RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "14335-580-20",
      "PackageDescription": "20 kg in 1 DRUM (14335-580-20) ",
      "NDC11Code": "14335-0580-20",
      "ProductNDC": "14335-580",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Gadobutrol",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20231130",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "GADOBUTROL",
      "StrengthNumber": "20",
      "StrengthUnit": "kg/20kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-12-07",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "30-NOV-23"
    },
    {
      "NDCCode": "14335-080-01",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (14335-080-01)  > 20 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "14335-0080-01",
      "ProductNDC": "14335-080",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Voriconazole",
      "NonProprietaryName": "Voriconazole",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190128",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211661",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "VORICONAZOLE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190128",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "14335-120-01",
      "PackageDescription": "20 mL in 1 VIAL, SINGLE-DOSE (14335-120-01) ",
      "NDC11Code": "14335-0120-01",
      "ProductNDC": "14335-120",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Daptomycin",
      "NonProprietaryName": "Daptomycin",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215890",
      "LabelerName": "Hainan Poly Pharm., Co., Ltd.",
      "SubstanceName": "DAPTOMYCIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/20mL",
      "Pharm_Classes": "Lipopeptide Antibacterial [EPC], Lipopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2023-11-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Daptomycin for injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) ( 1.1) and, , 2 Staphylococcus aureusbloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis. ( 1.2) , 3 Staphylococcus aureusbloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). ( 1.3) .",
      "Description": "Daptomycin for injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D‑asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl- threo-3‑methyl-L-glutamyl-3-anthraniloyl-L-alanine ε 1-lactone. The chemical structure is:. The empirical formula is C 72H 101N 17O 26; the molecular weight is 1620.67. Daptomycin for injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake containing approximately 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration ( 2.7)] . The only inactive ingredient is sodium hydroxide, which is used for pH adjustment. Freshly reconstituted solutions of daptomycin for injection range in color from pale yellow to light brown."
    },
    {
      "NDCCode": "14335-171-01",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (14335-171-01)  > 20 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "14335-0171-01",
      "ProductNDC": "14335-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dobutamine",
      "NonProprietaryName": "Dobutamine",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20210601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216131",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "DOBUTAMINE HYDROCHLORIDE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20210601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dobutamine Injection, USP is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risk of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.",
      "Description": "Dobutamine Injection, USP is a clear, practically colorless, sterile, nonpyrogenic solution of dobutamine hydrochloride for intravenous use only. Each milliliter contains 12.5 mg (41.5 µmol) dobutamine, as the hydrochloride and sodium metabisulfite, 0.2 mg added as antioxidant. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH is 3.3 (2.5 to 5.0). Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(ρ-hydroxyphenyl)-1-methylpropyl] amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Molecular Weight: 337.85. Molecular Formula: C 18H 23NO 3  HCl."
    },
    {
      "NDCCode": "14335-330-10",
      "PackageDescription": "10 VIAL, GLASS in 1 CARTON (14335-330-10)  / 20 mL in 1 VIAL, GLASS",
      "NDC11Code": "14335-0330-10",
      "ProductNDC": "14335-330",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lacosamide",
      "NonProprietaryName": "Lacosamide",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20220331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217311",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "LACOSAMIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20220331",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lacosamide Injection is indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).",
      "Description": "The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
    },
    {
      "NDCCode": "14335-390-20",
      "PackageDescription": "20 kg in 1 DRUM (14335-390-20) ",
      "NDC11Code": "14335-0390-20",
      "ProductNDC": "14335-390",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Gadoteridol",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230209",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "GADOTERIDOL",
      "StrengthNumber": "20",
      "StrengthUnit": "kg/20kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-11-27",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "09-FEB-23"
    },
    {
      "NDCCode": "14335-450-01",
      "PackageDescription": "20 kg in 1 DRUM (14335-450-01) ",
      "NDC11Code": "14335-0450-01",
      "ProductNDC": "14335-450",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Voriconazole",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230901",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "VORICONAZOLE",
      "StrengthNumber": "20",
      "StrengthUnit": "kg/20kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-11-27",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-SEP-23"
    },
    {
      "NDCCode": "14335-730-10",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (14335-730-10)  / 20 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "14335-0730-10",
      "ProductNDC": "14335-730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Voriconazole",
      "NonProprietaryName": "Voriconazole",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20251120",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA220043",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "VORICONAZOLE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-03-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251120",
      "SamplePackage": "N",
      "IndicationAndUsage": "Voriconazole injection is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis ( 1.1) , 2 Candidemia in non-neutropenics and other deep tissue Candidainfections ( 1.2) , 3 Esophageal candidiasis ( 1.3) , 4 Serious fungal infections caused by Scedosporium apiospermumand Fusariumspecies including Fusarium solani, in patients intolerant of, or refractory to, other therapy ( 1.4) .",
      "Description": "Voriconazole, an azole antifungal agent is available as a sterile, clear, colorless solution for intravenous infusion. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1 H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C 16H 14F 3N 5O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. Voriconazole injection is a solution containing nominally 200 mg/20 mL (10 mg/mL) of voriconazole and 3,200 mg/20 mL (160 mg/mL) of sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. Voriconazole injection is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. The solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)] ."
    },
    {
      "NDCCode": "49283-580-20",
      "PackageDescription": "59 mL in 1 TUBE (49283-580-20) ",
      "NDC11Code": "49283-0580-20",
      "ProductNDC": "49283-580",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Menthol, Camphor",
      "NonProprietaryName": "Menthol, Camphor",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260129",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "CHEMCO CORPORATION",
      "SubstanceName": "MENTHOL, UNSPECIFIED FORM; CAMPHOR (NATURAL)",
      "StrengthNumber": "10; 3",
      "StrengthUnit": "g/100mL; g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-02-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260129",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains and strains."
    },
    {
      "NDCCode": "51079-580-20",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-580-20)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-580-01) ",
      "NDC11Code": "51079-0580-20",
      "ProductNDC": "51079-580",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Thioridazine Hydrochloride",
      "NonProprietaryName": "Thioridazine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19980622",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088004",
      "LabelerName": "Mylan Institutional Inc.",
      "SubstanceName": "THIORIDAZINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19980622",
      "SamplePackage": "N",
      "IndicationAndUsage": "Thioridazine hydrochloride tablets are indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Due to the risk of significant, potentially life threatening, proarrhythmic effects with thioridazine treatment, thioridazine hydrochloride tablets should be used only in patients who have failed to respond adequately to treatment with appropriate courses of other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs. Consequently, before initiating treatment with thioridazine hydrochloride tablets, it is strongly recommended that a patient be given at least two trials, each with a different antipsychotic drug product, at an adequate dose, and for an adequate duration (see WARNINGSand CONTRAINDICATIONS). However, the prescriber should be aware that thioridazine hydrochloride tablets have not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.",
      "Description": "Thioridazine hydrochloride is 2-methylmercapto-10-[2-(N-methyl-2-piperidyl) ethyl] phenothiazine. Its structural formula, molecular weight and molecular formula are. Thioridazine hydrochloride, USP is available as tablets for oral administration containing 10 mg, 25 mg, 50 mg or 100 mg. Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide."
