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How to Find 59212-423-10 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "59212-423-10",
      "PackageDescription": "10 mL in 1 BOTTLE (59212-423-10) ",
      "NDC11Code": "59212-0423-10",
      "ProductNDC": "59212-423",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Donnatal",
      "NonProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
      "DosageFormName": "ELIXIR",
      "RouteName": "ORAL",
      "StartMarketingDate": "19801230",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Advanz Pharma (US) Corp.",
      "SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
      "StrengthNumber": "16.2; .1037; .0194; .0065",
      "StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
      "Pharm_Classes": "Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19801230",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59212-423-12",
      "PackageDescription": "12 BOTTLE in 1 PACKAGE (59212-423-12)  > 10 mL in 1 BOTTLE (59212-423-11)",
      "NDC11Code": "59212-0423-12",
      "ProductNDC": "59212-423",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Donnatal",
      "NonProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
      "DosageFormName": "ELIXIR",
      "RouteName": "ORAL",
      "StartMarketingDate": "19801230",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA086661",
      "LabelerName": "Concordia Pharmaceuticals Inc.",
      "SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
      "StrengthNumber": "16.2; .1037; .0194; .0065",
      "StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
      "Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-02-13"
    },
    {
      "NDCCode": "59212-423-04",
      "PackageDescription": "118 mL in 1 BOTTLE (59212-423-04) ",
      "NDC11Code": "59212-0423-04",
      "ProductNDC": "59212-423",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Donnatal",
      "NonProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
      "DosageFormName": "ELIXIR",
      "RouteName": "ORAL",
      "StartMarketingDate": "19801230",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Advanz Pharma (US) Corp.",
      "SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
      "StrengthNumber": "16.2; .1037; .0194; .0065",
      "StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
      "Pharm_Classes": "Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19801230",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59212-423-16",
      "PackageDescription": "473 mL in 1 BOTTLE (59212-423-16) ",
      "NDC11Code": "59212-0423-16",
      "ProductNDC": "59212-423",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Donnatal",
      "NonProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
      "DosageFormName": "ELIXIR",
      "RouteName": "ORAL",
      "StartMarketingDate": "19801230",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Advanz Pharma (US) Corp.",
      "SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
      "StrengthNumber": "16.2; .1037; .0194; .0065",
      "StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
      "Pharm_Classes": "Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19801230",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59212-111-10",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (59212-111-10)  > 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "59212-0111-10",
      "ProductNDC": "59212-111",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nilandron",
      "NonProprietaryName": "Nilutamide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130715",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020169",
      "LabelerName": "Concordia Pharmaceuticals Inc.",
      "SubstanceName": "NILUTAMIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-10-27",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "59212-111-14",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (59212-111-14)  / 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "59212-0111-14",
      "ProductNDC": "59212-111",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nilandron",
      "NonProprietaryName": "Nilutamide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130715",
      "EndMarketingDate": "20260331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020169",
      "LabelerName": "Advanz Pharma (US) Corp.",
      "SubstanceName": "NILUTAMIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20130715",
      "EndMarketingDatePackage": "20260331",
      "SamplePackage": "N",
      "IndicationAndUsage": "NILANDRON tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2). For maximum benefit, NILANDRON treatment must begin on the same day as or on the day after surgical castration.",
      "Description": "NILANDRON® tablets contain nilutamide, a nonsteroidal, orally active antiandrogen having the chemical name 5,5-dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-2,4-imidazolidinedione with the following structural formula. Nilutamide is a microcrystalline, white to practically white powder with a molecular weight of 317.25. Its molecular formula is C12H10F3N3O4. It is freely soluble in ethyl acetate, acetone, chloroform, ethyl alcohol, dichloromethane, and methanol. It is slightly soluble in water [<0.1% W/V at 25°C (77°F)]. It melts between 153°C and 156°C (307.4°F and 312.8°F). Each NILANDRON tablet contains 150 mg of nilutamide. Other ingredients in NILANDRON tablets are corn starch, lactose, povidone, docusate sodium, magnesium stearate, and talc."
    },
    {
      "NDCCode": "59212-200-10",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-10) ",
      "NDC11Code": "59212-0200-10",
      "ProductNDC": "59212-200",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Uroxatral",
      "NonProprietaryName": "Alfuzosin Hcl",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130603",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021287",
      "LabelerName": "Advanz Pharma (US) Corp.",
      "SubstanceName": "ALFUZOSIN HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130603",
      "SamplePackage": "N",
      "IndicationAndUsage": "UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.",
      "Description": "Each UROXATRAL extended-release tablet contains 10 mg alfuzosin hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The empirical formula of alfuzosin hydrochloride is C19H27N5O4HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is. The tablet also contains the following inactive ingredients: colloidal silicon dioxide (NF), ethylcellulose (NF), hydrogenated castor oil (NF), hydroxypropyl methylcellulose (USP), magnesium stearate (NF), mannitol (USP), microcrystalline cellulose (NF), povidone (USP), and yellow ferric oxide (NF)."
    },
    {
      "NDCCode": "59212-242-56",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (59212-242-56)  / 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "59212-0242-56",
      "ProductNDC": "59212-242",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lanoxin",
      "NonProprietaryName": "Digoxin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120930",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020405",
      "LabelerName": "Advanz Pharma (US) Corp.",
      "SubstanceName": "DIGOXIN",
      "StrengthNumber": ".125",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120930",
      "SamplePackage": "N",
      "IndicationAndUsage": "LANOXIN is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3  Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
      "Description": "LANOXIN (digoxin) is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium.  These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. LANOXIN is supplied as 62.5 mcg (unscored), 125 mcg (scored), and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn and potato starches, lactose and magnesium stearate. The 125 mcg tablets contain D&C Yellow No. 10 and FD&C Yellow No. 6, and the 62.5 mcg tablets contain FD&C Yellow No. 6."
