RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (236 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "0026-3792-20",
      "PackageDescription": "1 KIT in 1 BOX (0026-3792-20)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4792-01)  *  2.5 mL in 1 SYRINGE (0026-0426-02)",
      "NDC11Code": "00026-3792-20",
      "ProductNDC": "0026-3792",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Kogenate Fs",
      "NonProprietaryName": "Antihemophilic Factor (recombinant)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20051117",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103332",
      "LabelerName": "Bayer HealthCare LLC",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-31",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "0026-3782-20",
      "PackageDescription": "1 KIT in 1 BOX (0026-3782-20)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4782-01)  *  2.5 mL in 1 VIAL (0026-0425-02)",
      "NDC11Code": "00026-3782-20",
      "ProductNDC": "0026-3782",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Kogenate Fs",
      "NonProprietaryName": "Antihemophilic Factor (recombinant)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20000626",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103332",
      "LabelerName": "Bayer HealthCare LLC",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-31",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "10738-026-20",
      "PackageDescription": "1 TUBE in 1 PACKAGE (10738-026-20)  / 56.7 g in 1 TUBE (10738-026-25) ",
      "NDC11Code": "10738-0026-20",
      "ProductNDC": "10738-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Triderma Genuine Aloe Burn",
      "NonProprietaryName": "Aloe Burn Relief",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Genuine Virgin Aloe Corporation",
      "SubstanceName": "ALLANTOIN",
      "StrengthNumber": "1.5",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2026-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily protects minor cuts, scrapes and burns."
    },
    {
      "NDCCode": "17337-0026-1",
      "PackageDescription": "20 kg in 1 DRUM (17337-0026-1) ",
      "NDC11Code": "17337-0026-01",
      "ProductNDC": "17337-0026",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20121227",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Olon SpA",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "02-NOV-19"
    },
    {
      "NDCCode": "42292-026-20",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (42292-026-20)  > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (42292-026-01) ",
      "NDC11Code": "42292-0026-20",
      "ProductNDC": "42292-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Paliperidone",
      "NonProprietaryName": "Paliperidone",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160920",
      "EndMarketingDate": "20231129",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203802",
      "LabelerName": "Mylan Institutional Inc.",
      "SubstanceName": "PALIPERIDONE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-11-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160920",
      "EndMarketingDatePackage": "20231129",
      "SamplePackage": "N",
      "IndicationAndUsage": "Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for. Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12-17): Efficacy was established in one 6-week trial. (    14.1)    .",
      "Description": "Paliperidone Extended-Release Tablets contain paliperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3 and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (brown), 3 mg (white), 6 mg (light beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize osmotic drug-release technology [see Description (11)] . Inactive ingredients are butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, polyethylene glycol, polyethylene oxide, red iron oxide, sodium chloride, sodium stearyl fumarate, talc, titanium dioxide and yellow iron oxide. The 1.5 mg tablets also contain black iron oxide and polydextrose. The 3 mg tablets also contain polyvinyl alcohol. The 6 mg tablets also contain black iron oxide, FD&C Blue No. 1 Aluminum Lake and polyvinyl alcohol. The 9 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and polyvinyl alcohol. The imprinting ink contains the following: black iron oxide, hypromellose and propylene glycol. Delivery System Components and Performance. Paliperidone extended-release tablets contain a bi-layer core tablet that consists of a drug layer containing the entire amount of active ingredient in a hydrophilic polymer matrix and a push layer that contains an osmotic agent in a hydrophilic, swell-able polymer matrix. The bi-layer core tablet is coated with a release-controlling semi-permeable membrane (SPM). The SPM allows water permeation into the core without allowing components to quickly dissipate from the core. A laser-drilled aperture is present on the drug layer side of the SPM-coated tablet and is necessary for delivery. The tablets contain a water soluble cosmetic over-coating that is imprinted with an identifier. Once ingested, the cosmetic over-coating rapidly dissipates in the gastrointestinal tract. The SPM allows water to penetrate into the core as the osmotic agent in the push layer provides a driving force for water influx. Once hydrated, the swell-able polymer matrix in the push layer (high molecular weight polyethylene oxide) expands, exerting a pressure on the drug layer portion of the core tablet which forces it out of the laser-drilled aperture in a plug-flow fashion. After an initial lag time (about 2 to 4 hours), water influx into the core reaches a steady-state and the drug layer is released from the laser-drilled aperture at a constant rate for approximately 20 to 24 hours. As the release rate is controlled by the rate of water influx into the core (SPM permeability), the delivery is independent of pH or gastrointestinal motility. The biologically inert tablet core (ghost), containing residual push layer components, remains intact and is eliminated in the feces. Drug absorption is controlled by a combination of drug release from the tablet and subsequent dissolution in the gastrointestinal tract."
