RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "72663-171-05",
      "PackageDescription": "1 KIT in 1 KIT (72663-171-05)  *  14 g in 1 TUBE",
      "NDC11Code": "72663-0171-05",
      "ProductNDC": "72663-171",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Welly Bravery First Aid Kit",
      "NonProprietaryName": "Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, Pramoxine Hcl",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20190807",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Welly Health PBC",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190807",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent infection in and temporarily relieves pain due to minor:  cuts  scrapes  burns."
    },
    {
      "NDCCode": "72663-150-05",
      "PackageDescription": "1 KIT in 1 KIT (72663-150-05)  *  .5 mL in 1 POUCH *  16 TABLET in 1 BOTTLE *  1  in 1 POUCH *  .9 mL in 1 POUCH",
      "NDC11Code": "72663-0150-05",
      "ProductNDC": "72663-150",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Welly Adventure First Aid Kit",
      "NonProprietaryName": "Hydrocortisone, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride, Ibuprofen",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20200406",
      "EndMarketingDate": "20231001",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Welly Health PBC",
      "Status": "Deprecated",
      "LastUpdate": "2023-10-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200406",
      "EndMarketingDatePackage": "20231001",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "72663-152-05",
      "PackageDescription": "1 KIT in 1 KIT (72663-152-05)  *  .5 mL in 1 POUCH (72663-560-34)  *  2 TABLET in 1 BLISTER PACK (72663-428-08)  *  10 CLOTH in 1 POUCH *  .9 mL in 1 POUCH (72663-580-02) ",
      "NDC11Code": "72663-0152-05",
      "ProductNDC": "72663-152",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Welly First Aid Kit",
      "NonProprietaryName": "Hydrocortisone, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Ibuprofen",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20200406",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Welly Health PBC",
      "Status": "Active",
      "LastUpdate": "2025-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200406",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "13537-171-06",
      "PackageDescription": "1 TUBE in 1 BOX (13537-171-06)  > 4.3 g in 1 TUBE (13537-171-05)",
      "NDC11Code": "13537-0171-06",
      "ProductNDC": "13537-171",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cy Better Lips Balm Humectante Para Labios Con Color Fps 18",
      "ProprietaryNameSuffix": "(pure Oxygen) - Beige",
      "NonProprietaryName": "Avobenzone, Octisalate, Zinc Oxide, Octinoxate, And Oxybenzone",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140127",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE",
      "StrengthNumber": ".0003; .0003; .01; .071; .02",
      "StrengthUnit": "g/g; g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Ayuda a prevenir quemaduras solares."
    },
    {
      "NDCCode": "13668-171-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (13668-171-05) ",
      "NDC11Code": "13668-0171-05",
      "ProductNDC": "13668-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine",
      "NonProprietaryName": "Olanzapine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091434",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "OLANZAPINE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated. As oral formulation for the.    Treatment of schizophrenia. ( 1.1).        Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1).        Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1).   Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2).        Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2).        Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2).   Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3).   Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2).          Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the.   Treatment of depressive episodes associated with bipolar I disorder. ( 1.5).        Efficacy was established with Symbynax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. ( 1.6).       Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
      "Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, magnesium stearate, mannitol and microcrystalline cellulose. For olanzapine tablets, USP: Meets USP Dissolution Test 2. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol and microcrystalline cellulose. For olanzapine orally disintegrating tablets, USP:  Meets USP Disintegration Test 2."
    },
    {
      "NDCCode": "14445-171-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (14445-171-05) ",
      "NDC11Code": "14445-0171-05",
      "ProductNDC": "14445-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Allopurinol",
      "NonProprietaryName": "Allopurinol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160728",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204467",
      "LabelerName": "Indoco Remedies Limited",
      "SubstanceName": "ALLOPURINOL",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-08-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160728",
      "SamplePackage": "N",
      "IndicationAndUsage": "Allopurinol Tablets are indicated for: : 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) , 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels  , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .",
      "Description": "Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula:. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally.  Each scored white, flat cylindrical tablet contains 100 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone.Each scored white round tablet contains 200 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone. Each scored peach, flat cylindrical tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&C Yellow No. 6 Aluminium Lake, lactose monohydrate, magnesium stearate and povidone."
    },
    {
      "NDCCode": "29300-171-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-171-05) ",
      "NDC11Code": "29300-0171-05",
      "ProductNDC": "29300-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Memantine Hydrochloride",
      "NonProprietaryName": "Memantine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200022",
      "LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
      "SubstanceName": "MEMANTINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2020-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Memantine hydrochloride tablets are an N-methyl-D-asparate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).",
      "Description": "Memantine hydrochloride, USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride tablets, USP are available for oral administration as round-shaped, film-coated tablets containing 5 mg of memantine hydrochloride and as capsule-shaped, film-coated tablets containing 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, talc, povidone, crospovidone and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coating: hypromellose, titanium dioxide and polyethylene glycol 4000."
    },
    {
      "NDCCode": "49643-171-05",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-171-05) ",
      "NDC11Code": "49643-0171-05",
      "ProductNDC": "49643-171",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Smut, Barley",
      "NonProprietaryName": "Ustilago Nuda",
      "DosageFormName": "LIQUID",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19740312",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102211",
      "LabelerName": "Allermed Laboratories, Inc.",
      "SubstanceName": "USTILAGO NUDA",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Allergens [Chemical/Ingredient], Cell-mediated Immunity [PE], Fungal Proteins [Chemical/Ingredient], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19740312",
      "SamplePackage": "N",
      "IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease.(4,5,6). Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms.(7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
      "Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency."