    },
    {
      "NDCCode": "59212-249-56",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (59212-249-56)  > 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "59212-0249-56",
      "ProductNDC": "59212-249",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lanoxin",
      "NonProprietaryName": "Digoxin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120930",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020405",
      "LabelerName": "Concordia Pharmaceuticals Inc.",
      "SubstanceName": "DIGOXIN",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cardiac Glycoside [EPC],Cardiac Glycosides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20120930",
      "EndMarketingDatePackage": "20200930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59212-422-10",
      "PackageDescription": "10 mL in 1 BOTTLE (59212-422-10) ",
      "NDC11Code": "59212-0422-10",
      "ProductNDC": "59212-422",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Donnatal",
      "NonProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
      "DosageFormName": "ELIXIR",
      "RouteName": "ORAL",
      "StartMarketingDate": "19801230",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Advanz Pharma (US) Corp.",
      "SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
      "StrengthNumber": "16.2; .1037; .0194; .0065",
      "StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
      "Pharm_Classes": "Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19801230",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59212-422-12",
      "PackageDescription": "12 BOTTLE in 1 PACKAGE (59212-422-12)  > 10 mL in 1 BOTTLE (59212-422-11)",
      "NDC11Code": "59212-0422-12",
      "ProductNDC": "59212-422",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Donnatal",
      "NonProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
      "DosageFormName": "ELIXIR",
      "RouteName": "ORAL",
      "StartMarketingDate": "19801230",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA086661",
      "LabelerName": "Concordia Pharmaceuticals Inc.",
      "SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
      "StrengthNumber": "16.2; .1037; .0194; .0065",
      "StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
      "Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-02-13"
    },
    {
      "NDCCode": "59212-425-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (59212-425-10) ",
      "NDC11Code": "59212-0425-10",
      "ProductNDC": "59212-425",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Donnatal",
      "NonProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19801230",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Advanz Pharma (US) Corp.",
      "SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
      "StrengthNumber": "16.2; .1037; .0194; .0065",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19801230",
      "SamplePackage": "N",
      "Description": "Donnatal® Tablets. Each Donnatal® Tablet contains. Phenobarbital, USP..................................... 16.2 mg Hyoscyamine Sulfate, USP...................... 0.1037 mg Atropine Sulfate, USP .............................0.0194 mg Scopolamine Hydrobromide, USP ...........0.0065 mg."
    },
    {
      "NDCCode": "59212-447-10",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (59212-447-10) ",
      "NDC11Code": "59212-0447-10",
      "ProductNDC": "59212-447",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Parnate",
      "NonProprietaryName": "Tranylcypromine Sulfate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130114",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA012342",
      "LabelerName": "Advanz Pharma (US) Corp.",
      "SubstanceName": "TRANYLCYPROMINE SULFATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-07-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130114",
      "SamplePackage": "N",
      "IndicationAndUsage": "PARNATE is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. PARNATE is not indicated for the initial treatment of MDD due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions [see Contraindications (4), Warnings and Precautions (5), and Drug Interactions (7)].",
      "Description": "Tranylcypromine sulfate, the active ingredient of PARNATE, is a non-hydrazine MAOI. The chemical name is (±)‑trans‑2‑phenylcyclopropylamine sulfate (2:1). The molecular formula is (C9H11N)2H2SO4 and its molecular weight is 364.46. The structural formula is. PARNATE film-coated tablets are intended for oral administration. Each round, rose‑red tablet is debossed on one side with the product name “PARNATE” and “SB” and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine. Inactive ingredients consist of microcrystalline cellulose, anhydrous citric acid, croscarmellose sodium, D&C Red No. 7, FD&C Blue No. 2, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, talc, titanium dioxide, carnauba wax, polyethylene glycol 400 and 8000, and hypromellose."
    },
    {
      "NDCCode": "59212-562-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE (59212-562-10) ",
      "NDC11Code": "59212-0562-10",
      "ProductNDC": "59212-562",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Plaquenil",
      "NonProprietaryName": "Hydroxychloroquine Sulfate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130628",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA009768",
      "LabelerName": "Advanz Pharma (US) Corp.",
      "SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130628",
      "SamplePackage": "N",
      "IndicationAndUsage": "PLAQUENIL is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1) Treatment of rheumatoid arthritis in adults.(1.2) Treatment of systemic lupus erythematosus in adults.(1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4) Limitations of Use (1.1):PLAQUENIL is not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.",
      "Description": "PLAQUENIL (hydroxychloroquine sulfate) is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4- quinolyl) amino]pentyl] ethylamino]ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or off-white crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether.  PLAQUENIL (hydroxychloroquine sulfate) tablets for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: black iron oxide, carnauba wax, corn starch, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide."
    },
    {
      "NDCCode": "59212-680-10",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (59212-680-10) ",
      "NDC11Code": "59212-0680-10",
      "ProductNDC": "59212-680",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zonegran",
      "NonProprietaryName": "Zonisamide",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20000327",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020789",
      "LabelerName": "Advanz Pharma (US) Corp.",
      "SubstanceName": "ZONISAMIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20000327",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZONEGRAN is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
      "Description": "ZONEGRAN® (zonisamide) is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The empirical formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is. ZONEGRAN is supplied for oral administration as capsules containing 25 mg or 100 mg zonisamide. Each 25 mg capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, sodium lauryl sulfate, gelatin, and titanium dioxide. Each 100 mg capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, sodium lauryl sulfate, gelatin, titanium dioxide, FD&C Red No. 40 and FD&C Yellow No. 6."
    },
    {
      "NDCCode": "59212-681-10",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (59212-681-10) ",
      "NDC11Code": "59212-0681-10",
      "ProductNDC": "59212-681",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zonegran",
      "NonProprietaryName": "Zonisamide",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20000327",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020789",
      "LabelerName": "Advanz Pharma (US) Corp.",
      "SubstanceName": "ZONISAMIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20000327",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZONEGRAN is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
      "Description": "ZONEGRAN® (zonisamide) is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The empirical formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is. ZONEGRAN is supplied for oral administration as capsules containing 25 mg or 100 mg zonisamide. Each 25 mg capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, sodium lauryl sulfate, gelatin, and titanium dioxide. Each 100 mg capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, sodium lauryl sulfate, gelatin, titanium dioxide, FD&C Red No. 40 and FD&C Yellow No. 6."
    },
    {
      "NDCCode": "59212-705-10",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (59212-705-10) ",
      "NDC11Code": "59212-0705-10",
      "ProductNDC": "59212-705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Salagen",
      "NonProprietaryName": "Pilocarpine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020237",
      "LabelerName": "Advanz Pharma (US) Corp.",
      "SubstanceName": "PILOCARPINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190901",
      "SamplePackage": "N",
      "IndicationAndUsage": "SALAGEN® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.",
      "Description": "SALAGEN® Tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder which is soluble in water and alcohol and virtually insoluble in most non-polar solvents. Pilocarpine hydrochloride, with a chemical name of (3S-cis)-2(3H)-Furanone, 3-ethyl-dihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl] mono-hydrochloride, has a molecular weight of 244.72. Each 5 mg SALAGEN® Tablet for oral administration contains 5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet, the tablet’s film coating, and polishing are: carnauba wax, hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide and other ingredients. Each 7.5 mg SALAGEN® Tablet for oral administration contains 7.5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet, the tablet’s film coating, and polishing are: carnauba wax, hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide, FD&C blue#2 aluminum lake, and other ingredients."