    },
    {
      "NDCCode": "43353-026-20",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-026-20)",
      "NDC11Code": "43353-0026-20",
      "ProductNDC": "43353-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zolpidem Tartrate",
      "NonProprietaryName": "Zolpidem Tartrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070423",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076578",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "ZOLPIDEM TARTRATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "43419-026-20",
      "PackageDescription": "1 CONTAINER in 1 CARTON (43419-026-20)  > 10 g in 1 CONTAINER",
      "NDC11Code": "43419-0026-20",
      "ProductNDC": "43419-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sulwhasoo Evenfair Smoothing Foundation",
      "ProprietaryNameSuffix": "Spf25 No.3 Medium Ocher",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20121123",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Amorepacific Corporation",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": ".32; .4268; .196",
      "StrengthUnit": "g/10g; g/10g; g/10g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20121123",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "48943-0026-2",
      "PackageDescription": "20 g in 1 CANISTER (48943-0026-2) ",
      "NDC11Code": "48943-0026-02",
      "ProductNDC": "48943-0026",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Calcipotriene Anhydrous",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20160609",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "CHONGQING HUAPONT SHENGCHEM PHARM. CO., INC.",
      "SubstanceName": "CALCIPOTRIENE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2024-12-31",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "09-JUN-16"
    },
    {
      "NDCCode": "49035-026-20",
      "PackageDescription": "2 BOTTLE in 1 CARTON (49035-026-20)  > 100 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "49035-0026-20",
      "ProductNDC": "49035-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen And Diphenhydramine Hydrochloride",
      "NonProprietaryName": "Acetaminophen And Diphenhydramine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140601",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "WALMART STORES INC",
      "SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "500; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness."
    },
    {
      "NDCCode": "50090-0026-2",
      "PackageDescription": "20 CAPSULE, GELATIN COATED in 1 BOTTLE (50090-0026-2) ",
      "NDC11Code": "50090-0026-02",
      "ProductNDC": "50090-0026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline Hyclate",
      "NonProprietaryName": "Doxycycline Hyclate",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19841107",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062396",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "DOXYCYCLINE HYCLATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20140417",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52959-026-20",
      "PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (52959-026-20)",
      "NDC11Code": "52959-0026-20",
      "ProductNDC": "52959-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carisoprodol",
      "NonProprietaryName": "Carisoprodol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960124",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040124",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "CARISOPRODOL",
      "StrengthNumber": "350",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see DOSAGE AND ADMINISTRATION (2)].",
      "Description": "Carisoprodol Tablets are available as 350 mg round, white tablets.  Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste.  It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH.  Carisoprodol is present as a racemic mixture.  Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33.   The structural formula is. Other Ingredients:  colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, methylcellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid."
    },
    {
      "NDCCode": "54868-0026-6",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (54868-0026-6)",
      "NDC11Code": "54868-0026-06",
      "ProductNDC": "54868-0026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Diphenhydramine Hcl",
      "NonProprietaryName": "Diphenhydramine Hcl",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100127",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. Sneezing. Nasal congestion. Runny nose. Itchy, watery eyes."
    },
    {
      "NDCCode": "66005-0026-1",
      "PackageDescription": "20 kg in 1 DRUM (66005-0026-1)",
      "NDC11Code": "66005-0026-01",
      "ProductNDC": "66005-0026",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Pramipexole",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20090326",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Amino Chemicals Ltd",
      "SubstanceName": "PRAMIPEXOLE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "67835-0026-2",
      "PackageDescription": "1 BAG in 1 DRUM (67835-0026-2)  > 20 kg in 1 BAG",
      "NDC11Code": "67835-0026-02",
      "ProductNDC": "67835-0026",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Perampanel",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20210916",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SMS Pharmaceuticals Limited",
      "SubstanceName": "PERAMPANEL HYDRATE (4:3)",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2021-09-18",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "16-SEP-21"
    },
    {
      "NDCCode": "68016-026-20",
      "PackageDescription": "1 BOTTLE in 1 CARTON (68016-026-20)  > 20 CAPSULE in 1 BOTTLE",
      "NDC11Code": "68016-0026-20",
      "ProductNDC": "68016-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Adult Long Lasting-cough Relief",
      "NonProprietaryName": "Dextromethorphan Hbr,usp",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130522",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Chain Drug Consortium LLC",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold."
