DataLabs.Health : REST Lookup Web Service Test-Drive

RESTful Lookup — Test-Drive (2007 – 2026)

How to Find 46122-333-43 NDC Data Using DataLabs API

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REST API URI Example

GET https://www.datalabs.health/api/ndc/search?q=46122-333-43&rt=json&token=3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66

REST API Response Samples

Query complete (14 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "46122-333-43",
      "PackageDescription": "473 mL in 1 BOTTLE (46122-333-43)",
      "NDC11Code": "46122-0333-43",
      "ProductNDC": "46122-333",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gnp Isopropyl Alcohol 50 Percent With Wintergreen Oil",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Amerisource Bergen",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-02",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "IndicationAndUsage": "First aid to help prevent the risk of infection in. : 1 minor cuts, 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "62327-333-43",
      "PackageDescription": "4 VIAL, GLASS in 1 BOX (62327-333-43)  / 10 mL in 1 VIAL, GLASS (62327-333-03) ",
      "NDC11Code": "62327-0333-43",
      "ProductNDC": "62327-333",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Steritalc",
      "ProprietaryNameSuffix": "3g",
      "NonProprietaryName": "Talc",
      "DosageFormName": "POWDER",
      "RouteName": "INTRAPLEURAL",
      "StartMarketingDate": "20171101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205555",
      "LabelerName": "Novatech SA",
      "SubstanceName": "TALC",
      "StrengthNumber": "3",
      "StrengthUnit": "g/10mL",
      "Status": "Active",
      "LastUpdate": "2025-06-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20171101",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.INDICATIONS AND USAGE. 1.1 Malignant Pleural Effusion. STERITALC is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. 1.2 Pneumothorax. STERITALC is indicated in adults to decrease the recurrence of pneumothorax.",
      "Description": "STERITALC (talc) is a sclerosing agent for intrapleural administration. The molecular formula for talc is Mg3Si4O10(OH)2. The molecular weight is 379.3 g/mole. The chemical name of talc is hydrated magnesium silicate. The talc powder contains ≥ 95% of hydrated magnesium silicate; associated minerals include chlorites (hydrated aluminum and magnesium silicates), magnesite (magnesium carbonate), calcite (calcium carbonate), and dolomite (calcium and magnesium carbonate). The talc elementary sheet is composed of a layer of magnesium-oxygen/hydroxyl octahedra, sandwiched between two layers of silicon-oxygen tetrahedra. Talc is insoluble in water. STERITALC is tested for asbestos and asbestiform fibers consistent with USP standards for talc-containing products. STERITALC is supplied as 2 grams, 3 grams, and 4 grams white or off-white to light gray, sterile powder. STERITALC contains particle size-controlled talc, graded to decrease the proportion of smaller particles."
    },
    {
      "NDCCode": "63742-333-01",
      "PackageDescription": "35.43 g in 1 BOTTLE, PLASTIC (63742-333-01) ",
      "NDC11Code": "63742-0333-01",
      "ProductNDC": "63742-333",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Quick Numb",
      "NonProprietaryName": "Lidocaine",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250514",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M015",
      "LabelerName": "Clinical Resolution Laboratory, Inc.",
      "SubstanceName": "LIDOCAINE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-05-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250514",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. ■ For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation. ■ For the temporary relief of pain, burning and soreness."
    },
    {
      "NDCCode": "46122-059-43",
      "PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (46122-059-43) ",
      "NDC11Code": "46122-0059-43",
      "ProductNDC": "46122-059",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Isopropyl Alcohol",
      "ProprietaryNameSuffix": "70 Percent Wintergreen",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141231",
      "EndMarketingDate": "20201231",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "AmerisourceBergen (Good Neighbor Pharmacy) 46122",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20141231",
      "EndMarketingDatePackage": "20201231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "46122-060-43",
      "PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (46122-060-43) ",
      "NDC11Code": "46122-0060-43",
      "ProductNDC": "46122-060",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Isopropyl Alcohol",
      "ProprietaryNameSuffix": "91 Percent",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141231",
      "EndMarketingDate": "20191231",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "AmerisourceBergen (Good Neighbor Pharmacy) 46122",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "91",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20141231",
      "EndMarketingDatePackage": "20191231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "46122-137-43",
      "PackageDescription": "473 mL in 1 BOTTLE (46122-137-43) ",
      "NDC11Code": "46122-0137-43",
      "ProductNDC": "46122-137",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antiseptic Skin Cleanser",
      "NonProprietaryName": "Chlorhexidine Gluconate 4%",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130401",
      "EndMarketingDate": "20270228",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019125",
      "LabelerName": "AmerisourceBergen Drug Corporation",
      "SubstanceName": "CHLORHEXIDINE GLUCONATE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190101",
      "EndMarketingDatePackage": "20270131",
      "SamplePackage": "N",
      "IndicationAndUsage": "healthcare personnel handwash: helps reduce bacteria that potentially can cause disease . skin wound and general skin cleansing."
    },
    {
      "NDCCode": "46122-280-43",
      "PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (46122-280-43) ",
      "NDC11Code": "46122-0280-43",
      "ProductNDC": "46122-280",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Witch Hazel",
      "NonProprietaryName": "Witch Hazel",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140930",
      "EndMarketingDate": "20221231",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "AmerisourceBergen (Good Neighbor Pharmacy) 46122",
      "SubstanceName": "WITCH HAZEL",
      "StrengthNumber": "842",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20140930",
      "EndMarketingDatePackage": "20221231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "46122-328-43",
      "PackageDescription": "473 mL in 1 BOTTLE (46122-328-43)",
      "NDC11Code": "46122-0328-43",
      "ProductNDC": "46122-328",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gnp Isopropyl Alcohol 50 Percent",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Amerisource Bergen",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-02",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "IndicationAndUsage": "First aid to help prevent the risk of infection in. : 1 minor cuts, 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "46122-329-43",
      "PackageDescription": "473 mL in 1 BOTTLE (46122-329-43) ",
      "NDC11Code": "46122-0329-43",
      "ProductNDC": "46122-329",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gnp Ethyl Rubbing Alcohol 70 Percent",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Amerisource Bergen",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "700",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160101",
      "SamplePackage": "N",
      "IndicationAndUsage": "First aid to help prevent the risk of infection in. : 1 minor cuts , 2 scrapes , 3 burns."
    },
    {
      "NDCCode": "46122-330-43",
      "PackageDescription": "473 mL in 1 BOTTLE (46122-330-43) ",
      "NDC11Code": "46122-0330-43",
      "ProductNDC": "46122-330",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gnp Isopropyl Rubbing Alcohol 70 Percent",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160101",
