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How to Find 0065-0006-03 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "0065-0006-03",
      "PackageDescription": "3 mL in 1 BOTTLE (0065-0006-03) ",
      "NDC11Code": "00065-0006-03",
      "ProductNDC": "0065-0006",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Moxeza",
      "NonProprietaryName": "Moxifloxacin Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20110118",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022428",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20110118",
      "SamplePackage": "N",
      "IndicationAndUsage": "MOXEZA is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms. Aerococcus viridans*Corynebacterium macginleyi*Enterococcus faecalis*Micrococcus luteus*Staphylococcus arlettae*Staphylococcus aureusStaphylococcus capitisStaphylococcus epidermidisStaphylococcus haemolyticusStaphylococcus hominisStaphylococcus saprophyticus*Staphylococcus warneri*Streptococcus mitis*Streptococcus pneumoniaeStreptococcus parasanguinis*Escherichia coli*Haemophilus influenzaKlebsiella pneumoniae*Propionibacterium acnesChlamydia trachomatis**Efficacy for this organism was studied in fewer than 10 infections.",
      "Description": "MOXEZA is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. C21H24FN3O4HCl                   Molecular Weight 437.9 g/mol. Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. Each mL of MOXEZA solution contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base. Inactives: boric acid, hydrochloric acid and/or sodium hydroxide to adjust pH, purified water, sodium chloride, sorbitol, tyloxapol, and xanthan gum. MOXEZA is a greenish-yellow, isotonic solution with an osmolality of 300-370 mOsm/kg and a pH of approximately 7.4. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder."
    },
    {
      "NDCCode": "0065-0002-03",
      "PackageDescription": "3 mL in 1 BOTTLE, PLASTIC (0065-0002-03) ",
      "NDC11Code": "00065-0002-03",
      "ProductNDC": "0065-0002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nevanac",
      "NonProprietaryName": "Nepafenac",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20050906",
      "EndMarketingDate": "20230430",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021862",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "NEPAFENAC",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-05-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20050906",
      "EndMarketingDatePackage": "20230430",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0065-0342-03",
      "PackageDescription": "3 mL in 1 BOTTLE, DROPPER (0065-0342-03)",
      "NDC11Code": "00065-0342-03",
      "ProductNDC": "0065-0342",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mydfrin",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19790215",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2015-06-05"
    },
    {
      "NDCCode": "0065-0355-03",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0065-0355-03)  > 3 mL in 1 BOTTLE",
      "NDC11Code": "00065-0355-03",
      "ProductNDC": "0065-0355",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mydriacyl",
      "NonProprietaryName": "Tropicamide",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19590401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA084306",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "TROPICAMIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-12-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19590401",
      "SamplePackage": "N",
      "IndicationAndUsage": "For mydriasis and cycloplegia for diagnostic procedures.",
      "Description": "MYDRIACYL® (tropicamide ophthalmic solution, USP) is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the chemical structure. Each mL of MYDRIACYL® (tropicamide ophthalmic solution, USP) contains: Active: tropicamide 0.5% or 1%. Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water; pH range 4.0-5.8."
    },
    {
      "NDCCode": "0065-0627-03",
      "PackageDescription": "10 mL in 1 BOTTLE, PLASTIC (0065-0627-03)",
      "NDC11Code": "00065-0627-03",
      "ProductNDC": "0065-0627",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vexol",
      "NonProprietaryName": "Rimexolone",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19950915",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020474",
      "LabelerName": "Alcon Laboratories, Inc",
      "SubstanceName": "RIMEXOLONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0065-0817-03",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0817-03)  > 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "00065-0817-03",
      "ProductNDC": "0065-0817",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atropine Sulfate",
      "NonProprietaryName": "Atropine Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20220501",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA208151",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "ATROPINE SULFATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-10-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20220501",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0065-1432-03",
      "PackageDescription": "72 VIAL in 1 CARTON (0065-1432-03)  > .4 mL in 1 VIAL",
      "NDC11Code": "00065-1432-03",
      "ProductNDC": "0065-1432",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Systane",
      "ProprietaryNameSuffix": "Ultra",
      "NonProprietaryName": "Polyethylene Glycol 400 And Propylene Glycol",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20090727",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part349",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL",
      "StrengthNumber": "4; 3",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20090727",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0065-3290-03",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-3290-03)  / 10 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "00065-3290-03",
      "ProductNDC": "0065-3290",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Systane Pro Pf",
      "NonProprietaryName": "Propylene Glycol",
      "DosageFormName": "EMULSION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20250131",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M018",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "PROPYLENE GLYCOL",
      "StrengthNumber": "6",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250131",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of burning and irritation due to dryness of the eye. for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun. for use as a protectant against further irritation or to relieve dryness of the eye. for use as a lubricant to prevent further irritation or to relieve dryness of the eye."
    },
    {
      "NDCCode": "0065-4013-03",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0065-4013-03)  > 3 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00065-4013-03",
      "ProductNDC": "0065-4013",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vigamox",
      "NonProprietaryName": "Moxifloxacin Hydrochloride",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20030507",
      "EndMarketingDate": "20220731",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021598",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20030507",
      "EndMarketingDatePackage": "20220731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0065-8000-03",
      "PackageDescription": "10000 mL in 1 BOTTLE (0065-8000-03) ",
      "NDC11Code": "00065-8000-03",
      "ProductNDC": "0065-8000",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alcohol Antiseptic 80%",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200403",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "80",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-10-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200403",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0065-8150-03",
      "PackageDescription": "2 BOTTLE, PLASTIC in 1 CARTON (0065-8150-03)  / 2.5 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00065-8150-03",
      "ProductNDC": "0065-8150",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pataday Once Daily Relief",
      "NonProprietaryName": "Olopatadine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20200228",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021545",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "OLOPATADINE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander."
