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How to Find 63285-782-06 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "63285-782-06",
      "PackageDescription": "12 CARTON in 1 CASE (63285-782-06)  > 6 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "63285-0782-06",
      "ProductNDC": "63285-782",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160803",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "63187-782-06",
      "PackageDescription": "6 TABLET in 1 BOTTLE (63187-782-06) ",
      "NDC11Code": "63187-0782-06",
      "ProductNDC": "63187-782",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100913",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076899",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
      "StrengthNumber": "800; 160",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2019-11-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20161101",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jiroveci Pneumonia:For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P.jiroveci pneumonia. Traveler’s Diarrhea in Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
      "Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole, USP and 160 mg trimethoprim, USP; in tablets, each containing 400 mg sulfamethoxazole, USP and 80 mg trimethoprim, USP for oral administration. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula. Inactive Ingredients: Magnesium stearate, povidone, pregelatinized starch and sodium starch glycolate."
    },
    {
      "NDCCode": "64380-782-06",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (64380-782-06) ",
      "NDC11Code": "64380-0782-06",
      "ProductNDC": "64380-782",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210901",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210785",
      "LabelerName": "Strides Pharma Science Limited",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisone tablets USP are indicated in the following conditions. Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; posttraumatic osteoarthritis; synovitis of osteoarthritis; epicondylitis. Collagen Diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, acute rheumatic carditis. Dermatologic Diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis. Allergic States: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions. Ophthalmic Diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia. Respiratory Diseases: symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis. Hematologic Disorders: idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia. Neoplastic Diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement. In addition to the above indications, prednisone tablets are indicated for systemic dermatomyositis (polymyositis).",
      "Description": "Prednisone Tablets USP are available for oral administration containing 1 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize starch), sodium starch glycolate. Prednisone tablets USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17, 21-dihydroxypregna-1,4-diene-3,11,20-trione. The structural formula is represented below. Prednisone is a white to partially white, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "68382-782-06",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (68382-782-06) ",
      "NDC11Code": "68382-0782-06",
      "ProductNDC": "68382-782",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline",
      "NonProprietaryName": "Doxycycline",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160314",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205115",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "DOXYCYCLINE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160314",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline capsules, USP are indicated for the treatment of the following infections. Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia  trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma  urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline capsules, USP are also indicated for the treatment of infections caused by the following gram-negative microorganisms:. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis   due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema  pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria  monocytogenes. Vincent's infection caused by Fusobacterium    fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.",
      "Description": "Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline capsules 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate, USP equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow to pale yellow powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C22H24N2O8  H2O           M.W. = 462.45. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each doxycycline capsule, USP intended for oral administration contains 50 mg or 75 mg or 100 mg of doxycycline. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. Additionally, each 50 and 100 mg capsule shell contains iron oxide yellow, each 75 mg and 100 mg capsule shell contains: D & C yellow # 10, FD & C blue # 1, FD & C red # 3 and FD & C yellow # 6 and each 100 mg capsule shell contains iron oxide red. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The Product meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "63285-778-06",
      "PackageDescription": "12 CARTON in 1 CASE (63285-778-06)  > 6 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "63285-0778-06",
      "ProductNDC": "63285-778",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160803",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "63285-779-06",
      "PackageDescription": "12 CARTON in 1 CASE (63285-779-06)  > 6 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "63285-0779-06",
      "ProductNDC": "63285-779",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160803",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "63285-780-06",
      "PackageDescription": "12 CARTON in 1 CASE (63285-780-06)  > 6 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "63285-0780-06",
      "ProductNDC": "63285-780",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160803",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "63285-781-06",
      "PackageDescription": "12 CARTON in 1 CASE (63285-781-06)  > 6 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "63285-0781-06",
      "ProductNDC": "63285-781",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160803",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "63285-783-06",
      "PackageDescription": "12 CARTON in 1 CASE (63285-783-06)  > 6 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "63285-0783-06",
      "ProductNDC": "63285-783",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Norethindrone And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160803",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "63285-785-06",
      "PackageDescription": "12 CARTON in 1 CASE (63285-785-06)  > 6 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "63285-0785-06",
      "ProductNDC": "63285-785",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Norethindrone And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160803",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "63285-787-06",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (63285-787-06)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "63285-0787-06",