    },
    {
      "NDCCode": "68703-026-20",
      "PackageDescription": "20000 mg in 1 BOTTLE, GLASS (68703-026-20)",
      "NDC11Code": "68703-0026-20",
      "ProductNDC": "68703-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sniffly Sprinkles",
      "NonProprietaryName": "Allium Cepa, Ferrum Phos, Nat Mur, Nuz Vom, Pulsatilla",
      "DosageFormName": "GRANULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130130",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Native Remedies, LLC",
      "SubstanceName": "ONION; FERROSOFERRIC PHOSPHATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS",
      "StrengthNumber": "6; 8; 6; 30; 6",
      "StrengthUnit": "[hp_C]/16mg; [hp_X]/16mg; [hp_X]/16mg; [hp_C]/16mg; [hp_C]/16mg",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Uses:Homeopathic decongestant for runny, blocked noses and cold and flu in babies and children."
    },
    {
      "NDCCode": "71602-0026-1",
      "PackageDescription": "20 kg in 1 CARTON (71602-0026-1)",
      "NDC11Code": "71602-0026-01",
      "ProductNDC": "71602-0026",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20190801",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "EASTHILL CORPORATION",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "83",
      "StrengthUnit": "kg/100kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "73581-026-20",
      "PackageDescription": "200 TABLET in 1 BOTTLE (73581-026-20) ",
      "NDC11Code": "73581-0026-20",
      "ProductNDC": "73581-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fexofenadine Hydrochloride",
      "NonProprietaryName": "Fexofenadine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211075",
      "LabelerName": "YYBA Corp",
      "SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251218",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies."
    },
    {
      "NDCCode": "76420-026-20",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (76420-026-20) ",
      "NDC11Code": "76420-0026-20",
      "ProductNDC": "76420-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eszopiclone",
      "NonProprietaryName": "Eszopiclone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202929",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "ESZOPICLONE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-02-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200617",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).",
      "Description": "Eszopiclone, USP is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1carboxylate. Its molecular weight is 388.81, and its empirical formula is C 17H 17C lN 6O 3. Eszopiclone, USP has a single chiral center with an (S)-configuration. It has the following chemical structure:. Eszopiclone, USP is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone, USP is formulated as film-coated tablets for oral administration. Eszopiclone tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone, USP and the following inactive ingredients: dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2."
    },
    {
      "NDCCode": "81033-026-20",
      "PackageDescription": "20.13 mL in 1 CUP, UNIT-DOSE (81033-026-20) ",
      "NDC11Code": "81033-0026-20",
      "ProductNDC": "81033-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Childrens Acetaminophen",
      "NonProprietaryName": "Childrens Acetaminophen",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260227",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Kesin Pharma Corporation",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/5mL",
      "Status": "Active",
      "LastUpdate": "2026-02-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260227",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily reduces fever Temporarily relieves minor aches and pains due to: : 1 the common cold, 2 flu, 3 headaches, 4 sore throat, 5 toothaches."
    },
    {
      "NDCCode": "84130-026-20",
      "PackageDescription": "60 mL in 1 BOTTLE, PUMP (84130-026-20) ",
      "NDC11Code": "84130-0026-20",
      "ProductNDC": "84130-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sun Juice Body Mist Sunscreen Spf30 - Cotton Candy Skies Paradiso",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260710",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Koco Life LLC",
      "SubstanceName": "HOMOSALATE; OCTISALATE; AVOBENZONE",
      "StrengthNumber": "75; 50; 30",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-07-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260710",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreass the risk of skin cancer & early skin aging caused by the sun."