    },
    {
      "NDCCode": "59212-775-10",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (59212-775-10) ",
      "NDC11Code": "59212-0775-10",
      "ProductNDC": "59212-775",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Salagen",
      "NonProprietaryName": "Pilocarpine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020237",
      "LabelerName": "Advanz Pharma (US) Corp.",
      "SubstanceName": "PILOCARPINE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190901",
      "SamplePackage": "N",
      "IndicationAndUsage": "SALAGEN® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.",
      "Description": "SALAGEN® Tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder which is soluble in water and alcohol and virtually insoluble in most non-polar solvents. Pilocarpine hydrochloride, with a chemical name of (3S-cis)-2(3H)-Furanone, 3-ethyl-dihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl] mono-hydrochloride, has a molecular weight of 244.72. Each 5 mg SALAGEN® Tablet for oral administration contains 5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet, the tablet’s film coating, and polishing are: carnauba wax, hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide and other ingredients. Each 7.5 mg SALAGEN® Tablet for oral administration contains 7.5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet, the tablet’s film coating, and polishing are: carnauba wax, hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide, FD&C blue#2 aluminum lake, and other ingredients."
    },
    {
      "NDCCode": "16590-423-10",
      "PackageDescription": "10 CAPSULE in 1 BOTTLE (16590-423-10)",
      "NDC11Code": "16590-0423-10",
      "ProductNDC": "16590-423",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loperamide Hydrochloride",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA073192",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.",
      "Description": "Loperamide hydrochloride is a white to slightly yellow powder and is freely soluble in methanol, isopropyl alcohol, chloroform and slightly soluble in water. Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Its structural formula is. C29H33ClN2O2HCl M.W. 513.51. Loperamide hydrochloride is available in 2 mg capsules. Each capsule, for oral administration, contains 2 mg loperamide hydrochloride. Loperamide hydrochloride capsules USP also contain the inactive ingredients: dimethylpolysiloxane, gelatin, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, pregelatinized corn starch, magnesium stearate, shellac, and titanium dioxide."
    },
    {
      "NDCCode": "33332-423-10",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (33332-423-10)  / 5 mL in 1 VIAL, MULTI-DOSE (33332-423-11) ",
      "NDC11Code": "33332-0423-10",
      "ProductNDC": "33332-423",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Afluria Quadrivalent",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/darwin/6/2021 Ivr-227 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (propiolactone Inactivated), Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20230701",
      "EndMarketingDate": "20240731",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125254",
      "LabelerName": "Seqirus PTY LTD.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/6/2021 IVR-227 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230701",
      "EndMarketingDatePackage": "20240731",
      "SamplePackage": "N",
      "IndicationAndUsage": "AFLURIA® QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. AFLURIA QUADRIVALENT is approved for use in persons 6 months of age and older.",
      "Description": "AFLURIA QUADRIVALENT, Influenza Vaccine for intramuscular injection, is a sterile, clear, colorless to slightly opalescent suspension with some sediment that resuspends upon shaking to form a homogeneous suspension. AFLURIA QUADRIVALENT is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the virus is purified in a sucrose density gradient using continuous flow zonal centrifugation. The purified virus is inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce a “split virion”. The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution. AFLURIA QUADRIVALENT is standardized according to USPHS requirements for the 2023-2024 influenza season and is formulated to contain 60 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the four influenza strains recommended for the 2023-2024 Northern Hemisphere influenza season:. A/Victoria/4897/2022 IVR-238 (an A/Victoria/4897/2022 (H1N1)pdm09-like virus), A/Darwin/6/2021 IVR-227 (an A/Darwin/9/2021 (H3N2)-like virus, B/Austria/1359417/2021 BVR-26 (a B/Austria/1359417/2021-like virus) and B/Phuket/3073/2013 BVR-1B (a B/Phuket/3073/2013-like virus). A 0.25 mL dose contains 7.5 mcg HA of each of the same four influenza strains. Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentation. This presentation does not contain preservative. The multi-dose presentation contains thimerosal added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury and each 0.25 mL dose contains 12.25 mcg of mercury. A single 0.5 mL dose of AFLURIA QUADRIVALENT contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (0.5 mcg). From the manufacturing process, each 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (< 1 mcg), sucrose (< 10 mcg), neomycin sulfate (≤ 81.8 nanograms [ng]), polymyxin B (≤ 14 ng), beta-propiolactone (≤ 1.5 ng) and hydrocortisone (≤ 0.56 ng). A single 0.25 mL dose of AFLURIA QUADRIVALENT contains half of these quantities. The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial are not made with natural rubber latex."
    },
    {
      "NDCCode": "33342-423-10",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (33342-423-10) ",
      "NDC11Code": "33342-0423-10",
      "ProductNDC": "33342-423",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lurasidone Hydrochloride",
      "NonProprietaryName": "Lurasidone Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230609",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212124",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "LURASIDONE HYDROCHLORIDE",
      "StrengthNumber": "120",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230609",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lurasidone hydrochloride is indicated for:.  Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)].   Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].   Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].",
      "Description": "Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR, 4S, 7R, 7aS)-2-{(1R, 2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1yl-methyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate. The film-coating consists of polyethylene glycol, titanium dioxide and yellow iron oxide (80 mg only)."
    },
    {
      "NDCCode": "42291-423-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (42291-423-10) ",
      "NDC11Code": "42291-0423-10",
      "ProductNDC": "42291-423",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Losartan Potassium Tablets, 50 Mg",
      "NonProprietaryName": "Losartan Potassium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181023",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201170",
      "LabelerName": "AvKARE",
      "SubstanceName": "LOSARTAN POTASSIUM",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-09-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20181023",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42806-423-10",
      "PackageDescription": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42806-423-10) ",
      "NDC11Code": "42806-0423-10",
      "ProductNDC": "42806-423",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230807",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209314",
      "LabelerName": "Epic Pharma, LLC",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230807",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium Chloride Extended-Release Tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
      "Description": "Potassium Chloride Extended-Release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-Release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: colloidal silicon dioxide, hydroxypropyl cellulose and hydrogenated vegetable oil. The film coating contains lecithin, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "43602-423-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (43602-423-10) ",
      "NDC11Code": "43602-0423-10",
      "ProductNDC": "43602-423",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levothyroxine Sodium",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215259",
      "LabelerName": "Ascent Pharmaceuticals, Inc",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": ".125",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230118",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
      "Description": "Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine sodium tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxyanisole, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate and color additive(s). Table 6 provides a listing of the color additives by tablet strength. FDA approved Dissolution test differs from the USP dissolution test. FDA approved Assay test differs from the USP assay test."