    },
    {
      "NDCCode": "52125-580-03",
      "PackageDescription": "20 TABLET in 1 VIAL (52125-580-03)",
      "NDC11Code": "52125-0580-03",
      "ProductNDC": "52125-580",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130624",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091416",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-01-05"
    },
    {
      "NDCCode": "52125-580-20",
      "PackageDescription": "100 TABLET in 1 BOTTLE (52125-580-20)",
      "NDC11Code": "52125-0580-20",
      "ProductNDC": "52125-580",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140416",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091416",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-01-05"
    },
    {
      "NDCCode": "55513-580-01",
      "PackageDescription": "20 mL in 1 VIAL, SINGLE-USE (55513-580-01)",
      "NDC11Code": "55513-0580-01",
      "ProductNDC": "55513-580",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Voriconazole",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "StartMarketingDate": "20020524",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Amgen Inc",
      "SubstanceName": "VORICONAZOLE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "55700-580-20",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE (55700-580-20) ",
      "NDC11Code": "55700-0580-20",
      "ProductNDC": "55700-580",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Diphenhydramine Hydrochloride",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180112",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part336",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20180202",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "58980-580-20",
      "PackageDescription": "1 TUBE in 1 BOX (58980-580-20)  > 56.7 g in 1 TUBE",
      "NDC11Code": "58980-0580-20",
      "ProductNDC": "58980-580",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alphaquin Hp",
      "NonProprietaryName": "Hydroquinone, Octinoxate, And Oxybenzone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19930101",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Stratus Pharamceuticals",
      "SubstanceName": "HYDROQUINONE; OCTINOXATE; OXYBENZONE",
      "StrengthNumber": "40; 75; 50",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Pharm_Classes": "Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-10-03"
    },
    {
      "NDCCode": "59310-580-20",
      "PackageDescription": "1 INHALER in 1 BOX (59310-580-20)  / 200 POWDER, METERED in 1 INHALER",
      "NDC11Code": "59310-0580-20",
      "ProductNDC": "59310-580",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Proair Respiclick",
      "NonProprietaryName": "Albuterol Sulfate",
      "DosageFormName": "POWDER, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20150423",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205636",
      "LabelerName": "Teva Respiratory, LLC",
      "SubstanceName": "ALBUTEROL SULFATE",
      "StrengthNumber": "90",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150511",
      "SamplePackage": "N",
      "IndicationAndUsage": "PROAIR RESPICLICK is a beta2-adrenergic agonist indicated for: 1 Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1), 2 Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2).",
      "Description": "The active ingredient of PROAIR RESPICLICK inhalation powder is albuterol sulfate, a racemic salt of albuterol. Albuterol sulfate is a beta2-adrenergic agonist. It has the chemical name α1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following chemical structure. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official U.S. Adopted Name in the United States, and salbutamol sulfate is the recommended World Health Organization international nonproprietary name. PROAIR RESPICLICK is an inhalation-driven, multi-dose inhalation powder (dry powder inhaler) for oral inhalation only. It contains a formulation blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation provides a metered dose of 2.6 mg of the formulation containing 117 mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) and lactose from the device reservoir. Under standardized in vitro test conditions with fixed flow rates ranging from 58 to 71 L/min, and with a total air volume of 2 L, the PROAIR RESPICLICK inhaler delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) with lactose from the mouthpiece. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. In a study that investigated the peak inspiratory flow rate (PIFR) in asthma (n=27, ages 12 to 17 years old and n=50, ages 18 to 45 years old) and COPD (n=50, over 50 years old) patients, the mean PIFR achieved by subjects was >60 L/min (range = 31 to 110 L/min.), indicating that patients would be able to achieve the required inspiratory flow to operate the MDPI device correctly. The inhaler is provided for 200 actuations (inhalations)."
    },
    {
      "NDCCode": "63323-580-20",
      "PackageDescription": "10 VIAL, MULTI-DOSE in 1 TRAY (63323-580-20)  / 20 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "63323-0580-20",
      "ProductNDC": "63323-580",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atropine Sulfate",
      "NonProprietaryName": "Atropine Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "20170123",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209260",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "ATROPINE SULFATE",
      "StrengthNumber": ".4",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170123",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia.",
      "Description": "Atropine Sulfate Injection, USP is a sterile, nonpyrogenic, isotonic, clear solution of atropine sulfate in water for injection with sodium chloride sufficient to render the solution isotonic.  It is administered parenterally by subcutaneous, intramuscular or intravenous injection. Each mL contains atropine sulfate, 0.4 mg; benzyl alcohol, 9 mg; sodium chloride 9 mg.  May contain sulfuric acid for pH adjustment.  pH 3.5 (3.0 to 3.8). Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na+) and chloride (Cl-) ions. Atropine Sulfate, USP is chemically designated lα H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 · H2SO4 · H2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water."
    },
    {
      "NDCCode": "70934-580-20",
      "PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (70934-580-20) ",
      "NDC11Code": "70934-0580-20",
      "ProductNDC": "70934-580",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200226",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210525",
      "LabelerName": "Denton Pharma, Inc. dba Northwind Pharmaceuticals",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200811",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "84549-580-20",
      "PackageDescription": "20 mL in 1 VIAL, MULTI-DOSE (84549-580-20) ",
      "NDC11Code": "84549-0580-20",
      "ProductNDC": "84549-580",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atropine Sulfate",
      "NonProprietaryName": "Atropine Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "20170123",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209260",
      "LabelerName": "ProPharma Distribution",
      "SubstanceName": "ATROPINE SULFATE",
      "StrengthNumber": ".4",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250827",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia.",
      "Description": "Atropine Sulfate Injection, USP is a sterile, nonpyrogenic, isotonic, clear solution of atropine sulfate in water for injection with sodium chloride sufficient to render the solution isotonic.  It is administered parenterally by subcutaneous, intramuscular or intravenous injection. Each mL contains atropine sulfate, 0.4 mg; benzyl alcohol, 9 mg; sodium chloride 9 mg.  May contain sulfuric acid for pH adjustment.  pH 3.5 (3.0 to 3.8). Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na +) and chloride (Cl -) ions. Atropine Sulfate, USP is chemically designated lα H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C 17H 23NO 3) 2· H 2SO 4· H 2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula:. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water."