      "ProductNDC": "63285-787",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Norethindrone And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19741227",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "63285-019-00",
      "PackageDescription": "6263 TABLET, FILM COATED in 1 CONTAINER (63285-019-00) ",
      "NDC11Code": "63285-0019-00",
      "ProductNDC": "63285-019",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20060720",
      "EndMarketingDate": "20250331",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "SubstanceName": "EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
      "StrengthNumber": "600; 200; 300",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "StartMarketingDatePackage": "20-JUL-06",
      "EndMarketingDatePackage": "31-MAR-25"
    },
    {
      "NDCCode": "63285-301-01",
      "PackageDescription": "80 BOTTLE in 1 CONTAINER (63285-301-01)  > 30 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "63285-0301-01",
      "ProductNDC": "63285-301",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20110810",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "SubstanceName": "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE",
      "StrengthNumber": "200; 25; 300",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2020-06-12",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "63285-738-00",
      "PackageDescription": "7192 TABLET, FILM COATED in 1 CONTAINER (63285-738-00)",
      "NDC11Code": "63285-0738-00",
      "ProductNDC": "63285-738",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20120827",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "SubstanceName": "ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
      "StrengthNumber": "150; 150; 200; 300",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2020-06-26",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "63285-738-01",
      "PackageDescription": "80 BOTTLE, PLASTIC in 1 CONTAINER (63285-738-01)  > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
      "NDC11Code": "63285-0738-01",
      "ProductNDC": "63285-738",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20120827",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "SubstanceName": "ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
      "StrengthNumber": "150; 150; 200; 300",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2020-06-26",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "63285-753-01",
      "PackageDescription": "80 BOTTLE in 1 CONTAINER (63285-753-01)  > 60 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "63285-0753-01",
      "ProductNDC": "63285-753",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Idelalisib",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20140723",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "SubstanceName": "IDELALISIB",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2020-06-12",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "63285-754-01",
      "PackageDescription": "80 BOTTLE in 1 CONTAINER (63285-754-01)  > 60 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "63285-0754-01",
      "ProductNDC": "63285-754",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Idelalisib",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20140723",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "SubstanceName": "IDELALISIB",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2020-06-12",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "63285-836-00",
      "PackageDescription": "72 BOTTLE in 1 CASE (63285-836-00)  > 30 CAPSULE in 1 BOTTLE",
      "NDC11Code": "63285-0836-00",
      "ProductNDC": "63285-836",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Sonidegib Phosphate",
      "DosageFormName": "CAPSULE",
      "StartMarketingDate": "20170921",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "SubstanceName": "SONIDEGIB PHOSPHATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2020-06-23",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "63285-861-00",
      "PackageDescription": "80 BOTTLE in 1 CASE (63285-861-00)  > 30 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "63285-0861-00",
      "ProductNDC": "63285-861",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Alafenamide Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20160301",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "SubstanceName": "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE",
      "StrengthNumber": "200; 25; 25",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2020-06-20",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "63285-923-02",
      "PackageDescription": "11520 BLISTER PACK in 1 CONTAINER (63285-923-02)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "63285-0923-02",
      "ProductNDC": "63285-923",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Iloperidone",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20241005",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "Status": "Unfinished",
      "LastUpdate": "2025-06-30",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "05-OCT-24"
    },
    {
      "NDCCode": "63285-924-02",
      "PackageDescription": "9600 BLISTER PACK in 1 CONTAINER (63285-924-02)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "63285-0924-02",
      "ProductNDC": "63285-924",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Iloperidone",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240527",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "Status": "Unfinished",
      "LastUpdate": "2025-06-30",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "27-MAY-24"
    },
    {
      "NDCCode": "0185-1047-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0185-1047-01) ",
      "NDC11Code": "00185-1047-01",
      "ProductNDC": "0185-1047",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quinidine Sulfate",
      "NonProprietaryName": "Quinidine Sulfate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19830926",
      "EndMarketingDate": "20250531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088072",
      "LabelerName": "Eon Labs, Inc.",
      "SubstanceName": "QUINIDINE SULFATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19830926",
      "EndMarketingDatePackage": "20250531",
      "SamplePackage": "N",
      "Description": "Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with class 1A activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine sulfate is the sulfate salt of quinidine; its chemical name is cinchonan-9-ol,6’- methoxy-,(9S)-, sulfate(2:1) dihydrate; its structural formula is. Its molecular formula is: C40H48N4O4H2SO42H2O; and its molecular weight is 782.96, of which 82.9% is quinidine base. Quinidine sulfate occurs as fine needle-like, white crystals, frequently cohering in masses, or fine, white powder. It is odorless, has a very bitter taste, and darkens on exposure to light. It is slightly soluble in water, soluble in alcohol and in chloroform, and insoluble in ether. Each tablet, for oral administration, contains 200 mg of quinidine sulfate (equivalent to 166 mg of quinidine base) 300 mg of quinidine sulfate (equivalent to 249 mg of quinidine base). In addition, each tablet contains the following inactive ingredients: confectioner’s sugar, corn starch, microcrystalline cellulose, pregelatinized starch and zinc stearate."