    },
    {
      "NDCCode": "44567-423-10",
      "PackageDescription": "10 BAG in 1 CARTON (44567-423-10)  / 1000 mL in 1 BAG",
      "NDC11Code": "44567-0423-10",
      "ProductNDC": "44567-423",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Magnesium Sulfate In Water",
      "NonProprietaryName": "Magnesium Sulfate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180109",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207350",
      "LabelerName": "WG Critical Care, LLC",
      "SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
      "StrengthNumber": "40",
      "StrengthUnit": "g/1000mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180109",
      "SamplePackage": "N",
      "IndicationAndUsage": "Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.",
      "Description": "Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. SeeHOW SUPPLIEDsection for the content and characteristics of available dosage forms and sizes. Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4  7H2O, colorless crystals or white powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The single port bag is made of Nexcel M312A material, a 5-layer, polyolefin based on co-extrude film. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "49281-423-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-423-50)  / .5 mL in 1 SYRINGE, GLASS (49281-423-88) ",
      "NDC11Code": "49281-0423-50",
      "ProductNDC": "49281-423",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20230630",
      "EndMarketingDate": "20240630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230630",
      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone Quadrivalent is approved for use in persons 6 months of age and older.",
      "Description": "Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone Quadrivalent. The Fluzone Quadrivalent prefilled syringe and multi-dose vial presentations are not made with natural rubber latex. Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2023-2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. The single-dose, pre-filled syringe (0.5 mL) is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
    },
    {
      "NDCCode": "49643-423-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49643-423-10) ",
      "NDC11Code": "49643-0423-10",
      "ProductNDC": "49643-423",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Nettle Pollen",
      "NonProprietaryName": "Urtica Dioica",
      "DosageFormName": "INJECTION",
      "RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740312",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102211",
      "LabelerName": "Allermed Laboratories, Inc.",
      "SubstanceName": "URTICA DIOICA POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19740312",
      "SamplePackage": "N",
      "IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
      "Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
    },
    {
      "NDCCode": "50157-423-10",
      "PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (50157-423-10) ",
      "NDC11Code": "50157-0423-10",
      "ProductNDC": "50157-423",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210305",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Brands International Corporation",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210305",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses for handwashing or decrease bacteria to the skin."
    },
    {
      "NDCCode": "50742-423-10",
      "PackageDescription": "1 VIAL in 1 CARTON (50742-423-10)  > 10 mL in 1 VIAL",
      "NDC11Code": "50742-0423-10",
      "ProductNDC": "50742-423",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluorouracil",
      "NonProprietaryName": "Fluorouracil",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20191221",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209219",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "FLUOROURACIL",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20191221",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51013-423-08",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-423-08)  > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "51013-0423-08",
      "ProductNDC": "51013-423",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gas Relief",
      "NonProprietaryName": "Simethicone",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171122",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part332",
      "LabelerName": "PuraCap Pharmaceutical LLC",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "125",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "IndicationAndUsage": "for the relief of: 1 pressure, bloating, and fullness commonly referred to as gas."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"59212-423-10","ProprietaryName":"Donnatal","NonProprietaryName":"Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide"},{"NDCCode":"59212-423-12","ProprietaryName":"Donnatal","NonProprietaryName":"Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide"},{"NDCCode":"59212-423-04","ProprietaryName":"Donnatal","NonProprietaryName":"Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide"},{"NDCCode":"59212-423-16","ProprietaryName":"Donnatal","NonProprietaryName":"Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide"},{"NDCCode":"59212-111-10","ProprietaryName":"Nilandron","NonProprietaryName":"Nilutamide"},{"NDCCode":"59212-111-14","ProprietaryName":"Nilandron","NonProprietaryName":"Nilutamide"},{"NDCCode":"59212-200-10","ProprietaryName":"Uroxatral","NonProprietaryName":"Alfuzosin Hcl"},{"NDCCode":"59212-242-56","ProprietaryName":"Lanoxin","NonProprietaryName":"Digoxin"},{"NDCCode":"59212-249-56","ProprietaryName":"Lanoxin","NonProprietaryName":"Digoxin"},{"NDCCode":"59212-422-10","ProprietaryName":"Donnatal","NonProprietaryName":"Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide"},{"NDCCode":"59212-422-12","ProprietaryName":"Donnatal","NonProprietaryName":"Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide"},{"NDCCode":"59212-425-10","ProprietaryName":"Donnatal","NonProprietaryName":"Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide"},{"NDCCode":"59212-447-10","ProprietaryName":"Parnate","NonProprietaryName":"Tranylcypromine Sulfate"},{"NDCCode":"59212-562-10","ProprietaryName":"Plaquenil","NonProprietaryName":"Hydroxychloroquine Sulfate"},{"NDCCode":"59212-680-10","ProprietaryName":"Zonegran","NonProprietaryName":"Zonisamide"},{"NDCCode":"59212-681-10","ProprietaryName":"Zonegran","NonProprietaryName":"Zonisamide"},{"NDCCode":"59212-705-10","ProprietaryName":"Salagen","NonProprietaryName":"Pilocarpine Hydrochloride"},{"NDCCode":"59212-775-10","ProprietaryName":"Salagen","NonProprietaryName":"Pilocarpine Hydrochloride"},{"NDCCode":"16590-423-10","ProprietaryName":"Loperamide Hydrochloride","NonProprietaryName":"Loperamide Hydrochloride"},{"NDCCode":"33332-423-10","ProprietaryName":"Afluria Quadrivalent","NonProprietaryName":"Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/darwin/6/2021 Ivr-227 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (propiolactone Inactivated), Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)"},{"NDCCode":"33342-423-10","ProprietaryName":"Lurasidone Hydrochloride","NonProprietaryName":"Lurasidone Hydrochloride"},{"NDCCode":"42291-423-10","ProprietaryName":"Losartan Potassium Tablets, 50 Mg","NonProprietaryName":"Losartan Potassium"},{"NDCCode":"42806-423-10","ProprietaryName":"Potassium Chloride","NonProprietaryName":"Potassium Chloride"},{"NDCCode":"43602-423-10","ProprietaryName":"Levothyroxine Sodium","NonProprietaryName":"Levothyroxine Sodium"},{"NDCCode":"44567-423-10","ProprietaryName":"Magnesium Sulfate In Water","NonProprietaryName":"Magnesium Sulfate"},{"NDCCode":"49281-423-50","ProprietaryName":"Fluzone Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49643-423-10","ProprietaryName":"Nettle Pollen","NonProprietaryName":"Urtica Dioica"},{"NDCCode":"50157-423-10","ProprietaryName":"Antibacterial","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"50742-423-10","ProprietaryName":"Fluorouracil","NonProprietaryName":"Fluorouracil"},{"NDCCode":"51013-423-08","ProprietaryName":"Gas Relief","NonProprietaryName":"Simethicone"}]}
                    
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<NDCList>
  <NDC>
    <NDCCode>59212-423-10</NDCCode>
    <PackageDescription>10 mL in 1 BOTTLE (59212-423-10) </PackageDescription>
    <NDC11Code>59212-0423-10</NDC11Code>
    <ProductNDC>59212-423</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Donnatal</ProprietaryName>
    <NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName>