    },
    {
      "NDCCode": "85766-026-20",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (85766-026-20) ",
      "NDC11Code": "85766-0026-20",
      "ProductNDC": "85766-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Valacyclovir Hydrochloride",
      "NonProprietaryName": "Valacyclovir Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100524",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090682",
      "LabelerName": "Sportpharm LLC",
      "SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
      "Status": "Active",
      "LastUpdate": "2026-02-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250805",
      "SamplePackage": "N",
      "IndicationAndUsage": "Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for:  Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-1-infected patientsReduction of transmission, 3 Herpes Zoster  .",
      "Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 1 gram of valacyclovir, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
    },
    {
      "NDCCode": "0026-3821-25",
      "PackageDescription": "1 KIT in 1 BOX (0026-3821-25)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-99)  *  2.5 mL in 1 SYRINGE (0026-0426-02)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-01) ",
      "NDC11Code": "00026-3821-25",
      "ProductNDC": "0026-3821",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Kovaltry",
      "NonProprietaryName": "Antihemophilic Factor (recombinant)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160317",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125574",
      "LabelerName": "Bayer HealthCare LLC",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160317",
      "SamplePackage": "N",
      "IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
    },
    {
      "NDCCode": "0026-3821-99",
      "PackageDescription": "1 KIT in 1 BOX (0026-3821-99)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-99)  *  2.5 mL in 1 SYRINGE (0026-0426-02)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-01) ",
      "NDC11Code": "00026-3821-99",
      "ProductNDC": "0026-3821",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Kovaltry",
      "NonProprietaryName": "Antihemophilic Factor (recombinant)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160317",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125574",
      "LabelerName": "Bayer HealthCare LLC",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160317",
      "SamplePackage": "N",
      "IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
    },
    {
      "NDCCode": "0026-3822-25",
      "PackageDescription": "1 KIT in 1 BOX (0026-3822-25)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-99)  *  2.5 mL in 1 SYRINGE (0026-0426-02)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-01) ",
      "NDC11Code": "00026-3822-25",
      "ProductNDC": "0026-3822",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Kovaltry",
      "NonProprietaryName": "Antihemophilic Factor (recombinant)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160317",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125574",
      "LabelerName": "Bayer HealthCare LLC",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160317",
      "SamplePackage": "N",
      "IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
    },
    {
      "NDCCode": "0026-3822-99",
      "PackageDescription": "1 KIT in 1 BOX (0026-3822-99)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-99)  *  2.5 mL in 1 SYRINGE (0026-0426-02)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-01) ",
      "NDC11Code": "00026-3822-99",
      "ProductNDC": "0026-3822",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Kovaltry",
      "NonProprietaryName": "Antihemophilic Factor (recombinant)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160317",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125574",
      "LabelerName": "Bayer HealthCare LLC",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160317",
      "SamplePackage": "N",
      "IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
    },
    {
      "NDCCode": "0026-3824-25",
      "PackageDescription": "1 KIT in 1 BOX (0026-3824-25)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4824-99)  *  2.5 mL in 1 SYRINGE (0026-0426-02)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4824-01) ",
      "NDC11Code": "00026-3824-25",
      "ProductNDC": "0026-3824",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Kovaltry",
      "NonProprietaryName": "Antihemophilic Factor (recombinant)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160317",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125574",
      "LabelerName": "Bayer HealthCare LLC",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160317",
      "SamplePackage": "N",
      "IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
    },
    {
      "NDCCode": "0026-3824-99",
      "PackageDescription": "1 KIT in 1 BOX (0026-3824-99)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4824-99)  *  2.5 mL in 1 SYRINGE (0026-0426-02)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4824-01) ",
      "NDC11Code": "00026-3824-99",
      "ProductNDC": "0026-3824",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Kovaltry",
      "NonProprietaryName": "Antihemophilic Factor (recombinant)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160317",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125574",
      "LabelerName": "Bayer HealthCare LLC",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160317",
      "SamplePackage": "N",
      "IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
    },
    {
      "NDCCode": "0026-3826-50",
      "PackageDescription": "1 KIT in 1 BOX (0026-3826-50)  *  5 mL in 1 VIAL, SINGLE-USE (0026-4826-99)  *  5 mL in 1 SYRINGE (0026-0426-15)  *  5 mL in 1 VIAL, SINGLE-USE (0026-4826-01)  *  5 mL in 1 SYRINGE (0026-0426-05) ",
      "NDC11Code": "00026-3826-50",
      "ProductNDC": "0026-3826",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Kovaltry",
      "NonProprietaryName": "Antihemophilic Factor (recombinant)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160317",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125574",