    },
    {
      "NDCCode": "50419-171-06",
      "PackageDescription": "4 BOTTLE, PLASTIC in 1 CARTON (50419-171-06)  / 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-05) ",
      "NDC11Code": "50419-0171-06",
      "ProductNDC": "50419-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Stivarga",
      "NonProprietaryName": "Regorafenib",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120927",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA203085",
      "LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
      "SubstanceName": "REGORAFENIB",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A9 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210501",
      "SamplePackage": "N",
      "IndicationAndUsage": "STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: 1 Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. (1.1), 2 Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. (1.2), 3 Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.3) .",
      "Description": "STIVARGA (regorafenib) is a multikinase inhibitor with the chemical name 4-[4-({[4-chloro-3-(trifluoromethyl) phenyl] carbamoyl} amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate. Regorafenib has the following structural formula. Regorafenib is a monohydrate and it has a molecular formula C21H15ClF4N4O3  H2O and a molecular weight of 500.83. Regorafenib is practically insoluble in water, slightly soluble in acetonitrile, methanol, ethanol, and ethyl acetate and sparingly soluble in acetone. STIVARGA tablets for oral administration are formulated as light pink, oval-shaped tablets debossed with \"BAYER\" on one side and \"40\" on the other. Each tablet contains 40 mg of regorafenib in the anhydrous state, which corresponds to 41.49 mg of regorafenib monohydrate, and the following inactive ingredients: cellulose microcrystalline, croscarmellose sodium, magnesium stearate, povidone, and colloidal silicon dioxide. The film-coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lecithin (soy), polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide."
    },
    {
      "NDCCode": "52038-171-05",
      "PackageDescription": "25 kg in 1 DRUM (52038-171-05) ",
      "NDC11Code": "52038-0171-05",
      "ProductNDC": "52038-171",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170413",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Chieron Active Ingredients Private Limited",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "25",
      "StrengthUnit": "kg/25kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-06-10",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "13-APR-17"
    },
    {
      "NDCCode": "54340-171-06",
      "PackageDescription": "6 POUCH in 1 CARTON (54340-171-06)  / 443 mL in 1 POUCH (54340-171-05) ",
      "NDC11Code": "54340-0171-06",
      "ProductNDC": "54340-171",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dial Professional Gel Sanitizer",
      "NonProprietaryName": "Dial Professional Gel Hand Sanitizer",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220621",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Henkel Corporation",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62.75",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220621",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use(s)Hand sanitizer to help reduce bacteria thatpotentially may cause disease."
    },
    {
      "NDCCode": "55111-171-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-171-05) ",
      "NDC11Code": "55111-0171-05",
      "ProductNDC": "55111-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Finasteride",
      "NonProprietaryName": "Finasteride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130102",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076436",
      "LabelerName": "Dr. Reddy's Laboratories Limited",
      "SubstanceName": "FINASTERIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130102",
      "SamplePackage": "N",
      "IndicationAndUsage": "Finasteride tablets are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Efficacy in bitemporal recession has not been established. Finasteride tablets are not indicated for use in women.",
      "Description": "Finasteride tablets USP contain finasteride USP as the active ingredient. Finasteride USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). The chemical name of finasteride USP is N-tert-Butyl-3-oxo-4-aza-5a-androst-1-ene-17β-carboxamide. The molecular formula of finasteride USP is C23H36N2O2 and its molecular weight is 372.55. Its structural formula is:. Finasteride USP is a white to off-white crystalline solid with a melting point between 251°C to 258°C. It is freely soluble in chloroform and in alcohol. Finasteride tablets USP are film-coated tablets for oral administration. Each tablet contains 1 mg of finasteride USP and the following inactive ingredients: docusate sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, titanium dioxide and yellow iron oxide."
    },
    {
      "NDCCode": "57237-171-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (57237-171-05) ",
      "NDC11Code": "57237-0171-05",
      "ProductNDC": "57237-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rosuvastatin Calcium",
      "NonProprietaryName": "Rosuvastatin Calcium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160719",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079170",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "ROSUVASTATIN CALCIUM",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160719",
      "SamplePackage": "N",
      "IndicationAndUsage": "Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).",
      "Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP  is a white to off-white powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. Meets USP Dissolution Test-2."