      "EndMarketingDate": "20280331",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Amerisource Bergen",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "700",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160101",
      "EndMarketingDatePackage": "20280331",
      "SamplePackage": "N",
      "IndicationAndUsage": "First aid to help prevent the risk of infection in. : 1 minor cuts , 2 scrapes , 3 burns."
    },
    {
      "NDCCode": "46122-331-43",
      "PackageDescription": "473 mL in 1 BOTTLE (46122-331-43) ",
      "NDC11Code": "46122-0331-43",
      "ProductNDC": "46122-331",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gnp Isopropyl Alcohol 70 Percent With Wintergreen Oil",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160101",
      "EndMarketingDate": "20280301",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Amerisource Bergen",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "700",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160101",
      "EndMarketingDatePackage": "20280301",
      "SamplePackage": "N",
      "IndicationAndUsage": "First aid to help prevent the risk of infection in. : 1 minor cuts , 2 scrapes , 3 burns."
    },
    {
      "NDCCode": "46122-332-43",
      "PackageDescription": "473 mL in 1 BOTTLE (46122-332-43) ",
      "NDC11Code": "46122-0332-43",
      "ProductNDC": "46122-332",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gnp Isopropyl Alcohol 91 Percent",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Amerisource Bergen",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "910",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160101",
      "SamplePackage": "N",
      "IndicationAndUsage": "First aid to help prevent the risk of infection in. : 1 minor cuts , 2 scrapes , 3 burns."
    },
    {
      "NDCCode": "46122-334-43",
      "PackageDescription": "473 mL in 1 BOTTLE (46122-334-43) ",
      "NDC11Code": "46122-0334-43",
      "ProductNDC": "46122-334",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gnp Hydrogen Peroxide 3 Percent",
      "NonProprietaryName": "Hydrogen Peroxide",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Amerisource Bergen",
      "SubstanceName": "HYDROGEN PEROXIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160101",
      "SamplePackage": "N",
      "IndicationAndUsage": "As an antiseptic to help prevent infection in minor cuts, scrapes, burns. As an oral rinse for temporary use in cleaning of minor wounds or irritation/inflammation to the mouth and gums resulting from minor dental procedures, orthodontic appliances or accidental injury."
    },
    {
      "NDCCode": "46122-335-43",
      "PackageDescription": "473 mL in 1 BOTTLE (46122-335-43) ",
      "NDC11Code": "46122-0335-43",
      "ProductNDC": "46122-335",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gnp Witch Hazel",
      "NonProprietaryName": "Witch Hazel",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Amerisource Bergen",
      "SubstanceName": "WITCH HAZEL",
      "StrengthNumber": "855",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2023-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160101",
      "SamplePackage": "N",
      "IndicationAndUsage": "For relief of minor skin Irritations due to. minor cuts. minor scraps. insect bites."
    },
    {
      "NDCCode": "46122-399-43",
      "PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (46122-399-43) ",
      "NDC11Code": "46122-0399-43",
      "ProductNDC": "46122-399",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Stool Softener Liquid",
      "NonProprietaryName": "Docusate Sodium",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170901",
      "EndMarketingDate": "20200831",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "AMERISOURCEBERGEN DRUG CORPORATION",
      "SubstanceName": "DOCUSATE SODIUM",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/5mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170901",
      "EndMarketingDatePackage": "20200831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "46122-400-43",
      "PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (46122-400-43) ",
      "NDC11Code": "46122-0400-43",
      "ProductNDC": "46122-400",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Stool Softener Syrup",
      "NonProprietaryName": "Docusate Sodium",
      "DosageFormName": "SYRUP",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170901",
      "EndMarketingDate": "20200930",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "AMERISOURCEBERGEN DRUG CORPORATION",
      "SubstanceName": "DOCUSATE SODIUM",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/15mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170901",
      "EndMarketingDatePackage": "20200930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "46122-461-43",
      "PackageDescription": "454 g in 1 POUCH (46122-461-43) ",
      "NDC11Code": "46122-0461-43",
      "ProductNDC": "46122-461",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Epsom Salt",
      "NonProprietaryName": "Epsom Salt",
      "DosageFormName": "GRANULE",
      "RouteName": "ORAL; TOPICAL",
      "StartMarketingDate": "20180430",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "AmerisourceBergen (Good Neighbor Pharmacy) 46122",
      "SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180530",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces bowel movement in 1/2 to 6 hours."
    },
    {
      "NDCCode": "0310-6100-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6100-30) ",
      "NDC11Code": "00310-6100-30",
      "ProductNDC": "0310-6100",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Onglyza",
      "NonProprietaryName": "Saxagliptin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141120",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022350",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "SAXAGLIPTIN HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20141121",
      "SamplePackage": "N",
      "Description": "Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: iron oxides, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
    },
    {
      "NDCCode": "0310-6100-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6100-90) ",
      "NDC11Code": "00310-6100-90",
      "ProductNDC": "0310-6100",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Onglyza",
      "NonProprietaryName": "Saxagliptin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141120",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022350",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "SAXAGLIPTIN HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20150106",
      "SamplePackage": "N",
      "Description": "Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: iron oxides, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
    },
    {
      "NDCCode": "0310-6100-95",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (0310-6100-95)  / 7 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "00310-6100-95",
      "ProductNDC": "0310-6100",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Onglyza",
      "NonProprietaryName": "Saxagliptin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141120",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022350",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "SAXAGLIPTIN HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-02-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20150811",
      "SamplePackage": "N",
      "Description": "Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides."
    },
    {
      "NDCCode": "0310-6105-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6105-30) ",
      "NDC11Code": "00310-6105-30",
      "ProductNDC": "0310-6105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Onglyza",
      "NonProprietaryName": "Saxagliptin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141120",
      "EndMarketingDate": "20260331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022350",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "SAXAGLIPTIN HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20141218",
      "EndMarketingDatePackage": "20260331",