    },
    {
      "NDCCode": "0065-8533-03",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-8533-03)  > 1.5 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "00065-8533-03",
      "ProductNDC": "0065-8533",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciprodex",
      "NonProprietaryName": "Ciprofloxacin And Dexamethasone",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "AURICULAR (OTIC)",
      "StartMarketingDate": "20030804",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021537",
      "LabelerName": "Alcon Laboratories, Inc.",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE",
      "StrengthNumber": "3; 1",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20030804",
      "SamplePackage": "Y"
    },
    {
      "NDCCode": "0280-0065-03",
      "PackageDescription": "120 PACKAGE in 1 BOTTLE (0280-0065-03)  / 3 SPRAY, METERED in 1 PACKAGE",
      "NDC11Code": "00280-0065-03",
      "ProductNDC": "0280-0065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Astepro Allergy",
      "NonProprietaryName": "Azelastine Hcl",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "NASAL",
      "StartMarketingDate": "20220627",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA213872",
      "LabelerName": "Bayer HealthCare LLC.",
      "SubstanceName": "AZELASTINE HYDROCHLORIDE",
      "StrengthNumber": "205.5",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220705",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose."
    },
    {
      "NDCCode": "10702-065-03",
      "PackageDescription": "30 TABLET in 1 BOTTLE (10702-065-03) ",
      "NDC11Code": "10702-0065-03",
      "ProductNDC": "10702-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextroamphetamine Sulfate",
      "NonProprietaryName": "Dextroamphetamine Sulfate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151123",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203548",
      "LabelerName": "KVK-Tech, Inc.",
      "SubstanceName": "DEXTROAMPHETAMINE SULFATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2024-01-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151123",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextroamphetamine Sulfate Tablets USP are indicated for. 1. Narcolepsy. 2. Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.",
      "Description": "Dextroamphetamine sulfate, USP is the dextro isomer of the compound d, l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows:. Inactive Ingredients. Magnesium stearate, microcrystalline cellulose, and silicon dioxide. The 5 mg tablet also contains D&C yellow no. 10 aluminum lake and FD&C red no. 40 aluminum lake. The 10 mg tablet also contains FD&C red no. 40 aluminum lake and FD&C yellow no. 6 aluminum lake."
    },
    {
      "NDCCode": "15631-0065-3",
      "PackageDescription": "750 PELLET in 1 PACKAGE (15631-0065-3) ",
      "NDC11Code": "15631-0065-03",
      "ProductNDC": "15631-0065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aurum Metallicum",
      "NonProprietaryName": "Aurum Metallicum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150912",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "GOLD",
      "StrengthNumber": "3",
      "StrengthUnit": "[hp_X]/1",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "23155-065-03",
      "PackageDescription": "30 TABLET in 1 BOTTLE (23155-065-03)",
      "NDC11Code": "23155-0065-03",
      "ProductNDC": "23155-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metronidazole",
      "NonProprietaryName": "Metronidazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131216",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079067",
      "LabelerName": "Heritage Pharmaceuticals Inc.",
      "SubstanceName": "METRONIDAZOLE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-15",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "49288-0065-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0065-3)",
      "NDC11Code": "49288-0065-03",
      "ProductNDC": "49288-0065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bermuda Grass Smut",
      "NonProprietaryName": "Bermuda Grass Smut",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "USTILAGO CYNODONTIS",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "50021-065-03",
      "PackageDescription": "104 g in 1 BOTTLE, PLASTIC (50021-065-03)",
      "NDC11Code": "50021-0065-03",
      "ProductNDC": "50021-065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zytec",
      "ProprietaryNameSuffix": "Germ Buster Hand Sanitizer",
      "NonProprietaryName": "Ethanol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110128",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Empack",
      "SubstanceName": "ETHANOL",
      "StrengthNumber": "143",
      "StrengthUnit": "g/238g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "wet hands thoroughly with product. briskly rub hands together until dry. supervise children in the use of this product."
    },
    {
      "NDCCode": "50436-0065-3",
      "PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50436-0065-3)",
      "NDC11Code": "50436-0065-03",
      "ProductNDC": "50436-0065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Omeprazole",
      "NonProprietaryName": "Omeprazole",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20031111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076048",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "OMEPRAZOLE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: : 1 Treatment of active duodenal ulcer in adults (1.1) , 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).",
      "Description": "The active ingredient in omeprazole delayed-release capsules  is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: magnesium hydroxide, mannitol, methacrylic acid copolymer dispersion, povidone and triethyl citrate. The capsule shells have the following inactive ingredients: D&C Red No. 28*, D&C Red No.33*, D&C Yellow No. 10*, FD&C Blue No. 1*, FD&C Red No. 40*, gelatin, iron oxide red* and titanium dioxide (*contains one or more of these ingredients). The capsule imprinting ink contains ammonium hydroxide, black iron oxide, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, potassium hydroxide, propylene glycol and shellac."