    <DosageFormName>ELIXIR</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19801230</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>16.2; .1037; .0194; .0065</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19801230</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59212-423-12</NDCCode>
    <PackageDescription>12 BOTTLE in 1 PACKAGE (59212-423-12)  &gt; 10 mL in 1 BOTTLE (59212-423-11)</PackageDescription>
    <NDC11Code>59212-0423-12</NDC11Code>
    <ProductNDC>59212-423</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Donnatal</ProprietaryName>
    <NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName>
    <DosageFormName>ELIXIR</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19801230</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA086661</ApplicationNumber>
    <LabelerName>Concordia Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>16.2; .1037; .0194; .0065</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-02-13</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>59212-423-04</NDCCode>
    <PackageDescription>118 mL in 1 BOTTLE (59212-423-04) </PackageDescription>
    <NDC11Code>59212-0423-04</NDC11Code>
    <ProductNDC>59212-423</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Donnatal</ProprietaryName>
    <NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName>
    <DosageFormName>ELIXIR</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19801230</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>16.2; .1037; .0194; .0065</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19801230</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59212-423-16</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (59212-423-16) </PackageDescription>
    <NDC11Code>59212-0423-16</NDC11Code>
    <ProductNDC>59212-423</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Donnatal</ProprietaryName>
    <NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName>
    <DosageFormName>ELIXIR</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19801230</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>16.2; .1037; .0194; .0065</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19801230</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59212-111-10</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (59212-111-10)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59212-0111-10</NDC11Code>
    <ProductNDC>59212-111</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nilandron</ProprietaryName>
    <NonProprietaryName>Nilutamide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130715</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020169</ApplicationNumber>
    <LabelerName>Concordia Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>NILUTAMIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-27</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>59212-111-14</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (59212-111-14)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59212-0111-14</NDC11Code>
    <ProductNDC>59212-111</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nilandron</ProprietaryName>
    <NonProprietaryName>Nilutamide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130715</StartMarketingDate>
    <EndMarketingDate>20260331</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020169</ApplicationNumber>
    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>NILUTAMIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20130715</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NILANDRON tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2). For maximum benefit, NILANDRON treatment must begin on the same day as or on the day after surgical castration.</IndicationAndUsage>
    <Description>NILANDRON® tablets contain nilutamide, a nonsteroidal, orally active antiandrogen having the chemical name 5,5-dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-2,4-imidazolidinedione with the following structural formula. Nilutamide is a microcrystalline, white to practically white powder with a molecular weight of 317.25. Its molecular formula is C12H10F3N3O4. It is freely soluble in ethyl acetate, acetone, chloroform, ethyl alcohol, dichloromethane, and methanol. It is slightly soluble in water [&lt;0.1% W/V at 25°C (77°F)]. It melts between 153°C and 156°C (307.4°F and 312.8°F). Each NILANDRON tablet contains 150 mg of nilutamide. Other ingredients in NILANDRON tablets are corn starch, lactose, povidone, docusate sodium, magnesium stearate, and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>59212-200-10</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-10) </PackageDescription>
    <NDC11Code>59212-0200-10</NDC11Code>
    <ProductNDC>59212-200</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Uroxatral</ProprietaryName>
    <NonProprietaryName>Alfuzosin Hcl</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130603</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021287</ApplicationNumber>
    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>ALFUZOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.</IndicationAndUsage>
    <Description>Each UROXATRAL extended-release tablet contains 10 mg alfuzosin hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The empirical formula of alfuzosin hydrochloride is C19H27N5O4HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is. The tablet also contains the following inactive ingredients: colloidal silicon dioxide (NF), ethylcellulose (NF), hydrogenated castor oil (NF), hydroxypropyl methylcellulose (USP), magnesium stearate (NF), mannitol (USP), microcrystalline cellulose (NF), povidone (USP), and yellow ferric oxide (NF).</Description>
  </NDC>
  <NDC>
    <NDCCode>59212-242-56</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (59212-242-56)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59212-0242-56</NDC11Code>
    <ProductNDC>59212-242</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lanoxin</ProprietaryName>
    <NonProprietaryName>Digoxin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120930</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020405</ApplicationNumber>
    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>DIGOXIN</SubstanceName>
    <StrengthNumber>.125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LANOXIN is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3  Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
    <Description>LANOXIN (digoxin) is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium.  These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. LANOXIN is supplied as 62.5 mcg (unscored), 125 mcg (scored), and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn and potato starches, lactose and magnesium stearate. The 125 mcg tablets contain D&amp;C Yellow No. 10 and FD&amp;C Yellow No. 6, and the 62.5 mcg tablets contain FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>59212-249-56</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (59212-249-56)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59212-0249-56</NDC11Code>
    <ProductNDC>59212-249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lanoxin</ProprietaryName>
    <NonProprietaryName>Digoxin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120930</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020405</ApplicationNumber>
    <LabelerName>Concordia Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DIGOXIN</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cardiac Glycoside [EPC],Cardiac Glycosides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120930</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59212-422-10</NDCCode>
    <PackageDescription>10 mL in 1 BOTTLE (59212-422-10) </PackageDescription>
    <NDC11Code>59212-0422-10</NDC11Code>
    <ProductNDC>59212-422</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Donnatal</ProprietaryName>
    <NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName>
    <DosageFormName>ELIXIR</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19801230</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>16.2; .1037; .0194; .0065</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19801230</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59212-422-12</NDCCode>
    <PackageDescription>12 BOTTLE in 1 PACKAGE (59212-422-12)  &gt; 10 mL in 1 BOTTLE (59212-422-11)</PackageDescription>
    <NDC11Code>59212-0422-12</NDC11Code>
    <ProductNDC>59212-422</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Donnatal</ProprietaryName>
    <NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName>
    <DosageFormName>ELIXIR</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19801230</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA086661</ApplicationNumber>