      "SamplePackage": "N",
      "Description": "Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: iron oxides, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
    },
    {
      "NDCCode": "0310-6105-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6105-90) ",
      "NDC11Code": "00310-6105-90",
      "ProductNDC": "0310-6105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Onglyza",
      "NonProprietaryName": "Saxagliptin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141120",
      "EndMarketingDate": "20260331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022350",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "SAXAGLIPTIN HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20141219",
      "EndMarketingDatePackage": "20260331",
      "SamplePackage": "N",
      "Description": "Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: iron oxides, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
    },
    {
      "NDCCode": "0310-6105-95",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (0310-6105-95)  / 7 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "00310-6105-95",
      "ProductNDC": "0310-6105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Onglyza",
      "NonProprietaryName": "Saxagliptin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141120",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022350",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "SAXAGLIPTIN HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-02-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20150815",
      "SamplePackage": "N",
      "Description": "Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides."
    },
    {
      "NDCCode": "0310-6770-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0310-6770-30) ",
      "NDC11Code": "00310-6770-30",
      "ProductNDC": "0310-6770",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Qtern",
      "NonProprietaryName": "Dapagliflozin And Saxagliptin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171204",
      "EndMarketingDate": "20260228",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209091",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE",
      "StrengthNumber": "5; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190617",
      "EndMarketingDatePackage": "20260228",
      "SamplePackage": "N",
      "IndicationAndUsage": "QTERN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. QTERN is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see WARNINGS AND PRECAUTIONS (5.1)].",
      "Description": "QTERN tablets for oral use contain dapagliflozin and saxagliptin. Dapagliflozin propanediol is an active inhibitor of sodium‑glucose cotransporter 2 (SGLT2). It is described chemically as D‑glucitol, 1,5‑anhydro‑1‑C‑[4‑chloro‑3‑[(4‑ethoxyphenyl)methyl]phenyl]‑, (1S)‑. Dapagliflozin is compounded with (2S)‑1,2‑propanediol, hydrate (1:1:1) with an empirical formula as C21H25ClO6C3H8O2H2O and the molecular weight of 502.98. The structural formula is. Saxagliptin is an active inhibitor of the dipeptidyl‑peptidase‑4 (DPP‑4) enzyme. It is isolated in the monohydrate form chemically known as (1S,3S,5S)‑2‑[(2S)‑2‑amino‑2‑(3‑hydroxytricyclo [3.3.1.1] dec‑1‑yl)acetyl]‑2‑azabicyclo[3.1.0]hexane‑3‑carbonitrile, monohydrate or (1S,3S,5S)‑2‑[(2S)‑2‑amino‑2‑(3‑hydroxy‑1‑adamantan‑1‑yl)acetyl]‑2‑azabicyclo[3.1.0]hexane‑3‑carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. QTERN is available as film-coated tablets of two strengths: 1 5 mg dapagliflozin/5 mg saxagliptin. Each tablet contains 5 mg dapagliflozin (equivalent to 6.15 mg dapagliflozin propanediol) and 5 mg saxagliptin (exists in the form of HCl salt). , 2 10 mg dapagliflozin/5 mg saxagliptin. Each tablet contains 10 mg dapagliflozin (equivalent to 12.3 mg dapagliflozin propanediol) and 5 mg saxagliptin (exists in the form of HCl salt)."
    },
    {
      "NDCCode": "0310-6780-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0310-6780-30) ",
      "NDC11Code": "00310-6780-30",
      "ProductNDC": "0310-6780",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Qtern",
      "NonProprietaryName": "Dapagliflozin And Saxagliptin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171204",
      "EndMarketingDate": "20251231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209091",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE",
      "StrengthNumber": "10; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20171204",
      "EndMarketingDatePackage": "20251231",
      "SamplePackage": "N",
      "IndicationAndUsage": "QTERN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. QTERN is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see WARNINGS AND PRECAUTIONS (5.1)].",
      "Description": "QTERN tablets for oral use contain dapagliflozin and saxagliptin. Dapagliflozin propanediol is an active inhibitor of sodium‑glucose cotransporter 2 (SGLT2). It is described chemically as D‑glucitol, 1,5‑anhydro‑1‑C‑[4‑chloro‑3‑[(4‑ethoxyphenyl)methyl]phenyl]‑, (1S)‑. Dapagliflozin is compounded with (2S)‑1,2‑propanediol, hydrate (1:1:1) with an empirical formula as C21H25ClO6C3H8O2H2O and the molecular weight of 502.98. The structural formula is. Saxagliptin is an active inhibitor of the dipeptidyl‑peptidase‑4 (DPP‑4) enzyme. It is isolated in the monohydrate form chemically known as (1S,3S,5S)‑2‑[(2S)‑2‑amino‑2‑(3‑hydroxytricyclo [3.3.1.1] dec‑1‑yl)acetyl]‑2‑azabicyclo[3.1.0]hexane‑3‑carbonitrile, monohydrate or (1S,3S,5S)‑2‑[(2S)‑2‑amino‑2‑(3‑hydroxy‑1‑adamantan‑1‑yl)acetyl]‑2‑azabicyclo[3.1.0]hexane‑3‑carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. QTERN is available as film-coated tablets of two strengths: 1 5 mg dapagliflozin/5 mg saxagliptin. Each tablet contains 5 mg dapagliflozin (equivalent to 6.15 mg dapagliflozin propanediol) and 5 mg saxagliptin (exists in the form of HCl salt). , 2 10 mg dapagliflozin/5 mg saxagliptin. Each tablet contains 10 mg dapagliflozin (equivalent to 12.3 mg dapagliflozin propanediol) and 5 mg saxagliptin (exists in the form of HCl salt)."
    },
    {
      "NDCCode": "43598-618-60",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-618-60) ",
      "NDC11Code": "43598-0618-60",
      "ProductNDC": "43598-618",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Saxagliptin And Metformin Hydrochloride",
      "NonProprietaryName": "Saxagliptin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230809",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207678",
      "LabelerName": "Dr.Reddys Laboratories Inc",
      "SubstanceName": "SAXAGLIPTIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "2.5; 1000",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230809",
      "SamplePackage": "N",
      "IndicationAndUsage": "Saxagliptin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)].",
      "Description": "Saxagliptin and metformin hydrochloride extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes mellitus: saxagliptin and metformin HCl. Saxagliptin. Saxagliptin is an orally active inhibitor of the dipeptidyl-peptidase-4 (DPP4) enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile monohydrate. The molecular formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic powder. It is very soluble at room temperate in methanol, freely soluble in ethanol, soluble in acetone, sparingly soluble in ethyl acetate and water, and slightly soluble in 1-octanol. Metformin Hydrochloride, USP. Metformin HCl (N,N-dimethyl imido-dicarbonimidic diamide HCl) is a white crystalline powder with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and practically insoluble in acetone and in methylene chloride. The pKa of metformin HCl is 8.6. The structural formula is. Saxagliptin and Metformin Hydrochloride Extended-release Tablets. Saxagliptin and metformin hydrochloride extended-release tablets are available for oral administration as tablets containing either 5.58 mg saxagliptin HCl (anhydrous) equivalent to 5 mg saxagliptin and 500 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 5 mg/500 mg), or 5.58 mg saxagliptin HCl (anhydrous) equivalent to 5 mg saxagliptin and 1,000 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 5 mg/1,000 mg), or 2.79 saxagliptin HCl (anhydrous) equivalent to 2.5 mg saxagliptin and 1,000 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 2.5 mg/1,000 mg). Each film-coated tablet of saxagliptin and metformin hydrochloride extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, hydrochloric acid, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac, talc, titanium dioxide. In addition, 5 mg/500 mg tablets contain iron oxide red and iron oxide yellow; 5 mg/1,000 mg tablets contain iron oxide red; 2.5 mg/1,000 mg tablets contain iron oxide yellow. The biologically inert components of the tablet may occasionally remain intact during gastrointestinal transit and will be eliminated in the feces as a soft, hydrated mass."