    },
    {
      "NDCCode": "54765-065-03",
      "PackageDescription": "50 mL in 1 BOTTLE (54765-065-03) ",
      "NDC11Code": "54765-0065-03",
      "ProductNDC": "54765-065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mery Alcohol Based Hand Sanitizer",
      "NonProprietaryName": "Hand Sanitizer",
      "DosageFormName": "LIQUID",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200326",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Shanghai Mecen Cosmetics Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "46.5",
      "StrengthUnit": "mL/75mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200326",
      "SamplePackage": "N",
      "IndicationAndUsage": "Take an appropriate amount and apply it to your hand."
    },
    {
      "NDCCode": "54868-0065-3",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-0065-3)",
      "NDC11Code": "54868-0065-03",
      "ProductNDC": "54868-0065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amitriptyline Hydrochloride",
      "NonProprietaryName": "Amitriptyline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19951107",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA085966",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
      "Description": "Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d] cycloheptene-Δ5, γ-propylamine hydrochloride. It has the following structural formula. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn) and titanium dioxide. The 10 mg also includes D&C Red #27 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake; 25 mg – D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake; 50 mg – FD&C Blue #2 Aluminum Lake and FD&C Red #40 Aluminum Lake; 75 mg – D&C Red #7 Calcium Lake and FD&C Blue #2 Aluminum Lake; 100 mg – D&C Red #30 Aluminum Lake and D&C Yellow #10 Aluminum Lake; 150 mg – D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake."
    },
    {
      "NDCCode": "55648-065-03",
      "PackageDescription": "15 kg in 1 CONTAINER (55648-065-03)",
      "NDC11Code": "55648-0065-03",
      "ProductNDC": "55648-065",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Paliperidone Micronized",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20140830",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Wockhardt Limited",
      "SubstanceName": "PALIPERIDONE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "58232-0065-3",
      "PackageDescription": "1 TUBE in 1 CARTON (58232-0065-3)  > 85 g in 1 TUBE",
      "NDC11Code": "58232-0065-03",
      "ProductNDC": "58232-0065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aveeno Baby Organic Harvest Diaper Rash",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110929",
      "EndMarketingDate": "20170901",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "130",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2017-09-07"
    },
    {
      "NDCCode": "60505-0065-3",
      "PackageDescription": "7 BLISTER PACK in 1 CARTON (60505-0065-3)  / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "60505-0065-03",
      "ProductNDC": "60505-0065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Omeprazole",
      "NonProprietaryName": "Omeprazole",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20031111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076048",
      "LabelerName": "Apotex Corp",
      "SubstanceName": "OMEPRAZOLE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20031111",
      "SamplePackage": "N",
      "IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: : 1 Treatment of active duodenal ulcer in adults (1.1) , 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).",
      "Description": "The active ingredient in omeprazole delayed-release capsules  is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42 g/mol. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: magnesium hydroxide, mannitol, methacrylic acid copolymer dispersion, povidone and triethyl citrate. The capsule shells have the following inactive ingredients: D&C Red No. 28*, D&C Red No.33*, D&C Yellow No. 10*, FD&C Blue No. 1*, FD&C Red No. 40*, gelatin, iron oxide red* and titanium dioxide (*contains one or more of these ingredients). The capsule imprinting ink contains ammonium hydroxide, black iron oxide, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, potassium hydroxide, propylene glycol and shellac."
    },
    {
      "NDCCode": "63379-065-03",
      "PackageDescription": "72 SPRAY, METERED in 1 BOTTLE (63379-065-03)",
      "NDC11Code": "63379-0065-03",
      "ProductNDC": "63379-065",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Fluticasone Furoate",
      "DosageFormName": "SPRAY, METERED",
      "StartMarketingDate": "20160901",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Glaxo Operations UK Ltd",
      "SubstanceName": "FLUTICASONE FUROATE",
      "StrengthNumber": "27.5",
      "StrengthUnit": "ug/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20221231"
    },
    {
      "NDCCode": "63545-065-03",
      "PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (63545-065-03) ",
      "NDC11Code": "63545-0065-03",
      "ProductNDC": "63545-065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Apocynum Cannabinum",
      "NonProprietaryName": "Apocynum Cannabinum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210223",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, Inc.",
      "SubstanceName": "APOCYNUM CANNABINUM ROOT",
      "StrengthNumber": "10",
      "StrengthUnit": "[hp_M]/1",
      "Status": "Active",
      "LastUpdate": "2021-02-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210223",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65085-0065-3",
      "PackageDescription": "25 kg in 1 DRUM (65085-0065-3) ",
      "NDC11Code": "65085-0065-03",
      "ProductNDC": "65085-0065",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Bexagliflozin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20180926",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Piramal Pharma Limited",
      "SubstanceName": "BEXAGLIFLOZIN",
      "StrengthNumber": "25",
      "StrengthUnit": "kg/25kg",
      "Status": "Unfinished",
      "LastUpdate": "2021-02-17",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "26-SEP-18"
    },
    {
      "NDCCode": "67296-0065-3",
      "PackageDescription": "20 TABLET in 1 BOTTLE (67296-0065-3) ",
      "NDC11Code": "67296-0065-03",
      "ProductNDC": "67296-0065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetaminophen And Codeine Phosphate",
      "NonProprietaryName": "Acetaminophen And Codeine Phosphate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110706",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040419",
      "LabelerName": "RedPharm Drug",
      "SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
      "StrengthNumber": "300; 30",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20110706",
      "SamplePackage": "N",
      "IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Have not been tolerated, or are not expected to be tolerated.",
      "Description": "Acetaminophen and codeine phosphate tablets are available in tablet form for oral administration. Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. [Acetaminophen Chemical Structure]. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. [Codeine Phosphate Chemical Structure]. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains. Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains. Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains. Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg. In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid."