    },
    {
      "NDCCode": "14335-132-01",
      "PackageDescription": "1 VIAL in 1 CARTON (14335-132-01)  > 50 mL in 1 VIAL",
      "NDC11Code": "14335-0132-01",
      "ProductNDC": "14335-132",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Nitroprusside",
      "NonProprietaryName": "Sodium Nitroprusside",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20221231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215846",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "SODIUM NITROPRUSSIDE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Vasodilation [PE], Vasodilator [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium nitroprusside is a direct acting vasodilator indicated for. Immediate reduction of blood pressure ( 1.1). Producing controlled hypotension to reduce bleeding during surgery. ( 1.2). Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. (  1.3).",
      "Description": "Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is. Sodium Nitroprusside has molecular formula Na 2[Fe(CN) 5NO]  2H 2O and molecular weight of 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes [see Dosage and Administration ( 2.1)] . Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 50 mg of sodium nitroprusside (0.5 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 20 mg of sodium nitroprusside (0.2 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 50-mL vial. Each 50 mL of solution in vial contains 10 mg of sodium nitroprusside (0.2 mg/mL), 450 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP."
    },
    {
      "NDCCode": "14335-133-01",
      "PackageDescription": "1 VIAL in 1 CARTON (14335-133-01)  > 100 mL in 1 VIAL",
      "NDC11Code": "14335-0133-01",
      "ProductNDC": "14335-133",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Nitroprusside",
      "NonProprietaryName": "Sodium Nitroprusside",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20221231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215846",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "SODIUM NITROPRUSSIDE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Vasodilation [PE], Vasodilator [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium nitroprusside is a direct acting vasodilator indicated for. Immediate reduction of blood pressure ( 1.1). Producing controlled hypotension to reduce bleeding during surgery. ( 1.2). Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. (  1.3).",
      "Description": "Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is. Sodium Nitroprusside has molecular formula Na 2[Fe(CN) 5NO]  2H 2O and molecular weight of 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes [see Dosage and Administration ( 2.1)] . Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 50 mg of sodium nitroprusside (0.5 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 20 mg of sodium nitroprusside (0.2 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 50-mL vial. Each 50 mL of solution in vial contains 10 mg of sodium nitroprusside (0.2 mg/mL), 450 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP."
    },
    {
      "NDCCode": "14335-134-01",
      "PackageDescription": "1 VIAL in 1 CARTON (14335-134-01)  > 100 mL in 1 VIAL",
      "NDC11Code": "14335-0134-01",
      "ProductNDC": "14335-134",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Nitroprusside",
      "NonProprietaryName": "Sodium Nitroprusside",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20221231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215846",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "SODIUM NITROPRUSSIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Vasodilation [PE], Vasodilator [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium nitroprusside is a direct acting vasodilator indicated for. Immediate reduction of blood pressure ( 1.1). Producing controlled hypotension to reduce bleeding during surgery. ( 1.2). Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. (  1.3).",
      "Description": "Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is. Sodium Nitroprusside has molecular formula Na 2[Fe(CN) 5NO]  2H 2O and molecular weight of 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes [see Dosage and Administration ( 2.1)] . Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 50 mg of sodium nitroprusside (0.5 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 20 mg of sodium nitroprusside (0.2 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 50-mL vial. Each 50 mL of solution in vial contains 10 mg of sodium nitroprusside (0.2 mg/mL), 450 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP."
    },
    {
      "NDCCode": "14335-430-10",
      "PackageDescription": "3 mL in 1 VIAL, GLASS (14335-430-10) ",
      "NDC11Code": "14335-0430-10",
      "ProductNDC": "14335-430",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amiodarone Hydrochloride",
      "NonProprietaryName": "Amiodarone Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218253",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "AMIODARONE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230206",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)] . Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary.",
      "Description": "Amiodarone Hydrochloride Injection, USP contains amiodarone hydrochloride, USP (C 25H 29I 2NO 3HCl), a class III antiarrhythmic drug. Amiodarone hydrochloride is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride. Amiodarone hydrochloride has the following structural formula. Amiodarone HCl is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. Amiodarone Hydrochloride Injection, USP is a sterile clear, pale-yellow micellar solution visually free from particulates. Each milliliter of the Amiodarone Hydrochloride Injection, USP formulation contains 50 mg of amiodarone hydrochloride, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection. Amiodarone Hydrochloride Injection, USP is injection administration. Amiodarone Hydrochloride Injection, USP contains polysorbate 80, which is known to leach di-(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) [see Dosage and Administration (2)] ."
    },
    {
      "NDCCode": "14335-431-10",
      "PackageDescription": "9 mL in 1 VIAL, GLASS (14335-431-10) ",
      "NDC11Code": "14335-0431-10",
      "ProductNDC": "14335-431",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amiodarone Hydrochloride",
      "NonProprietaryName": "Amiodarone Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218253",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "AMIODARONE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230206",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)] . Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary.",
      "Description": "Amiodarone Hydrochloride Injection, USP contains amiodarone hydrochloride, USP (C 25H 29I 2NO 3HCl), a class III antiarrhythmic drug. Amiodarone hydrochloride is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride. Amiodarone hydrochloride has the following structural formula. Amiodarone HCl is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. Amiodarone Hydrochloride Injection, USP is a sterile clear, pale-yellow micellar solution visually free from particulates. Each milliliter of the Amiodarone Hydrochloride Injection, USP formulation contains 50 mg of amiodarone hydrochloride, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection. Amiodarone Hydrochloride Injection, USP is injection administration. Amiodarone Hydrochloride Injection, USP contains polysorbate 80, which is known to leach di-(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) [see Dosage and Administration (2)] ."
    },
    {
      "NDCCode": "14335-432-10",
      "PackageDescription": "18 mL in 1 VIAL, GLASS (14335-432-10) ",
      "NDC11Code": "14335-0432-10",
      "ProductNDC": "14335-432",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amiodarone Hydrochloride",
      "NonProprietaryName": "Amiodarone Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218253",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "AMIODARONE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230206",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)] . Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary.",
      "Description": "Amiodarone Hydrochloride Injection, USP contains amiodarone hydrochloride, USP (C 25H 29I 2NO 3HCl), a class III antiarrhythmic drug. Amiodarone hydrochloride is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride. Amiodarone hydrochloride has the following structural formula. Amiodarone HCl is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. Amiodarone Hydrochloride Injection, USP is a sterile clear, pale-yellow micellar solution visually free from particulates. Each milliliter of the Amiodarone Hydrochloride Injection, USP formulation contains 50 mg of amiodarone hydrochloride, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection. Amiodarone Hydrochloride Injection, USP is injection administration. Amiodarone Hydrochloride Injection, USP contains polysorbate 80, which is known to leach di-(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) [see Dosage and Administration (2)] ."