    },
    {
      "NDCCode": "60429-171-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (60429-171-05)",
      "NDC11Code": "60429-0171-05",
      "ProductNDC": "60429-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulindac",
      "NonProprietaryName": "Sulindac",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100125",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072710",
      "LabelerName": "Golden State Medical Supply, Inc.",
      "SubstanceName": "SULINDAC",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-10-11",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "61442-171-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (61442-171-05) ",
      "NDC11Code": "61442-0171-05",
      "ProductNDC": "61442-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cefaclor",
      "NonProprietaryName": "Cefaclor",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065146",
      "LabelerName": "Carlsbad Technology, Inc.",
      "SubstanceName": "CEFACLOR",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-05-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20080731",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae,staphylococci, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae,and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. Note:Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp .,and coagulase-negative staphylococci. Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsule and other antibacterial drugs, Cefaclor Capsule 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.",
      "Description": "Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C 15H 14ClN 3O 4S  H 2O and the molecular weight is 385.82. Each 250-mg capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) of anhydrous cefaclor and inactive ingredients: magnesium stearate, sodium starch glycolate, lactose monohydrate, talc. The 250 mg capsule shell contains gelatin, titanium dioxide, FD & C Blue No. 1, FD & C Red No. 3, and imprinting ink components: shellac, strong ammonia solution, potassium hydroxide, black iron oxide, .dehydrated alcohol, isopropyl alcohol, butyl alcohol and propylene glycol. Each 500-mg capsule contains cefaclor monohydrate equivalent to 500 mg (1.36 mmol) of anhydrous cefaclor and inactive ingredients: magnesium stearate, sodium starch glycolate, lactose monohydrate, talc. The 500 mg capsule shell contains gelatin, titanium dioxide, FD & C Blue No. 1, FD & C Red No. 3, FD & C Yellow No. 6, FD & C Red No. 40, and imprinting ink components: shellac, strong ammonia solution, titanium dioxide, FD & C Blue No. 1 aluminum lake, dehydrated alcohol, isopropyl alcohol, butyl alcohol and propylene glycol."
    },
    {
      "NDCCode": "62559-171-05",
      "PackageDescription": "500 mL in 1 BOTTLE (62559-171-05) ",
      "NDC11Code": "62559-0171-05",
      "ProductNDC": "62559-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Morphine Sulfate",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180709",
      "EndMarketingDate": "20220731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205509",
      "LabelerName": "ANI Pharmaceuticals, Inc.",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180709",
      "EndMarketingDatePackage": "20220228",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63730-171-05",
      "PackageDescription": "100 mL in 1 CARTON (63730-171-05)",
      "NDC11Code": "63730-0171-05",
      "ProductNDC": "63730-171",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "The Cure Sheer Cream",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100201",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Natura Bisse International",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": "2; 4",
      "StrengthUnit": "mL/50mL; g/50mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Uses: Helps prevent sunburn.  Higher SPF gives more sunburn protection. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.  Moderate sun protection product.  Do not use this product if the seal is broken. Made in Spain by. Natura Bisse Int. S.A. PQUE. Tecnol. del Valles. Cerdanyola 08290 Barcelona."
    },
    {
      "NDCCode": "64220-171-05",
      "PackageDescription": "10 kg in 1 DRUM (64220-171-05) ",
      "NDC11Code": "64220-0171-05",
      "ProductNDC": "64220-171",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Telmisartan",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20220901",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
      "SubstanceName": "TELMISARTAN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2022-09-03",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "01-SEP-22"
    },
    {
      "NDCCode": "65862-171-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65862-171-05) ",
      "NDC11Code": "65862-0171-05",
      "ProductNDC": "65862-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090327",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078462",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220411",
      "SamplePackage": "N",
      "IndicationAndUsage": "Topiramate tablets are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3) .",
      "Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5­-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch (maize), sodium starch glycolate, and titanium dioxide. In addition, the 50 mg and 100 mg tablets contain iron oxide yellow and 200 mg tablet contains iron oxide red."
    },
    {
      "NDCCode": "67767-171-05",
      "PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67767-171-05)",
      "NDC11Code": "67767-0171-05",
      "ProductNDC": "67767-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupropion Hydrochloride",
      "NonProprietaryName": "Bupropion Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100719",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077455",
      "LabelerName": "Actavis South Atlantic LLC",
      "SubstanceName": "BUPROPION HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-25"
    },
    {
      "NDCCode": "68428-171-05",
      "PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-171-05) ",
      "NDC11Code": "68428-0171-05",
      "ProductNDC": "68428-171",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Abies Can",
      "NonProprietaryName": "Tsuga Canadensis Bark - Tsuga Canadensis Flower Bud",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110126",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "TSUGA CANADENSIS BARK; TSUGA CANADENSIS FLOWER BUD",
      "StrengthNumber": "30; 30",
      "StrengthUnit": "[hp_C]/1; [hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20110126",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69339-171-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (69339-171-05) ",
      "NDC11Code": "69339-0171-05",
      "ProductNDC": "69339-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron",
      "NonProprietaryName": "Ondansetron",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221024",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077851",
      "LabelerName": "Natco Pharma USA LLC",
      "SubstanceName": "ONDANSETRON HYDROCHLORIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250627",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.",
      "Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.5. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "70069-171-05",
      "PackageDescription": "5 VIAL in 1 CARTON (70069-171-05)  / 30 mL in 1 VIAL",
      "NDC11Code": "70069-0171-05",
      "ProductNDC": "70069-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyanocobalamin",
      "NonProprietaryName": "Cyanocobalamin",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "20181218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209429",
      "LabelerName": "Somerset Therapeutics, LLC",
      "SubstanceName": "CYANOCOBALAMIN",
      "StrengthNumber": "1000",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Vitamin B 12 [CS], Vitamin B12 [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-09-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: 1 Addisonian (pernicious) anemia, 2 Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy, 3 Fish tapeworm infestation, 4 Malignancy of pancreas or bowel, 5 Folic acid deficiency.",
      "Description": "Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as red crystalline or small crystals. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below."
