RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "54569-0517-2",
      "PackageDescription": "180 TABLET in 1 BOTTLE (54569-0517-2)",
      "NDC11Code": "54569-0517-02",
      "ProductNDC": "54569-0517",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydralazine Hydrochloride",
      "NonProprietaryName": "Hydralazine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040901",
      "LabelerName": "A-S Medication Solutions LLC",
      "SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-10",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "54569-0517-1",
      "PackageDescription": "60 TABLET in 1 BOTTLE (54569-0517-1)",
      "NDC11Code": "54569-0517-01",
      "ProductNDC": "54569-0517",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydralazine Hydrochloride",
      "NonProprietaryName": "Hydralazine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040901",
      "LabelerName": "A-S Medication Solutions LLC",
      "SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-10",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0517-0125-05",
      "PackageDescription": "5 AMPULE in 1 CARTON (0517-0125-05)  / 2 mL in 1 AMPULE (0517-0125-01) ",
      "NDC11Code": "00517-0125-05",
      "ProductNDC": "0517-0125",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Provayblue",
      "NonProprietaryName": "Methylene Blue",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200408",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204630",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "METHYLENE BLUE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200408",
      "SamplePackage": "N",
      "IndicationAndUsage": "PROVAYBLUE is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.",
      "Description": "Methylene blue is an oxidation-reduction agent. Its chemical name is 3,7-bis(dimethylamino)phenothiazin-5-ium, chloride hydrate. The molecular formula of methylene blue is C16H18ClN3S.xH2O and its molecular weight of 319.86 g/mol for the anhydrous form. The structural formula of methylene blue is. PROVAYBLUE (methylene blue) injection USP is a sterile solution intended for intravenous administration. Each mL of solution contains 5 mg methylene blue and water for injection. PROVAYBLUE (methylene blue) injection, USP: is a clear dark blue solution with a pH value between 3.0 and 4.5.  The osmolality is between 10 and 15 mOsm/kg. PROVAYBLUE (methylene blue) injection strength is expressed in terms of trihydrate."
    },
    {
      "NDCCode": "0517-0131-25",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0131-25)  > 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00517-0131-25",
      "ProductNDC": "0517-0131",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexpanthenol",
      "NonProprietaryName": "Dexpanthenol",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19930820",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "DEXPANTHENOL",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "0517-0234-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 BOX (0517-0234-10)  > 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00517-0234-10",
      "ProductNDC": "0517-0234",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexferrum",
      "NonProprietaryName": "Iron Dextran",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19960301",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA040024",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "IRON DEXTRAN",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-03-09",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "0517-0371-05",
      "PackageDescription": "5 VIAL, SINGLE-DOSE in 1 CARTON (0517-0371-05)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-0371-01) ",
      "NDC11Code": "00517-0371-05",
      "ProductNDC": "0517-0371",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Provayblue",
      "NonProprietaryName": "Methylene Blue",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200408",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204630",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "METHYLENE BLUE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211231",
      "SamplePackage": "N",
      "IndicationAndUsage": "PROVAYBLUE is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.",
      "Description": "Methylene blue is an oxidation-reduction agent. Its chemical name is 3,7-bis(dimethylamino)phenothiazin-5-ium, chloride hydrate. The molecular formula of methylene blue is C16H18ClN3S.xH2O and its molecular weight of 319.86 g/mol for the anhydrous form. The structural formula of methylene blue is. PROVAYBLUE (methylene blue) injection USP is a sterile solution intended for intravenous administration. Each mL of solution contains 5 mg methylene blue and water for injection. PROVAYBLUE (methylene blue) injection, USP: is a clear dark blue solution with a pH value between 3.0 and 4.5.  The osmolality is between 10 and 15 mOsm/kg. PROVAYBLUE (methylene blue) injection strength is expressed in terms of trihydrate."
    },
    {
      "NDCCode": "0517-0602-01",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01)  / 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00517-0602-01",
      "ProductNDC": "0517-0602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Injectafer",
      "NonProprietaryName": "Ferric Carboxymaltose Injection",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20220601",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA203565",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "FERRIC CARBOXYMALTOSE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220728",
      "SamplePackage": "N",
      "IndicationAndUsage": "Injectafer is indicated for the treatment of:.      iron deficiency anemia (IDA) in: 1 adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron., 2 adult patients who have non-dialysis dependent chronic kidney disease.",
      "Description": "Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III)-hydroxide 4(R)-(poly-(1→4)-O-α-D-glucopyranosyl)-oxy-2(R),3(R),5(R),6-tetrahydroxy-hexanoate. It has a relative molecular weight of approximately 150,000 Da corresponding to the following empirical formula. [FeOx(OH)y(H2O)z]n [{(C6H10O5)m (C6H12O7)}l]k. where n ≈ 103, m ≈ 8, l ≈ 11, and k ≈ 4 (l represents the mean branching degree of the ligand). The chemical structure is presented below. Injectafer (ferric carboxymaltose injection) is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. Each mL contains 50 mg iron as ferric carboxymaltose in water for injection. Injectafer is available in 2 mL, 10 mL, 15 mL and 20 mL single-dose vials.  Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH to 5.0-7.0. Vial closure is not made with natural rubber latex."