    },
    {
      "NDCCode": "69844-065-03",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (69844-065-03) ",
      "NDC11Code": "69844-0065-03",
      "ProductNDC": "69844-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupropion Hydrochloride",
      "NonProprietaryName": "Extended-release",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190128",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211020",
      "LabelerName": "Graviti Pharmaceuticals Private Limited",
      "SubstanceName": "BUPROPION HYDROCHLORIDE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20190128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
      "Description": "Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg which are pink round biconvex coated tablets imprinted with '188' in black ink on one side and plain on other side and 300 mg which are pink, round biconvex coated tablets imprinted with '189' in black ink on one side and plain on the other side. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), opadry® pink (it contains hypromellose, titanium dioxide, triacetin, talc, iron oxide red), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14."
    },
    {
      "NDCCode": "71335-0065-3",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (71335-0065-3) ",
      "NDC11Code": "71335-0065-03",
      "ProductNDC": "71335-0065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nortriptyline Hydrochloride",
      "NonProprietaryName": "Nortriptyline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950405",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074132",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211227",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
      "Description": "Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. C19H21NHCl   M.W. 299.84. Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, dimethicone, gelatin, iron oxide black, potassium hydroxide, propylene glycol, shellac glaze, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C yellow #10, FD&C blue #1, and FD&C yellow #6."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"0065-0006-03","ProprietaryName":"Moxeza","NonProprietaryName":"Moxifloxacin Hydrochloride"},{"NDCCode":"0065-0002-03","ProprietaryName":"Nevanac","NonProprietaryName":"Nepafenac"},{"NDCCode":"0065-0342-03","ProprietaryName":"Mydfrin","NonProprietaryName":"Phenylephrine Hydrochloride"},{"NDCCode":"0065-0355-03","ProprietaryName":"Mydriacyl","NonProprietaryName":"Tropicamide"},{"NDCCode":"0065-0627-03","ProprietaryName":"Vexol","NonProprietaryName":"Rimexolone"},{"NDCCode":"0065-0817-03","ProprietaryName":"Atropine Sulfate","NonProprietaryName":"Atropine Sulfate"},{"NDCCode":"0065-1432-03","ProprietaryName":"Systane","NonProprietaryName":"Polyethylene Glycol 400 And Propylene Glycol"},{"NDCCode":"0065-3290-03","ProprietaryName":"Systane Pro Pf","NonProprietaryName":"Propylene Glycol"},{"NDCCode":"0065-4013-03","ProprietaryName":"Vigamox","NonProprietaryName":"Moxifloxacin Hydrochloride"},{"NDCCode":"0065-8000-03","ProprietaryName":"Alcohol Antiseptic 80%","NonProprietaryName":"Alcohol"},{"NDCCode":"0065-8150-03","ProprietaryName":"Pataday Once Daily Relief","NonProprietaryName":"Olopatadine Hydrochloride"},{"NDCCode":"0065-8533-03","ProprietaryName":"Ciprodex","NonProprietaryName":"Ciprofloxacin And Dexamethasone"},{"NDCCode":"0280-0065-03","ProprietaryName":"Astepro Allergy","NonProprietaryName":"Azelastine Hcl"},{"NDCCode":"10702-065-03","ProprietaryName":"Dextroamphetamine Sulfate","NonProprietaryName":"Dextroamphetamine Sulfate"},{"NDCCode":"15631-0065-3","ProprietaryName":"Aurum Metallicum","NonProprietaryName":"Aurum Metallicum"},{"NDCCode":"23155-065-03","ProprietaryName":"Metronidazole","NonProprietaryName":"Metronidazole"},{"NDCCode":"49288-0065-3","ProprietaryName":"Bermuda Grass Smut","NonProprietaryName":"Bermuda Grass Smut"},{"NDCCode":"50021-065-03","ProprietaryName":"Zytec","NonProprietaryName":"Ethanol"},{"NDCCode":"50436-0065-3","ProprietaryName":"Omeprazole","NonProprietaryName":"Omeprazole"},{"NDCCode":"54765-065-03","ProprietaryName":"Mery Alcohol Based Hand Sanitizer","NonProprietaryName":"Hand Sanitizer"},{"NDCCode":"54868-0065-3","ProprietaryName":"Amitriptyline Hydrochloride","NonProprietaryName":"Amitriptyline Hydrochloride"},{"NDCCode":"55648-065-03","NonProprietaryName":"Paliperidone Micronized"},{"NDCCode":"58232-0065-3","ProprietaryName":"Aveeno Baby Organic Harvest Diaper Rash","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"60505-0065-3","ProprietaryName":"Omeprazole","NonProprietaryName":"Omeprazole"},{"NDCCode":"63379-065-03","NonProprietaryName":"Fluticasone Furoate"},{"NDCCode":"63545-065-03","ProprietaryName":"Apocynum Cannabinum","NonProprietaryName":"Apocynum Cannabinum"},{"NDCCode":"65085-0065-3","NonProprietaryName":"Bexagliflozin"},{"NDCCode":"67296-0065-3","ProprietaryName":"Acetaminophen And Codeine Phosphate","NonProprietaryName":"Acetaminophen And Codeine Phosphate"},{"NDCCode":"69844-065-03","ProprietaryName":"Bupropion Hydrochloride","NonProprietaryName":"Extended-release"},{"NDCCode":"71335-0065-3","ProprietaryName":"Nortriptyline Hydrochloride","NonProprietaryName":"Nortriptyline Hydrochloride"}]}
                    
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>0065-0006-03</NDCCode>
    <PackageDescription>3 mL in 1 BOTTLE (0065-0006-03) </PackageDescription>
    <NDC11Code>00065-0006-03</NDC11Code>
    <ProductNDC>0065-0006</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Moxeza</ProprietaryName>
    <NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20110118</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022428</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>MOXEZA is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms. Aerococcus viridans*Corynebacterium macginleyi*Enterococcus faecalis*Micrococcus luteus*Staphylococcus arlettae*Staphylococcus aureusStaphylococcus capitisStaphylococcus epidermidisStaphylococcus haemolyticusStaphylococcus hominisStaphylococcus saprophyticus*Staphylococcus warneri*Streptococcus mitis*Streptococcus pneumoniaeStreptococcus parasanguinis*Escherichia coli*Haemophilus influenzaKlebsiella pneumoniae*Propionibacterium acnesChlamydia trachomatis**Efficacy for this organism was studied in fewer than 10 infections.</IndicationAndUsage>