    },
    {
      "NDCCode": "75009-171-05",
      "PackageDescription": "1040980 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (75009-171-05) ",
      "NDC11Code": "75009-0171-05",
      "ProductNDC": "75009-171",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Alpha Aromatics",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "83589-171-05",
      "PackageDescription": "5000 g in 1 BAG (83589-171-05) ",
      "NDC11Code": "83589-0171-05",
      "ProductNDC": "83589-171",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "5-amino-1-methylquinolinium Chloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20260501",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Nanjing Chengong Pharmaceutical Co., Ltd.",
      "SubstanceName": "5-AMINO-1-METHYLQUINOLINIUM IODIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "01-MAY-26"
    },
    {
      "NDCCode": "99207-171-05",
      "PackageDescription": "30 PATCH in 1 CARTON (99207-171-05) ",
      "NDC11Code": "99207-0171-05",
      "ProductNDC": "99207-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minitran",
      "NonProprietaryName": "Nitroglycerin",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20120221",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089772",
      "LabelerName": "Bausch Health US, LLC",
      "SubstanceName": "NITROGLYCERIN",
      "StrengthNumber": "18",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2021-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20120221",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0121-4067-40",
      "PackageDescription": "4 TRAY in 1 CASE (0121-4067-40)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4067-05) ",
      "NDC11Code": "00121-4067-40",
      "ProductNDC": "0121-4067",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250612",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211330",
      "LabelerName": "PAI Holdings, LLC dba PAI Pharma",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250612",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gabapentin oral solution is indicated for: : 1 Management of postherpetic neuralgia in adults .",
      "Description": "The active ingredient in gabapentin oral solution is gabapentin, which has the chemical name 1-(amino methyl)cyclohexane acetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: acesulfame potassium, carboxymethylcellulose sodium, diluted hydrochloric acid, ethylparaben, methylparaben sodium, propylparaben sodium, purified water, and sodium hydroxide."
    },
    {
      "NDCCode": "0440-5562-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (0440-5562-05)",
      "NDC11Code": "00440-5562-05",
      "ProductNDC": "0440-5562",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121102",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202764",
      "LabelerName": "Liberty Pharmaceuticals, Inc.",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Gabapentin Tablets, USP. Read the Medication Guide before you start taking gabapentin and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about gabapentin?. Do not stop taking gabapentin without first talking to your healthcare provider. Stopping gabapentin suddenly can cause serious problems. Gabapentin can cause serious side effects including. 1. Like other antiepileptic drugs, gabapentin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: 1 thoughts about suicide or dying , 2 attempts to commit suicide , 3 new or worse depression, 4 new or worse anxiety, 5 feeling agitated or restless, 6 panic attacks, 7 trouble sleeping (insomnia), 8 new or worse irritability, 9 acting aggressive, being angry, or violent, 10 acting on dangerous impulses, 11 an extreme increase in activity and talking (mania), 12 other unusual changes in behavior or mood.",
      "Description": "Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. Each tablet for oral administration contains the following inactive ingredients: Mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium Stearate and Aquarius® BP18114 Cool Vanilla. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular  formula of  C9H17NO2  and  a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. This product(Gabapentin Tablets, USP 600 mg and 800 mg) meets the USP Dissolution Test 1."
    },
    {
      "NDCCode": "0440-5563-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (0440-5563-05)",
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      "ProductNDC": "0440-5563",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
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      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121102",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202764",
      "LabelerName": "Liberty Pharmaceuticals, Inc.",
      "SubstanceName": "GABAPENTIN",
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      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
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      "IndicationAndUsage": "Gabapentin Tablets, USP. Read the Medication Guide before you start taking gabapentin and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about gabapentin?. Do not stop taking gabapentin without first talking to your healthcare provider. Stopping gabapentin suddenly can cause serious problems. Gabapentin can cause serious side effects including. 1. Like other antiepileptic drugs, gabapentin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: 1 thoughts about suicide or dying , 2 attempts to commit suicide , 3 new or worse depression, 4 new or worse anxiety, 5 feeling agitated or restless, 6 panic attacks, 7 trouble sleeping (insomnia), 8 new or worse irritability, 9 acting aggressive, being angry, or violent, 10 acting on dangerous impulses, 11 an extreme increase in activity and talking (mania), 12 other unusual changes in behavior or mood.",
      "Description": "Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. Each tablet for oral administration contains the following inactive ingredients: Mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium Stearate and Aquarius® BP18114 Cool Vanilla. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular  formula of  C9H17NO2  and  a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. This product(Gabapentin Tablets, USP 600 mg and 800 mg) meets the USP Dissolution Test 1."
    },
    {
      "NDCCode": "0480-3494-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (0480-3494-05) ",
      "NDC11Code": "00480-3494-05",
      "ProductNDC": "0480-3494",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
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      "RouteName": "ORAL",
      "StartMarketingDate": "20260112",
      "MarketingCategoryName": "ANDA",
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      "LabelerName": "Teva Pharmaceuticals, Inc.",
      "SubstanceName": "GABAPENTIN",
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      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-24",
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      "ListingRecordCertifiedThrough": "20271231",
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      "IndicationAndUsage": "Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
      "Description": "The active ingredient in gabapentin capsules, USP is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin, USP is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin, USP is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin capsule, USP contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: ammonium hydroxide, black iron oxide, corn starch, gelatin, mannitol, propylene glycol, red iron oxide, shellac, talc, titanium dioxide, yellow iron oxide and may contain potassium hydroxide and sodium lauryl sulfate. In addition, the 100 mg strength contains simethicone."