    },
    {
      "NDCCode": "14335-440-01",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (14335-440-01)  / 1 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "14335-0440-01",
      "ProductNDC": "14335-440",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenylephrine Hydrochloride",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240319",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218412",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-03-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240319",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.",
      "Description": "Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)- m-hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C 9H 14ClNO 2with a molecular weight of 203.66 g/mol. Its structural formula is depicted below:. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5."
    },
    {
      "NDCCode": "14335-441-01",
      "PackageDescription": "10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (14335-441-01)  / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE",
      "NDC11Code": "14335-0441-01",
      "ProductNDC": "14335-441",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenylephrine Hydrochloride",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240319",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218412",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-03-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240319",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.",
      "Description": "Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)- m-hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C 9H 14ClNO 2with a molecular weight of 203.66 g/mol. Its structural formula is depicted below:. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5."
    },
    {
      "NDCCode": "14335-442-01",
      "PackageDescription": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (14335-442-01)  / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE",
      "NDC11Code": "14335-0442-01",
      "ProductNDC": "14335-442",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenylephrine Hydrochloride",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240319",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218412",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-03-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240319",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.",
      "Description": "Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)- m-hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C 9H 14ClNO 2with a molecular weight of 203.66 g/mol. Its structural formula is depicted below:. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5."
    },
    {
      "NDCCode": "14335-680-01",
      "PackageDescription": "5 kg in 1 DRUM (14335-680-01) ",
      "NDC11Code": "14335-0680-01",
      "ProductNDC": "14335-680",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Tecovirimat Monohydrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230920",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "TECOVIRIMAT MONOHYDRATE",
      "StrengthNumber": "5",
      "StrengthUnit": "kg/5kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-12-07",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20-SEP-23"
    },
    {
      "NDCCode": "0173-0922-45",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45) ",
      "NDC11Code": "00173-0922-45",
      "ProductNDC": "0173-0922",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Blujepa",
      "NonProprietaryName": "Gepotidacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250325",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA218230",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "GEPOTIDACIN MESYLATE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinesterase Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Topoisomerase 2 Inhibitors [MoA], Topoisomerase 4 Inhibitors [MoA], Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250325",
      "SamplePackage": "N",
      "IndicationAndUsage": "BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: 1 Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). (1.1), 2 Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. (1.2, 6.1).",
      "Description": "BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is (R)-2-((4-(((3,4-dihydro-2H-pyrano[2,3-c]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3H,8H-2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C24H28N6O3●CH4O3S●2H2O and its molecular mass is 580.66. The structural formula is shown below. *stereogenic center. Each BLUJEPA oral tablet contains gepotidacin 750 mg (equivalent to 910.7 mg of gepotidacin mesylate [anhydrous]). Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"14335-580-20","NonProprietaryName":"Gadobutrol"},{"NDCCode":"14335-080-01","ProprietaryName":"Voriconazole","NonProprietaryName":"Voriconazole"},{"NDCCode":"14335-120-01","ProprietaryName":"Daptomycin","NonProprietaryName":"Daptomycin"},{"NDCCode":"14335-171-01","ProprietaryName":"Dobutamine","NonProprietaryName":"Dobutamine"},{"NDCCode":"14335-330-10","ProprietaryName":"Lacosamide","NonProprietaryName":"Lacosamide"},{"NDCCode":"14335-390-20","NonProprietaryName":"Gadoteridol"},{"NDCCode":"14335-450-01","NonProprietaryName":"Voriconazole"},{"NDCCode":"14335-730-10","ProprietaryName":"Voriconazole","NonProprietaryName":"Voriconazole"},{"NDCCode":"49283-580-20","ProprietaryName":"Menthol, Camphor","NonProprietaryName":"Menthol, Camphor"},{"NDCCode":"51079-580-20","ProprietaryName":"Thioridazine Hydrochloride","NonProprietaryName":"Thioridazine Hydrochloride"},{"NDCCode":"52125-580-03","ProprietaryName":"Naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"52125-580-20","ProprietaryName":"Naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"55513-580-01","NonProprietaryName":"Voriconazole"},{"NDCCode":"55700-580-20","ProprietaryName":"Diphenhydramine Hydrochloride","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"58980-580-20","ProprietaryName":"Alphaquin Hp","NonProprietaryName":"Hydroquinone, Octinoxate, And Oxybenzone"},{"NDCCode":"59310-580-20","ProprietaryName":"Proair Respiclick","NonProprietaryName":"Albuterol Sulfate"},{"NDCCode":"63323-580-20","ProprietaryName":"Atropine Sulfate","NonProprietaryName":"Atropine Sulfate"},{"NDCCode":"70934-580-20","ProprietaryName":"Prednisone","NonProprietaryName":"Prednisone"},{"NDCCode":"84549-580-20","ProprietaryName":"Atropine Sulfate","NonProprietaryName":"Atropine Sulfate"},{"NDCCode":"14335-132-01","ProprietaryName":"Sodium Nitroprusside","NonProprietaryName":"Sodium Nitroprusside"},{"NDCCode":"14335-133-01","ProprietaryName":"Sodium Nitroprusside","NonProprietaryName":"Sodium Nitroprusside"},{"NDCCode":"14335-134-01","ProprietaryName":"Sodium Nitroprusside","NonProprietaryName":"Sodium Nitroprusside"},{"NDCCode":"14335-430-10","ProprietaryName":"Amiodarone Hydrochloride","NonProprietaryName":"Amiodarone Hydrochloride"},{"NDCCode":"14335-431-10","ProprietaryName":"Amiodarone Hydrochloride","NonProprietaryName":"Amiodarone Hydrochloride"},{"NDCCode":"14335-432-10","ProprietaryName":"Amiodarone Hydrochloride","NonProprietaryName":"Amiodarone Hydrochloride"},{"NDCCode":"14335-440-01","ProprietaryName":"Phenylephrine Hydrochloride","NonProprietaryName":"Phenylephrine Hydrochloride"},{"NDCCode":"14335-441-01","ProprietaryName":"Phenylephrine Hydrochloride","NonProprietaryName":"Phenylephrine Hydrochloride"},{"NDCCode":"14335-442-01","ProprietaryName":"Phenylephrine Hydrochloride","NonProprietaryName":"Phenylephrine Hydrochloride"},{"NDCCode":"14335-680-01","NonProprietaryName":"Tecovirimat Monohydrate"},{"NDCCode":"0173-0922-45","ProprietaryName":"Blujepa","NonProprietaryName":"Gepotidacin"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>14335-580-20</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (14335-580-20) </PackageDescription>
    <NDC11Code>14335-0580-20</NDC11Code>
    <ProductNDC>14335-580</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Gadobutrol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20231130</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>GADOBUTROL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>kg/20kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-12-07</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-NOV-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14335-080-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (14335-080-01)  &gt; 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>14335-0080-01</NDC11Code>
    <ProductNDC>14335-080</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211661</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>14335-120-01</NDCCode>
    <PackageDescription>20 mL in 1 VIAL, SINGLE-DOSE (14335-120-01) </PackageDescription>
    <NDC11Code>14335-0120-01</NDC11Code>
    <ProductNDC>14335-120</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Daptomycin</ProprietaryName>