    },
    {
      "NDCCode": "0517-0650-02",
      "PackageDescription": "2 VIAL, SINGLE-DOSE in 1 BOX (0517-0650-02)  > 15 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00517-0650-02",
      "ProductNDC": "0517-0650",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Injectafer",
      "NonProprietaryName": "Ferric Carboxymaltose Injection",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20130812",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA203565",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "FERRIC CARBOXYMALTOSE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-05-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20171001",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0517-0770-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0517-0770-10)  > 2 mL in 1 VIAL, SINGLE-DOSE (0517-0770-01) ",
      "NDC11Code": "00517-0770-10",
      "ProductNDC": "0517-0770",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Torsemide",
      "NonProprietaryName": "Torsemide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20100521",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090656",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "TORSEMIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100521",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0517-0785-05",
      "PackageDescription": "5 VIAL, SINGLE-USE in 1 CARTON (0517-0785-05)  > 2 mL in 1 VIAL, SINGLE-USE (0517-0785-01)",
      "NDC11Code": "00517-0785-05",
      "ProductNDC": "0517-0785",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benztropine Mesylate",
      "NonProprietaryName": "Benztropine Mesylate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20110204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091152",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "BENZTROPINE MESYLATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0517-0830-01",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0517-0830-01)  > 2.5 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00517-0830-01",
      "ProductNDC": "0517-0830",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Latanoprost",
      "NonProprietaryName": "Latanoprost",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20110802",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200925",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "LATANOPROST",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Prostaglandin Analog [EPC],Prostaglandins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "0517-0830-03",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0517-0830-03)  > 2.5 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00517-0830-03",
      "ProductNDC": "0517-0830",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Latanoprost",
      "NonProprietaryName": "Latanoprost",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20110802",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200925",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "LATANOPROST",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Prostaglandin Analog [EPC],Prostaglandins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "0517-0902-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 BOX (0517-0902-10)  > 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00517-0902-10",
      "ProductNDC": "0517-0902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketorolac Tromethamine",
      "NonProprietaryName": "Ketorolac Tromethamine",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20080530",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078145",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "KETOROLAC TROMETHAMINE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "0517-0902-25",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0902-25)  > 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00517-0902-25",
      "ProductNDC": "0517-0902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketorolac Tromethamine",
      "NonProprietaryName": "Ketorolac Tromethamine",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20080530",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078145",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "KETOROLAC TROMETHAMINE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "0517-0955-01",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (0517-0955-01)  / 2 mL in 1 VIAL, GLASS",
      "NDC11Code": "00517-0955-01",
      "ProductNDC": "0517-0955",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine",
      "NonProprietaryName": "Olanzapine",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20120627",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201741",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "OLANZAPINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120627",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olanzapine for injection is an atypical antipsychotic indicated for the: 1 Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4), 2 Efficacy was established in three 1-day trials in adults. (14.3).",
      "Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine for injection is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients lactose monohydrate 50 mg and tartaric acid 3.5 mg. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH."
    },
    {
      "NDCCode": "0517-1980-05",
      "PackageDescription": "5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-05)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01) ",
      "NDC11Code": "00517-1980-05",
      "ProductNDC": "0517-1980",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dicyclomine Hydrochloride",
      "NonProprietaryName": "Dicyclomine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20170901",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208353",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-01-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170911",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dicyclomine hydrochloride injection is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
      "Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form: 1 Dicyclomine Hydrochloride Injection, USP is a sterile, pyrogen-free, aqueous solution for intramuscular injection (NOT FOR INTRAVENOUS USE) supplied as a vial containing 20 mg/2 mL (10 mg/mL). Each mL contains 10 mg dicyclomine hydrochloride USP in sterile water for injection, made isotonic with sodium chloride. Dicyclomine Hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C19H35NO2HCl and the following structural formula:."
    },
    {
      "NDCCode": "0517-1980-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-10)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01) ",
      "NDC11Code": "00517-1980-10",
      "ProductNDC": "0517-1980",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dicyclomine Hydrochloride",
      "NonProprietaryName": "Dicyclomine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20170901",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208353",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-01-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170911",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dicyclomine hydrochloride injection is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
      "Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form: 1 Dicyclomine Hydrochloride Injection, USP is a sterile, pyrogen-free, aqueous solution for intramuscular injection (NOT FOR INTRAVENOUS USE) supplied as a vial containing 20 mg/2 mL (10 mg/mL). Each mL contains 10 mg dicyclomine hydrochloride USP in sterile water for injection, made isotonic with sodium chloride. Dicyclomine Hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C19H35NO2HCl and the following structural formula:."
    },
    {
      "NDCCode": "0517-2325-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 BOX (0517-2325-10)  / 2.5 mL in 1 VIAL, SINGLE-DOSE (0517-2325-01) ",
      "NDC11Code": "00517-2325-10",
      "ProductNDC": "0517-2325",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Venofer",
      "NonProprietaryName": "Iron Sucrose",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20110127",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021135",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "IRON SUCROSE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-03-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20110127",
      "SamplePackage": "N",
      "IndicationAndUsage": "Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).",
      "Description": "Venofer (iron sucrose injection, USP), an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11). where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Venofer is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity.  Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L."
    },
    {
      "NDCCode": "0517-2502-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 BOX (0517-2502-10)  > 2 mL in 1 VIAL, SINGLE-DOSE (0517-2502-01) ",
      "NDC11Code": "00517-2502-10",
      "ProductNDC": "0517-2502",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Caffeine And Sodium Benzoate",
      "NonProprietaryName": "Caffeine And Sodium Benzoate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19930201",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "CAFFEINE",
      "StrengthNumber": "125",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
      "Status": "Active",
      "LastUpdate": "2022-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19930201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Caffeine and Sodium Benzoate Injection has been used in conjunction with supportive measure to treat respiratory depression associated with overdosage with CNS depressant drugs (e.g., narcotic analgesics, alcohol). However, because of questionable benefit and transient action, most authorities believe caffeine and other analeptics should not be used in these conditions and recommend other supportive therapy.",
      "Description": "Caffeine and Sodium Benzoate Injection, USP is a clear, sterile, nonpyrogenic, solution of Caffeine Alkaloid. Each mL contains: Caffeine (anhydrous) 125 mg; Sodium Benzoate (added to increase the solubility of Caffeine) 125 mg; Water for Injection, USP q.s. pH (range 6.5 to 8.5) adjusted with Hydrochloric Acid and/or Sodium Hydroxide. For intramuscular or slow intravenous administration only."
    },
    {
      "NDCCode": "0517-2602-25",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2602-25)  > 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00517-2602-25",
      "ProductNDC": "0517-2602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Magnesium Sulfate",
      "NonProprietaryName": "Magnesium Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19900930",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-25"
    },
    {
      "NDCCode": "0517-2901-01",
      "PackageDescription": "1 VIAL in 1 CARTON (0517-2901-01)  / .2 mL in 1 VIAL",
      "NDC11Code": "00517-2901-01",
      "ProductNDC": "0517-2901",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gvoke Vialdx",
      "NonProprietaryName": "Glucagon Injection",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250819",
      "EndMarketingDate": "20270930",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212097",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "GLUCAGON",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/.2mL",
      "Pharm_Classes": "Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20250819",
      "EndMarketingDatePackage": "20270930",
      "SamplePackage": "N",
      "IndicationAndUsage": "GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).",
      "Description": "Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent."