    }
  ]
}
                    

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    <NonProprietaryName>Avobenzone, Octisalate, Zinc Oxide, Octinoxate, And Oxybenzone</NonProprietaryName>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <StartMarketingDate>20260228</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091434</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
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    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the.    Treatment of schizophrenia. ( 1.1).        Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1).        Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1).   Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2).        Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2).        Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2).   Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3).   Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2).          Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the.   Treatment of depressive episodes associated with bipolar I disorder. ( 1.5).        Efficacy was established with Symbynax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. ( 1.6).       Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, magnesium stearate, mannitol and microcrystalline cellulose. For olanzapine tablets, USP: Meets USP Dissolution Test 2. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol and microcrystalline cellulose. For olanzapine orally disintegrating tablets, USP:  Meets USP Disintegration Test 2.</Description>
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    <PackageDescription>500 TABLET in 1 BOTTLE (14445-171-05) </PackageDescription>
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    <ProductNDC>14445-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Allopurinol</ProprietaryName>
    <NonProprietaryName>Allopurinol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160728</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204467</ApplicationNumber>
    <LabelerName>Indoco Remedies Limited</LabelerName>
    <SubstanceName>ALLOPURINOL</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <IndicationAndUsage>Allopurinol Tablets are indicated for: : 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) , 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels  , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .</IndicationAndUsage>
    <Description>Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula:. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally.  Each scored white, flat cylindrical tablet contains 100 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone.Each scored white round tablet contains 200 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone. Each scored peach, flat cylindrical tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&amp;C Yellow No. 6 Aluminium Lake, lactose monohydrate, magnesium stearate and povidone.</Description>
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    <ProprietaryName>Memantine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200022</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-12-16</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Memantine hydrochloride tablets are an N-methyl-D-asparate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).</IndicationAndUsage>
    <Description>Memantine hydrochloride, USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride tablets, USP are available for oral administration as round-shaped, film-coated tablets containing 5 mg of memantine hydrochloride and as capsule-shaped, film-coated tablets containing 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, talc, povidone, crospovidone and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coating: hypromellose, titanium dioxide and polyethylene glycol 4000.</Description>
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    <NDCCode>49643-171-05</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-171-05) </PackageDescription>
    <NDC11Code>49643-0171-05</NDC11Code>
    <ProductNDC>49643-171</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Smut, Barley</ProprietaryName>
    <NonProprietaryName>Ustilago Nuda</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740312</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102211</ApplicationNumber>
    <LabelerName>Allermed Laboratories, Inc.</LabelerName>
    <SubstanceName>USTILAGO NUDA</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Allergens [Chemical/Ingredient], Cell-mediated Immunity [PE], Fungal Proteins [Chemical/Ingredient], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19740312</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease.(4,5,6). Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms.(7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
    <Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency.</Description>
  </NDC>
  <NDC>
    <NDCCode>50419-171-06</NDCCode>
    <PackageDescription>4 BOTTLE, PLASTIC in 1 CARTON (50419-171-06)  / 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-05) </PackageDescription>
    <NDC11Code>50419-0171-06</NDC11Code>
    <ProductNDC>50419-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Stivarga</ProprietaryName>
    <NonProprietaryName>Regorafenib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120927</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA203085</ApplicationNumber>
    <LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>REGORAFENIB</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A9 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: 1 Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. (1.1), 2 Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. (1.2), 3 Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.3) .</IndicationAndUsage>
    <Description>STIVARGA (regorafenib) is a multikinase inhibitor with the chemical name 4-[4-({[4-chloro-3-(trifluoromethyl) phenyl] carbamoyl} amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate. Regorafenib has the following structural formula. Regorafenib is a monohydrate and it has a molecular formula C21H15ClF4N4O3  H2O and a molecular weight of 500.83. Regorafenib is practically insoluble in water, slightly soluble in acetonitrile, methanol, ethanol, and ethyl acetate and sparingly soluble in acetone. STIVARGA tablets for oral administration are formulated as light pink, oval-shaped tablets debossed with "BAYER" on one side and "40" on the other. Each tablet contains 40 mg of regorafenib in the anhydrous state, which corresponds to 41.49 mg of regorafenib monohydrate, and the following inactive ingredients: cellulose microcrystalline, croscarmellose sodium, magnesium stearate, povidone, and colloidal silicon dioxide. The film-coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lecithin (soy), polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>52038-171-05</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (52038-171-05) </PackageDescription>
    <NDC11Code>52038-0171-05</NDC11Code>
    <ProductNDC>52038-171</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170413</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Chieron Active Ingredients Private Limited</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>kg/25kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>13-APR-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>54340-171-06</NDCCode>