    <LabelerName>Concordia Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>16.2; .1037; .0194; .0065</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-02-13</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>59212-425-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (59212-425-10) </PackageDescription>
    <NDC11Code>59212-0425-10</NDC11Code>
    <ProductNDC>59212-425</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Donnatal</ProprietaryName>
    <NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19801230</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>16.2; .1037; .0194; .0065</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19801230</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Donnatal® Tablets. Each Donnatal® Tablet contains. Phenobarbital, USP..................................... 16.2 mg Hyoscyamine Sulfate, USP...................... 0.1037 mg Atropine Sulfate, USP .............................0.0194 mg Scopolamine Hydrobromide, USP ...........0.0065 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>59212-447-10</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59212-447-10) </PackageDescription>
    <NDC11Code>59212-0447-10</NDC11Code>
    <ProductNDC>59212-447</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Parnate</ProprietaryName>
    <NonProprietaryName>Tranylcypromine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130114</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA012342</ApplicationNumber>
    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>TRANYLCYPROMINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PARNATE is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. PARNATE is not indicated for the initial treatment of MDD due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions [see Contraindications (4), Warnings and Precautions (5), and Drug Interactions (7)].</IndicationAndUsage>
    <Description>Tranylcypromine sulfate, the active ingredient of PARNATE, is a non-hydrazine MAOI. The chemical name is (±)‑trans‑2‑phenylcyclopropylamine sulfate (2:1). The molecular formula is (C9H11N)2H2SO4 and its molecular weight is 364.46. The structural formula is. PARNATE film-coated tablets are intended for oral administration. Each round, rose‑red tablet is debossed on one side with the product name “PARNATE” and “SB” and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine. Inactive ingredients consist of microcrystalline cellulose, anhydrous citric acid, croscarmellose sodium, D&amp;C Red No. 7, FD&amp;C Blue No. 2, FD&amp;C Yellow No. 6, gelatin, lactose, magnesium stearate, talc, titanium dioxide, carnauba wax, polyethylene glycol 400 and 8000, and hypromellose.</Description>
  </NDC>
  <NDC>
    <NDCCode>59212-562-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59212-562-10) </PackageDescription>
    <NDC11Code>59212-0562-10</NDC11Code>
    <ProductNDC>59212-562</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Plaquenil</ProprietaryName>
    <NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130628</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA009768</ApplicationNumber>
    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PLAQUENIL is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1) Treatment of rheumatoid arthritis in adults.(1.2) Treatment of systemic lupus erythematosus in adults.(1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4) Limitations of Use (1.1):PLAQUENIL is not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.</IndicationAndUsage>
    <Description>PLAQUENIL (hydroxychloroquine sulfate) is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4- quinolyl) amino]pentyl] ethylamino]ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or off-white crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether.  PLAQUENIL (hydroxychloroquine sulfate) tablets for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: black iron oxide, carnauba wax, corn starch, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>59212-680-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (59212-680-10) </PackageDescription>
    <NDC11Code>59212-0680-10</NDC11Code>
    <ProductNDC>59212-680</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zonegran</ProprietaryName>
    <NonProprietaryName>Zonisamide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20000327</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020789</ApplicationNumber>
    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>ZONISAMIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20000327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZONEGRAN is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
    <Description>ZONEGRAN® (zonisamide) is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The empirical formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is. ZONEGRAN is supplied for oral administration as capsules containing 25 mg or 100 mg zonisamide. Each 25 mg capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, sodium lauryl sulfate, gelatin, and titanium dioxide. Each 100 mg capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, sodium lauryl sulfate, gelatin, titanium dioxide, FD&amp;C Red No. 40 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>59212-681-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (59212-681-10) </PackageDescription>
    <NDC11Code>59212-0681-10</NDC11Code>
    <ProductNDC>59212-681</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zonegran</ProprietaryName>
    <NonProprietaryName>Zonisamide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20000327</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020789</ApplicationNumber>
    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>ZONISAMIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20000327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZONEGRAN is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
    <Description>ZONEGRAN® (zonisamide) is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The empirical formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is. ZONEGRAN is supplied for oral administration as capsules containing 25 mg or 100 mg zonisamide. Each 25 mg capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, sodium lauryl sulfate, gelatin, and titanium dioxide. Each 100 mg capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, sodium lauryl sulfate, gelatin, titanium dioxide, FD&amp;C Red No. 40 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>59212-705-10</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59212-705-10) </PackageDescription>
    <NDC11Code>59212-0705-10</NDC11Code>
    <ProductNDC>59212-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Salagen</ProprietaryName>
    <NonProprietaryName>Pilocarpine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190901</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020237</ApplicationNumber>
    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>PILOCARPINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SALAGEN® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.</IndicationAndUsage>
    <Description>SALAGEN® Tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder which is soluble in water and alcohol and virtually insoluble in most non-polar solvents. Pilocarpine hydrochloride, with a chemical name of (3S-cis)-2(3H)-Furanone, 3-ethyl-dihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl] mono-hydrochloride, has a molecular weight of 244.72. Each 5 mg SALAGEN® Tablet for oral administration contains 5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet, the tablet’s film coating, and polishing are: carnauba wax, hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide and other ingredients. Each 7.5 mg SALAGEN® Tablet for oral administration contains 7.5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet, the tablet’s film coating, and polishing are: carnauba wax, hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide, FD&amp;C blue#2 aluminum lake, and other ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>59212-775-10</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59212-775-10) </PackageDescription>
    <NDC11Code>59212-0775-10</NDC11Code>
    <ProductNDC>59212-775</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Salagen</ProprietaryName>
    <NonProprietaryName>Pilocarpine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190901</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020237</ApplicationNumber>
    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>PILOCARPINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SALAGEN® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.</IndicationAndUsage>