    },
    {
      "NDCCode": "0480-2602-06",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE (0480-2602-06) ",
      "NDC11Code": "00480-2602-06",
      "ProductNDC": "0480-2602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextromethorphan Hydrobromide And Quinidine Sulfate",
      "NonProprietaryName": "Dextromethorphan Hydrobromide And Quinidine Sulfate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260916",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202934",
      "LabelerName": "Teva Pharmaceuticals, Inc.",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE",
      "StrengthNumber": "20; 10",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260916",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextromethorphan hydrobromide and quinidine sulfate capsules are indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.",
      "Description": "Dextromethorphan hydrobromide and quinidine sulfate capsules are an oral formulation of dextromethorphan hydrobromide, USP and quinidine sulfate, USP in a fixed dose combination. Dextromethorphan hydrobromide, USP is the pharmacologically active ingredient of dextromethorphan hydrobromide and quinidine sulfate capsules that acts on the central nervous system (CNS). The chemical name is dextromethorphan hydrobromide, USP: morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide, USP has the molecular formula C18H25NOHBrH2O with a molecular weight of 370.32. The structural formula is. Quinidine sulfate, USP is a specific inhibitor of CYP2D6-dependent oxidative metabolism used in dextromethorphan hydrobromide and quinidine sulfate capsules to increase the systemic bioavailability of dextromethorphan. The chemical name is quinidine sulfate, USP: cinchonan-9-ol, 6’-methoxy-, (9S) sulfate (2:1), (salt), dihydrate. Quinidine sulfate dihydrate, USP has the molecular formula of (C20H24N2O2)2H2SO42H2O with a molecular weight of 782.94. The structural formula is. The combination product, dextromethorphan hydrobromide and quinidine sulfate, is a white to off-white powder. Dextromethorphan hydrobromide and quinidine sulfate is available for oral use as dextromethorphan hydrobromide and quinidine sulfate capsules which contain 20 mg of dextromethorphan hydrobromide, USP and 10 mg of quinidine sulfate, USP. The active ingredients are dextromethorphan hydrobromide monohydrate, USP and quinidine sulfate dihydrate, USP. The inactive ingredients are as follows: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The capsules contain FD&C Red #3, FD&C Yellow #6, gelatin and titanium dioxide. The capsules are imprinted with black ink which contains black iron oxide, potassium hydroxide, propylene glycol and shellac."
    },
    {
      "NDCCode": "16571-782-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16571-782-01) ",
      "NDC11Code": "16571-0782-01",
      "ProductNDC": "16571-782",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080926",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078643",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-06-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20080926",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217ºC, and a pKa of 8.47 at 25ºC. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as 5 mg or 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch (maize) and titanium dioxide. In addition 5 mg also contains D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake and 10 mg also contains yellow iron oxide. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "16571-782-10",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (16571-782-10) ",
      "NDC11Code": "16571-0782-10",
      "ProductNDC": "16571-782",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080926",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078643",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-06-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20080926",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217ºC, and a pKa of 8.47 at 25ºC. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as 5 mg or 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch (maize) and titanium dioxide. In addition 5 mg also contains D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake and 10 mg also contains yellow iron oxide. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "16571-782-50",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (16571-782-50) ",
      "NDC11Code": "16571-0782-50",
      "ProductNDC": "16571-782",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080926",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078643",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-06-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20080926",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217ºC, and a pKa of 8.47 at 25ºC. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as 5 mg or 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch (maize) and titanium dioxide. In addition 5 mg also contains D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake and 10 mg also contains yellow iron oxide. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "50474-782-84",
      "PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (50474-782-84)  / 2 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "50474-0782-84",
      "ProductNDC": "50474-782",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bimzelx",
      "NonProprietaryName": "Bimekizumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20241205",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761151",
      "LabelerName": "UCB, Inc.",
      "SubstanceName": "BIMEKIZUMAB",
      "StrengthNumber": "320",
      "StrengthUnit": "mg/2mL",
      "Status": "Active",
      "LastUpdate": "2025-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241205",
      "SamplePackage": "N",
      "IndicationAndUsage": "BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .",
      "Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
    },
    {
      "NDCCode": "50474-782-86",
      "PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (50474-782-86)  / 1 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "50474-0782-86",
      "ProductNDC": "50474-782",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bimzelx",
      "NonProprietaryName": "Bimekizumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20241205",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761151",
      "LabelerName": "UCB, Inc.",
      "SubstanceName": "BIMEKIZUMAB",
      "StrengthNumber": "320",
      "StrengthUnit": "mg/2mL",
      "Status": "Active",
      "LastUpdate": "2025-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241205",
      "SamplePackage": "N",
      "IndicationAndUsage": "BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .",
      "Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
    },
    {
      "NDCCode": "50991-782-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (50991-782-60) ",
      "NDC11Code": "50991-0782-60",
      "ProductNDC": "50991-782",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ala-hist Pe",
      "NonProprietaryName": "Phenylephrine Hydrochloride, Dexbrompheniramine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110915",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Poly Pharmaceuticals, Inc.",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE",
      "StrengthNumber": "10; 2",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-06-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20110915",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "60687-782-01",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (60687-782-01)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-782-11) ",
      "NDC11Code": "60687-0782-01",
      "ProductNDC": "60687-782",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupropion Hydrochloride Xl",
      "NonProprietaryName": "Bupropion Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090693",
      "LabelerName": "American Health Packaging",
      "SubstanceName": "BUPROPION HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-10-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bupropion hydrochloride extended-release tablet (XL) is an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
      "Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1 propanone hydrochloride. The molecular weight is 276.21. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablet USP (XL) is supplied for oral administration as 150 mg and 300 mg, off-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, glyceryl behenate, hydrophobic colloidal silica, hydroxypropyl cellulose, iron oxide black, L-cysteine hydrochloride monohydrate, methacrylic acid copolymer dispersion, polyvinyl alcohol, povidone, propylene glycol, shellac and triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The Drug Product Meets USP Dissolution Test 20."