    },
    {
      "NDCCode": "0517-2901-10",
      "PackageDescription": "10 VIAL in 1 CARTON (0517-2901-10)  / .2 mL in 1 VIAL",
      "NDC11Code": "00517-2901-10",
      "ProductNDC": "0517-2901",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gvoke Vialdx",
      "NonProprietaryName": "Glucagon Injection",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250819",
      "EndMarketingDate": "20270930",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212097",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "GLUCAGON",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/.2mL",
      "Pharm_Classes": "Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20250819",
      "EndMarketingDatePackage": "20270930",
      "SamplePackage": "N",
      "IndicationAndUsage": "GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).",
      "Description": "Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent."
    },
    {
      "NDCCode": "0517-4002-25",
      "PackageDescription": "25 VIAL in 1 CARTON (0517-4002-25)  / 2 mL in 1 VIAL (0517-4002-01) ",
      "NDC11Code": "00517-4002-25",
      "ProductNDC": "0517-4002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Papaverine Hydrochloride",
      "NonProprietaryName": "Papaverine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19950901",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "PAPAVERINE HYDROCHLORIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-07-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19950901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Papaverine is recommended in various conditions accompanied by spasm of smooth muscle, such as vascular spasm associated with acute myocardial infarction (coronary occlusion), angina pectoris, peripheral and pulmonary embolism, peripheral vascular disease in which there is a vasospastic element, or certain cerebral angiospastic states; and visceral spasm, as in ureteral, biliary, or gastrointestinal colic.",
      "Description": "Papaverine Hydrochloride, USP, is the hydrochloride of an alkaloid obtained from opium or prepared synthetically. It belongs to the benzylisoquinoline group of alkaloids. It does not contain a phenanthrene group as do morphine and codeine. Papaverine Hydrochloride, USP, is 6,7-dimethoxy-1- veratrylisoquinoline hydrochloride and contains, on the dried basis, not less than 98.5% of C20H21NO4HCI. The molecular weight is 375.85. The structural formula is as shown. Papaverine Hydrochloride occurs as white crystals or white crystalline powder. One gram dissolves in about 30 mL of water and in 120 mL of alcohol. It is soluble in chloroform and practically insoluble in ether. Papaverine Hydrochloride Injection, USP, is a clear, colorless to pale-yellow solution. Papaverine Hydrochloride, for parenteral administration, is a smooth-muscle relaxant that is available in vials containing 30 mg/mL. Each vial also contains edetate disodium 0.005%. The 10 mL vials also contain chlorobutanol 0.5% as a preservative. pH may be adjusted with sodium citrate and/or citric acid."
    },
    {
      "NDCCode": "0517-4602-25",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4602-25)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-4602-01) ",
      "NDC11Code": "00517-4602-25",
      "ProductNDC": "0517-4602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glycopyrrolate",
      "NonProprietaryName": "Glycopyrrolate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19900930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089335",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "GLYCOPYRROLATE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19900930",
      "SamplePackage": "N",
      "IndicationAndUsage": "In Anesthesia: Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. In Peptic Ulcer:For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.",
      "Description": "Glycopyrrolate Injection, USP is a clear, colorless, sterile solution of Glycopyrrolate, USP with Benzyl Alcohol, NF in Water for Injection, USP. The formulation is used for intramuscular or intravenous administration. Each mL contains:Glycopyrrolate, USP…………………………..0.2 mgBenzyl Alcohol, NF (preservative)………….….0.9%Water for Injection, USP.................................... q.s. When necessary, pH (2.0 to 3.0) adjusted with hydrochloric acid and/or sodium hydroxide. Glycopyrrolate is a quaternary ammonium salt with the following chemical name. 3[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethyl pyrrolidinium bromide.  Glycopyrrolate is a synthetic anticholinergic agent that has the following molecular structure and molecular weight. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C)."
    },
    {
      "NDCCode": "0517-5602-25",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-5602-25)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-5602-01) ",
      "NDC11Code": "00517-5602-25",
      "ProductNDC": "0517-5602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydroxyzine Hydrochloride",
      "NonProprietaryName": "Hydroxyzine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19900930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA087408",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19900930",
      "SamplePackage": "N",
      "IndicationAndUsage": "The total management of anxiety, tension, and psychomotor agitation in conditions of emotional stress requires in most instances a combined approach of psychotherapy and chemotherapy. Hydroxyzine has been found to be particularly useful for this latter phase of therapy in its ability to render the disturbed patient more amenable to psychotherapy in long term treatment of the psychoneurotic and psychotic, although it should not be used as the sole treatment of psychosis or of clearly demonstrated cases of depression. Hydroxyzine is also useful in alleviating the manifestations of anxiety and tension as in the preparation for dental procedures and in acute emotional problems. It has also been recommended for the management of anxiety associated with organic disturbances and as adjunctive therapy in alcoholism and allergic conditions with strong emotional overlay, such as in asthma, chronic urticaria, and pruritus. Hydroxyzine hydrochloride intramuscular solution is useful in treating the following types of patients when intramuscular administration is indicated. 1. The acutely disturbed or hysterical patient. 2. The acute or chronic alcoholic with anxiety withdrawal symptoms or delirium tremens. 3. As pre-and postoperative and pre- and postpartum adjunctive medication to permit reduction in narcotic dosage, allay anxiety and control emesis. Hydroxyzine hydrochloride has also demonstrated effectiveness in controlling nausea and vomiting, excluding nausea and vomiting of pregnancy. (See CONTRAINDICATIONS). In prepartum states, the reduction in narcotic requirement effected by hydroxyzine is of particular benefit to both mother and neonate. Hydroxyzine benefits the cardiac patient by its ability to allay the associated anxiety and apprehension attendant to certain types of heart disease. Hydroxyzine is not known to interfere with the action of digitalis in any way and may be used concurrently with this agent. The effectiveness of hydroxyzine in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
      "Description": "Hydroxyzine hydrochloride has the chemical name of (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride and occurs as a white, odorless powder which is very soluble in water. It has the following structural formula. Hydroxyzine Hydrochloride Injection, USP is a sterile aqueous solution intended for intramuscular administration. Each mL contains: Hydroxyzine HCl 25 mg or 50 mg, Benzyl Alcohol 0.9%, and Water for Injection q.s.  pH adjusted with Sodium Hydroxide and/or Hydrochloric Acid."