    },
    {
      "NDCCode": "43598-619-30",
      "PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-619-30) ",
      "NDC11Code": "43598-0619-30",
      "ProductNDC": "43598-619",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Saxagliptin And Metformin Hydrochloride",
      "NonProprietaryName": "Saxagliptin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230809",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207678",
      "LabelerName": "Dr.Reddys Laboratories Inc",
      "SubstanceName": "SAXAGLIPTIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "5; 1000",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230809",
      "SamplePackage": "N",
      "IndicationAndUsage": "Saxagliptin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)].",
      "Description": "Saxagliptin and metformin hydrochloride extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes mellitus: saxagliptin and metformin HCl. Saxagliptin. Saxagliptin is an orally active inhibitor of the dipeptidyl-peptidase-4 (DPP4) enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile monohydrate. The molecular formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic powder. It is very soluble at room temperate in methanol, freely soluble in ethanol, soluble in acetone, sparingly soluble in ethyl acetate and water, and slightly soluble in 1-octanol. Metformin Hydrochloride, USP. Metformin HCl (N,N-dimethyl imido-dicarbonimidic diamide HCl) is a white crystalline powder with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and practically insoluble in acetone and in methylene chloride. The pKa of metformin HCl is 8.6. The structural formula is. Saxagliptin and Metformin Hydrochloride Extended-release Tablets. Saxagliptin and metformin hydrochloride extended-release tablets are available for oral administration as tablets containing either 5.58 mg saxagliptin HCl (anhydrous) equivalent to 5 mg saxagliptin and 500 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 5 mg/500 mg), or 5.58 mg saxagliptin HCl (anhydrous) equivalent to 5 mg saxagliptin and 1,000 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 5 mg/1,000 mg), or 2.79 saxagliptin HCl (anhydrous) equivalent to 2.5 mg saxagliptin and 1,000 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 2.5 mg/1,000 mg). Each film-coated tablet of saxagliptin and metformin hydrochloride extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, hydrochloric acid, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac, talc, titanium dioxide. In addition, 5 mg/500 mg tablets contain iron oxide red and iron oxide yellow; 5 mg/1,000 mg tablets contain iron oxide red; 2.5 mg/1,000 mg tablets contain iron oxide yellow. The biologically inert components of the tablet may occasionally remain intact during gastrointestinal transit and will be eliminated in the feces as a soft, hydrated mass."
    },
    {
      "NDCCode": "43598-620-30",
      "PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-620-30) ",
      "NDC11Code": "43598-0620-30",
      "ProductNDC": "43598-620",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Saxagliptin And Metformin Hydrochloride",
      "NonProprietaryName": "Saxagliptin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230809",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207678",
      "LabelerName": "Dr.Reddys Laboratories Inc",
      "SubstanceName": "SAXAGLIPTIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "5; 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": "2026-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230809",
      "SamplePackage": "N",
      "IndicationAndUsage": "Saxagliptin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)].",
      "Description": "Saxagliptin and metformin hydrochloride extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes mellitus: saxagliptin and metformin HCl. Saxagliptin. Saxagliptin is an orally active inhibitor of the dipeptidyl-peptidase-4 (DPP4) enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile monohydrate. The molecular formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic powder. It is very soluble at room temperate in methanol, freely soluble in ethanol, soluble in acetone, sparingly soluble in ethyl acetate and water, and slightly soluble in 1-octanol. Metformin Hydrochloride, USP. Metformin HCl (N,N-dimethyl imido-dicarbonimidic diamide HCl) is a white crystalline powder with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and practically insoluble in acetone and in methylene chloride. The pKa of metformin HCl is 8.6. The structural formula is. Saxagliptin and Metformin Hydrochloride Extended-release Tablets. Saxagliptin and metformin hydrochloride extended-release tablets are available for oral administration as tablets containing either 5.58 mg saxagliptin HCl (anhydrous) equivalent to 5 mg saxagliptin and 500 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 5 mg/500 mg), or 5.58 mg saxagliptin HCl (anhydrous) equivalent to 5 mg saxagliptin and 1,000 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 5 mg/1,000 mg), or 2.79 saxagliptin HCl (anhydrous) equivalent to 2.5 mg saxagliptin and 1,000 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 2.5 mg/1,000 mg). Each film-coated tablet of saxagliptin and metformin hydrochloride extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, hydrochloric acid, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac, talc, titanium dioxide. In addition, 5 mg/500 mg tablets contain iron oxide red and iron oxide yellow; 5 mg/1,000 mg tablets contain iron oxide red; 2.5 mg/1,000 mg tablets contain iron oxide yellow. The biologically inert components of the tablet may occasionally remain intact during gastrointestinal transit and will be eliminated in the feces as a soft, hydrated mass."
    },
    {
      "NDCCode": "54868-6309-0",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-6309-0)",
      "NDC11Code": "54868-6309-00",
      "ProductNDC": "54868-6309",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Onglyza",
      "NonProprietaryName": "Saxagliptin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110922",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022350",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "SAXAGLIPTIN HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "ONGLYZA is a dipeptidyl peptidase-4 (DPP4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1.1, 14). Important limitations of use: : 1 Should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. (1.2), 2 Has not been studied in patients with a history of pancreatitis. (1.2, 5.1).",
      "Description": "Saxagliptin is an orally-active inhibitor of the DPP4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides."
    },
    {
      "NDCCode": "55154-6931-2",
      "PackageDescription": "1080 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-6931-2) ",
      "NDC11Code": "55154-6931-02",
      "ProductNDC": "55154-6931",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Onglyza",
      "NonProprietaryName": "Saxagliptin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141120",
      "EndMarketingDate": "20250731",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022350",
      "LabelerName": "Cardinal Health 107, LLC",
      "SubstanceName": "SAXAGLIPTIN HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20141120",
      "EndMarketingDatePackage": "20250731",
      "SamplePackage": "N",
      "Description": "Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides."
    }
  ]
}