    <NonProprietaryName>Daptomycin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20231114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215890</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm., Co., Ltd.</LabelerName>
    <SubstanceName>DAPTOMYCIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Lipopeptide Antibacterial [EPC], Lipopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Daptomycin for injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) ( 1.1) and, , 2 Staphylococcus aureusbloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis. ( 1.2) , 3 Staphylococcus aureusbloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). ( 1.3) .</IndicationAndUsage>
    <Description>Daptomycin for injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D‑asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl- threo-3‑methyl-L-glutamyl-3-anthraniloyl-L-alanine ε 1-lactone. The chemical structure is:. The empirical formula is C 72H 101N 17O 26; the molecular weight is 1620.67. Daptomycin for injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake containing approximately 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration ( 2.7)] . The only inactive ingredient is sodium hydroxide, which is used for pH adjustment. Freshly reconstituted solutions of daptomycin for injection range in color from pale yellow to light brown.</Description>
  </NDC>
  <NDC>
    <NDCCode>14335-171-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (14335-171-01)  &gt; 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>14335-0171-01</NDC11Code>
    <ProductNDC>14335-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dobutamine</ProprietaryName>
    <NonProprietaryName>Dobutamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216131</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>DOBUTAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dobutamine Injection, USP is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risk of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.</IndicationAndUsage>
    <Description>Dobutamine Injection, USP is a clear, practically colorless, sterile, nonpyrogenic solution of dobutamine hydrochloride for intravenous use only. Each milliliter contains 12.5 mg (41.5 µmol) dobutamine, as the hydrochloride and sodium metabisulfite, 0.2 mg added as antioxidant. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH is 3.3 (2.5 to 5.0). Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(ρ-hydroxyphenyl)-1-methylpropyl] amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Molecular Weight: 337.85. Molecular Formula: C 18H 23NO 3  HCl.</Description>
  </NDC>
  <NDC>
    <NDCCode>14335-330-10</NDCCode>
    <PackageDescription>10 VIAL, GLASS in 1 CARTON (14335-330-10)  / 20 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>14335-0330-10</NDC11Code>
    <ProductNDC>14335-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lacosamide</ProprietaryName>
    <NonProprietaryName>Lacosamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220331</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217311</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>LACOSAMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lacosamide Injection is indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).</IndicationAndUsage>
    <Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>14335-390-20</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (14335-390-20) </PackageDescription>
    <NDC11Code>14335-0390-20</NDC11Code>
    <ProductNDC>14335-390</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Gadoteridol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230209</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>GADOTERIDOL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>kg/20kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-11-27</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>09-FEB-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14335-450-01</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (14335-450-01) </PackageDescription>
    <NDC11Code>14335-0450-01</NDC11Code>
    <ProductNDC>14335-450</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230901</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>kg/20kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-11-27</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-SEP-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14335-730-10</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (14335-730-10)  / 20 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>14335-0730-10</NDC11Code>
    <ProductNDC>14335-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20251120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA220043</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Voriconazole injection is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis ( 1.1) , 2 Candidemia in non-neutropenics and other deep tissue Candidainfections ( 1.2) , 3 Esophageal candidiasis ( 1.3) , 4 Serious fungal infections caused by Scedosporium apiospermumand Fusariumspecies including Fusarium solani, in patients intolerant of, or refractory to, other therapy ( 1.4) .</IndicationAndUsage>
    <Description>Voriconazole, an azole antifungal agent is available as a sterile, clear, colorless solution for intravenous infusion. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1 H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C 16H 14F 3N 5O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. Voriconazole injection is a solution containing nominally 200 mg/20 mL (10 mg/mL) of voriconazole and 3,200 mg/20 mL (160 mg/mL) of sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. Voriconazole injection is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. The solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)] .</Description>
  </NDC>
  <NDC>
    <NDCCode>49283-580-20</NDCCode>
    <PackageDescription>59 mL in 1 TUBE (49283-580-20) </PackageDescription>
    <NDC11Code>49283-0580-20</NDC11Code>
    <ProductNDC>49283-580</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Menthol, Camphor</ProprietaryName>
    <NonProprietaryName>Menthol, Camphor</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260129</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>CHEMCO CORPORATION</LabelerName>
    <SubstanceName>MENTHOL, UNSPECIFIED FORM; CAMPHOR (NATURAL)</SubstanceName>
    <StrengthNumber>10; 3</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains and strains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51079-580-20</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (51079-580-20)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-580-01) </PackageDescription>
    <NDC11Code>51079-0580-20</NDC11Code>
    <ProductNDC>51079-580</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thioridazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Thioridazine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980622</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088004</ApplicationNumber>
    <LabelerName>Mylan Institutional Inc.</LabelerName>
    <SubstanceName>THIORIDAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980622</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Thioridazine hydrochloride tablets are indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Due to the risk of significant, potentially life threatening, proarrhythmic effects with thioridazine treatment, thioridazine hydrochloride tablets should be used only in patients who have failed to respond adequately to treatment with appropriate courses of other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs. Consequently, before initiating treatment with thioridazine hydrochloride tablets, it is strongly recommended that a patient be given at least two trials, each with a different antipsychotic drug product, at an adequate dose, and for an adequate duration (see WARNINGSand CONTRAINDICATIONS). However, the prescriber should be aware that thioridazine hydrochloride tablets have not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.</IndicationAndUsage>
    <Description>Thioridazine hydrochloride is 2-methylmercapto-10-[2-(N-methyl-2-piperidyl) ethyl] phenothiazine. Its structural formula, molecular weight and molecular formula are. Thioridazine hydrochloride, USP is available as tablets for oral administration containing 10 mg, 25 mg, 50 mg or 100 mg. Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&amp;C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>52125-580-03</NDCCode>
    <PackageDescription>20 TABLET in 1 VIAL (52125-580-03)</PackageDescription>
    <NDC11Code>52125-0580-03</NDC11Code>
    <ProductNDC>52125-580</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130624</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091416</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>52125-580-20</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (52125-580-20)</PackageDescription>
    <NDC11Code>52125-0580-20</NDC11Code>
    <ProductNDC>52125-580</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140416</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091416</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55513-580-01</NDCCode>