    <Description>MOXEZA is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. C21H24FN3O4HCl                   Molecular Weight 437.9 g/mol. Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. Each mL of MOXEZA solution contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base. Inactives: boric acid, hydrochloric acid and/or sodium hydroxide to adjust pH, purified water, sodium chloride, sorbitol, tyloxapol, and xanthan gum. MOXEZA is a greenish-yellow, isotonic solution with an osmolality of 300-370 mOsm/kg and a pH of approximately 7.4. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder.</Description>
  </NDC>
  <NDC>
    <NDCCode>0065-0002-03</NDCCode>
    <PackageDescription>3 mL in 1 BOTTLE, PLASTIC (0065-0002-03) </PackageDescription>
    <NDC11Code>00065-0002-03</NDC11Code>
    <ProductNDC>0065-0002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nevanac</ProprietaryName>
    <NonProprietaryName>Nepafenac</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20050906</StartMarketingDate>
    <EndMarketingDate>20230430</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021862</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>NEPAFENAC</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20050906</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0065-0342-03</NDCCode>
    <PackageDescription>3 mL in 1 BOTTLE, DROPPER (0065-0342-03)</PackageDescription>
    <NDC11Code>00065-0342-03</NDC11Code>
    <ProductNDC>0065-0342</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mydfrin</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19790215</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-06-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0065-0355-03</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0065-0355-03)  &gt; 3 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00065-0355-03</NDC11Code>
    <ProductNDC>0065-0355</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mydriacyl</ProprietaryName>
    <NonProprietaryName>Tropicamide</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19590401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA084306</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>TROPICAMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19590401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For mydriasis and cycloplegia for diagnostic procedures.</IndicationAndUsage>
    <Description>MYDRIACYL® (tropicamide ophthalmic solution, USP) is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the chemical structure. Each mL of MYDRIACYL® (tropicamide ophthalmic solution, USP) contains: Active: tropicamide 0.5% or 1%. Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water; pH range 4.0-5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>0065-0627-03</NDCCode>
    <PackageDescription>10 mL in 1 BOTTLE, PLASTIC (0065-0627-03)</PackageDescription>
    <NDC11Code>00065-0627-03</NDC11Code>
    <ProductNDC>0065-0627</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vexol</ProprietaryName>
    <NonProprietaryName>Rimexolone</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19950915</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020474</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc</LabelerName>
    <SubstanceName>RIMEXOLONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0065-0817-03</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0817-03)  &gt; 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00065-0817-03</NDC11Code>
    <ProductNDC>0065-0817</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atropine Sulfate</ProprietaryName>
    <NonProprietaryName>Atropine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20220501</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208151</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>ATROPINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0065-1432-03</NDCCode>
    <PackageDescription>72 VIAL in 1 CARTON (0065-1432-03)  &gt; .4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00065-1432-03</NDC11Code>
    <ProductNDC>0065-1432</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Systane</ProprietaryName>
    <ProprietaryNameSuffix>Ultra</ProprietaryNameSuffix>
    <NonProprietaryName>Polyethylene Glycol 400 And Propylene Glycol</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20090727</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL</SubstanceName>
    <StrengthNumber>4; 3</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090727</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0065-3290-03</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-3290-03)  / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00065-3290-03</NDC11Code>
    <ProductNDC>0065-3290</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Systane Pro Pf</ProprietaryName>
    <NonProprietaryName>Propylene Glycol</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20250131</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M018</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>PROPYLENE GLYCOL</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of burning and irritation due to dryness of the eye. for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun. for use as a protectant against further irritation or to relieve dryness of the eye. for use as a lubricant to prevent further irritation or to relieve dryness of the eye.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0065-4013-03</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0065-4013-03)  &gt; 3 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>00065-4013-03</NDC11Code>
    <ProductNDC>0065-4013</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vigamox</ProprietaryName>
    <NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20030507</StartMarketingDate>
    <EndMarketingDate>20220731</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021598</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20030507</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0065-8000-03</NDCCode>
    <PackageDescription>10000 mL in 1 BOTTLE (0065-8000-03) </PackageDescription>
    <NDC11Code>00065-8000-03</NDC11Code>
    <ProductNDC>0065-8000</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alcohol Antiseptic 80%</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200403</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-10-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200403</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0065-8150-03</NDCCode>
    <PackageDescription>2 BOTTLE, PLASTIC in 1 CARTON (0065-8150-03)  / 2.5 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>00065-8150-03</NDC11Code>
    <ProductNDC>0065-8150</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pataday Once Daily Relief</ProprietaryName>