    <PackageDescription>6 POUCH in 1 CARTON (54340-171-06)  / 443 mL in 1 POUCH (54340-171-05) </PackageDescription>
    <NDC11Code>54340-0171-06</NDC11Code>
    <ProductNDC>54340-171</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dial Professional Gel Sanitizer</ProprietaryName>
    <NonProprietaryName>Dial Professional Gel Hand Sanitizer</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220621</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Henkel Corporation</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62.75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220621</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use(s)Hand sanitizer to help reduce bacteria thatpotentially may cause disease.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55111-171-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-171-05) </PackageDescription>
    <NDC11Code>55111-0171-05</NDC11Code>
    <ProductNDC>55111-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Finasteride</ProprietaryName>
    <NonProprietaryName>Finasteride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076436</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>FINASTERIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Finasteride tablets are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Efficacy in bitemporal recession has not been established. Finasteride tablets are not indicated for use in women.</IndicationAndUsage>
    <Description>Finasteride tablets USP contain finasteride USP as the active ingredient. Finasteride USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). The chemical name of finasteride USP is N-tert-Butyl-3-oxo-4-aza-5a-androst-1-ene-17β-carboxamide. The molecular formula of finasteride USP is C23H36N2O2 and its molecular weight is 372.55. Its structural formula is:. Finasteride USP is a white to off-white crystalline solid with a melting point between 251°C to 258°C. It is freely soluble in chloroform and in alcohol. Finasteride tablets USP are film-coated tablets for oral administration. Each tablet contains 1 mg of finasteride USP and the following inactive ingredients: docusate sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, titanium dioxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>57237-171-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (57237-171-05) </PackageDescription>
    <NDC11Code>57237-0171-05</NDC11Code>
    <ProductNDC>57237-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079170</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
    <Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP  is a white to off-white powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. Meets USP Dissolution Test-2.</Description>
  </NDC>
  <NDC>
    <NDCCode>60429-171-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (60429-171-05)</PackageDescription>
    <NDC11Code>60429-0171-05</NDC11Code>
    <ProductNDC>60429-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulindac</ProprietaryName>
    <NonProprietaryName>Sulindac</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072710</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>SULINDAC</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-11</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>61442-171-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (61442-171-05) </PackageDescription>
    <NDC11Code>61442-0171-05</NDC11Code>
    <ProductNDC>61442-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefaclor</ProprietaryName>
    <NonProprietaryName>Cefaclor</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065146</ApplicationNumber>
    <LabelerName>Carlsbad Technology, Inc.</LabelerName>
    <SubstanceName>CEFACLOR</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae,staphylococci, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae,and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. Note:Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp .,and coagulase-negative staphylococci. Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsule and other antibacterial drugs, Cefaclor Capsule 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.</IndicationAndUsage>
    <Description>Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C 15H 14ClN 3O 4S  H 2O and the molecular weight is 385.82. Each 250-mg capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) of anhydrous cefaclor and inactive ingredients: magnesium stearate, sodium starch glycolate, lactose monohydrate, talc. The 250 mg capsule shell contains gelatin, titanium dioxide, FD &amp; C Blue No. 1, FD &amp; C Red No. 3, and imprinting ink components: shellac, strong ammonia solution, potassium hydroxide, black iron oxide, .dehydrated alcohol, isopropyl alcohol, butyl alcohol and propylene glycol. Each 500-mg capsule contains cefaclor monohydrate equivalent to 500 mg (1.36 mmol) of anhydrous cefaclor and inactive ingredients: magnesium stearate, sodium starch glycolate, lactose monohydrate, talc. The 500 mg capsule shell contains gelatin, titanium dioxide, FD &amp; C Blue No. 1, FD &amp; C Red No. 3, FD &amp; C Yellow No. 6, FD &amp; C Red No. 40, and imprinting ink components: shellac, strong ammonia solution, titanium dioxide, FD &amp; C Blue No. 1 aluminum lake, dehydrated alcohol, isopropyl alcohol, butyl alcohol and propylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>62559-171-05</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE (62559-171-05) </PackageDescription>
    <NDC11Code>62559-0171-05</NDC11Code>
    <ProductNDC>62559-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180709</StartMarketingDate>
    <EndMarketingDate>20220731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205509</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180709</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63730-171-05</NDCCode>
    <PackageDescription>100 mL in 1 CARTON (63730-171-05)</PackageDescription>
    <NDC11Code>63730-0171-05</NDC11Code>
    <ProductNDC>63730-171</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>The Cure Sheer Cream</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Natura Bisse International</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>2; 4</StrengthNumber>
    <StrengthUnit>mL/50mL; g/50mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses: Helps prevent sunburn.  Higher SPF gives more sunburn protection. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.  Moderate sun protection product.  Do not use this product if the seal is broken. Made in Spain by. Natura Bisse Int. S.A. PQUE. Tecnol. del Valles. Cerdanyola 08290 Barcelona.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>64220-171-05</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (64220-171-05) </PackageDescription>
    <NDC11Code>64220-0171-05</NDC11Code>
    <ProductNDC>64220-171</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Telmisartan</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20220901</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
    <SubstanceName>TELMISARTAN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-09-03</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-SEP-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>65862-171-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65862-171-05) </PackageDescription>