    }
  ]
}
                    
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    <PackageDescription>12 CARTON in 1 CASE (63285-782-06)  &gt; 6 BLISTER PACK in 1 CARTON &gt; 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63285-0782-06</NDC11Code>
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    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160803</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63187-782-06</NDCCode>
    <PackageDescription>6 TABLET in 1 BOTTLE (63187-782-06) </PackageDescription>
    <NDC11Code>63187-0782-06</NDC11Code>
    <ProductNDC>63187-782</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
    <NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100913</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076899</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
    <StrengthNumber>800; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-11-30</LastUpdate>
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    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jiroveci Pneumonia:For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P.jiroveci pneumonia. Traveler’s Diarrhea in Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
    <Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole, USP and 160 mg trimethoprim, USP; in tablets, each containing 400 mg sulfamethoxazole, USP and 80 mg trimethoprim, USP for oral administration. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula. Inactive Ingredients: Magnesium stearate, povidone, pregelatinized starch and sodium starch glycolate.</Description>
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  <NDC>
    <NDCCode>64380-782-06</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (64380-782-06) </PackageDescription>
    <NDC11Code>64380-0782-06</NDC11Code>
    <ProductNDC>64380-782</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210785</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone tablets USP are indicated in the following conditions. Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; posttraumatic osteoarthritis; synovitis of osteoarthritis; epicondylitis. Collagen Diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, acute rheumatic carditis. Dermatologic Diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis. Allergic States: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions. Ophthalmic Diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia. Respiratory Diseases: symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis. Hematologic Disorders: idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia. Neoplastic Diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement. In addition to the above indications, prednisone tablets are indicated for systemic dermatomyositis (polymyositis).</IndicationAndUsage>
    <Description>Prednisone Tablets USP are available for oral administration containing 1 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize starch), sodium starch glycolate. Prednisone tablets USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17, 21-dihydroxypregna-1,4-diene-3,11,20-trione. The structural formula is represented below. Prednisone is a white to partially white, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
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  <NDC>
    <NDCCode>68382-782-06</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (68382-782-06) </PackageDescription>
    <NDC11Code>68382-0782-06</NDC11Code>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160314</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205115</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160314</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline capsules, USP are indicated for the treatment of the following infections. Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia  trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma  urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline capsules, USP are also indicated for the treatment of infections caused by the following gram-negative microorganisms:. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis   due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema  pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria  monocytogenes. Vincent's infection caused by Fusobacterium    fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.</IndicationAndUsage>
    <Description>Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline capsules 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate, USP equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow to pale yellow powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C22H24N2O8  H2O           M.W. = 462.45. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each doxycycline capsule, USP intended for oral administration contains 50 mg or 75 mg or 100 mg of doxycycline. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. Additionally, each 50 and 100 mg capsule shell contains iron oxide yellow, each 75 mg and 100 mg capsule shell contains: D &amp; C yellow # 10, FD &amp; C blue # 1, FD &amp; C red # 3 and FD &amp; C yellow # 6 and each 100 mg capsule shell contains iron oxide red. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The Product meets USP Dissolution Test 2.</Description>
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  <NDC>
    <NDCCode>63285-778-06</NDCCode>
    <PackageDescription>12 CARTON in 1 CASE (63285-778-06)  &gt; 6 BLISTER PACK in 1 CARTON &gt; 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63285-0778-06</NDC11Code>
    <ProductNDC>63285-778</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160803</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63285-779-06</NDCCode>
    <PackageDescription>12 CARTON in 1 CASE (63285-779-06)  &gt; 6 BLISTER PACK in 1 CARTON &gt; 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63285-0779-06</NDC11Code>
    <ProductNDC>63285-779</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160803</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63285-780-06</NDCCode>
    <PackageDescription>12 CARTON in 1 CASE (63285-780-06)  &gt; 6 BLISTER PACK in 1 CARTON &gt; 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63285-0780-06</NDC11Code>
    <ProductNDC>63285-780</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160803</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63285-781-06</NDCCode>