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    <ProductNDC>46122-333</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gnp Isopropyl Alcohol 50 Percent With Wintergreen Oil</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
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    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
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    <LastUpdate>2022-08-02</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>First aid to help prevent the risk of infection in. : 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
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    <PackageDescription>4 VIAL, GLASS in 1 BOX (62327-333-43)  / 10 mL in 1 VIAL, GLASS (62327-333-03) </PackageDescription>
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    <Description>STERITALC (talc) is a sclerosing agent for intrapleural administration. The molecular formula for talc is Mg3Si4O10(OH)2. The molecular weight is 379.3 g/mole. The chemical name of talc is hydrated magnesium silicate. The talc powder contains ≥ 95% of hydrated magnesium silicate; associated minerals include chlorites (hydrated aluminum and magnesium silicates), magnesite (magnesium carbonate), calcite (calcium carbonate), and dolomite (calcium and magnesium carbonate). The talc elementary sheet is composed of a layer of magnesium-oxygen/hydroxyl octahedra, sandwiched between two layers of silicon-oxygen tetrahedra. Talc is insoluble in water. STERITALC is tested for asbestos and asbestiform fibers consistent with USP standards for talc-containing products. STERITALC is supplied as 2 grams, 3 grams, and 4 grams white or off-white to light gray, sterile powder. STERITALC contains particle size-controlled talc, graded to decrease the proportion of smaller particles.</Description>
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    <NDC11Code>46122-0280-43</NDC11Code>
    <ProductNDC>46122-280</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Witch Hazel</ProprietaryName>
    <NonProprietaryName>Witch Hazel</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140930</StartMarketingDate>
    <EndMarketingDate>20221231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>AmerisourceBergen (Good Neighbor Pharmacy) 46122</LabelerName>
    <SubstanceName>WITCH HAZEL</SubstanceName>
    <StrengthNumber>842</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140930</StartMarketingDatePackage>
    <EndMarketingDatePackage>20221231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>46122-328-43</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (46122-328-43)</PackageDescription>
    <NDC11Code>46122-0328-43</NDC11Code>
    <ProductNDC>46122-328</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gnp Isopropyl Alcohol 50 Percent</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Amerisource Bergen</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-02</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>First aid to help prevent the risk of infection in. : 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>46122-329-43</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (46122-329-43) </PackageDescription>
    <NDC11Code>46122-0329-43</NDC11Code>
    <ProductNDC>46122-329</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gnp Ethyl Rubbing Alcohol 70 Percent</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Amerisource Bergen</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>700</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>First aid to help prevent the risk of infection in. : 1 minor cuts , 2 scrapes , 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>46122-330-43</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (46122-330-43) </PackageDescription>
    <NDC11Code>46122-0330-43</NDC11Code>
    <ProductNDC>46122-330</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gnp Isopropyl Rubbing Alcohol 70 Percent</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160101</StartMarketingDate>
    <EndMarketingDate>20280331</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Amerisource Bergen</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>700</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20160101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20280331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>First aid to help prevent the risk of infection in. : 1 minor cuts , 2 scrapes , 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>46122-331-43</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (46122-331-43) </PackageDescription>
    <NDC11Code>46122-0331-43</NDC11Code>
    <ProductNDC>46122-331</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gnp Isopropyl Alcohol 70 Percent With Wintergreen Oil</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160101</StartMarketingDate>
    <EndMarketingDate>20280301</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Amerisource Bergen</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>700</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20160101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20280301</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>First aid to help prevent the risk of infection in. : 1 minor cuts , 2 scrapes , 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>46122-332-43</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (46122-332-43) </PackageDescription>
    <NDC11Code>46122-0332-43</NDC11Code>
    <ProductNDC>46122-332</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gnp Isopropyl Alcohol 91 Percent</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Amerisource Bergen</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>910</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>First aid to help prevent the risk of infection in. : 1 minor cuts , 2 scrapes , 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>46122-334-43</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (46122-334-43) </PackageDescription>
    <NDC11Code>46122-0334-43</NDC11Code>
    <ProductNDC>46122-334</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gnp Hydrogen Peroxide 3 Percent</ProprietaryName>
    <NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Amerisource Bergen</LabelerName>
    <SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>As an antiseptic to help prevent infection in minor cuts, scrapes, burns. As an oral rinse for temporary use in cleaning of minor wounds or irritation/inflammation to the mouth and gums resulting from minor dental procedures, orthodontic appliances or accidental injury.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>46122-335-43</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (46122-335-43) </PackageDescription>
    <NDC11Code>46122-0335-43</NDC11Code>
    <ProductNDC>46122-335</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gnp Witch Hazel</ProprietaryName>
    <NonProprietaryName>Witch Hazel</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Amerisource Bergen</LabelerName>
    <SubstanceName>WITCH HAZEL</SubstanceName>
    <StrengthNumber>855</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For relief of minor skin Irritations due to. minor cuts. minor scraps. insect bites.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>46122-399-43</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE, PLASTIC (46122-399-43) </PackageDescription>
    <NDC11Code>46122-0399-43</NDC11Code>
    <ProductNDC>46122-399</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Stool Softener Liquid</ProprietaryName>
    <NonProprietaryName>Docusate Sodium</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170901</StartMarketingDate>
    <EndMarketingDate>20200831</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>AMERISOURCEBERGEN DRUG CORPORATION</LabelerName>
    <SubstanceName>DOCUSATE SODIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170901</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>46122-400-43</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE, PLASTIC (46122-400-43) </PackageDescription>
    <NDC11Code>46122-0400-43</NDC11Code>
    <ProductNDC>46122-400</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Stool Softener Syrup</ProprietaryName>
    <NonProprietaryName>Docusate Sodium</NonProprietaryName>
    <DosageFormName>SYRUP</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170901</StartMarketingDate>
    <EndMarketingDate>20200930</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>AMERISOURCEBERGEN DRUG CORPORATION</LabelerName>
    <SubstanceName>DOCUSATE SODIUM</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/15mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170901</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>46122-461-43</NDCCode>
    <PackageDescription>454 g in 1 POUCH (46122-461-43) </PackageDescription>
    <NDC11Code>46122-0461-43</NDC11Code>
    <ProductNDC>46122-461</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Epsom Salt</ProprietaryName>
    <NonProprietaryName>Epsom Salt</NonProprietaryName>
    <DosageFormName>GRANULE</DosageFormName>
    <RouteName>ORAL; TOPICAL</RouteName>
    <StartMarketingDate>20180430</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>AmerisourceBergen (Good Neighbor Pharmacy) 46122</LabelerName>