    <NonProprietaryName>Olopatadine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20200228</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021545</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>OLOPATADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0065-8533-03</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-8533-03)  &gt; 1.5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00065-8533-03</NDC11Code>
    <ProductNDC>0065-8533</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprodex</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin And Dexamethasone</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>AURICULAR (OTIC)</RouteName>
    <StartMarketingDate>20030804</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021537</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE</SubstanceName>
    <StrengthNumber>3; 1</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030804</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0280-0065-03</NDCCode>
    <PackageDescription>120 PACKAGE in 1 BOTTLE (0280-0065-03)  / 3 SPRAY, METERED in 1 PACKAGE</PackageDescription>
    <NDC11Code>00280-0065-03</NDC11Code>
    <ProductNDC>0280-0065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Astepro Allergy</ProprietaryName>
    <NonProprietaryName>Azelastine Hcl</NonProprietaryName>
    <DosageFormName>SPRAY, METERED</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20220627</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA213872</ApplicationNumber>
    <LabelerName>Bayer HealthCare LLC.</LabelerName>
    <SubstanceName>AZELASTINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>205.5</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220705</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10702-065-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (10702-065-03) </PackageDescription>
    <NDC11Code>10702-0065-03</NDC11Code>
    <ProductNDC>10702-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
    <NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203548</ApplicationNumber>
    <LabelerName>KVK-Tech, Inc.</LabelerName>
    <SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-01-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dextroamphetamine Sulfate Tablets USP are indicated for. 1. Narcolepsy. 2. Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.</IndicationAndUsage>
    <Description>Dextroamphetamine sulfate, USP is the dextro isomer of the compound d, l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows:. Inactive Ingredients. Magnesium stearate, microcrystalline cellulose, and silicon dioxide. The 5 mg tablet also contains D&amp;C yellow no. 10 aluminum lake and FD&amp;C red no. 40 aluminum lake. The 10 mg tablet also contains FD&amp;C red no. 40 aluminum lake and FD&amp;C yellow no. 6 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>15631-0065-3</NDCCode>
    <PackageDescription>750 PELLET in 1 PACKAGE (15631-0065-3) </PackageDescription>
    <NDC11Code>15631-0065-03</NDC11Code>
    <ProductNDC>15631-0065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aurum Metallicum</ProprietaryName>
    <NonProprietaryName>Aurum Metallicum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150912</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>GOLD</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>23155-065-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (23155-065-03)</PackageDescription>
    <NDC11Code>23155-0065-03</NDC11Code>
    <ProductNDC>23155-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole</ProprietaryName>
    <NonProprietaryName>Metronidazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079067</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-15</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>49288-0065-3</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0065-3)</PackageDescription>
    <NDC11Code>49288-0065-03</NDC11Code>
    <ProductNDC>49288-0065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bermuda Grass Smut</ProprietaryName>
    <NonProprietaryName>Bermuda Grass Smut</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>USTILAGO CYNODONTIS</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>50021-065-03</NDCCode>
    <PackageDescription>104 g in 1 BOTTLE, PLASTIC (50021-065-03)</PackageDescription>
    <NDC11Code>50021-0065-03</NDC11Code>
    <ProductNDC>50021-065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zytec</ProprietaryName>
    <ProprietaryNameSuffix>Germ Buster Hand Sanitizer</ProprietaryNameSuffix>
    <NonProprietaryName>Ethanol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110128</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Empack</LabelerName>
    <SubstanceName>ETHANOL</SubstanceName>
    <StrengthNumber>143</StrengthNumber>
    <StrengthUnit>g/238g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>wet hands thoroughly with product. briskly rub hands together until dry. supervise children in the use of this product.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50436-0065-3</NDCCode>
    <PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50436-0065-3)</PackageDescription>
    <NDC11Code>50436-0065-03</NDC11Code>
    <ProductNDC>50436-0065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20031111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076048</ApplicationNumber>
    <LabelerName>Unit Dose Services</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: : 1 Treatment of active duodenal ulcer in adults (1.1) , 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
    <Description>The active ingredient in omeprazole delayed-release capsules  is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: magnesium hydroxide, mannitol, methacrylic acid copolymer dispersion, povidone and triethyl citrate. The capsule shells have the following inactive ingredients: D&amp;C Red No. 28*, D&amp;C Red No.33*, D&amp;C Yellow No. 10*, FD&amp;C Blue No. 1*, FD&amp;C Red No. 40*, gelatin, iron oxide red* and titanium dioxide (*contains one or more of these ingredients). The capsule imprinting ink contains ammonium hydroxide, black iron oxide, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, potassium hydroxide, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>54765-065-03</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE (54765-065-03) </PackageDescription>
    <NDC11Code>54765-0065-03</NDC11Code>
    <ProductNDC>54765-065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mery Alcohol Based Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Hand Sanitizer</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200326</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Shanghai Mecen Cosmetics Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>46.5</StrengthNumber>