      "LabelerName": "Bayer HealthCare LLC",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
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      "IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
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    },
    {
      "NDCCode": "0026-3826-99",
      "PackageDescription": "1 KIT in 1 BOX (0026-3826-99)  *  5 mL in 1 VIAL, SINGLE-USE (0026-4826-99)  *  5 mL in 1 SYRINGE (0026-0426-15)  *  5 mL in 1 VIAL, SINGLE-USE (0026-4826-01)  *  5 mL in 1 SYRINGE (0026-0426-05) ",
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      "ProductTypeName": "PLASMA DERIVATIVE",
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      "DosageFormName": "KIT",
      "StartMarketingDate": "20160317",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125574",
      "LabelerName": "Bayer HealthCare LLC",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160317",
      "SamplePackage": "N",
      "IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
    }
  ]
}
                    

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    <NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
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    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103332</ApplicationNumber>
    <LabelerName>Bayer HealthCare LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-31</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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    <NDCCode>0026-3782-20</NDCCode>
    <PackageDescription>1 KIT in 1 BOX (0026-3782-20)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4782-01)  *  2.5 mL in 1 VIAL (0026-0425-02)</PackageDescription>
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    <ProductNDC>0026-3782</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Kogenate Fs</ProprietaryName>
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    <DosageFormName>KIT</DosageFormName>
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    <MarketingCategoryName>BLA</MarketingCategoryName>
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    <LabelerName>Bayer HealthCare LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-31</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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    <NDCCode>10738-026-20</NDCCode>
    <PackageDescription>1 TUBE in 1 PACKAGE (10738-026-20)  / 56.7 g in 1 TUBE (10738-026-25) </PackageDescription>
    <NDC11Code>10738-0026-20</NDC11Code>
    <ProductNDC>10738-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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    <DosageFormName>CREAM</DosageFormName>
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    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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    <LabelerName>Genuine Virgin Aloe Corporation</LabelerName>
    <SubstanceName>ALLANTOIN</SubstanceName>
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    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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    <IndicationAndUsage>Temporarily protects minor cuts, scrapes and burns.</IndicationAndUsage>
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    <NDCCode>17337-0026-1</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (17337-0026-1) </PackageDescription>
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    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
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    <LabelerName>Olon SpA</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>02-NOV-19</StartMarketingDatePackage>
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    <PackageDescription>100 BLISTER PACK in 1 CARTON (42292-026-20)  &gt; 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (42292-026-01) </PackageDescription>
    <NDC11Code>42292-0026-20</NDC11Code>
    <ProductNDC>42292-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
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    <EndMarketingDate>20231129</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203802</ApplicationNumber>
    <LabelerName>Mylan Institutional Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20160920</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231129</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for. Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12-17): Efficacy was established in one 6-week trial. (    14.1)    .</IndicationAndUsage>
    <Description>Paliperidone Extended-Release Tablets contain paliperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3 and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (brown), 3 mg (white), 6 mg (light beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize osmotic drug-release technology [see Description (11)] . Inactive ingredients are butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, polyethylene glycol, polyethylene oxide, red iron oxide, sodium chloride, sodium stearyl fumarate, talc, titanium dioxide and yellow iron oxide. The 1.5 mg tablets also contain black iron oxide and polydextrose. The 3 mg tablets also contain polyvinyl alcohol. The 6 mg tablets also contain black iron oxide, FD&amp;C Blue No. 1 Aluminum Lake and polyvinyl alcohol. The 9 mg tablets also contain FD&amp;C Blue No. 1 Aluminum Lake and polyvinyl alcohol. The imprinting ink contains the following: black iron oxide, hypromellose and propylene glycol. Delivery System Components and Performance. Paliperidone extended-release tablets contain a bi-layer core tablet that consists of a drug layer containing the entire amount of active ingredient in a hydrophilic polymer matrix and a push layer that contains an osmotic agent in a hydrophilic, swell-able polymer matrix. The bi-layer core tablet is coated with a release-controlling semi-permeable membrane (SPM). The SPM allows water permeation into the core without allowing components to quickly dissipate from the core. A laser-drilled aperture is present on the drug layer side of the SPM-coated tablet and is necessary for delivery. The tablets contain a water soluble cosmetic over-coating that is