    <SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180530</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves occasional constipation (irregularity). generally produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0310-6100-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6100-30) </PackageDescription>
    <NDC11Code>00310-6100-30</NDC11Code>
    <ProductNDC>0310-6100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Onglyza</ProprietaryName>
    <NonProprietaryName>Saxagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141120</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022350</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
    <SubstanceName>SAXAGLIPTIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: iron oxides, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0310-6100-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6100-90) </PackageDescription>
    <NDC11Code>00310-6100-90</NDC11Code>
    <ProductNDC>0310-6100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Onglyza</ProprietaryName>
    <NonProprietaryName>Saxagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141120</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022350</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
    <SubstanceName>SAXAGLIPTIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150106</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: iron oxides, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0310-6100-95</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (0310-6100-95)  / 7 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00310-6100-95</NDC11Code>
    <ProductNDC>0310-6100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Onglyza</ProprietaryName>
    <NonProprietaryName>Saxagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141120</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022350</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
    <SubstanceName>SAXAGLIPTIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150811</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides.</Description>
  </NDC>
  <NDC>
    <NDCCode>0310-6105-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6105-30) </PackageDescription>
    <NDC11Code>00310-6105-30</NDC11Code>
    <ProductNDC>0310-6105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Onglyza</ProprietaryName>
    <NonProprietaryName>Saxagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141120</StartMarketingDate>
    <EndMarketingDate>20260331</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022350</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
    <SubstanceName>SAXAGLIPTIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20141218</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: iron oxides, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0310-6105-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6105-90) </PackageDescription>
    <NDC11Code>00310-6105-90</NDC11Code>
    <ProductNDC>0310-6105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Onglyza</ProprietaryName>
    <NonProprietaryName>Saxagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141120</StartMarketingDate>
    <EndMarketingDate>20260331</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022350</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
    <SubstanceName>SAXAGLIPTIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20141219</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: iron oxides, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0310-6105-95</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (0310-6105-95)  / 7 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00310-6105-95</NDC11Code>
    <ProductNDC>0310-6105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Onglyza</ProprietaryName>
    <NonProprietaryName>Saxagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141120</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022350</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
    <SubstanceName>SAXAGLIPTIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides.</Description>
  </NDC>
  <NDC>
    <NDCCode>0310-6770-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0310-6770-30) </PackageDescription>
    <NDC11Code>00310-6770-30</NDC11Code>
    <ProductNDC>0310-6770</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Qtern</ProprietaryName>
    <NonProprietaryName>Dapagliflozin And Saxagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171204</StartMarketingDate>
    <EndMarketingDate>20260228</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209091</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190617</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>QTERN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. QTERN is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see WARNINGS AND PRECAUTIONS (5.1)].</IndicationAndUsage>
    <Description>QTERN tablets for oral use contain dapagliflozin and saxagliptin. Dapagliflozin propanediol is an active inhibitor of sodium‑glucose cotransporter 2 (SGLT2). It is described chemically as D‑glucitol, 1,5‑anhydro‑1‑C‑[4‑chloro‑3‑[(4‑ethoxyphenyl)methyl]phenyl]‑, (1S)‑. Dapagliflozin is compounded with (2S)‑1,2‑propanediol, hydrate (1:1:1) with an empirical formula as C21H25ClO6C3H8O2H2O and the molecular weight of 502.98. The structural formula is. Saxagliptin is an active inhibitor of the dipeptidyl‑peptidase‑4 (DPP‑4) enzyme. It is isolated in the monohydrate form chemically known as (1S,3S,5S)‑2‑[(2S)‑2‑amino‑2‑(3‑hydroxytricyclo [3.3.1.1] dec‑1‑yl)acetyl]‑2‑azabicyclo[3.1.0]hexane‑3‑carbonitrile, monohydrate or (1S,3S,5S)‑2‑[(2S)‑2‑amino‑2‑(3‑hydroxy‑1‑adamantan‑1‑yl)acetyl]‑2‑azabicyclo[3.1.0]hexane‑3‑carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. QTERN is available as film-coated tablets of two strengths: 1 5 mg dapagliflozin/5 mg saxagliptin. Each tablet contains 5 mg dapagliflozin (equivalent to 6.15 mg dapagliflozin propanediol) and 5 mg saxagliptin (exists in the form of HCl salt). , 2 10 mg dapagliflozin/5 mg saxagliptin. Each tablet contains 10 mg dapagliflozin (equivalent to 12.3 mg dapagliflozin propanediol) and 5 mg saxagliptin (exists in the form of HCl salt).</Description>
  </NDC>
  <NDC>
    <NDCCode>0310-6780-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0310-6780-30) </PackageDescription>
    <NDC11Code>00310-6780-30</NDC11Code>
    <ProductNDC>0310-6780</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Qtern</ProprietaryName>
    <NonProprietaryName>Dapagliflozin And Saxagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171204</StartMarketingDate>
    <EndMarketingDate>20251231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209091</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20171204</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>QTERN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. QTERN is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see WARNINGS AND PRECAUTIONS (5.1)].</IndicationAndUsage>
    <Description>QTERN tablets for oral use contain dapagliflozin and saxagliptin. Dapagliflozin propanediol is an active inhibitor of sodium‑glucose cotransporter 2 (SGLT2). It is described chemically as D‑glucitol, 1,5‑anhydro‑1‑C‑[4‑chloro‑3‑[(4‑ethoxyphenyl)methyl]phenyl]‑, (1S)‑. Dapagliflozin is compounded with (2S)‑1,2‑propanediol, hydrate (1:1:1) with an empirical formula as C21H25ClO6C3H8O2H2O and the molecular weight of 502.98. The structural formula is. Saxagliptin is an active inhibitor of the dipeptidyl‑peptidase‑4 (DPP‑4) enzyme. It is isolated in the monohydrate form chemically known as (1S,3S,5S)‑2‑[(2S)‑2‑amino‑2‑(3‑hydroxytricyclo [3.3.1.1] dec‑1‑yl)acetyl]‑2‑azabicyclo[3.1.0]hexane‑3‑carbonitrile, monohydrate or (1S,3S,5S)‑2‑[(2S)‑2‑amino‑2‑(3‑hydroxy‑1‑adamantan‑1‑yl)acetyl]‑2‑azabicyclo[3.1.0]hexane‑3‑carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. QTERN is available as film-coated tablets of two strengths: 1 5 mg dapagliflozin/5 mg saxagliptin. Each tablet contains 5 mg dapagliflozin (equivalent to 6.15 mg dapagliflozin propanediol) and 5 mg saxagliptin (exists in the form of HCl salt). , 2 10 mg dapagliflozin/5 mg saxagliptin. Each tablet contains 10 mg dapagliflozin (equivalent to 12.3 mg dapagliflozin propanediol) and 5 mg saxagliptin (exists in the form of HCl salt).</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-618-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-618-60) </PackageDescription>
    <NDC11Code>43598-0618-60</NDC11Code>
    <ProductNDC>43598-618</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Saxagliptin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Saxagliptin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230809</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207678</ApplicationNumber>
    <LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