    <PackageDescription>20 mL in 1 VIAL, SINGLE-USE (55513-580-01)</PackageDescription>
    <NDC11Code>55513-0580-01</NDC11Code>
    <ProductNDC>55513-580</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <StartMarketingDate>20020524</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Amgen Inc</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55700-580-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE (55700-580-20) </PackageDescription>
    <NDC11Code>55700-0580-20</NDC11Code>
    <ProductNDC>55700-580</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Diphenhydramine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180112</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part336</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>58980-580-20</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (58980-580-20)  &gt; 56.7 g in 1 TUBE</PackageDescription>
    <NDC11Code>58980-0580-20</NDC11Code>
    <ProductNDC>58980-580</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alphaquin Hp</ProprietaryName>
    <NonProprietaryName>Hydroquinone, Octinoxate, And Oxybenzone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19930101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Stratus Pharamceuticals</LabelerName>
    <SubstanceName>HYDROQUINONE; OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>40; 75; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-10-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>59310-580-20</NDCCode>
    <PackageDescription>1 INHALER in 1 BOX (59310-580-20)  / 200 POWDER, METERED in 1 INHALER</PackageDescription>
    <NDC11Code>59310-0580-20</NDC11Code>
    <ProductNDC>59310-580</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Proair Respiclick</ProprietaryName>
    <NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
    <DosageFormName>POWDER, METERED</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20150423</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205636</ApplicationNumber>
    <LabelerName>Teva Respiratory, LLC</LabelerName>
    <SubstanceName>ALBUTEROL SULFATE</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150511</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PROAIR RESPICLICK is a beta2-adrenergic agonist indicated for: 1 Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1), 2 Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2).</IndicationAndUsage>
    <Description>The active ingredient of PROAIR RESPICLICK inhalation powder is albuterol sulfate, a racemic salt of albuterol. Albuterol sulfate is a beta2-adrenergic agonist. It has the chemical name α1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following chemical structure. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official U.S. Adopted Name in the United States, and salbutamol sulfate is the recommended World Health Organization international nonproprietary name. PROAIR RESPICLICK is an inhalation-driven, multi-dose inhalation powder (dry powder inhaler) for oral inhalation only. It contains a formulation blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation provides a metered dose of 2.6 mg of the formulation containing 117 mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) and lactose from the device reservoir. Under standardized in vitro test conditions with fixed flow rates ranging from 58 to 71 L/min, and with a total air volume of 2 L, the PROAIR RESPICLICK inhaler delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) with lactose from the mouthpiece. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. In a study that investigated the peak inspiratory flow rate (PIFR) in asthma (n=27, ages 12 to 17 years old and n=50, ages 18 to 45 years old) and COPD (n=50, over 50 years old) patients, the mean PIFR achieved by subjects was &gt;60 L/min (range = 31 to 110 L/min.), indicating that patients would be able to achieve the required inspiratory flow to operate the MDPI device correctly. The inhaler is provided for 200 actuations (inhalations).</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-580-20</NDCCode>
    <PackageDescription>10 VIAL, MULTI-DOSE in 1 TRAY (63323-580-20)  / 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>63323-0580-20</NDC11Code>
    <ProductNDC>63323-580</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atropine Sulfate</ProprietaryName>
    <NonProprietaryName>Atropine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20170123</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209260</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ATROPINE SULFATE</SubstanceName>
    <StrengthNumber>.4</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>2024-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia.</IndicationAndUsage>
    <Description>Atropine Sulfate Injection, USP is a sterile, nonpyrogenic, isotonic, clear solution of atropine sulfate in water for injection with sodium chloride sufficient to render the solution isotonic.  It is administered parenterally by subcutaneous, intramuscular or intravenous injection. Each mL contains atropine sulfate, 0.4 mg; benzyl alcohol, 9 mg; sodium chloride 9 mg.  May contain sulfuric acid for pH adjustment.  pH 3.5 (3.0 to 3.8). Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na+) and chloride (Cl-) ions. Atropine Sulfate, USP is chemically designated lα H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 · H2SO4 · H2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.</Description>
  </NDC>
  <NDC>
    <NDCCode>70934-580-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (70934-580-20) </PackageDescription>
    <NDC11Code>70934-0580-20</NDC11Code>
    <ProductNDC>70934-580</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200226</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210525</ApplicationNumber>
    <LabelerName>Denton Pharma, Inc. dba Northwind Pharmaceuticals</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200811</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>84549-580-20</NDCCode>
    <PackageDescription>20 mL in 1 VIAL, MULTI-DOSE (84549-580-20) </PackageDescription>
    <NDC11Code>84549-0580-20</NDC11Code>
    <ProductNDC>84549-580</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atropine Sulfate</ProprietaryName>
    <NonProprietaryName>Atropine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20170123</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209260</ApplicationNumber>
    <LabelerName>ProPharma Distribution</LabelerName>
    <SubstanceName>ATROPINE SULFATE</SubstanceName>
    <StrengthNumber>.4</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>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250827</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia.</IndicationAndUsage>
    <Description>Atropine Sulfate Injection, USP is a sterile, nonpyrogenic, isotonic, clear solution of atropine sulfate in water for injection with sodium chloride sufficient to render the solution isotonic.  It is administered parenterally by subcutaneous, intramuscular or intravenous injection. Each mL contains atropine sulfate, 0.4 mg; benzyl alcohol, 9 mg; sodium chloride 9 mg.  May contain sulfuric acid for pH adjustment.  pH 3.5 (3.0 to 3.8). Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na +) and chloride (Cl -) ions. Atropine Sulfate, USP is chemically designated lα H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C 17H 23NO 3) 2· H 2SO 4· H 2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula:. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.</Description>
  </NDC>
  <NDC>
    <NDCCode>14335-132-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (14335-132-01)  &gt; 50 mL in 1 VIAL</PackageDescription>
    <NDC11Code>14335-0132-01</NDC11Code>
    <ProductNDC>14335-132</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Nitroprusside</ProprietaryName>
    <NonProprietaryName>Sodium Nitroprusside</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20221231</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215846</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>SODIUM NITROPRUSSIDE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Vasodilation [PE], Vasodilator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium nitroprusside is a direct acting vasodilator indicated for. Immediate reduction of blood pressure ( 1.1). Producing controlled hypotension to reduce bleeding during surgery. ( 1.2). Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. (  1.3).</IndicationAndUsage>
    <Description>Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is. Sodium Nitroprusside has molecular formula Na 2[Fe(CN) 5NO]  2H 2O and molecular weight of 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes [see Dosage and Administration ( 2.1)] . Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 50 mg of sodium nitroprusside (0.5 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 20 mg of sodium nitroprusside (0.2 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 50-mL vial. Each 50 mL of solution in vial contains 10 mg of sodium nitroprusside (0.2 mg/mL), 450 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>14335-133-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (14335-133-01)  &gt; 100 mL in 1 VIAL</PackageDescription>