imprinted with an identifier. Once ingested, the cosmetic over-coating rapidly dissipates in the gastrointestinal tract. The SPM allows water to penetrate into the core as the osmotic agent in the push layer provides a driving force for water influx. Once hydrated, the swell-able polymer matrix in the push layer (high molecular weight polyethylene oxide) expands, exerting a pressure on the drug layer portion of the core tablet which forces it out of the laser-drilled aperture in a plug-flow fashion. After an initial lag time (about 2 to 4 hours), water influx into the core reaches a steady-state and the drug layer is released from the laser-drilled aperture at a constant rate for approximately 20 to 24 hours. As the release rate is controlled by the rate of water influx into the core (SPM permeability), the delivery is independent of pH or gastrointestinal motility. The biologically inert tablet core (ghost), containing residual push layer components, remains intact and is eliminated in the feces. Drug absorption is controlled by a combination of drug release from the tablet and subsequent dissolution in the gastrointestinal tract.</Description>
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    <NDCCode>43353-026-20</NDCCode>
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    <ProductNDC>43353-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zolpidem Tartrate</ProprietaryName>
    <NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
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    <StartMarketingDate>20070423</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076578</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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    <NDCCode>43419-026-20</NDCCode>
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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sulwhasoo Evenfair Smoothing Foundation</ProprietaryName>
    <ProprietaryNameSuffix>Spf25 No.3 Medium Ocher</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20121123</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Amorepacific Corporation</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.32; .4268; .196</StrengthNumber>
    <StrengthUnit>g/10g; g/10g; g/10g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <PackageDescription>20 g in 1 CANISTER (48943-0026-2) </PackageDescription>
    <NDC11Code>48943-0026-02</NDC11Code>
    <ProductNDC>48943-0026</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Calcipotriene Anhydrous</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
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    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CHONGQING HUAPONT SHENGCHEM PHARM. CO., INC.</LabelerName>
    <SubstanceName>CALCIPOTRIENE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-12-31</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>09-JUN-16</StartMarketingDatePackage>
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    <NDCCode>49035-026-20</NDCCode>
    <PackageDescription>2 BOTTLE in 1 CARTON (49035-026-20)  &gt; 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>49035-0026-20</NDC11Code>
    <ProductNDC>49035-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen And Diphenhydramine Hydrochloride</ProprietaryName>
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    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>WALMART STORES INC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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    <NDCCode>50090-0026-2</NDCCode>
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    <ProductNDC>50090-0026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19841107</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062396</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140417</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52959-026-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (52959-026-20)</PackageDescription>
    <NDC11Code>52959-0026-20</NDC11Code>
    <ProductNDC>52959-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carisoprodol</ProprietaryName>
    <NonProprietaryName>Carisoprodol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960124</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040124</ApplicationNumber>
    <LabelerName>H.J. Harkins Company, Inc.</LabelerName>
    <SubstanceName>CARISOPRODOL</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see DOSAGE AND ADMINISTRATION (2)].</IndicationAndUsage>
    <Description>Carisoprodol Tablets are available as 350 mg round, white tablets.  Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste.  It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH.  Carisoprodol is present as a racemic mixture.  Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33.   The structural formula is. Other Ingredients:  colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, methylcellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-0026-6</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (54868-0026-6)</PackageDescription>
    <NDC11Code>54868-0026-06</NDC11Code>
    <ProductNDC>54868-0026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Diphenhydramine Hcl</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100127</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. Sneezing. Nasal congestion. Runny nose. Itchy, watery eyes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>66005-0026-1</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (66005-0026-1)</PackageDescription>
    <NDC11Code>66005-0026-01</NDC11Code>
    <ProductNDC>66005-0026</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Pramipexole</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20090326</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Amino Chemicals Ltd</LabelerName>
    <SubstanceName>PRAMIPEXOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>67835-0026-2</NDCCode>
    <PackageDescription>1 BAG in 1 DRUM (67835-0026-2)  &gt; 20 kg in 1 BAG</PackageDescription>
    <NDC11Code>67835-0026-02</NDC11Code>
