-81</NDC11Code>
    <ProductNDC>0078-0741</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Signifor Lar</ProprietaryName>
    <NonProprietaryName>Pasireotide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20141215</StartMarketingDate>
    <EndMarketingDate>20220930</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA203255</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180629</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-0748-81</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0078-0748-81)  *  6 mL in 1 VIAL, SINGLE-USE (0078-0755-61)  *  2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00078-0748-81</NDC11Code>
    <ProductNDC>0078-0748</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Signifor Lar</ProprietaryName>
    <NonProprietaryName>Pasireotide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20141215</StartMarketingDate>
    <EndMarketingDate>20220930</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA203255</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180629</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-0811-81</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0078-0811-81)  *  6 mL in 1 VIAL (0078-0790-61)  *  2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00078-0811-81</NDC11Code>
    <ProductNDC>0078-0811</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandostatin Lar Depot</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160722</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021008</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160722</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.</IndicationAndUsage>
    <Description>Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)]. The molecular weight of octreotide is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is. SANDOSTATIN LAR DEPOT is available in a single-dose vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability. SANDOSTATIN LAR DEPOT is available as: sterile 6-mL single-dose vials in 3 strengths delivering 10 mg, 20 mg, or 30 mg octreotide-free peptide. Each single-dose vial of SANDOSTATIN LAR DEPOT delivers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0818-81</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0078-0818-81)  *  6 mL in 1 VIAL (0078-0797-61)  *  2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00078-0818-81</NDC11Code>
    <ProductNDC>0078-0818</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandostatin Lar Depot</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160722</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021008</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160722</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.</IndicationAndUsage>
    <Description>Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)]. The molecular weight of octreotide is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is. SANDOSTATIN LAR DEPOT is available in a single-dose vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability. SANDOSTATIN LAR DEPOT is available as: sterile 6-mL single-dose vials in 3 strengths delivering 10 mg, 20 mg, or 30 mg octreotide-free peptide. Each single-dose vial of SANDOSTATIN LAR DEPOT delivers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0825-81</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0078-0825-81)  *  2 mL in 1 SYRINGE *  6 mL in 1 VIAL (0078-0804-61) </PackageDescription>
    <NDC11Code>00078-0825-81</NDC11Code>
    <ProductNDC>0078-0825</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandostatin Lar Depot</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160722</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021008</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160722</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.</IndicationAndUsage>
    <Description>Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)]. The molecular weight of octreotide is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is. SANDOSTATIN LAR DEPOT is available in a single-dose vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability. SANDOSTATIN LAR DEPOT is available as: sterile 6-mL single-dose vials in 3 strengths delivering 10 mg, 20 mg, or 30 mg octreotide-free peptide. Each single-dose vial of SANDOSTATIN LAR DEPOT delivers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0904-98</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0078-0904-98)  &gt; 2.5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00078-0904-98</NDC11Code>
    <ProductNDC>0078-0904</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simbrinza</ProprietaryName>
    <NonProprietaryName>Brinzolamide/brimonidine Tartrate</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20130501</StartMarketingDate>
    <EndMarketingDate>20230228</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204251</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE; BRINZOLAMIDE</SubstanceName>
    <StrengthNumber>2; 10</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-03-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200804</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230228</EndMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-0911-12</NDCCode>
    <PackageDescription>12 POUCH in 1 CARTON (0078-0911-12)  / 5 AMPULE in 1 POUCH (0078-0911-05)  / .2 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>00078-0911-12</NDC11Code>
    <ProductNDC>0078-0911</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xiidra</ProprietaryName>