    <Description>SALAGEN® Tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder which is soluble in water and alcohol and virtually insoluble in most non-polar solvents. Pilocarpine hydrochloride, with a chemical name of (3S-cis)-2(3H)-Furanone, 3-ethyl-dihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl] mono-hydrochloride, has a molecular weight of 244.72. Each 5 mg SALAGEN® Tablet for oral administration contains 5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet, the tablet’s film coating, and polishing are: carnauba wax, hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide and other ingredients. Each 7.5 mg SALAGEN® Tablet for oral administration contains 7.5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet, the tablet’s film coating, and polishing are: carnauba wax, hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide, FD&amp;C blue#2 aluminum lake, and other ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-423-10</NDCCode>
    <PackageDescription>10 CAPSULE in 1 BOTTLE (16590-423-10)</PackageDescription>
    <NDC11Code>16590-0423-10</NDC11Code>
    <ProductNDC>16590-423</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA073192</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.</IndicationAndUsage>
    <Description>Loperamide hydrochloride is a white to slightly yellow powder and is freely soluble in methanol, isopropyl alcohol, chloroform and slightly soluble in water. Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Its structural formula is. C29H33ClN2O2HCl M.W. 513.51. Loperamide hydrochloride is available in 2 mg capsules. Each capsule, for oral administration, contains 2 mg loperamide hydrochloride. Loperamide hydrochloride capsules USP also contain the inactive ingredients: dimethylpolysiloxane, gelatin, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, pregelatinized corn starch, magnesium stearate, shellac, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>33332-423-10</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (33332-423-10)  / 5 mL in 1 VIAL, MULTI-DOSE (33332-423-11) </PackageDescription>
    <NDC11Code>33332-0423-10</NDC11Code>
    <ProductNDC>33332-423</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Afluria Quadrivalent</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/darwin/6/2021 Ivr-227 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (propiolactone Inactivated), Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20230701</StartMarketingDate>
    <EndMarketingDate>20240731</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125254</ApplicationNumber>
    <LabelerName>Seqirus PTY LTD.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/DARWIN/6/2021 IVR-227 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230701</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>AFLURIA® QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. AFLURIA QUADRIVALENT is approved for use in persons 6 months of age and older.</IndicationAndUsage>
    <Description>AFLURIA QUADRIVALENT, Influenza Vaccine for intramuscular injection, is a sterile, clear, colorless to slightly opalescent suspension with some sediment that resuspends upon shaking to form a homogeneous suspension. AFLURIA QUADRIVALENT is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the virus is purified in a sucrose density gradient using continuous flow zonal centrifugation. The purified virus is inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce a “split virion”. The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution. AFLURIA QUADRIVALENT is standardized according to USPHS requirements for the 2023-2024 influenza season and is formulated to contain 60 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the four influenza strains recommended for the 2023-2024 Northern Hemisphere influenza season:. A/Victoria/4897/2022 IVR-238 (an A/Victoria/4897/2022 (H1N1)pdm09-like virus), A/Darwin/6/2021 IVR-227 (an A/Darwin/9/2021 (H3N2)-like virus, B/Austria/1359417/2021 BVR-26 (a B/Austria/1359417/2021-like virus) and B/Phuket/3073/2013 BVR-1B (a B/Phuket/3073/2013-like virus). A 0.25 mL dose contains 7.5 mcg HA of each of the same four influenza strains. Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentation. This presentation does not contain preservative. The multi-dose presentation contains thimerosal added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury and each 0.25 mL dose contains 12.25 mcg of mercury. A single 0.5 mL dose of AFLURIA QUADRIVALENT contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (0.5 mcg). From the manufacturing process, each 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (&lt; 1 mcg), sucrose (&lt; 10 mcg), neomycin sulfate (≤ 81.8 nanograms [ng]), polymyxin B (≤ 14 ng), beta-propiolactone (≤ 1.5 ng) and hydrocortisone (≤ 0.56 ng). A single 0.25 mL dose of AFLURIA QUADRIVALENT contains half of these quantities. The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-423-10</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (33342-423-10) </PackageDescription>
    <NDC11Code>33342-0423-10</NDC11Code>
    <ProductNDC>33342-423</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230609</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212124</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230609</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride is indicated for:.  Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)].   Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].   Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR, 4S, 7R, 7aS)-2-{(1R, 2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1yl-methyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate. The film-coating consists of polyethylene glycol, titanium dioxide and yellow iron oxide (80 mg only).</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-423-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (42291-423-10) </PackageDescription>
    <NDC11Code>42291-0423-10</NDC11Code>
    <ProductNDC>42291-423</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Losartan Potassium Tablets, 50 Mg</ProprietaryName>
    <NonProprietaryName>Losartan Potassium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181023</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201170</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181023</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42806-423-10</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42806-423-10) </PackageDescription>
    <NDC11Code>42806-0423-10</NDC11Code>
    <ProductNDC>42806-423</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209314</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230807</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Chloride Extended-Release Tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
    <Description>Potassium Chloride Extended-Release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-Release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: colloidal silicon dioxide, hydroxypropyl cellulose and hydrogenated vegetable oil. The film coating contains lecithin, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>43602-423-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (43602-423-10) </PackageDescription>
    <NDC11Code>43602-0423-10</NDC11Code>
    <ProductNDC>43602-423</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levothyroxine Sodium</ProprietaryName>
    <NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215259</ApplicationNumber>
    <LabelerName>Ascent Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
    <StrengthNumber>.125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
    <Description>Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine sodium tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxyanisole, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate and color additive(s). Table 6 provides a listing of the color additives by tablet strength. FDA approved Dissolution test differs from the USP dissolution test. FDA approved Assay test differs from the USP assay test.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-423-10</NDCCode>
    <PackageDescription>10 BAG in 1 CARTON (44567-423-10)  / 1000 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0423-10</NDC11Code>
    <ProductNDC>44567-423</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Magnesium Sulfate In Water</ProprietaryName>
    <NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207350</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>g/1000mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.</IndicationAndUsage>