    },
    {
      "NDCCode": "0517-5702-25",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-5702-25)  > 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00517-5702-25",
      "ProductNDC": "0517-5702",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Furosemide",
      "NonProprietaryName": "Furosemide",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19900930",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018579",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "FUROSEMIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-01-20"
    },
    {
      "NDCCode": "0517-6202-25",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-6202-25)  > 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00517-6202-25",
      "ProductNDC": "0517-6202",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Multitrace-4 Neonatal",
      "NonProprietaryName": "Trace Elements 4",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19900930",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; ZINC SULFATE HEPTAHYDRATE",
      "StrengthNumber": "4.36; .39; 77; 6.6",
      "StrengthUnit": "ug/mL; mg/mL; mg/mL; mg/mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "19900930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0517-6502-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 BOX (0517-6502-10)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-6502-01) ",
      "NDC11Code": "00517-6502-10",
      "ProductNDC": "0517-6502",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Selenious Acid",
      "NonProprietaryName": "Selenious Acid",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20220328",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209379",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "SELENIUM",
      "StrengthNumber": "6",
      "StrengthUnit": "ug/mL",
      "Status": "Active",
      "LastUpdate": "2024-01-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220328",
      "SamplePackage": "N",
      "IndicationAndUsage": "Selenious Acid Injection is indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
      "Description": "Selenious Acid Injection, USP is a sterile, non-pyrogenic, clear, colorless solution intended for use as a trace element and additive to intravenous solutions for parenteral nutrition. Each 600 mcg/10 mL Pharmacy Bulk Package vial contains 10 mL of selenious acid solution. Each 6 mcg/mL single-dose vial contains 2 mL of selenious acid solution. None of the presentations contain preservatives. Each mL of the 60 mcg/mL strength contains 60 mcg of selenium present as 98 mcg of selenious acid, nitric acid for pH adjustment (1.8 to 2.4), and water for injection q.s. Each mL of the 6 mcg/mL strength contains 6 mcg of selenium present as 9.8 mcg of selenious acid, nitric acid for pH adjustment (1.8 to 2.4), and water for injection q.s. Selenious Acid Injection 60 mcg/mL contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 16 mOsmol/L. Selenious Acid Injection 6 mcg/mL contains no more than 900 mcg/L of aluminum and has a calculated osmolarity of 13 mOsmol/L. Selenious acid has a molecular weight of 128.97 g/mol and a formula of H2SeO3.  The structural formula is."
    },
    {
      "NDCCode": "0517-6902-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 BOX (0517-6902-10)  > 2 mL in 1 VIAL, SINGLE-DOSE (0517-6902-01)",
      "NDC11Code": "00517-6902-10",
      "ProductNDC": "0517-6902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fosphenytoin Sodium",
      "NonProprietaryName": "Fosphenytoin Sodium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20100730",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090099",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "FOSPHENYTOIN SODIUM",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-08-29"
    },
    {
      "NDCCode": "0517-6902-25",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-6902-25)  > 2 mL in 1 VIAL, SINGLE-DOSE (0517-6902-01)",
      "NDC11Code": "00517-6902-25",
      "ProductNDC": "0517-6902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fosphenytoin Sodium",
      "NonProprietaryName": "Fosphenytoin Sodium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20100730",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090099",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "FOSPHENYTOIN SODIUM",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-08-29"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"54569-0517-2","ProprietaryName":"Hydralazine Hydrochloride","NonProprietaryName":"Hydralazine Hydrochloride"},{"NDCCode":"54569-0517-1","ProprietaryName":"Hydralazine Hydrochloride","NonProprietaryName":"Hydralazine Hydrochloride"},{"NDCCode":"0517-0125-05","ProprietaryName":"Provayblue","NonProprietaryName":"Methylene Blue"},{"NDCCode":"0517-0131-25","ProprietaryName":"Dexpanthenol","NonProprietaryName":"Dexpanthenol"},{"NDCCode":"0517-0234-10","ProprietaryName":"Dexferrum","NonProprietaryName":"Iron Dextran"},{"NDCCode":"0517-0371-05","ProprietaryName":"Provayblue","NonProprietaryName":"Methylene Blue"},{"NDCCode":"0517-0602-01","ProprietaryName":"Injectafer","NonProprietaryName":"Ferric Carboxymaltose Injection"},{"NDCCode":"0517-0650-02","ProprietaryName":"Injectafer","NonProprietaryName":"Ferric Carboxymaltose Injection"},{"NDCCode":"0517-0770-10","ProprietaryName":"Torsemide","NonProprietaryName":"Torsemide"},{"NDCCode":"0517-0785-05","ProprietaryName":"Benztropine Mesylate","NonProprietaryName":"Benztropine Mesylate"},{"NDCCode":"0517-0830-01","ProprietaryName":"Latanoprost","NonProprietaryName":"Latanoprost"},{"NDCCode":"0517-0830-03","ProprietaryName":"Latanoprost","NonProprietaryName":"Latanoprost"},{"NDCCode":"0517-0902-10","ProprietaryName":"Ketorolac Tromethamine","NonProprietaryName":"Ketorolac Tromethamine"},{"NDCCode":"0517-0902-25","ProprietaryName":"Ketorolac Tromethamine","NonProprietaryName":"Ketorolac Tromethamine"},{"NDCCode":"0517-0955-01","ProprietaryName":"Olanzapine","NonProprietaryName":"Olanzapine"},{"NDCCode":"0517-1980-05","ProprietaryName":"Dicyclomine Hydrochloride","NonProprietaryName":"Dicyclomine Hydrochloride"},{"NDCCode":"0517-1980-10","ProprietaryName":"Dicyclomine Hydrochloride","NonProprietaryName":"Dicyclomine Hydrochloride"},{"NDCCode":"0517-2325-10","ProprietaryName":"Venofer","NonProprietaryName":"Iron Sucrose"},{"NDCCode":"0517-2502-10","ProprietaryName":"Caffeine And Sodium Benzoate","NonProprietaryName":"Caffeine And Sodium Benzoate"},{"NDCCode":"0517-2602-25","ProprietaryName":"Magnesium Sulfate","NonProprietaryName":"Magnesium Sulfate"},{"NDCCode":"0517-2901-01","ProprietaryName":"Gvoke Vialdx","NonProprietaryName":"Glucagon Injection"},{"NDCCode":"0517-2901-10","ProprietaryName":"Gvoke Vialdx","NonProprietaryName":"Glucagon Injection"},{"NDCCode":"0517-4002-25","ProprietaryName":"Papaverine Hydrochloride","NonProprietaryName":"Papaverine Hydrochloride"},{"NDCCode":"0517-4602-25","ProprietaryName":"Glycopyrrolate","NonProprietaryName":"Glycopyrrolate"},{"NDCCode":"0517-5602-25","ProprietaryName":"Hydroxyzine Hydrochloride","NonProprietaryName":"Hydroxyzine Hydrochloride"},{"NDCCode":"0517-5702-25","ProprietaryName":"Furosemide","NonProprietaryName":"Furosemide"},{"NDCCode":"0517-6202-25","ProprietaryName":"Multitrace-4 Neonatal","NonProprietaryName":"Trace Elements 4"},{"NDCCode":"0517-6502-10","ProprietaryName":"Selenious Acid","NonProprietaryName":"Selenious Acid"},{"NDCCode":"0517-6902-10","ProprietaryName":"Fosphenytoin Sodium","NonProprietaryName":"Fosphenytoin Sodium"},{"NDCCode":"0517-6902-25","ProprietaryName":"Fosphenytoin Sodium","NonProprietaryName":"Fosphenytoin Sodium"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>54569-0517-2</NDCCode>
    <PackageDescription>180 TABLET in 1 BOTTLE (54569-0517-2)</PackageDescription>
    <NDC11Code>54569-0517-02</NDC11Code>
    <ProductNDC>54569-0517</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040901</ApplicationNumber>
    <LabelerName>A-S Medication Solutions LLC</LabelerName>
    <SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-10</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>54569-0517-1</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (54569-0517-1)</PackageDescription>