    <NDC11Code>14335-0133-01</NDC11Code>
    <ProductNDC>14335-133</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Nitroprusside</ProprietaryName>
    <NonProprietaryName>Sodium Nitroprusside</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20221231</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215846</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>SODIUM NITROPRUSSIDE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Vasodilation [PE], Vasodilator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium nitroprusside is a direct acting vasodilator indicated for. Immediate reduction of blood pressure ( 1.1). Producing controlled hypotension to reduce bleeding during surgery. ( 1.2). Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. (  1.3).</IndicationAndUsage>
    <Description>Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is. Sodium Nitroprusside has molecular formula Na 2[Fe(CN) 5NO]  2H 2O and molecular weight of 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes [see Dosage and Administration ( 2.1)] . Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 50 mg of sodium nitroprusside (0.5 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 20 mg of sodium nitroprusside (0.2 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 50-mL vial. Each 50 mL of solution in vial contains 10 mg of sodium nitroprusside (0.2 mg/mL), 450 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>14335-134-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (14335-134-01)  &gt; 100 mL in 1 VIAL</PackageDescription>
    <NDC11Code>14335-0134-01</NDC11Code>
    <ProductNDC>14335-134</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Nitroprusside</ProprietaryName>
    <NonProprietaryName>Sodium Nitroprusside</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20221231</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215846</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>SODIUM NITROPRUSSIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Vasodilation [PE], Vasodilator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium nitroprusside is a direct acting vasodilator indicated for. Immediate reduction of blood pressure ( 1.1). Producing controlled hypotension to reduce bleeding during surgery. ( 1.2). Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. (  1.3).</IndicationAndUsage>
    <Description>Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is. Sodium Nitroprusside has molecular formula Na 2[Fe(CN) 5NO]  2H 2O and molecular weight of 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes [see Dosage and Administration ( 2.1)] . Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 50 mg of sodium nitroprusside (0.5 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 20 mg of sodium nitroprusside (0.2 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 50-mL vial. Each 50 mL of solution in vial contains 10 mg of sodium nitroprusside (0.2 mg/mL), 450 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>14335-430-10</NDCCode>
    <PackageDescription>3 mL in 1 VIAL, GLASS (14335-430-10) </PackageDescription>
    <NDC11Code>14335-0430-10</NDC11Code>
    <ProductNDC>14335-430</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amiodarone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218253</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>AMIODARONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)] . Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary.</IndicationAndUsage>
    <Description>Amiodarone Hydrochloride Injection, USP contains amiodarone hydrochloride, USP (C 25H 29I 2NO 3HCl), a class III antiarrhythmic drug. Amiodarone hydrochloride is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride. Amiodarone hydrochloride has the following structural formula. Amiodarone HCl is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. Amiodarone Hydrochloride Injection, USP is a sterile clear, pale-yellow micellar solution visually free from particulates. Each milliliter of the Amiodarone Hydrochloride Injection, USP formulation contains 50 mg of amiodarone hydrochloride, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection. Amiodarone Hydrochloride Injection, USP is injection administration. Amiodarone Hydrochloride Injection, USP contains polysorbate 80, which is known to leach di-(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) [see Dosage and Administration (2)] .</Description>
  </NDC>
  <NDC>
    <NDCCode>14335-431-10</NDCCode>
    <PackageDescription>9 mL in 1 VIAL, GLASS (14335-431-10) </PackageDescription>
    <NDC11Code>14335-0431-10</NDC11Code>
    <ProductNDC>14335-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amiodarone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218253</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>AMIODARONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)] . Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary.</IndicationAndUsage>
    <Description>Amiodarone Hydrochloride Injection, USP contains amiodarone hydrochloride, USP (C 25H 29I 2NO 3HCl), a class III antiarrhythmic drug. Amiodarone hydrochloride is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride. Amiodarone hydrochloride has the following structural formula. Amiodarone HCl is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. Amiodarone Hydrochloride Injection, USP is a sterile clear, pale-yellow micellar solution visually free from particulates. Each milliliter of the Amiodarone Hydrochloride Injection, USP formulation contains 50 mg of amiodarone hydrochloride, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection. Amiodarone Hydrochloride Injection, USP is injection administration. Amiodarone Hydrochloride Injection, USP contains polysorbate 80, which is known to leach di-(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) [see Dosage and Administration (2)] .</Description>
  </NDC>
  <NDC>
    <NDCCode>14335-432-10</NDCCode>
    <PackageDescription>18 mL in 1 VIAL, GLASS (14335-432-10) </PackageDescription>
    <NDC11Code>14335-0432-10</NDC11Code>
    <ProductNDC>14335-432</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amiodarone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218253</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>AMIODARONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)] . Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary.</IndicationAndUsage>
    <Description>Amiodarone Hydrochloride Injection, USP contains amiodarone hydrochloride, USP (C 25H 29I 2NO 3HCl), a class III antiarrhythmic drug. Amiodarone hydrochloride is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride. Amiodarone hydrochloride has the following structural formula. Amiodarone HCl is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. Amiodarone Hydrochloride Injection, USP is a sterile clear, pale-yellow micellar solution visually free from particulates. Each milliliter of the Amiodarone Hydrochloride Injection, USP formulation contains 50 mg of amiodarone hydrochloride, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection. Amiodarone Hydrochloride Injection, USP is injection administration. Amiodarone Hydrochloride Injection, USP contains polysorbate 80, which is known to leach di-(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) [see Dosage and Administration (2)] .</Description>
  </NDC>
  <NDC>
    <NDCCode>14335-440-01</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (14335-440-01)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>14335-0440-01</NDC11Code>
    <ProductNDC>14335-440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240319</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218412</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.</IndicationAndUsage>
    <Description>Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)- m-hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C 9H 14ClNO 2with a molecular weight of 203.66 g/mol. Its structural formula is depicted below:. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>14335-441-01</NDCCode>
    <PackageDescription>10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (14335-441-01)  / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
    <NDC11Code>14335-0441-01</NDC11Code>
    <ProductNDC>14335-441</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240319</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218412</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.</IndicationAndUsage>
    <Description>Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)- m-hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C 9H 14ClNO 2with a molecular weight of 203.66 g/mol. Its structural formula is depicted below:. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>14335-442-01</NDCCode>