    <SubstanceName>SAXAGLIPTIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.5; 1000</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>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230809</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Saxagliptin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Saxagliptin and metformin hydrochloride extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes mellitus: saxagliptin and metformin HCl. Saxagliptin. Saxagliptin is an orally active inhibitor of the dipeptidyl-peptidase-4 (DPP4) enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile monohydrate. The molecular formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic powder. It is very soluble at room temperate in methanol, freely soluble in ethanol, soluble in acetone, sparingly soluble in ethyl acetate and water, and slightly soluble in 1-octanol. Metformin Hydrochloride, USP. Metformin HCl (N,N-dimethyl imido-dicarbonimidic diamide HCl) is a white crystalline powder with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and practically insoluble in acetone and in methylene chloride. The pKa of metformin HCl is 8.6. The structural formula is. Saxagliptin and Metformin Hydrochloride Extended-release Tablets. Saxagliptin and metformin hydrochloride extended-release tablets are available for oral administration as tablets containing either 5.58 mg saxagliptin HCl (anhydrous) equivalent to 5 mg saxagliptin and 500 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 5 mg/500 mg), or 5.58 mg saxagliptin HCl (anhydrous) equivalent to 5 mg saxagliptin and 1,000 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 5 mg/1,000 mg), or 2.79 saxagliptin HCl (anhydrous) equivalent to 2.5 mg saxagliptin and 1,000 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 2.5 mg/1,000 mg). Each film-coated tablet of saxagliptin and metformin hydrochloride extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, hydrochloric acid, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac, talc, titanium dioxide. In addition, 5 mg/500 mg tablets contain iron oxide red and iron oxide yellow; 5 mg/1,000 mg tablets contain iron oxide red; 2.5 mg/1,000 mg tablets contain iron oxide yellow. The biologically inert components of the tablet may occasionally remain intact during gastrointestinal transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-619-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-619-30) </PackageDescription>
    <NDC11Code>43598-0619-30</NDC11Code>
    <ProductNDC>43598-619</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Saxagliptin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Saxagliptin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230809</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207678</ApplicationNumber>
    <LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
    <SubstanceName>SAXAGLIPTIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5; 1000</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>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230809</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Saxagliptin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Saxagliptin and metformin hydrochloride extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes mellitus: saxagliptin and metformin HCl. Saxagliptin. Saxagliptin is an orally active inhibitor of the dipeptidyl-peptidase-4 (DPP4) enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile monohydrate. The molecular formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic powder. It is very soluble at room temperate in methanol, freely soluble in ethanol, soluble in acetone, sparingly soluble in ethyl acetate and water, and slightly soluble in 1-octanol. Metformin Hydrochloride, USP. Metformin HCl (N,N-dimethyl imido-dicarbonimidic diamide HCl) is a white crystalline powder with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and practically insoluble in acetone and in methylene chloride. The pKa of metformin HCl is 8.6. The structural formula is. Saxagliptin and Metformin Hydrochloride Extended-release Tablets. Saxagliptin and metformin hydrochloride extended-release tablets are available for oral administration as tablets containing either 5.58 mg saxagliptin HCl (anhydrous) equivalent to 5 mg saxagliptin and 500 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 5 mg/500 mg), or 5.58 mg saxagliptin HCl (anhydrous) equivalent to 5 mg saxagliptin and 1,000 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 5 mg/1,000 mg), or 2.79 saxagliptin HCl (anhydrous) equivalent to 2.5 mg saxagliptin and 1,000 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 2.5 mg/1,000 mg). Each film-coated tablet of saxagliptin and metformin hydrochloride extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, hydrochloric acid, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac, talc, titanium dioxide. In addition, 5 mg/500 mg tablets contain iron oxide red and iron oxide yellow; 5 mg/1,000 mg tablets contain iron oxide red; 2.5 mg/1,000 mg tablets contain iron oxide yellow. The biologically inert components of the tablet may occasionally remain intact during gastrointestinal transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-620-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-620-30) </PackageDescription>
    <NDC11Code>43598-0620-30</NDC11Code>
    <ProductNDC>43598-620</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Saxagliptin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Saxagliptin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230809</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207678</ApplicationNumber>
    <LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
    <SubstanceName>SAXAGLIPTIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5; 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>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230809</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Saxagliptin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Saxagliptin and metformin hydrochloride extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes mellitus: saxagliptin and metformin HCl. Saxagliptin. Saxagliptin is an orally active inhibitor of the dipeptidyl-peptidase-4 (DPP4) enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile monohydrate. The molecular formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic powder. It is very soluble at room temperate in methanol, freely soluble in ethanol, soluble in acetone, sparingly soluble in ethyl acetate and water, and slightly soluble in 1-octanol. Metformin Hydrochloride, USP. Metformin HCl (N,N-dimethyl imido-dicarbonimidic diamide HCl) is a white crystalline powder with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and practically insoluble in acetone and in methylene chloride. The pKa of metformin HCl is 8.6. The structural formula is. Saxagliptin and Metformin Hydrochloride Extended-release Tablets. Saxagliptin and metformin hydrochloride extended-release tablets are available for oral administration as tablets containing either 5.58 mg saxagliptin HCl (anhydrous) equivalent to 5 mg saxagliptin and 500 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 5 mg/500 mg), or 5.58 mg saxagliptin HCl (anhydrous) equivalent to 5 mg saxagliptin and 1,000 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 5 mg/1,000 mg), or 2.79 saxagliptin HCl (anhydrous) equivalent to 2.5 mg saxagliptin and 1,000 mg metformin HCl, USP (saxagliptin and metformin hydrochloride extended-release tablets 2.5 mg/1,000 mg). Each film-coated tablet of saxagliptin and metformin hydrochloride extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, hydrochloric acid, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac, talc, titanium dioxide. In addition, 5 mg/500 mg tablets contain iron oxide red and iron oxide yellow; 5 mg/1,000 mg tablets contain iron oxide red; 2.5 mg/1,000 mg tablets contain iron oxide yellow. The biologically inert components of the tablet may occasionally remain intact during gastrointestinal transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-6309-0</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-6309-0)</PackageDescription>
    <NDC11Code>54868-6309-00</NDC11Code>
    <ProductNDC>54868-6309</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Onglyza</ProprietaryName>
    <NonProprietaryName>Saxagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110922</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022350</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>SAXAGLIPTIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>ONGLYZA is a dipeptidyl peptidase-4 (DPP4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1.1, 14). Important limitations of use: : 1 Should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. (1.2), 2 Has not been studied in patients with a history of pancreatitis. (1.2, 5.1).</IndicationAndUsage>
    <Description>Saxagliptin is an orally-active inhibitor of the DPP4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides.</Description>
  </NDC>
  <NDC>
    <NDCCode>55154-6931-2</NDCCode>
    <PackageDescription>1080 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-6931-2) </PackageDescription>
    <NDC11Code>55154-6931-02</NDC11Code>
    <ProductNDC>55154-6931</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Onglyza</ProprietaryName>
    <NonProprietaryName>Saxagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141120</StartMarketingDate>
    <EndMarketingDate>20250731</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022350</ApplicationNumber>
    <LabelerName>Cardinal Health 107, LLC</LabelerName>
    <SubstanceName>SAXAGLIPTIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20141120</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides.</Description>
  </NDC>
</NDCList>