    <NDC11Code>54569-0517-01</NDC11Code>
    <ProductNDC>54569-0517</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040901</ApplicationNumber>
    <LabelerName>A-S Medication Solutions LLC</LabelerName>
    <SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-10</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0517-0125-05</NDCCode>
    <PackageDescription>5 AMPULE in 1 CARTON (0517-0125-05)  / 2 mL in 1 AMPULE (0517-0125-01) </PackageDescription>
    <NDC11Code>00517-0125-05</NDC11Code>
    <ProductNDC>0517-0125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Provayblue</ProprietaryName>
    <NonProprietaryName>Methylene Blue</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200408</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204630</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>METHYLENE BLUE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200408</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PROVAYBLUE is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.</IndicationAndUsage>
    <Description>Methylene blue is an oxidation-reduction agent. Its chemical name is 3,7-bis(dimethylamino)phenothiazin-5-ium, chloride hydrate. The molecular formula of methylene blue is C16H18ClN3S.xH2O and its molecular weight of 319.86 g/mol for the anhydrous form. The structural formula of methylene blue is. PROVAYBLUE (methylene blue) injection USP is a sterile solution intended for intravenous administration. Each mL of solution contains 5 mg methylene blue and water for injection. PROVAYBLUE (methylene blue) injection, USP: is a clear dark blue solution with a pH value between 3.0 and 4.5.  The osmolality is between 10 and 15 mOsm/kg. PROVAYBLUE (methylene blue) injection strength is expressed in terms of trihydrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-0131-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0131-25)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00517-0131-25</NDC11Code>
    <ProductNDC>0517-0131</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexpanthenol</ProprietaryName>
    <NonProprietaryName>Dexpanthenol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>19930820</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>DEXPANTHENOL</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0517-0234-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 BOX (0517-0234-10)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00517-0234-10</NDC11Code>
    <ProductNDC>0517-0234</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexferrum</ProprietaryName>
    <NonProprietaryName>Iron Dextran</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19960301</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA040024</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>IRON DEXTRAN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-03-09</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0517-0371-05</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 CARTON (0517-0371-05)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-0371-01) </PackageDescription>
    <NDC11Code>00517-0371-05</NDC11Code>
    <ProductNDC>0517-0371</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Provayblue</ProprietaryName>
    <NonProprietaryName>Methylene Blue</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200408</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204630</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>METHYLENE BLUE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PROVAYBLUE is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.</IndicationAndUsage>
    <Description>Methylene blue is an oxidation-reduction agent. Its chemical name is 3,7-bis(dimethylamino)phenothiazin-5-ium, chloride hydrate. The molecular formula of methylene blue is C16H18ClN3S.xH2O and its molecular weight of 319.86 g/mol for the anhydrous form. The structural formula of methylene blue is. PROVAYBLUE (methylene blue) injection USP is a sterile solution intended for intravenous administration. Each mL of solution contains 5 mg methylene blue and water for injection. PROVAYBLUE (methylene blue) injection, USP: is a clear dark blue solution with a pH value between 3.0 and 4.5.  The osmolality is between 10 and 15 mOsm/kg. PROVAYBLUE (methylene blue) injection strength is expressed in terms of trihydrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-0602-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01)  / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00517-0602-01</NDC11Code>
    <ProductNDC>0517-0602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Injectafer</ProprietaryName>
    <NonProprietaryName>Ferric Carboxymaltose Injection</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA203565</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>FERRIC CARBOXYMALTOSE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220728</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Injectafer is indicated for the treatment of:.      iron deficiency anemia (IDA) in: 1 adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron., 2 adult patients who have non-dialysis dependent chronic kidney disease.</IndicationAndUsage>
    <Description>Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III)-hydroxide 4(R)-(poly-(1→4)-O-α-D-glucopyranosyl)-oxy-2(R),3(R),5(R),6-tetrahydroxy-hexanoate. It has a relative molecular weight of approximately 150,000 Da corresponding to the following empirical formula. [FeOx(OH)y(H2O)z]n [{(C6H10O5)m (C6H12O7)}l]k. where n ≈ 103, m ≈ 8, l ≈ 11, and k ≈ 4 (l represents the mean branching degree of the ligand). The chemical structure is presented below. Injectafer (ferric carboxymaltose injection) is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. Each mL contains 50 mg iron as ferric carboxymaltose in water for injection. Injectafer is available in 2 mL, 10 mL, 15 mL and 20 mL single-dose vials.  Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH to 5.0-7.0. Vial closure is not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-0650-02</NDCCode>
    <PackageDescription>2 VIAL, SINGLE-DOSE in 1 BOX (0517-0650-02)  &gt; 15 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00517-0650-02</NDC11Code>
    <ProductNDC>0517-0650</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Injectafer</ProprietaryName>
    <NonProprietaryName>Ferric Carboxymaltose Injection</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20130812</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA203565</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>FERRIC CARBOXYMALTOSE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-05-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0517-0770-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0517-0770-10)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE (0517-0770-01) </PackageDescription>
    <NDC11Code>00517-0770-10</NDC11Code>
    <ProductNDC>0517-0770</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Torsemide</ProprietaryName>
    <NonProprietaryName>Torsemide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20100521</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090656</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>TORSEMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100521</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0517-0785-05</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-USE in 1 CARTON (0517-0785-05)  &gt; 2 mL in 1 VIAL, SINGLE-USE (0517-0785-01)</PackageDescription>
    <NDC11Code>00517-0785-05</NDC11Code>
    <ProductNDC>0517-0785</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benztropine Mesylate</ProprietaryName>
    <NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20110204</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091152</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0517-0830-01</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0517-0830-01)  &gt; 2.5 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>00517-0830-01</NDC11Code>
    <ProductNDC>0517-0830</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Latanoprost</ProprietaryName>