    <StrengthUnit>mL/75mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Take an appropriate amount and apply it to your hand.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54868-0065-3</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-0065-3)</PackageDescription>
    <NDC11Code>54868-0065-03</NDC11Code>
    <ProductNDC>54868-0065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19951107</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA085966</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
    <Description>Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d] cycloheptene-Δ5, γ-propylamine hydrochloride. It has the following structural formula. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn) and titanium dioxide. The 10 mg also includes D&amp;C Red #27 Aluminum Lake, D&amp;C Yellow #10 Aluminum Lake and FD&amp;C Blue #1 Aluminum Lake; 25 mg – D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Blue #1 Aluminum Lake and FD&amp;C Red #40 Aluminum Lake; 50 mg – FD&amp;C Blue #2 Aluminum Lake and FD&amp;C Red #40 Aluminum Lake; 75 mg – D&amp;C Red #7 Calcium Lake and FD&amp;C Blue #2 Aluminum Lake; 100 mg – D&amp;C Red #30 Aluminum Lake and D&amp;C Yellow #10 Aluminum Lake; 150 mg – D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Blue #1 Aluminum Lake and FD&amp;C Red #40 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>55648-065-03</NDCCode>
    <PackageDescription>15 kg in 1 CONTAINER (55648-065-03)</PackageDescription>
    <NDC11Code>55648-0065-03</NDC11Code>
    <ProductNDC>55648-065</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Paliperidone Micronized</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140830</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Wockhardt Limited</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>58232-0065-3</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (58232-0065-3)  &gt; 85 g in 1 TUBE</PackageDescription>
    <NDC11Code>58232-0065-03</NDC11Code>
    <ProductNDC>58232-0065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aveeno Baby Organic Harvest Diaper Rash</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110929</StartMarketingDate>
    <EndMarketingDate>20170901</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Products Company, Division of Johnson &amp; Johnson Consumer Companies, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>130</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-09-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>60505-0065-3</NDCCode>
    <PackageDescription>7 BLISTER PACK in 1 CARTON (60505-0065-3)  / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>60505-0065-03</NDC11Code>
    <ProductNDC>60505-0065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20031111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076048</ApplicationNumber>
    <LabelerName>Apotex Corp</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20031111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: : 1 Treatment of active duodenal ulcer in adults (1.1) , 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
    <Description>The active ingredient in omeprazole delayed-release capsules  is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42 g/mol. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: magnesium hydroxide, mannitol, methacrylic acid copolymer dispersion, povidone and triethyl citrate. The capsule shells have the following inactive ingredients: D&amp;C Red No. 28*, D&amp;C Red No.33*, D&amp;C Yellow No. 10*, FD&amp;C Blue No. 1*, FD&amp;C Red No. 40*, gelatin, iron oxide red* and titanium dioxide (*contains one or more of these ingredients). The capsule imprinting ink contains ammonium hydroxide, black iron oxide, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, potassium hydroxide, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>63379-065-03</NDCCode>
    <PackageDescription>72 SPRAY, METERED in 1 BOTTLE (63379-065-03)</PackageDescription>
    <NDC11Code>63379-0065-03</NDC11Code>
    <ProductNDC>63379-065</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
    <DosageFormName>SPRAY, METERED</DosageFormName>
    <StartMarketingDate>20160901</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Glaxo Operations UK Ltd</LabelerName>
    <SubstanceName>FLUTICASONE FUROATE</SubstanceName>
    <StrengthNumber>27.5</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63545-065-03</NDCCode>
    <PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (63545-065-03) </PackageDescription>
    <NDC11Code>63545-0065-03</NDC11Code>
    <ProductNDC>63545-065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Apocynum Cannabinum</ProprietaryName>
    <NonProprietaryName>Apocynum Cannabinum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210223</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
    <SubstanceName>APOCYNUM CANNABINUM ROOT</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>[hp_M]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65085-0065-3</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (65085-0065-3) </PackageDescription>
    <NDC11Code>65085-0065-03</NDC11Code>
    <ProductNDC>65085-0065</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Bexagliflozin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20180926</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Piramal Pharma Limited</LabelerName>
    <SubstanceName>BEXAGLIFLOZIN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>kg/25kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2021-02-17</LastUpdate>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>26-SEP-18</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>67296-0065-3</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (67296-0065-3) </PackageDescription>
    <NDC11Code>67296-0065-03</NDC11Code>
    <ProductNDC>67296-0065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
    <NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110706</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040419</ApplicationNumber>
    <LabelerName>RedPharm Drug</LabelerName>
    <SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
    <StrengthNumber>300; 30</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110706</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Have not been tolerated, or are not expected to be tolerated.</IndicationAndUsage>