    <PackageDescription>12 CARTON in 1 CASE (63285-781-06)  &gt; 6 BLISTER PACK in 1 CARTON &gt; 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63285-0781-06</NDC11Code>
    <ProductNDC>63285-781</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160803</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63285-783-06</NDCCode>
    <PackageDescription>12 CARTON in 1 CASE (63285-783-06)  &gt; 6 BLISTER PACK in 1 CARTON &gt; 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63285-0783-06</NDC11Code>
    <ProductNDC>63285-783</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Norethindrone And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160803</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63285-785-06</NDCCode>
    <PackageDescription>12 CARTON in 1 CASE (63285-785-06)  &gt; 6 BLISTER PACK in 1 CARTON &gt; 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63285-0785-06</NDC11Code>
    <ProductNDC>63285-785</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Norethindrone And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160803</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63285-787-06</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (63285-787-06)  &gt; 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63285-0787-06</NDC11Code>
    <ProductNDC>63285-787</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Norethindrone And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19741227</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63285-019-00</NDCCode>
    <PackageDescription>6263 TABLET, FILM COATED in 1 CONTAINER (63285-019-00) </PackageDescription>
    <NDC11Code>63285-0019-00</NDC11Code>
    <ProductNDC>63285-019</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20060720</StartMarketingDate>
    <EndMarketingDate>20250331</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <SubstanceName>EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
    <StrengthNumber>600; 200; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <StartMarketingDatePackage>20-JUL-06</StartMarketingDatePackage>
    <EndMarketingDatePackage>31-MAR-25</EndMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>63285-301-01</NDCCode>
    <PackageDescription>80 BOTTLE in 1 CONTAINER (63285-301-01)  &gt; 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>63285-0301-01</NDC11Code>
    <ProductNDC>63285-301</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20110810</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <SubstanceName>EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
    <StrengthNumber>200; 25; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2020-06-12</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63285-738-00</NDCCode>
    <PackageDescription>7192 TABLET, FILM COATED in 1 CONTAINER (63285-738-00)</PackageDescription>
    <NDC11Code>63285-0738-00</NDC11Code>
    <ProductNDC>63285-738</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20120827</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <SubstanceName>ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
    <StrengthNumber>150; 150; 200; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2020-06-26</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63285-738-01</NDCCode>
    <PackageDescription>80 BOTTLE, PLASTIC in 1 CONTAINER (63285-738-01)  &gt; 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>63285-0738-01</NDC11Code>
    <ProductNDC>63285-738</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20120827</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <SubstanceName>ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
    <StrengthNumber>150; 150; 200; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2020-06-26</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63285-753-01</NDCCode>
    <PackageDescription>80 BOTTLE in 1 CONTAINER (63285-753-01)  &gt; 60 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>63285-0753-01</NDC11Code>
    <ProductNDC>63285-753</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Idelalisib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20140723</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <SubstanceName>IDELALISIB</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2020-06-12</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63285-754-01</NDCCode>
    <PackageDescription>80 BOTTLE in 1 CONTAINER (63285-754-01)  &gt; 60 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>63285-0754-01</NDC11Code>
    <ProductNDC>63285-754</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Idelalisib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20140723</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <SubstanceName>IDELALISIB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2020-06-12</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63285-836-00</NDCCode>
    <PackageDescription>72 BOTTLE in 1 CASE (63285-836-00)  &gt; 30 CAPSULE in 1 BOTTLE</PackageDescription>
    <NDC11Code>63285-0836-00</NDC11Code>
    <ProductNDC>63285-836</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Sonidegib Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20170921</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <SubstanceName>SONIDEGIB PHOSPHATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2020-06-23</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63285-861-00</NDCCode>
    <PackageDescription>80 BOTTLE in 1 CASE (63285-861-00)  &gt; 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>63285-0861-00</NDC11Code>
    <ProductNDC>63285-861</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Alafenamide Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20160301</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <SubstanceName>EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE</SubstanceName>
    <StrengthNumber>200; 25; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2020-06-20</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63285-923-02</NDCCode>
    <PackageDescription>11520 BLISTER PACK in 1 CONTAINER (63285-923-02)  / 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63285-0923-02</NDC11Code>
    <ProductNDC>63285-923</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Iloperidone</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20241005</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <Status>Unfinished</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>05-OCT-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>63285-924-02</NDCCode>