    <NonProprietaryName>Latanoprost</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20110802</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200925</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>LATANOPROST</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Prostaglandin Analog [EPC],Prostaglandins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0517-0830-03</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0517-0830-03)  &gt; 2.5 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>00517-0830-03</NDC11Code>
    <ProductNDC>0517-0830</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Latanoprost</ProprietaryName>
    <NonProprietaryName>Latanoprost</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20110802</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200925</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>LATANOPROST</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Prostaglandin Analog [EPC],Prostaglandins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0517-0902-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 BOX (0517-0902-10)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00517-0902-10</NDC11Code>
    <ProductNDC>0517-0902</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20080530</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078145</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0517-0902-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0902-25)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00517-0902-25</NDC11Code>
    <ProductNDC>0517-0902</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20080530</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078145</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0517-0955-01</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (0517-0955-01)  / 2 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>00517-0955-01</NDC11Code>
    <ProductNDC>0517-0955</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20120627</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201741</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120627</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine for injection is an atypical antipsychotic indicated for the: 1 Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4), 2 Efficacy was established in three 1-day trials in adults. (14.3).</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine for injection is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients lactose monohydrate 50 mg and tartaric acid 3.5 mg. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-1980-05</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-05)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01) </PackageDescription>
    <NDC11Code>00517-1980-05</NDC11Code>
    <ProductNDC>0517-1980</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20170901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208353</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170911</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dicyclomine hydrochloride injection is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
    <Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form: 1 Dicyclomine Hydrochloride Injection, USP is a sterile, pyrogen-free, aqueous solution for intramuscular injection (NOT FOR INTRAVENOUS USE) supplied as a vial containing 20 mg/2 mL (10 mg/mL). Each mL contains 10 mg dicyclomine hydrochloride USP in sterile water for injection, made isotonic with sodium chloride. Dicyclomine Hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C19H35NO2HCl and the following structural formula:.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-1980-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-10)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01) </PackageDescription>
    <NDC11Code>00517-1980-10</NDC11Code>
    <ProductNDC>0517-1980</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20170901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208353</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170911</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dicyclomine hydrochloride injection is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
    <Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form: 1 Dicyclomine Hydrochloride Injection, USP is a sterile, pyrogen-free, aqueous solution for intramuscular injection (NOT FOR INTRAVENOUS USE) supplied as a vial containing 20 mg/2 mL (10 mg/mL). Each mL contains 10 mg dicyclomine hydrochloride USP in sterile water for injection, made isotonic with sodium chloride. Dicyclomine Hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C19H35NO2HCl and the following structural formula:.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-2325-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 BOX (0517-2325-10)  / 2.5 mL in 1 VIAL, SINGLE-DOSE (0517-2325-01) </PackageDescription>
    <NDC11Code>00517-2325-10</NDC11Code>
    <ProductNDC>0517-2325</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venofer</ProprietaryName>
    <NonProprietaryName>Iron Sucrose</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20110127</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021135</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>IRON SUCROSE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).</IndicationAndUsage>
    <Description>Venofer (iron sucrose injection, USP), an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11). where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Venofer is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity.  Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-2502-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 BOX (0517-2502-10)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE (0517-2502-01) </PackageDescription>
    <NDC11Code>00517-2502-10</NDC11Code>
    <ProductNDC>0517-2502</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Caffeine And Sodium Benzoate</ProprietaryName>
    <NonProprietaryName>Caffeine And Sodium Benzoate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>19930201</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>CAFFEINE</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19930201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Caffeine and Sodium Benzoate Injection has been used in conjunction with supportive measure to treat respiratory depression associated with overdosage with CNS depressant drugs (e.g., narcotic analgesics, alcohol). However, because of questionable benefit and transient action, most authorities believe caffeine and other analeptics should not be used in these conditions and recommend other supportive therapy.</IndicationAndUsage>
    <Description>Caffeine and Sodium Benzoate Injection, USP is a clear, sterile, nonpyrogenic, solution of Caffeine Alkaloid. Each mL contains: Caffeine (anhydrous) 125 mg; Sodium Benzoate (added to increase the solubility of Caffeine) 125 mg; Water for Injection, USP q.s. pH (range 6.5 to 8.5) adjusted with Hydrochloric Acid and/or Sodium Hydroxide. For intramuscular or slow intravenous administration only.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-2602-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2602-25)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00517-2602-25</NDC11Code>
    <ProductNDC>0517-2602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Magnesium Sulfate</ProprietaryName>
    <NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-07-25</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0517-2901-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (0517-2901-01)  / .2 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00517-2901-01</NDC11Code>
    <ProductNDC>0517-2901</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gvoke Vialdx</ProprietaryName>
    <NonProprietaryName>Glucagon Injection</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250819</StartMarketingDate>
    <EndMarketingDate>20270930</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212097</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>GLUCAGON</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/.2mL</StrengthUnit>