    <ProductNDC>67835-0026</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Perampanel</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20210916</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SMS Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PERAMPANEL HYDRATE (4:3)</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2021-09-18</LastUpdate>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>16-SEP-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>68016-026-20</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (68016-026-20)  &gt; 20 CAPSULE in 1 BOTTLE</PackageDescription>
    <NDC11Code>68016-0026-20</NDC11Code>
    <ProductNDC>68016-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Adult Long Lasting-cough Relief</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hbr,usp</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130522</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Chain Drug Consortium LLC</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68703-026-20</NDCCode>
    <PackageDescription>20000 mg in 1 BOTTLE, GLASS (68703-026-20)</PackageDescription>
    <NDC11Code>68703-0026-20</NDC11Code>
    <ProductNDC>68703-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sniffly Sprinkles</ProprietaryName>
    <NonProprietaryName>Allium Cepa, Ferrum Phos, Nat Mur, Nuz Vom, Pulsatilla</NonProprietaryName>
    <DosageFormName>GRANULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130130</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Native Remedies, LLC</LabelerName>
    <SubstanceName>ONION; FERROSOFERRIC PHOSPHATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS</SubstanceName>
    <StrengthNumber>6; 8; 6; 30; 6</StrengthNumber>
    <StrengthUnit>[hp_C]/16mg; [hp_X]/16mg; [hp_X]/16mg; [hp_C]/16mg; [hp_C]/16mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses:Homeopathic decongestant for runny, blocked noses and cold and flu in babies and children.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71602-0026-1</NDCCode>
    <PackageDescription>20 kg in 1 CARTON (71602-0026-1)</PackageDescription>
    <NDC11Code>71602-0026-01</NDC11Code>
    <ProductNDC>71602-0026</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20190801</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>EASTHILL CORPORATION</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>83</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>73581-026-20</NDCCode>
    <PackageDescription>200 TABLET in 1 BOTTLE (73581-026-20) </PackageDescription>
    <NDC11Code>73581-0026-20</NDC11Code>
    <ProductNDC>73581-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251218</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211075</ApplicationNumber>
    <LabelerName>YYBA Corp</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>76420-026-20</NDCCode>
    <PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (76420-026-20) </PackageDescription>
    <NDC11Code>76420-0026-20</NDC11Code>
    <ProductNDC>76420-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eszopiclone</ProprietaryName>
    <NonProprietaryName>Eszopiclone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202929</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>ESZOPICLONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-02-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200617</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).</IndicationAndUsage>
    <Description>Eszopiclone, USP is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1carboxylate. Its molecular weight is 388.81, and its empirical formula is C 17H 17C lN 6O 3. Eszopiclone, USP has a single chiral center with an (S)-configuration. It has the following chemical structure:. Eszopiclone, USP is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone, USP is formulated as film-coated tablets for oral administration. Eszopiclone tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone, USP and the following inactive ingredients: dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&amp;C Blue #2.</Description>
  </NDC>
  <NDC>
    <NDCCode>81033-026-20</NDCCode>
    <PackageDescription>20.13 mL in 1 CUP, UNIT-DOSE (81033-026-20) </PackageDescription>
    <NDC11Code>81033-0026-20</NDC11Code>
    <ProductNDC>81033-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Childrens Acetaminophen</ProprietaryName>
    <NonProprietaryName>Childrens Acetaminophen</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260227</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Kesin Pharma Corporation</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily reduces fever Temporarily relieves minor aches and pains due to: : 1 the common cold, 2 flu, 3 headaches, 4 sore throat, 5 toothaches.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84130-026-20</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, PUMP (84130-026-20) </PackageDescription>
    <NDC11Code>84130-0026-20</NDC11Code>
    <ProductNDC>84130-026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sun Juice Body Mist Sunscreen Spf30 - Cotton Candy Skies Paradiso</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260710</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Koco Life LLC</LabelerName>
    <SubstanceName>HOMOSALATE; OCTISALATE; AVOBENZONE</SubstanceName>
    <StrengthNumber>75; 50; 30</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260710</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreass the risk of skin cancer &amp; early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85766-026-20</NDCCode>
    <PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (85766-026-20) </PackageDescription>
    <NDC11Code>85766-0026-20</NDC11Code>
    <ProductNDC>85766-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
    <NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090682</ApplicationNumber>
    <LabelerName>Sportpharm LLC</LabelerName>
    <SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for:  Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-1-infected patientsReduction of transmission, 3 Herpes Zoster  .</IndicationAndUsage>
    <Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 1 gram of valacyclovir, and the inactive ingredients crospovidone, FD&amp;C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
  </NDC>
  <NDC>
    <NDCCode>0026-3821-25</NDCCode>