    <PackageDescription>1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (14335-442-01)  / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
    <NDC11Code>14335-0442-01</NDC11Code>
    <ProductNDC>14335-442</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240319</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218412</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.</IndicationAndUsage>
    <Description>Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)- m-hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C 9H 14ClNO 2with a molecular weight of 203.66 g/mol. Its structural formula is depicted below:. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>14335-680-01</NDCCode>
    <PackageDescription>5 kg in 1 DRUM (14335-680-01) </PackageDescription>
    <NDC11Code>14335-0680-01</NDC11Code>
    <ProductNDC>14335-680</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Tecovirimat Monohydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230920</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>TECOVIRIMAT MONOHYDRATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>kg/5kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-12-07</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20-SEP-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0173-0922-45</NDCCode>
    <PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45) </PackageDescription>
    <NDC11Code>00173-0922-45</NDC11Code>
    <ProductNDC>0173-0922</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Blujepa</ProprietaryName>
    <NonProprietaryName>Gepotidacin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250325</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA218230</ApplicationNumber>
    <LabelerName>GlaxoSmithKline LLC</LabelerName>
    <SubstanceName>GEPOTIDACIN MESYLATE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Topoisomerase 2 Inhibitors [MoA], Topoisomerase 4 Inhibitors [MoA], Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250325</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: 1 Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). (1.1), 2 Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. (1.2, 6.1).</IndicationAndUsage>
    <Description>BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is (R)-2-((4-(((3,4-dihydro-2H-pyrano[2,3-c]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3H,8H-2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C24H28N6O3●CH4O3S●2H2O and its molecular mass is 580.66. The structural formula is shown below. *stereogenic center. Each BLUJEPA oral tablet contains gepotidacin 750 mg (equivalent to 910.7 mg of gepotidacin mesylate [anhydrous]). Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>14335-580-20</NDCCode><NonProprietaryName>Gadobutrol</NonProprietaryName></NDC><NDC><NDCCode>14335-080-01</NDCCode><ProprietaryName>Voriconazole</ProprietaryName><NonProprietaryName>Voriconazole</NonProprietaryName></NDC><NDC><NDCCode>14335-120-01</NDCCode><ProprietaryName>Daptomycin</ProprietaryName><NonProprietaryName>Daptomycin</NonProprietaryName></NDC><NDC><NDCCode>14335-171-01</NDCCode><ProprietaryName>Dobutamine</ProprietaryName><NonProprietaryName>Dobutamine</NonProprietaryName></NDC><NDC><NDCCode>14335-330-10</NDCCode><ProprietaryName>Lacosamide</ProprietaryName><NonProprietaryName>Lacosamide</NonProprietaryName></NDC><NDC><NDCCode>14335-390-20</NDCCode><NonProprietaryName>Gadoteridol</NonProprietaryName></NDC><NDC><NDCCode>14335-450-01</NDCCode><NonProprietaryName>Voriconazole</NonProprietaryName></NDC><NDC><NDCCode>14335-730-10</NDCCode><ProprietaryName>Voriconazole</ProprietaryName><NonProprietaryName>Voriconazole</NonProprietaryName></NDC><NDC><NDCCode>49283-580-20</NDCCode><ProprietaryName>Menthol, Camphor</ProprietaryName><NonProprietaryName>Menthol, Camphor</NonProprietaryName></NDC><NDC><NDCCode>51079-580-20</NDCCode><ProprietaryName>Thioridazine Hydrochloride</ProprietaryName><NonProprietaryName>Thioridazine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>52125-580-03</NDCCode><ProprietaryName>Naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>52125-580-20</NDCCode><ProprietaryName>Naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>55513-580-01</NDCCode><NonProprietaryName>Voriconazole</NonProprietaryName></NDC><NDC><NDCCode>55700-580-20</NDCCode><ProprietaryName>Diphenhydramine Hydrochloride</ProprietaryName><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>58980-580-20</NDCCode><ProprietaryName>Alphaquin Hp</ProprietaryName><NonProprietaryName>Hydroquinone, Octinoxate, And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>59310-580-20</NDCCode><ProprietaryName>Proair Respiclick</ProprietaryName><NonProprietaryName>Albuterol Sulfate</NonProprietaryName></NDC><NDC><NDCCode>63323-580-20</NDCCode><ProprietaryName>Atropine Sulfate</ProprietaryName><NonProprietaryName>Atropine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>70934-580-20</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>84549-580-20</NDCCode><ProprietaryName>Atropine Sulfate</ProprietaryName><NonProprietaryName>Atropine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>14335-132-01</NDCCode><ProprietaryName>Sodium Nitroprusside</ProprietaryName><NonProprietaryName>Sodium Nitroprusside</NonProprietaryName></NDC><NDC><NDCCode>14335-133-01</NDCCode><ProprietaryName>Sodium Nitroprusside</ProprietaryName><NonProprietaryName>Sodium Nitroprusside</NonProprietaryName></NDC><NDC><NDCCode>14335-134-01</NDCCode><ProprietaryName>Sodium Nitroprusside</ProprietaryName><NonProprietaryName>Sodium Nitroprusside</NonProprietaryName></NDC><NDC><NDCCode>14335-430-10</NDCCode><ProprietaryName>Amiodarone Hydrochloride</ProprietaryName><NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>14335-431-10</NDCCode><ProprietaryName>Amiodarone Hydrochloride</ProprietaryName><NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>14335-432-10</NDCCode><ProprietaryName>Amiodarone Hydrochloride</ProprietaryName><NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>14335-440-01</NDCCode><ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>14335-441-01</NDCCode><ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>14335-442-01</NDCCode><ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>14335-680-01</NDCCode><NonProprietaryName>Tecovirimat Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>0173-0922-45</NDCCode><ProprietaryName>Blujepa</ProprietaryName><NonProprietaryName>Gepotidacin</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "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."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
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      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "07042-4837",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "973-429-6196",
      "FirstLinePracticeLocationAddress": "1 BAY AVE",
      "PracticeLocationAddressCityName": "MONTCLAIR",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "07042-4837",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "973-429-6196",
      "EnumerationDate": "03/23/2018",
      "LastUpdateDate": "03/23/2018",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "390200000X",
      "Taxonomy1": "Student in an Organized Health Care Education/Training Program",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1629068499",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "FAHOURY",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "4411 N HOLLAND SYLVANIA RD",
      "SecondLineMailingAddress": "SUITE 201",
      "MailingAddressCityName": "TOLEDO",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "43623-3525",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "419-843-3627",
      "MailingAddressFaxNumber": "419-843-9697",
      "FirstLinePracticeLocationAddress": "4411 N HOLLAND SYLVANIA RD",
      "SecondLinePracticeLocationAddress": "SUITE 201",
      "PracticeLocationAddressCityName": "TOLEDO",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "43623-3525",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "419-843-3627",
      "PracticeLocationAddressFaxNumber": "419-843-9697",
      "EnumerationDate": "10/24/2005",
      "LastUpdateDate": "09/02/2011",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "35086663",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2621621",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH",
      "OtherIdentifier2": "P00401238",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OH",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE"
    },
    {
      "NPI": "1033186986",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "NICOLA",
      "FirstName": "RANIA",
      "MiddleName": "SOLIMAN",
      "NamePrefix": "DR.",
      "Credential": "DDS",
      "FirstLineMailingAddress": "110 S WOODLAND ST",
      "MailingAddressCityName": "WINTER GARDEN",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "34787-3546",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "407-905-8827",
      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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