    <NDC11Code>65862-0171-05</NDC11Code>
    <ProductNDC>65862-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078462</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220411</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topiramate tablets are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3) .</IndicationAndUsage>
    <Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5­-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch (maize), sodium starch glycolate, and titanium dioxide. In addition, the 50 mg and 100 mg tablets contain iron oxide yellow and 200 mg tablet contains iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>67767-171-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67767-171-05)</PackageDescription>
    <NDC11Code>67767-0171-05</NDC11Code>
    <ProductNDC>67767-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077455</ApplicationNumber>
    <LabelerName>Actavis South Atlantic LLC</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-07-25</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>68428-171-05</NDCCode>
    <PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-171-05) </PackageDescription>
    <NDC11Code>68428-0171-05</NDC11Code>
    <ProductNDC>68428-171</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Abies Can</ProprietaryName>
    <NonProprietaryName>Tsuga Canadensis Bark - Tsuga Canadensis Flower Bud</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110126</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>TSUGA CANADENSIS BARK; TSUGA CANADENSIS FLOWER BUD</SubstanceName>
    <StrengthNumber>30; 30</StrengthNumber>
    <StrengthUnit>[hp_C]/1; [hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69339-171-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (69339-171-05) </PackageDescription>
    <NDC11Code>69339-0171-05</NDC11Code>
    <ProductNDC>69339-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron</ProprietaryName>
    <NonProprietaryName>Ondansetron</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221024</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077851</ApplicationNumber>
    <LabelerName>Natco Pharma USA LLC</LabelerName>
    <SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250627</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.</IndicationAndUsage>
    <Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.5. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>70069-171-05</NDCCode>
    <PackageDescription>5 VIAL in 1 CARTON (70069-171-05)  / 30 mL in 1 VIAL</PackageDescription>
    <NDC11Code>70069-0171-05</NDC11Code>
    <ProductNDC>70069-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyanocobalamin</ProprietaryName>
    <NonProprietaryName>Cyanocobalamin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20181218</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209429</ApplicationNumber>
    <LabelerName>Somerset Therapeutics, LLC</LabelerName>
    <SubstanceName>CYANOCOBALAMIN</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Vitamin B 12 [CS], Vitamin B12 [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: 1 Addisonian (pernicious) anemia, 2 Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy, 3 Fish tapeworm infestation, 4 Malignancy of pancreas or bowel, 5 Folic acid deficiency.</IndicationAndUsage>
    <Description>Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as red crystalline or small crystals. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below.</Description>
  </NDC>
  <NDC>
    <NDCCode>75009-171-05</NDCCode>
    <PackageDescription>1040980 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (75009-171-05) </PackageDescription>
    <NDC11Code>75009-0171-05</NDC11Code>
    <ProductNDC>75009-171</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Alpha Aromatics</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>83589-171-05</NDCCode>
    <PackageDescription>5000 g in 1 BAG (83589-171-05) </PackageDescription>
    <NDC11Code>83589-0171-05</NDC11Code>
    <ProductNDC>83589-171</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>5-amino-1-methylquinolinium Chloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20260501</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Nanjing Chengong Pharmaceutical Co., Ltd.</LabelerName>
    <SubstanceName>5-AMINO-1-METHYLQUINOLINIUM IODIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-MAY-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>99207-171-05</NDCCode>
    <PackageDescription>30 PATCH in 1 CARTON (99207-171-05) </PackageDescription>
    <NDC11Code>99207-0171-05</NDC11Code>
    <ProductNDC>99207-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minitran</ProprietaryName>
    <NonProprietaryName>Nitroglycerin</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20120221</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089772</ApplicationNumber>
    <LabelerName>Bausch Health US, LLC</LabelerName>
    <SubstanceName>NITROGLYCERIN</SubstanceName>
    <StrengthNumber>18</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0121-4067-40</NDCCode>
    <PackageDescription>4 TRAY in 1 CASE (0121-4067-40)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4067-05) </PackageDescription>
    <NDC11Code>00121-4067-40</NDC11Code>
    <ProductNDC>0121-4067</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211330</ApplicationNumber>
    <LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin oral solution is indicated for: : 1 Management of postherpetic neuralgia in adults .</IndicationAndUsage>
    <Description>The active ingredient in gabapentin oral solution is gabapentin, which has the chemical name 1-(amino methyl)cyclohexane acetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: acesulfame potassium, carboxymethylcellulose sodium, diluted hydrochloric acid, ethylparaben, methylparaben sodium, propylparaben sodium, purified water, and sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0440-5562-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0440-5562-05)</PackageDescription>
    <NDC11Code>00440-5562-05</NDC11Code>
    <ProductNDC>0440-5562</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202764</ApplicationNumber>
    <LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Gabapentin Tablets, USP. Read the Medication Guide before you start taking gabapentin and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about gabapentin?. Do not stop taking gabapentin without first talking to your healthcare provider. Stopping gabapentin suddenly can cause serious problems. Gabapentin can cause serious side effects including. 1. Like other antiepileptic drugs, gabapentin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: 1 thoughts about suicide or dying , 2 attempts to commit suicide , 3 new or worse depression, 4 new or worse anxiety, 5 feeling agitated or restless, 6 panic attacks, 7 trouble sleeping (insomnia), 8 new or worse irritability, 9 acting aggressive, being angry, or violent, 10 acting on dangerous impulses, 11 an extreme increase in activity and talking (mania), 12 other unusual changes in behavior or mood.</IndicationAndUsage>