<NDCList><NDC><NDCCode>46122-333-43</NDCCode><ProprietaryName>Gnp Isopropyl Alcohol 50 Percent With Wintergreen Oil</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>62327-333-43</NDCCode><ProprietaryName>Steritalc</ProprietaryName><NonProprietaryName>Talc</NonProprietaryName></NDC><NDC><NDCCode>63742-333-01</NDCCode><ProprietaryName>Quick Numb</ProprietaryName><NonProprietaryName>Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>46122-059-43</NDCCode><ProprietaryName>Isopropyl Alcohol</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>46122-060-43</NDCCode><ProprietaryName>Isopropyl Alcohol</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>46122-137-43</NDCCode><ProprietaryName>Antiseptic Skin Cleanser</ProprietaryName><NonProprietaryName>Chlorhexidine Gluconate 4%</NonProprietaryName></NDC><NDC><NDCCode>46122-280-43</NDCCode><ProprietaryName>Witch Hazel</ProprietaryName><NonProprietaryName>Witch Hazel</NonProprietaryName></NDC><NDC><NDCCode>46122-328-43</NDCCode><ProprietaryName>Gnp Isopropyl Alcohol 50 Percent</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>46122-329-43</NDCCode><ProprietaryName>Gnp Ethyl Rubbing Alcohol 70 Percent</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>46122-330-43</NDCCode><ProprietaryName>Gnp Isopropyl Rubbing Alcohol 70 Percent</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>46122-331-43</NDCCode><ProprietaryName>Gnp Isopropyl Alcohol 70 Percent With Wintergreen Oil</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>46122-332-43</NDCCode><ProprietaryName>Gnp Isopropyl Alcohol 91 Percent</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>46122-334-43</NDCCode><ProprietaryName>Gnp Hydrogen Peroxide 3 Percent</ProprietaryName><NonProprietaryName>Hydrogen Peroxide</NonProprietaryName></NDC><NDC><NDCCode>46122-335-43</NDCCode><ProprietaryName>Gnp Witch Hazel</ProprietaryName><NonProprietaryName>Witch Hazel</NonProprietaryName></NDC><NDC><NDCCode>46122-399-43</NDCCode><ProprietaryName>Stool Softener Liquid</ProprietaryName><NonProprietaryName>Docusate Sodium</NonProprietaryName></NDC><NDC><NDCCode>46122-400-43</NDCCode><ProprietaryName>Stool Softener Syrup</ProprietaryName><NonProprietaryName>Docusate Sodium</NonProprietaryName></NDC><NDC><NDCCode>46122-461-43</NDCCode><ProprietaryName>Epsom Salt</ProprietaryName><NonProprietaryName>Epsom Salt</NonProprietaryName></NDC><NDC><NDCCode>0310-6100-30</NDCCode><ProprietaryName>Onglyza</ProprietaryName><NonProprietaryName>Saxagliptin</NonProprietaryName></NDC><NDC><NDCCode>0310-6100-90</NDCCode><ProprietaryName>Onglyza</ProprietaryName><NonProprietaryName>Saxagliptin</NonProprietaryName></NDC><NDC><NDCCode>0310-6100-95</NDCCode><ProprietaryName>Onglyza</ProprietaryName><NonProprietaryName>Saxagliptin</NonProprietaryName></NDC><NDC><NDCCode>0310-6105-30</NDCCode><ProprietaryName>Onglyza</ProprietaryName><NonProprietaryName>Saxagliptin</NonProprietaryName></NDC><NDC><NDCCode>0310-6105-90</NDCCode><ProprietaryName>Onglyza</ProprietaryName><NonProprietaryName>Saxagliptin</NonProprietaryName></NDC><NDC><NDCCode>0310-6105-95</NDCCode><ProprietaryName>Onglyza</ProprietaryName><NonProprietaryName>Saxagliptin</NonProprietaryName></NDC><NDC><NDCCode>0310-6770-30</NDCCode><ProprietaryName>Qtern</ProprietaryName><NonProprietaryName>Dapagliflozin And Saxagliptin</NonProprietaryName></NDC><NDC><NDCCode>0310-6780-30</NDCCode><ProprietaryName>Qtern</ProprietaryName><NonProprietaryName>Dapagliflozin And Saxagliptin</NonProprietaryName></NDC><NDC><NDCCode>43598-618-60</NDCCode><ProprietaryName>Saxagliptin And Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Saxagliptin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43598-619-30</NDCCode><ProprietaryName>Saxagliptin And Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Saxagliptin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43598-620-30</NDCCode><ProprietaryName>Saxagliptin And Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Saxagliptin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-6309-0</NDCCode><ProprietaryName>Onglyza</ProprietaryName><NonProprietaryName>Saxagliptin</NonProprietaryName></NDC><NDC><NDCCode>55154-6931-2</NDCCode><ProprietaryName>Onglyza</ProprietaryName><NonProprietaryName>Saxagliptin</NonProprietaryName></NDC></NDCList>

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
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      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...

Full Text Search Fundamentals

Facts

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

How does it work

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

Full Text Search & DataLabs REST API

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

RESTful Lookup — Test-Drive (2007 – 2026)

How to Find 46122-333-43 NDC Data Using DataLabs API

REST API URI Example

REST API Response Samples

Using REST to Invoke DataLabs API

Introduction

Working With DataLabs REST API

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

Plus there are three NPI-specific operations:

REST Search Examples

Operation: search

Operation: getcode

Operation: getcodes

Operation: check_status

Operation: search_and_keywords

Operation: validate

Operation: paginate_with_predicates

Operation: search_with_predicates

Operation: zipradius

Operation: npideactivated

Query Parameter Reference

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

Output

Full Text Search Fundamentals

Facts

How does it work

Full Text Search & DataLabs REST API

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

Output

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

Output

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

Output

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

Output