    <Description>Acetaminophen and codeine phosphate tablets are available in tablet form for oral administration. Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. [Acetaminophen Chemical Structure]. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. [Codeine Phosphate Chemical Structure]. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains. Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains. Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains. Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg. In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>69844-065-03</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (69844-065-03) </PackageDescription>
    <NDC11Code>69844-0065-03</NDC11Code>
    <ProductNDC>69844-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <NonProprietaryName>Extended-release</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211020</ApplicationNumber>
    <LabelerName>Graviti Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
    <Description>Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg which are pink round biconvex coated tablets imprinted with '188' in black ink on one side and plain on other side and 300 mg which are pink, round biconvex coated tablets imprinted with '189' in black ink on one side and plain on the other side. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), opadry® pink (it contains hypromellose, titanium dioxide, triacetin, talc, iron oxide red), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0065-3</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (71335-0065-3) </PackageDescription>
    <NDC11Code>71335-0065-03</NDC11Code>
    <ProductNDC>71335-0065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19950405</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074132</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
    <Description>Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. C19H21NHCl   M.W. 299.84. Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, dimethicone, gelatin, iron oxide black, potassium hydroxide, propylene glycol, shellac glaze, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&amp;C yellow #10, FD&amp;C blue #1, and FD&amp;C yellow #6.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>0065-0006-03</NDCCode><ProprietaryName>Moxeza</ProprietaryName><NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0065-0002-03</NDCCode><ProprietaryName>Nevanac</ProprietaryName><NonProprietaryName>Nepafenac</NonProprietaryName></NDC><NDC><NDCCode>0065-0342-03</NDCCode><ProprietaryName>Mydfrin</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0065-0355-03</NDCCode><ProprietaryName>Mydriacyl</ProprietaryName><NonProprietaryName>Tropicamide</NonProprietaryName></NDC><NDC><NDCCode>0065-0627-03</NDCCode><ProprietaryName>Vexol</ProprietaryName><NonProprietaryName>Rimexolone</NonProprietaryName></NDC><NDC><NDCCode>0065-0817-03</NDCCode><ProprietaryName>Atropine Sulfate</ProprietaryName><NonProprietaryName>Atropine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>0065-1432-03</NDCCode><ProprietaryName>Systane</ProprietaryName><NonProprietaryName>Polyethylene Glycol 400 And Propylene Glycol</NonProprietaryName></NDC><NDC><NDCCode>0065-3290-03</NDCCode><ProprietaryName>Systane Pro Pf</ProprietaryName><NonProprietaryName>Propylene Glycol</NonProprietaryName></NDC><NDC><NDCCode>0065-4013-03</NDCCode><ProprietaryName>Vigamox</ProprietaryName><NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0065-8000-03</NDCCode><ProprietaryName>Alcohol Antiseptic 80%</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>0065-8150-03</NDCCode><ProprietaryName>Pataday Once Daily Relief</ProprietaryName><NonProprietaryName>Olopatadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0065-8533-03</NDCCode><ProprietaryName>Ciprodex</ProprietaryName><NonProprietaryName>Ciprofloxacin And Dexamethasone</NonProprietaryName></NDC><NDC><NDCCode>0280-0065-03</NDCCode><ProprietaryName>Astepro Allergy</ProprietaryName><NonProprietaryName>Azelastine Hcl</NonProprietaryName></NDC><NDC><NDCCode>10702-065-03</NDCCode><ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName><NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>15631-0065-3</NDCCode><ProprietaryName>Aurum Metallicum</ProprietaryName><NonProprietaryName>Aurum Metallicum</NonProprietaryName></NDC><NDC><NDCCode>23155-065-03</NDCCode><ProprietaryName>Metronidazole</ProprietaryName><NonProprietaryName>Metronidazole</NonProprietaryName></NDC><NDC><NDCCode>49288-0065-3</NDCCode><ProprietaryName>Bermuda Grass Smut</ProprietaryName><NonProprietaryName>Bermuda Grass Smut</NonProprietaryName></NDC><NDC><NDCCode>50021-065-03</NDCCode><ProprietaryName>Zytec</ProprietaryName><NonProprietaryName>Ethanol</NonProprietaryName></NDC><NDC><NDCCode>50436-0065-3</NDCCode><ProprietaryName>Omeprazole</ProprietaryName><NonProprietaryName>Omeprazole</NonProprietaryName></NDC><NDC><NDCCode>54765-065-03</NDCCode><ProprietaryName>Mery Alcohol Based Hand Sanitizer</ProprietaryName><NonProprietaryName>Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>54868-0065-3</NDCCode><ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName><NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55648-065-03</NDCCode><NonProprietaryName>Paliperidone Micronized</NonProprietaryName></NDC><NDC><NDCCode>58232-0065-3</NDCCode><ProprietaryName>Aveeno Baby Organic Harvest Diaper Rash</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>60505-0065-3</NDCCode><ProprietaryName>Omeprazole</ProprietaryName><NonProprietaryName>Omeprazole</NonProprietaryName></NDC><NDC><NDCCode>63379-065-03</NDCCode><NonProprietaryName>Fluticasone Furoate</NonProprietaryName></NDC><NDC><NDCCode>63545-065-03</NDCCode><ProprietaryName>Apocynum Cannabinum</ProprietaryName><NonProprietaryName>Apocynum Cannabinum</NonProprietaryName></NDC><NDC><NDCCode>65085-0065-3</NDCCode><NonProprietaryName>Bexagliflozin</NonProprietaryName></NDC><NDC><NDCCode>67296-0065-3</NDCCode><ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName><NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName></NDC><NDC><NDCCode>69844-065-03</NDCCode><ProprietaryName>Bupropion Hydrochloride</ProprietaryName><NonProprietaryName>Extended-release</NonProprietaryName></NDC><NDC><NDCCode>71335-0065-3</NDCCode><ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName><NonProprietaryName>Nortriptyline Hydrochloride</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",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
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      "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",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
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}
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