    <Pharm_Classes>Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20250819</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).</IndicationAndUsage>
    <Description>Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-2901-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (0517-2901-10)  / .2 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00517-2901-10</NDC11Code>
    <ProductNDC>0517-2901</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gvoke Vialdx</ProprietaryName>
    <NonProprietaryName>Glucagon Injection</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250819</StartMarketingDate>
    <EndMarketingDate>20270930</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212097</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>GLUCAGON</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/.2mL</StrengthUnit>
    <Pharm_Classes>Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20250819</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).</IndicationAndUsage>
    <Description>Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-4002-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (0517-4002-25)  / 2 mL in 1 VIAL (0517-4002-01) </PackageDescription>
    <NDC11Code>00517-4002-25</NDC11Code>
    <ProductNDC>0517-4002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Papaverine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Papaverine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19950901</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>PAPAVERINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19950901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Papaverine is recommended in various conditions accompanied by spasm of smooth muscle, such as vascular spasm associated with acute myocardial infarction (coronary occlusion), angina pectoris, peripheral and pulmonary embolism, peripheral vascular disease in which there is a vasospastic element, or certain cerebral angiospastic states; and visceral spasm, as in ureteral, biliary, or gastrointestinal colic.</IndicationAndUsage>
    <Description>Papaverine Hydrochloride, USP, is the hydrochloride of an alkaloid obtained from opium or prepared synthetically. It belongs to the benzylisoquinoline group of alkaloids. It does not contain a phenanthrene group as do morphine and codeine. Papaverine Hydrochloride, USP, is 6,7-dimethoxy-1- veratrylisoquinoline hydrochloride and contains, on the dried basis, not less than 98.5% of C20H21NO4HCI. The molecular weight is 375.85. The structural formula is as shown. Papaverine Hydrochloride occurs as white crystals or white crystalline powder. One gram dissolves in about 30 mL of water and in 120 mL of alcohol. It is soluble in chloroform and practically insoluble in ether. Papaverine Hydrochloride Injection, USP, is a clear, colorless to pale-yellow solution. Papaverine Hydrochloride, for parenteral administration, is a smooth-muscle relaxant that is available in vials containing 30 mg/mL. Each vial also contains edetate disodium 0.005%. The 10 mL vials also contain chlorobutanol 0.5% as a preservative. pH may be adjusted with sodium citrate and/or citric acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-4602-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4602-25)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-4602-01) </PackageDescription>
    <NDC11Code>00517-4602-25</NDC11Code>
    <ProductNDC>0517-4602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glycopyrrolate</ProprietaryName>
    <NonProprietaryName>Glycopyrrolate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089335</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>GLYCOPYRROLATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>In Anesthesia: Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. In Peptic Ulcer:For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.</IndicationAndUsage>
    <Description>Glycopyrrolate Injection, USP is a clear, colorless, sterile solution of Glycopyrrolate, USP with Benzyl Alcohol, NF in Water for Injection, USP. The formulation is used for intramuscular or intravenous administration. Each mL contains:Glycopyrrolate, USP…………………………..0.2 mgBenzyl Alcohol, NF (preservative)………….….0.9%Water for Injection, USP.................................... q.s. When necessary, pH (2.0 to 3.0) adjusted with hydrochloric acid and/or sodium hydroxide. Glycopyrrolate is a quaternary ammonium salt with the following chemical name. 3[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethyl pyrrolidinium bromide.  Glycopyrrolate is a synthetic anticholinergic agent that has the following molecular structure and molecular weight. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-5602-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-5602-25)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-5602-01) </PackageDescription>
    <NDC11Code>00517-5602-25</NDC11Code>
    <ProductNDC>0517-5602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA087408</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>The total management of anxiety, tension, and psychomotor agitation in conditions of emotional stress requires in most instances a combined approach of psychotherapy and chemotherapy. Hydroxyzine has been found to be particularly useful for this latter phase of therapy in its ability to render the disturbed patient more amenable to psychotherapy in long term treatment of the psychoneurotic and psychotic, although it should not be used as the sole treatment of psychosis or of clearly demonstrated cases of depression. Hydroxyzine is also useful in alleviating the manifestations of anxiety and tension as in the preparation for dental procedures and in acute emotional problems. It has also been recommended for the management of anxiety associated with organic disturbances and as adjunctive therapy in alcoholism and allergic conditions with strong emotional overlay, such as in asthma, chronic urticaria, and pruritus. Hydroxyzine hydrochloride intramuscular solution is useful in treating the following types of patients when intramuscular administration is indicated. 1. The acutely disturbed or hysterical patient. 2. The acute or chronic alcoholic with anxiety withdrawal symptoms or delirium tremens. 3. As pre-and postoperative and pre- and postpartum adjunctive medication to permit reduction in narcotic dosage, allay anxiety and control emesis. Hydroxyzine hydrochloride has also demonstrated effectiveness in controlling nausea and vomiting, excluding nausea and vomiting of pregnancy. (See CONTRAINDICATIONS). In prepartum states, the reduction in narcotic requirement effected by hydroxyzine is of particular benefit to both mother and neonate. Hydroxyzine benefits the cardiac patient by its ability to allay the associated anxiety and apprehension attendant to certain types of heart disease. Hydroxyzine is not known to interfere with the action of digitalis in any way and may be used concurrently with this agent. The effectiveness of hydroxyzine in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Hydroxyzine hydrochloride has the chemical name of (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride and occurs as a white, odorless powder which is very soluble in water. It has the following structural formula. Hydroxyzine Hydrochloride Injection, USP is a sterile aqueous solution intended for intramuscular administration. Each mL contains: Hydroxyzine HCl 25 mg or 50 mg, Benzyl Alcohol 0.9%, and Water for Injection q.s.  pH adjusted with Sodium Hydroxide and/or Hydrochloric Acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-5702-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-5702-25)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00517-5702-25</NDC11Code>
    <ProductNDC>0517-5702</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018579</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-20</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0517-6202-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-6202-25)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00517-6202-25</NDC11Code>