    <Description>Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. Each tablet for oral administration contains the following inactive ingredients: Mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium Stearate and Aquarius® BP18114 Cool Vanilla. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular  formula of  C9H17NO2  and  a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. This product(Gabapentin Tablets, USP 600 mg and 800 mg) meets the USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>0440-5563-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0440-5563-05)</PackageDescription>
    <NDC11Code>00440-5563-05</NDC11Code>
    <ProductNDC>0440-5563</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202764</ApplicationNumber>
    <LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Gabapentin Tablets, USP. Read the Medication Guide before you start taking gabapentin and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about gabapentin?. Do not stop taking gabapentin without first talking to your healthcare provider. Stopping gabapentin suddenly can cause serious problems. Gabapentin can cause serious side effects including. 1. Like other antiepileptic drugs, gabapentin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: 1 thoughts about suicide or dying , 2 attempts to commit suicide , 3 new or worse depression, 4 new or worse anxiety, 5 feeling agitated or restless, 6 panic attacks, 7 trouble sleeping (insomnia), 8 new or worse irritability, 9 acting aggressive, being angry, or violent, 10 acting on dangerous impulses, 11 an extreme increase in activity and talking (mania), 12 other unusual changes in behavior or mood.</IndicationAndUsage>
    <Description>Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. Each tablet for oral administration contains the following inactive ingredients: Mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium Stearate and Aquarius® BP18114 Cool Vanilla. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular  formula of  C9H17NO2  and  a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. This product(Gabapentin Tablets, USP 600 mg and 800 mg) meets the USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>0480-3494-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (0480-3494-05) </PackageDescription>
    <NDC11Code>00480-3494-05</NDC11Code>
    <ProductNDC>0480-3494</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260112</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075350</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
    <Description>The active ingredient in gabapentin capsules, USP is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin, USP is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin, USP is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin capsule, USP contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: ammonium hydroxide, black iron oxide, corn starch, gelatin, mannitol, propylene glycol, red iron oxide, shellac, talc, titanium dioxide, yellow iron oxide and may contain potassium hydroxide and sodium lauryl sulfate. In addition, the 100 mg strength contains simethicone.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>72663-171-05</NDCCode><ProprietaryName>Welly Bravery First Aid Kit</ProprietaryName><NonProprietaryName>Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, Pramoxine Hcl</NonProprietaryName></NDC><NDC><NDCCode>72663-150-05</NDCCode><ProprietaryName>Welly Adventure First Aid Kit</ProprietaryName><NonProprietaryName>Hydrocortisone, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride, Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>72663-152-05</NDCCode><ProprietaryName>Welly First Aid Kit</ProprietaryName><NonProprietaryName>Hydrocortisone, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>13537-171-06</NDCCode><ProprietaryName>Cy Better Lips Balm Humectante Para Labios Con Color Fps 18</ProprietaryName><NonProprietaryName>Avobenzone, Octisalate, Zinc Oxide, Octinoxate, And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>13668-171-05</NDCCode><ProprietaryName>Olanzapine</ProprietaryName><NonProprietaryName>Olanzapine</NonProprietaryName></NDC><NDC><NDCCode>14445-171-05</NDCCode><ProprietaryName>Allopurinol</ProprietaryName><NonProprietaryName>Allopurinol</NonProprietaryName></NDC><NDC><NDCCode>29300-171-05</NDCCode><ProprietaryName>Memantine Hydrochloride</ProprietaryName><NonProprietaryName>Memantine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>49643-171-05</NDCCode><ProprietaryName>Smut, Barley</ProprietaryName><NonProprietaryName>Ustilago Nuda</NonProprietaryName></NDC><NDC><NDCCode>50419-171-06</NDCCode><ProprietaryName>Stivarga</ProprietaryName><NonProprietaryName>Regorafenib</NonProprietaryName></NDC><NDC><NDCCode>52038-171-05</NDCCode><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>54340-171-06</NDCCode><ProprietaryName>Dial Professional Gel Sanitizer</ProprietaryName><NonProprietaryName>Dial Professional Gel Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>55111-171-05</NDCCode><ProprietaryName>Finasteride</ProprietaryName><NonProprietaryName>Finasteride</NonProprietaryName></NDC><NDC><NDCCode>57237-171-05</NDCCode><ProprietaryName>Rosuvastatin Calcium</ProprietaryName><NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName></NDC><NDC><NDCCode>60429-171-05</NDCCode><ProprietaryName>Sulindac</ProprietaryName><NonProprietaryName>Sulindac</NonProprietaryName></NDC><NDC><NDCCode>61442-171-05</NDCCode><ProprietaryName>Cefaclor</ProprietaryName><NonProprietaryName>Cefaclor</NonProprietaryName></NDC><NDC><NDCCode>62559-171-05</NDCCode><ProprietaryName>Morphine Sulfate</ProprietaryName><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>63730-171-05</NDCCode><ProprietaryName>The Cure Sheer Cream</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>64220-171-05</NDCCode><NonProprietaryName>Telmisartan</NonProprietaryName></NDC><NDC><NDCCode>65862-171-05</NDCCode><ProprietaryName>Topiramate</ProprietaryName><NonProprietaryName>Topiramate</NonProprietaryName></NDC><NDC><NDCCode>67767-171-05</NDCCode><ProprietaryName>Bupropion Hydrochloride</ProprietaryName><NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>68428-171-05</NDCCode><ProprietaryName>Abies Can</ProprietaryName><NonProprietaryName>Tsuga Canadensis Bark - Tsuga Canadensis Flower Bud</NonProprietaryName></NDC><NDC><NDCCode>69339-171-05</NDCCode><ProprietaryName>Ondansetron</ProprietaryName><NonProprietaryName>Ondansetron</NonProprietaryName></NDC><NDC><NDCCode>70069-171-05</NDCCode><ProprietaryName>Cyanocobalamin</ProprietaryName><NonProprietaryName>Cyanocobalamin</NonProprietaryName></NDC><NDC><NDCCode>75009-171-05</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>83589-171-05</NDCCode><NonProprietaryName>5-amino-1-methylquinolinium Chloride</NonProprietaryName></NDC><NDC><NDCCode>99207-171-05</NDCCode><ProprietaryName>Minitran</ProprietaryName><NonProprietaryName>Nitroglycerin</NonProprietaryName></NDC><NDC><NDCCode>0121-4067-40</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>0440-5562-05</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>0440-5563-05</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>0480-3494-05</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

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

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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