    <Description>Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. SeeHOW SUPPLIEDsection for the content and characteristics of available dosage forms and sizes. Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4  7H2O, colorless crystals or white powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The single port bag is made of Nexcel M312A material, a 5-layer, polyolefin based on co-extrude film. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-423-50</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-423-50)  / .5 mL in 1 SYRINGE, GLASS (49281-423-88) </PackageDescription>
    <NDC11Code>49281-0423-50</NDC11Code>
    <ProductNDC>49281-423</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent Northern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20230630</StartMarketingDate>
    <EndMarketingDate>20240630</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230630</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluzone® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone Quadrivalent is approved for use in persons 6 months of age and older.</IndicationAndUsage>
    <Description>Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone Quadrivalent. The Fluzone Quadrivalent prefilled syringe and multi-dose vial presentations are not made with natural rubber latex. Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2023-2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. The single-dose, pre-filled syringe (0.5 mL) is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.</Description>
  </NDC>
  <NDC>
    <NDCCode>49643-423-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49643-423-10) </PackageDescription>
    <NDC11Code>49643-0423-10</NDC11Code>
    <ProductNDC>49643-423</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Nettle Pollen</ProprietaryName>
    <NonProprietaryName>Urtica Dioica</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740312</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102211</ApplicationNumber>
    <LabelerName>Allermed Laboratories, Inc.</LabelerName>
    <SubstanceName>URTICA DIOICA POLLEN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19740312</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
    <Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
  </NDC>
  <NDC>
    <NDCCode>50157-423-10</NDCCode>
    <PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (50157-423-10) </PackageDescription>
    <NDC11Code>50157-0423-10</NDC11Code>
    <ProductNDC>50157-423</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antibacterial</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210305</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Brands International Corporation</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210305</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses for handwashing or decrease bacteria to the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50742-423-10</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (50742-423-10)  &gt; 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>50742-0423-10</NDC11Code>
    <ProductNDC>50742-423</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluorouracil</ProprietaryName>
    <NonProprietaryName>Fluorouracil</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20191221</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209219</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>FLUOROURACIL</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>51013-423-08</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (51013-423-08)  &gt; 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51013-0423-08</NDC11Code>
    <ProductNDC>51013-423</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gas Relief</ProprietaryName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171122</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part332</ApplicationNumber>
    <LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>for the relief of: 1 pressure, bloating, and fullness commonly referred to as gas.</IndicationAndUsage>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>59212-423-10</NDCCode><ProprietaryName>Donnatal</ProprietaryName><NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>59212-423-12</NDCCode><ProprietaryName>Donnatal</ProprietaryName><NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>59212-423-04</NDCCode><ProprietaryName>Donnatal</ProprietaryName><NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>59212-423-16</NDCCode><ProprietaryName>Donnatal</ProprietaryName><NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>59212-111-10</NDCCode><ProprietaryName>Nilandron</ProprietaryName><NonProprietaryName>Nilutamide</NonProprietaryName></NDC><NDC><NDCCode>59212-111-14</NDCCode><ProprietaryName>Nilandron</ProprietaryName><NonProprietaryName>Nilutamide</NonProprietaryName></NDC><NDC><NDCCode>59212-200-10</NDCCode><ProprietaryName>Uroxatral</ProprietaryName><NonProprietaryName>Alfuzosin Hcl</NonProprietaryName></NDC><NDC><NDCCode>59212-242-56</NDCCode><ProprietaryName>Lanoxin</ProprietaryName><NonProprietaryName>Digoxin</NonProprietaryName></NDC><NDC><NDCCode>59212-249-56</NDCCode><ProprietaryName>Lanoxin</ProprietaryName><NonProprietaryName>Digoxin</NonProprietaryName></NDC><NDC><NDCCode>59212-422-10</NDCCode><ProprietaryName>Donnatal</ProprietaryName><NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>59212-422-12</NDCCode><ProprietaryName>Donnatal</ProprietaryName><NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>59212-425-10</NDCCode><ProprietaryName>Donnatal</ProprietaryName><NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>59212-447-10</NDCCode><ProprietaryName>Parnate</ProprietaryName><NonProprietaryName>Tranylcypromine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>59212-562-10</NDCCode><ProprietaryName>Plaquenil</ProprietaryName><NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>59212-680-10</NDCCode><ProprietaryName>Zonegran</ProprietaryName><NonProprietaryName>Zonisamide</NonProprietaryName></NDC><NDC><NDCCode>59212-681-10</NDCCode><ProprietaryName>Zonegran</ProprietaryName><NonProprietaryName>Zonisamide</NonProprietaryName></NDC><NDC><NDCCode>59212-705-10</NDCCode><ProprietaryName>Salagen</ProprietaryName><NonProprietaryName>Pilocarpine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>59212-775-10</NDCCode><ProprietaryName>Salagen</ProprietaryName><NonProprietaryName>Pilocarpine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16590-423-10</NDCCode><ProprietaryName>Loperamide Hydrochloride</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>33332-423-10</NDCCode><ProprietaryName>Afluria Quadrivalent</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/darwin/6/2021 Ivr-227 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (propiolactone Inactivated), Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>33342-423-10</NDCCode><ProprietaryName>Lurasidone Hydrochloride</ProprietaryName><NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42291-423-10</NDCCode><ProprietaryName>Losartan Potassium Tablets, 50 Mg</ProprietaryName><NonProprietaryName>Losartan Potassium</NonProprietaryName></NDC><NDC><NDCCode>42806-423-10</NDCCode><ProprietaryName>Potassium Chloride</ProprietaryName><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>43602-423-10</NDCCode><ProprietaryName>Levothyroxine Sodium</ProprietaryName><NonProprietaryName>Levothyroxine Sodium</NonProprietaryName></NDC><NDC><NDCCode>44567-423-10</NDCCode><ProprietaryName>Magnesium Sulfate In Water</ProprietaryName><NonProprietaryName>Magnesium Sulfate</NonProprietaryName></NDC><NDC><NDCCode>49281-423-50</NDCCode><ProprietaryName>Fluzone Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49643-423-10</NDCCode><ProprietaryName>Nettle Pollen</ProprietaryName><NonProprietaryName>Urtica Dioica</NonProprietaryName></NDC><NDC><NDCCode>50157-423-10</NDCCode><ProprietaryName>Antibacterial</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>50742-423-10</NDCCode><ProprietaryName>Fluorouracil</ProprietaryName><NonProprietaryName>Fluorouracil</NonProprietaryName></NDC><NDC><NDCCode>51013-423-08</NDCCode><ProprietaryName>Gas Relief</ProprietaryName><NonProprietaryName>Simethicone</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
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      "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 ...
            
        

Full Text Search Fundamentals

Facts

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

How does it work

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

Full Text Search & DataLabs REST API

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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