    <PackageDescription>9600 BLISTER PACK in 1 CONTAINER (63285-924-02)  / 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63285-0924-02</NDC11Code>
    <ProductNDC>63285-924</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Iloperidone</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20240527</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <Status>Unfinished</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>27-MAY-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0185-1047-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0185-1047-01) </PackageDescription>
    <NDC11Code>00185-1047-01</NDC11Code>
    <ProductNDC>0185-1047</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quinidine Sulfate</ProprietaryName>
    <NonProprietaryName>Quinidine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19830926</StartMarketingDate>
    <EndMarketingDate>20250531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088072</ApplicationNumber>
    <LabelerName>Eon Labs, Inc.</LabelerName>
    <SubstanceName>QUINIDINE SULFATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19830926</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with class 1A activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine sulfate is the sulfate salt of quinidine; its chemical name is cinchonan-9-ol,6’- methoxy-,(9S)-, sulfate(2:1) dihydrate; its structural formula is. Its molecular formula is: C40H48N4O4H2SO42H2O; and its molecular weight is 782.96, of which 82.9% is quinidine base. Quinidine sulfate occurs as fine needle-like, white crystals, frequently cohering in masses, or fine, white powder. It is odorless, has a very bitter taste, and darkens on exposure to light. It is slightly soluble in water, soluble in alcohol and in chloroform, and insoluble in ether. Each tablet, for oral administration, contains 200 mg of quinidine sulfate (equivalent to 166 mg of quinidine base) 300 mg of quinidine sulfate (equivalent to 249 mg of quinidine base). In addition, each tablet contains the following inactive ingredients: confectioner’s sugar, corn starch, microcrystalline cellulose, pregelatinized starch and zinc stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0480-2602-06</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (0480-2602-06) </PackageDescription>
    <NDC11Code>00480-2602-06</NDC11Code>
    <ProductNDC>0480-2602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextromethorphan Hydrobromide And Quinidine Sulfate</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hydrobromide And Quinidine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260916</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202934</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE</SubstanceName>
    <StrengthNumber>20; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dextromethorphan hydrobromide and quinidine sulfate capsules are indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.</IndicationAndUsage>
    <Description>Dextromethorphan hydrobromide and quinidine sulfate capsules are an oral formulation of dextromethorphan hydrobromide, USP and quinidine sulfate, USP in a fixed dose combination. Dextromethorphan hydrobromide, USP is the pharmacologically active ingredient of dextromethorphan hydrobromide and quinidine sulfate capsules that acts on the central nervous system (CNS). The chemical name is dextromethorphan hydrobromide, USP: morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide, USP has the molecular formula C18H25NOHBrH2O with a molecular weight of 370.32. The structural formula is. Quinidine sulfate, USP is a specific inhibitor of CYP2D6-dependent oxidative metabolism used in dextromethorphan hydrobromide and quinidine sulfate capsules to increase the systemic bioavailability of dextromethorphan. The chemical name is quinidine sulfate, USP: cinchonan-9-ol, 6’-methoxy-, (9S) sulfate (2:1), (salt), dihydrate. Quinidine sulfate dihydrate, USP has the molecular formula of (C20H24N2O2)2H2SO42H2O with a molecular weight of 782.94. The structural formula is. The combination product, dextromethorphan hydrobromide and quinidine sulfate, is a white to off-white powder. Dextromethorphan hydrobromide and quinidine sulfate is available for oral use as dextromethorphan hydrobromide and quinidine sulfate capsules which contain 20 mg of dextromethorphan hydrobromide, USP and 10 mg of quinidine sulfate, USP. The active ingredients are dextromethorphan hydrobromide monohydrate, USP and quinidine sulfate dihydrate, USP. The inactive ingredients are as follows: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The capsules contain FD&amp;C Red #3, FD&amp;C Yellow #6, gelatin and titanium dioxide. The capsules are imprinted with black ink which contains black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-782-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (16571-782-01) </PackageDescription>
    <NDC11Code>16571-0782-01</NDC11Code>
    <ProductNDC>16571-782</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080926</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078643</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080926</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217ºC, and a pKa of 8.47 at 25ºC. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as 5 mg or 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch (maize) and titanium dioxide. In addition 5 mg also contains D&amp;C yellow #10 aluminum lake and FD&amp;C yellow #6 aluminum lake and 10 mg also contains yellow iron oxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-782-10</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (16571-782-10) </PackageDescription>
    <NDC11Code>16571-0782-10</NDC11Code>
    <ProductNDC>16571-782</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080926</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078643</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080926</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217ºC, and a pKa of 8.47 at 25ºC. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as 5 mg or 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch (maize) and titanium dioxide. In addition 5 mg also contains D&amp;C yellow #10 aluminum lake and FD&amp;C yellow #6 aluminum lake and 10 mg also contains yellow iron oxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-782-50</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (16571-782-50) </PackageDescription>