    <NonProprietaryName>Lifitegrast</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20160711</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208073</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>LIFITEGRAST</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Lymphocyte Function-Associated Antigen-1 Antagonist [EPC], Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200604</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270601</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Xiidra ®(lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED).</IndicationAndUsage>
    <Description>The chemical name for lifitegrast is (S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoic acid. The molecular formula of lifitegrast is C 29H 24Cl 2N 2O 7S and its molecular weight is 615.5 g/mol. The structural formula of lifitegrast is:. *Chiral center. Lifitegrast is a white to off-white powder, which is soluble in water. Xiidra (lifitegrast ophthalmic solution) 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist supplied as a sterile, clear, colorless to slightly brownish-yellow colored, isotonic solution of lifitegrast with a pH of 7.0-8.0, and an osmolality range of 200-330 mOsmol/kg. Xiidra contains Active:lifitegrast 50 mg/mL; Inactives: sodium chloride, sodium phosphate dibasic anhydrous, sodium thiosulfate pentahydrate, and water for injection. Sodium hydroxide and/or hydrochloric acid (to adjust pH).</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>43596-0078-2</NDCCode><ProprietaryName>Cy Bb Facial Hidratante Con Color Fps 25 Multibeneficios</ProprietaryName><NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>0006-0078-28</NDCCode><ProprietaryName>Janumet</ProprietaryName><NonProprietaryName>Sitagliptin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0078-0149-23</NDCCode><ProprietaryName>Miacalcin</ProprietaryName><NonProprietaryName>Calcitonin Salmon</NonProprietaryName></NDC><NDC><NDCCode>0078-0340-61</NDCCode><ProprietaryName>Sandostatin Lar Depot</ProprietaryName><NonProprietaryName>Octreotide Acetate</NonProprietaryName></NDC><NDC><NDCCode>0078-0341-61</NDCCode><ProprietaryName>Sandostatin Lar Depot</ProprietaryName><NonProprietaryName>Octreotide Acetate</NonProprietaryName></NDC><NDC><NDCCode>0078-0342-61</NDCCode><ProprietaryName>Sandostatin Lar Depot</ProprietaryName><NonProprietaryName>Octreotide Acetate</NonProprietaryName></NDC><NDC><NDCCode>0078-0393-61</NDCCode><ProprietaryName>Simulect</ProprietaryName><NonProprietaryName>Basiliximab</NonProprietaryName></NDC><NDC><NDCCode>0078-0429-57</NDCCode><ProprietaryName>Genteal</ProprietaryName><NonProprietaryName>Hypromellose</NonProprietaryName></NDC><NDC><NDCCode>0078-0474-61</NDCCode><ProprietaryName>Miochol E</ProprietaryName><NonProprietaryName>Acetylcholine Chloride</NonProprietaryName></NDC><NDC><NDCCode>0078-0476-41</NDCCode><ProprietaryName>Zaditor</ProprietaryName><NonProprietaryName>Ketotifen Fumarate</NonProprietaryName></NDC><NDC><NDCCode>0078-0569-12</NDCCode><ProprietaryName>Extavia</ProprietaryName><NonProprietaryName>Interferon Beta-1b</NonProprietaryName></NDC><NDC><NDCCode>0078-0639-41</NDCCode><ProprietaryName>Cosentyx</ProprietaryName><NonProprietaryName>Secukinumab</NonProprietaryName></NDC><NDC><NDCCode>0078-0639-98</NDCCode><ProprietaryName>Cosentyx</ProprietaryName><NonProprietaryName>Secukinumab</NonProprietaryName></NDC><NDC><NDCCode>0078-0641-81</NDCCode><ProprietaryName>Signifor Lar</ProprietaryName><NonProprietaryName>Pasireotide</NonProprietaryName></NDC><NDC><NDCCode>0078-0642-81</NDCCode><ProprietaryName>Signifor Lar</ProprietaryName><NonProprietaryName>Pasireotide</NonProprietaryName></NDC><NDC><NDCCode>0078-0643-81</NDCCode><ProprietaryName>Signifor Lar</ProprietaryName><NonProprietaryName>Pasireotide</NonProprietaryName></NDC><NDC><NDCCode>0078-0646-81</NDCCode><ProprietaryName>Sandostatin Lar Depot</ProprietaryName><NonProprietaryName>Octreotide Acetate</NonProprietaryName></NDC><NDC><NDCCode>0078-0647-81</NDCCode><ProprietaryName>Sandostatin Lar Depot</ProprietaryName><NonProprietaryName>Octreotide Acetate</NonProprietaryName></NDC><NDC><NDCCode>0078-0648-81</NDCCode><ProprietaryName>Sandostatin Lar Depot</ProprietaryName><NonProprietaryName>Octreotide Acetate</NonProprietaryName></NDC><NDC><NDCCode>0078-0698-19</NDCCode><ProprietaryName>Rydapt</ProprietaryName><NonProprietaryName>Rydapt</NonProprietaryName></NDC><NDC><NDCCode>0078-0698-99</NDCCode><ProprietaryName>Rydapt</ProprietaryName><NonProprietaryName>Rydapt</NonProprietaryName></NDC><NDC><NDCCode>0078-0708-02</NDCCode><ProprietaryName>Piqray</ProprietaryName><NonProprietaryName>Alpelisib</NonProprietaryName></NDC><NDC><NDCCode>0078-0715-02</NDCCode><ProprietaryName>Piqray</ProprietaryName><NonProprietaryName>Alpelisib</NonProprietaryName></NDC><NDC><NDCCode>0078-0741-81</NDCCode><ProprietaryName>Signifor Lar</ProprietaryName><NonProprietaryName>Pasireotide</NonProprietaryName></NDC><NDC><NDCCode>0078-0748-81</NDCCode><ProprietaryName>Signifor Lar</ProprietaryName><NonProprietaryName>Pasireotide</NonProprietaryName></NDC><NDC><NDCCode>0078-0811-81</NDCCode><ProprietaryName>Sandostatin Lar Depot</ProprietaryName><NonProprietaryName>Octreotide Acetate</NonProprietaryName></NDC><NDC><NDCCode>0078-0818-81</NDCCode><ProprietaryName>Sandostatin Lar Depot</ProprietaryName><NonProprietaryName>Octreotide Acetate</NonProprietaryName></NDC><NDC><NDCCode>0078-0825-81</NDCCode><ProprietaryName>Sandostatin Lar Depot</ProprietaryName><NonProprietaryName>Octreotide Acetate</NonProprietaryName></NDC><NDC><NDCCode>0078-0904-98</NDCCode><ProprietaryName>Simbrinza</ProprietaryName><NonProprietaryName>Brinzolamide/brimonidine Tartrate</NonProprietaryName></NDC><NDC><NDCCode>0078-0911-12</NDCCode><ProprietaryName>Xiidra</ProprietaryName><NonProprietaryName>Lifitegrast</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
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      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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