    <ProductNDC>0517-6202</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multitrace-4 Neonatal</ProprietaryName>
    <NonProprietaryName>Trace Elements 4</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; ZINC SULFATE HEPTAHYDRATE</SubstanceName>
    <StrengthNumber>4.36; .39; 77; 6.6</StrengthNumber>
    <StrengthUnit>ug/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0517-6502-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 BOX (0517-6502-10)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-6502-01) </PackageDescription>
    <NDC11Code>00517-6502-10</NDC11Code>
    <ProductNDC>0517-6502</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Selenious Acid</ProprietaryName>
    <NonProprietaryName>Selenious Acid</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220328</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209379</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>SELENIUM</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-01-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Selenious Acid Injection is indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
    <Description>Selenious Acid Injection, USP is a sterile, non-pyrogenic, clear, colorless solution intended for use as a trace element and additive to intravenous solutions for parenteral nutrition. Each 600 mcg/10 mL Pharmacy Bulk Package vial contains 10 mL of selenious acid solution. Each 6 mcg/mL single-dose vial contains 2 mL of selenious acid solution. None of the presentations contain preservatives. Each mL of the 60 mcg/mL strength contains 60 mcg of selenium present as 98 mcg of selenious acid, nitric acid for pH adjustment (1.8 to 2.4), and water for injection q.s. Each mL of the 6 mcg/mL strength contains 6 mcg of selenium present as 9.8 mcg of selenious acid, nitric acid for pH adjustment (1.8 to 2.4), and water for injection q.s. Selenious Acid Injection 60 mcg/mL contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 16 mOsmol/L. Selenious Acid Injection 6 mcg/mL contains no more than 900 mcg/L of aluminum and has a calculated osmolarity of 13 mOsmol/L. Selenious acid has a molecular weight of 128.97 g/mol and a formula of H2SeO3.  The structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-6902-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 BOX (0517-6902-10)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE (0517-6902-01)</PackageDescription>
    <NDC11Code>00517-6902-10</NDC11Code>
    <ProductNDC>0517-6902</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fosphenytoin Sodium</ProprietaryName>
    <NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20100730</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090099</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>FOSPHENYTOIN SODIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-08-29</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0517-6902-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-6902-25)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE (0517-6902-01)</PackageDescription>
    <NDC11Code>00517-6902-25</NDC11Code>
    <ProductNDC>0517-6902</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fosphenytoin Sodium</ProprietaryName>
    <NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20100730</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090099</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>FOSPHENYTOIN SODIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-08-29</LastUpdate>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>54569-0517-2</NDCCode><ProprietaryName>Hydralazine Hydrochloride</ProprietaryName><NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54569-0517-1</NDCCode><ProprietaryName>Hydralazine Hydrochloride</ProprietaryName><NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0517-0125-05</NDCCode><ProprietaryName>Provayblue</ProprietaryName><NonProprietaryName>Methylene Blue</NonProprietaryName></NDC><NDC><NDCCode>0517-0131-25</NDCCode><ProprietaryName>Dexpanthenol</ProprietaryName><NonProprietaryName>Dexpanthenol</NonProprietaryName></NDC><NDC><NDCCode>0517-0234-10</NDCCode><ProprietaryName>Dexferrum</ProprietaryName><NonProprietaryName>Iron Dextran</NonProprietaryName></NDC><NDC><NDCCode>0517-0371-05</NDCCode><ProprietaryName>Provayblue</ProprietaryName><NonProprietaryName>Methylene Blue</NonProprietaryName></NDC><NDC><NDCCode>0517-0602-01</NDCCode><ProprietaryName>Injectafer</ProprietaryName><NonProprietaryName>Ferric Carboxymaltose Injection</NonProprietaryName></NDC><NDC><NDCCode>0517-0650-02</NDCCode><ProprietaryName>Injectafer</ProprietaryName><NonProprietaryName>Ferric Carboxymaltose Injection</NonProprietaryName></NDC><NDC><NDCCode>0517-0770-10</NDCCode><ProprietaryName>Torsemide</ProprietaryName><NonProprietaryName>Torsemide</NonProprietaryName></NDC><NDC><NDCCode>0517-0785-05</NDCCode><ProprietaryName>Benztropine Mesylate</ProprietaryName><NonProprietaryName>Benztropine Mesylate</NonProprietaryName></NDC><NDC><NDCCode>0517-0830-01</NDCCode><ProprietaryName>Latanoprost</ProprietaryName><NonProprietaryName>Latanoprost</NonProprietaryName></NDC><NDC><NDCCode>0517-0830-03</NDCCode><ProprietaryName>Latanoprost</ProprietaryName><NonProprietaryName>Latanoprost</NonProprietaryName></NDC><NDC><NDCCode>0517-0902-10</NDCCode><ProprietaryName>Ketorolac Tromethamine</ProprietaryName><NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName></NDC><NDC><NDCCode>0517-0902-25</NDCCode><ProprietaryName>Ketorolac Tromethamine</ProprietaryName><NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName></NDC><NDC><NDCCode>0517-0955-01</NDCCode><ProprietaryName>Olanzapine</ProprietaryName><NonProprietaryName>Olanzapine</NonProprietaryName></NDC><NDC><NDCCode>0517-1980-05</NDCCode><ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName><NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0517-1980-10</NDCCode><ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName><NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0517-2325-10</NDCCode><ProprietaryName>Venofer</ProprietaryName><NonProprietaryName>Iron Sucrose</NonProprietaryName></NDC><NDC><NDCCode>0517-2502-10</NDCCode><ProprietaryName>Caffeine And Sodium Benzoate</ProprietaryName><NonProprietaryName>Caffeine And Sodium Benzoate</NonProprietaryName></NDC><NDC><NDCCode>0517-2602-25</NDCCode><ProprietaryName>Magnesium Sulfate</ProprietaryName><NonProprietaryName>Magnesium Sulfate</NonProprietaryName></NDC><NDC><NDCCode>0517-2901-01</NDCCode><ProprietaryName>Gvoke Vialdx</ProprietaryName><NonProprietaryName>Glucagon Injection</NonProprietaryName></NDC><NDC><NDCCode>0517-2901-10</NDCCode><ProprietaryName>Gvoke Vialdx</ProprietaryName><NonProprietaryName>Glucagon Injection</NonProprietaryName></NDC><NDC><NDCCode>0517-4002-25</NDCCode><ProprietaryName>Papaverine Hydrochloride</ProprietaryName><NonProprietaryName>Papaverine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0517-4602-25</NDCCode><ProprietaryName>Glycopyrrolate</ProprietaryName><NonProprietaryName>Glycopyrrolate</NonProprietaryName></NDC><NDC><NDCCode>0517-5602-25</NDCCode><ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName><NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0517-5702-25</NDCCode><ProprietaryName>Furosemide</ProprietaryName><NonProprietaryName>Furosemide</NonProprietaryName></NDC><NDC><NDCCode>0517-6202-25</NDCCode><ProprietaryName>Multitrace-4 Neonatal</ProprietaryName><NonProprietaryName>Trace Elements 4</NonProprietaryName></NDC><NDC><NDCCode>0517-6502-10</NDCCode><ProprietaryName>Selenious Acid</ProprietaryName><NonProprietaryName>Selenious Acid</NonProprietaryName></NDC><NDC><NDCCode>0517-6902-10</NDCCode><ProprietaryName>Fosphenytoin Sodium</ProprietaryName><NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName></NDC><NDC><NDCCode>0517-6902-25</NDCCode><ProprietaryName>Fosphenytoin Sodium</ProprietaryName><NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

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

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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