    <NDC11Code>16571-0782-50</NDC11Code>
    <ProductNDC>16571-782</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080926</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078643</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080926</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217ºC, and a pKa of 8.47 at 25ºC. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as 5 mg or 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch (maize) and titanium dioxide. In addition 5 mg also contains D&amp;C yellow #10 aluminum lake and FD&amp;C yellow #6 aluminum lake and 10 mg also contains yellow iron oxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>50474-782-84</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 CARTON (50474-782-84)  / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>50474-0782-84</NDC11Code>
    <ProductNDC>50474-782</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bimzelx</ProprietaryName>
    <NonProprietaryName>Bimekizumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20241205</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761151</ApplicationNumber>
    <LabelerName>UCB, Inc.</LabelerName>
    <SubstanceName>BIMEKIZUMAB</SubstanceName>
    <StrengthNumber>320</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .</IndicationAndUsage>
    <Description>Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1.</Description>
  </NDC>
  <NDC>
    <NDCCode>50474-782-86</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 CARTON (50474-782-86)  / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>50474-0782-86</NDC11Code>
    <ProductNDC>50474-782</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bimzelx</ProprietaryName>
    <NonProprietaryName>Bimekizumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20241205</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761151</ApplicationNumber>
    <LabelerName>UCB, Inc.</LabelerName>
    <SubstanceName>BIMEKIZUMAB</SubstanceName>
    <StrengthNumber>320</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .</IndicationAndUsage>
    <Description>Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1.</Description>
  </NDC>
  <NDC>
    <NDCCode>50991-782-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (50991-782-60) </PackageDescription>
    <NDC11Code>50991-0782-60</NDC11Code>
    <ProductNDC>50991-782</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ala-hist Pe</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride, Dexbrompheniramine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110915</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Poly Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE</SubstanceName>
    <StrengthNumber>10; 2</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-06-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>60687-782-01</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (60687-782-01)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-782-11) </PackageDescription>
    <NDC11Code>60687-0782-01</NDC11Code>
    <ProductNDC>60687-782</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride Xl</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090693</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride extended-release tablet (XL) is an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
    <Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1 propanone hydrochloride. The molecular weight is 276.21. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablet USP (XL) is supplied for oral administration as 150 mg and 300 mg, off-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, glyceryl behenate, hydrophobic colloidal silica, hydroxypropyl cellulose, iron oxide black, L-cysteine hydrochloride monohydrate, methacrylic acid copolymer dispersion, polyvinyl alcohol, povidone, propylene glycol, shellac and triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The Drug Product Meets USP Dissolution Test 20.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>63285-782-06</NDCCode><NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>63187-782-06</NDCCode><ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName><NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName></NDC><NDC><NDCCode>64380-782-06</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>68382-782-06</NDCCode><ProprietaryName>Doxycycline</ProprietaryName><NonProprietaryName>Doxycycline</NonProprietaryName></NDC><NDC><NDCCode>63285-778-06</NDCCode><NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>63285-779-06</NDCCode><NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>63285-780-06</NDCCode><NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>63285-781-06</NDCCode><NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>63285-783-06</NDCCode><NonProprietaryName>Norethindrone And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>63285-785-06</NDCCode><NonProprietaryName>Norethindrone And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>63285-787-06</NDCCode><NonProprietaryName>Norethindrone And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>63285-019-00</NDCCode><NonProprietaryName>Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>63285-301-01</NDCCode><NonProprietaryName>Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>63285-738-00</NDCCode><NonProprietaryName>Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>63285-738-01</NDCCode><NonProprietaryName>Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>63285-753-01</NDCCode><NonProprietaryName>Idelalisib</NonProprietaryName></NDC><NDC><NDCCode>63285-754-01</NDCCode><NonProprietaryName>Idelalisib</NonProprietaryName></NDC><NDC><NDCCode>63285-836-00</NDCCode><NonProprietaryName>Sonidegib Phosphate</NonProprietaryName></NDC><NDC><NDCCode>63285-861-00</NDCCode><NonProprietaryName>Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Alafenamide Fumarate</NonProprietaryName></NDC><NDC><NDCCode>63285-923-02</NDCCode><NonProprietaryName>Iloperidone</NonProprietaryName></NDC><NDC><NDCCode>63285-924-02</NDCCode><NonProprietaryName>Iloperidone</NonProprietaryName></NDC><NDC><NDCCode>0185-1047-01</NDCCode><ProprietaryName>Quinidine Sulfate</ProprietaryName><NonProprietaryName>Quinidine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>0480-2602-06</NDCCode><ProprietaryName>Dextromethorphan