    <PackageDescription>1 KIT in 1 BOX (0026-3821-25)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-99)  *  2.5 mL in 1 SYRINGE (0026-0426-02)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-01) </PackageDescription>
    <NDC11Code>00026-3821-25</NDC11Code>
    <ProductNDC>0026-3821</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Kovaltry</ProprietaryName>
    <NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160317</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125574</ApplicationNumber>
    <LabelerName>Bayer HealthCare LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.</IndicationAndUsage>
    <Description>KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates.</Description>
  </NDC>
  <NDC>
    <NDCCode>0026-3821-99</NDCCode>
    <PackageDescription>1 KIT in 1 BOX (0026-3821-99)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-99)  *  2.5 mL in 1 SYRINGE (0026-0426-02)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-01) </PackageDescription>
    <NDC11Code>00026-3821-99</NDC11Code>
    <ProductNDC>0026-3821</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Kovaltry</ProprietaryName>
    <NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160317</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125574</ApplicationNumber>
    <LabelerName>Bayer HealthCare LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0026-3792-20</NDCCode><ProprietaryName>Kogenate Fs</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3782-20</NDCCode><ProprietaryName>Kogenate Fs</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>10738-026-20</NDCCode><ProprietaryName>Triderma Genuine Aloe Burn</ProprietaryName><NonProprietaryName>Aloe Burn Relief</NonProprietaryName></NDC><NDC><NDCCode>17337-0026-1</NDCCode><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42292-026-20</NDCCode><ProprietaryName>Paliperidone</ProprietaryName><NonProprietaryName>Paliperidone</NonProprietaryName></NDC><NDC><NDCCode>43353-026-20</NDCCode><ProprietaryName>Zolpidem Tartrate</ProprietaryName><NonProprietaryName>Zolpidem Tartrate</NonProprietaryName></NDC><NDC><NDCCode>43419-026-20</NDCCode><ProprietaryName>Sulwhasoo Evenfair Smoothing Foundation</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>48943-0026-2</NDCCode><NonProprietaryName>Calcipotriene Anhydrous</NonProprietaryName></NDC><NDC><NDCCode>49035-026-20</NDCCode><ProprietaryName>Acetaminophen And Diphenhydramine Hydrochloride</ProprietaryName><NonProprietaryName>Acetaminophen And Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50090-0026-2</NDCCode><ProprietaryName>Doxycycline Hyclate</ProprietaryName><NonProprietaryName>Doxycycline Hyclate</NonProprietaryName></NDC><NDC><NDCCode>52959-026-20</NDCCode><ProprietaryName>Carisoprodol</ProprietaryName><NonProprietaryName>Carisoprodol</NonProprietaryName></NDC><NDC><NDCCode>54868-0026-6</NDCCode><ProprietaryName>Diphenhydramine Hcl</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>66005-0026-1</NDCCode><NonProprietaryName>Pramipexole</NonProprietaryName></NDC><NDC><NDCCode>67835-0026-2</NDCCode><NonProprietaryName>Perampanel</NonProprietaryName></NDC><NDC><NDCCode>68016-026-20</NDCCode><ProprietaryName>Adult Long Lasting-cough Relief</ProprietaryName><NonProprietaryName>Dextromethorphan Hbr,usp</NonProprietaryName></NDC><NDC><NDCCode>68703-026-20</NDCCode><ProprietaryName>Sniffly Sprinkles</ProprietaryName><NonProprietaryName>Allium Cepa, Ferrum Phos, Nat Mur, Nuz Vom, Pulsatilla</NonProprietaryName></NDC><NDC><NDCCode>71602-0026-1</NDCCode><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>73581-026-20</NDCCode><ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName><NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76420-026-20</NDCCode><ProprietaryName>Eszopiclone</ProprietaryName><NonProprietaryName>Eszopiclone</NonProprietaryName></NDC><NDC><NDCCode>81033-026-20</NDCCode><ProprietaryName>Childrens Acetaminophen</ProprietaryName><NonProprietaryName>Childrens Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>84130-026-20</NDCCode><ProprietaryName>Sun Juice Body Mist Sunscreen Spf30 - Cotton Candy Skies Paradiso</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate</NonProprietaryName></NDC><NDC><NDCCode>85766-026-20</NDCCode><ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName><NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0026-3821-25</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3821-99</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3822-25</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3822-99</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3824-25</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3824-99</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3826-50</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3826-99</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "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.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06492-1832",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "203-284-9448",
      "PracticeLocationAddressFaxNumber": "203-269-1361",
      "EnumerationDate": "09/28/2006",
      "LastUpdateDate": "03/07/2008",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "JOHN",
      "AuthorizedOfficialMiddleName": "W",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "203-284-9448",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1982789863",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "OVERLAKE EYE DESIGNS, P.C.",
      "FirstLineMailingAddress": "15230 NE 24TH ST STE Q",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-5540",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-562-2015",
      "MailingAddressFaxNumber": "425-562-2010",
      "FirstLinePracticeLocationAddress": "15230 NE 24TH ST STE Q",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-5540",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-562-2015",
      "PracticeLocationAddressFaxNumber": "425-562-2010",
      "EnumerationDate": "10/26/2006",
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      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
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}
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