Hydrobromide And Quinidine Sulfate</ProprietaryName><NonProprietaryName>Dextromethorphan Hydrobromide And Quinidine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>16571-782-01</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16571-782-10</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16571-782-50</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50474-782-84</NDCCode><ProprietaryName>Bimzelx</ProprietaryName><NonProprietaryName>Bimekizumab</NonProprietaryName></NDC><NDC><NDCCode>50474-782-86</NDCCode><ProprietaryName>Bimzelx</ProprietaryName><NonProprietaryName>Bimekizumab</NonProprietaryName></NDC><NDC><NDCCode>50991-782-60</NDCCode><ProprietaryName>Ala-hist Pe</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride, Dexbrompheniramine Maleate</NonProprietaryName></NDC><NDC><NDCCode>60687-782-01</NDCCode><ProprietaryName>Bupropion Hydrochloride Xl</ProprietaryName><NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "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",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "WONG",
      "AuthorizedOfficialFirstName": "TONY",
      "AuthorizedOfficialTitle": "OPTOMETRIST",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-562-2015",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "WA 3422 TX",
      "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": "1760539969",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "DR TIFFANY J HOLLENBECK PLLC",
      "OtherOrgName": "REDMOND RIDGE EYE CARE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "22310 NE MARKETPLACE DR",
      "SecondLineMailingAddress": "SUITE 106",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98053-2038",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-898-9222",
      "MailingAddressFaxNumber": "425-898-9225",
      "FirstLinePracticeLocationAddress": "22310 NE MARKETPLACE DR",
      "SecondLinePracticeLocationAddress": "SUITE 106",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98053-2038",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-898-9222",
      "PracticeLocationAddressFaxNumber": "425-898-9225",
      "EnumerationDate": "01/03/2007",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "HOLLENBECK",
      "AuthorizedOfficialFirstName": "TIFFANY",
      "AuthorizedOfficialMiddleName": "J",
      "AuthorizedOfficialTitle": "CO OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-898-9222",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3825",
      "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": "1629124649",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "TRI-COUNTY EYE CARE AND OPTOMETRY PC",
      "FirstLineMailingAddress": "3685 BURGOYNE AVE",
      "MailingAddressCityName": "HUDSON FALLS",
      "MailingAddressStateName": "NY",
      "MailingAddressPostalCode": "12839-2168",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "518-747-4100",
      "MailingAddressFaxNumber": "518-747-6151",
      "FirstLinePracticeLocationAddress": "3685 BURGOYNE AVE",
      "PracticeLocationAddressCityName": "HUDSON FALLS",
      "PracticeLocationAddressStateName": "NY",
      "PracticeLocationAddressPostalCode": "12839-2168",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "518-747-4100",
      "PracticeLocationAddressFaxNumber": "518-747-6151",
      "EnumerationDate": "01/25/2007",
      "LastUpdateDate": "08/29/2011",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "MONICA",
      "AuthorizedOfficialTitle": "OPTOMETRIST",
      "AuthorizedOfficialCredential": "OD",
      "AuthorizedOfficialTelephoneNumber": "518-747-4100",
      "TaxonomyCode1": "152WC0802X",
      "Taxonomy1": "Corneal and Contact Management",
      "LicenseNumber1": "TUV006839-1",
      "LicenseNumberStateCode1": "NY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "152WP0200X",
      "Taxonomy2": "Pediatrics",
      "LicenseNumber2": "TUV006839-1",
      "LicenseNumberStateCode2": "NY",
      "PrimaryTaxonomySwitch2": "Y",
      "TaxonomyCode3": "152WS0006X",
      "Taxonomy3": "Sports Vision",
      "LicenseNumber3": "TUV006839-1",
      "LicenseNumberStateCode3": "NY",
      "PrimaryTaxonomySwitch3": "N",
      "OtherIdentifier1": "10089360",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "NY",
      "OtherIdentifierIssuer1": "CDPHP",
      "OtherIdentifier2": "C369F1",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "NY",
      "OtherIdentifierIssuer2": "EMPIRE",
      "OtherIdentifier3": "782077",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "NY",
      "OtherIdentifierIssuer3": "MVP",
      "OtherIdentifier4": "000408532001",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierState4": "NY",
      "OtherIdentifierIssuer4": "BSNENY",
      "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": "1063635506",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "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": "04/11/2007",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "261QA1903X",
      "Taxonomy1": "Ambulatory Surgical",
      "LicenseNumber1": "071581",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "165450",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OR",
      "OtherIdentifier2": "138874101",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "BLUE CROSS PARTICIPATING",
      "OtherIdentifier3": "490003253",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "RR MEDICARE",
      "OtherIdentifier4": "180029258",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierState4": "OR",
      "OtherIdentifierIssuer4": "UNITED HEALTHCARE RR"
    },
    {
      "NPI": "1437480456",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "VANESSA MICHEL PLLC",
      "OtherOrgName": "REDMOND RIDGE EYE CARE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "23535 NE NOVELTY HILL RD",
      "SecondLineMailingAddress": "D302",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98053-5502",
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      "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 ...
            
        

Full Text Search Fundamentals

Facts

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

How does it work

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

Full Text Search & DataLabs REST API

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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