RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "74728-070-40",
      "PackageDescription": "10 mL in 1 BOTTLE (74728-070-40) ",
      "NDC11Code": "74728-0070-40",
      "ProductNDC": "74728-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Emurgent Usa Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210212",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "EmUrgent USA LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20210212",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "74728-070-30",
      "PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (74728-070-30) ",
      "NDC11Code": "74728-0070-30",
      "ProductNDC": "74728-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Emurgent Usa Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201105",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "EmUrgent USA LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20201105",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "37000-070-40",
      "PackageDescription": "400 mL in 1 BOTTLE, PUMP (37000-070-40) ",
      "NDC11Code": "37000-0070-40",
      "ProductNDC": "37000-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Head And Shoulders 2in1",
      "ProprietaryNameSuffix": "Classic Clean",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "LOTION/SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130901",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "M032",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "PYRITHIONE ZINC",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20130901",
      "EndMarketingDatePackage": "20240201",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
    },
    {
      "NDCCode": "50242-070-01",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-070-01)  / 40 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "50242-0070-01",
      "ProductNDC": "50242-070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gazyva",
      "NonProprietaryName": "Obinutuzumab",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20131101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125486",
      "LabelerName": "Genentech, Inc.",
      "SubstanceName": "OBINUTUZUMAB",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/40mL",
      "Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20131101",
      "SamplePackage": "N",
      "IndicationAndUsage": "GAZYVA is a CD20-directed cytolytic antibody indicated: 1 in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). (1.1, 14), 2 in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. (1.2, 14), 3 in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. (1.2, 14), 4 for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy (1.3, 14), 5 to reduce the risk of relapse in adult and pediatric patients 2 years of age and older with frequently relapsing or steroid dependent childhood-onset idiopathic nephrotic syndrome who are in complete remission. (1.4, 14).",
      "Description": "Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B cells. The molecular mass of the antibody is approximately 150 kDa. GAZYVA (obinutuzumab) injection is produced by mammalian cell (CHO) suspension culture. GAZYVA was engineered to have reduced fucose content as compared to a typical IgG1 produced in CHO cells. GAZYVA is a sterile, clear, colorless to slightly brown, preservative-free liquid concentrate for intravenous use. GAZYVA is supplied at a concentration of 25 mg/mL in 1,000 mg single-dose vials. Each vial contains in 40 mL: 1,000 mg obinutuzumab, L-histidine (57.6 mg), L-histidine hydrochloride monohydrate (89.6 mg), trehalose dihydrate (3632 mg), and poloxamer 188 (8 mg). The pH is 6.0."
    },
    {
      "NDCCode": "50242-070-86",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-070-86)  / 40 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "50242-0070-86",
      "ProductNDC": "50242-070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gazyva",
      "NonProprietaryName": "Obinutuzumab",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20131101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125486",
      "LabelerName": "Genentech, Inc.",
      "SubstanceName": "OBINUTUZUMAB",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/40mL",
      "Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20131104",
      "SamplePackage": "Y",
      "IndicationAndUsage": "GAZYVA is a CD20-directed cytolytic antibody indicated: 1 in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). (1.1, 14), 2 in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. (1.2, 14), 3 in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. (1.2, 14), 4 for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy (1.3, 14).",
      "Description": "Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B cells. The molecular mass of the antibody is approximately 150 kDa. GAZYVA (obinutuzumab) injection is produced by mammalian cell (CHO) suspension culture. GAZYVA was engineered to have reduced fucose content as compared to a typical IgG1 produced in CHO cells. GAZYVA is a sterile, clear, colorless to slightly brown, preservative-free liquid concentrate for intravenous use. GAZYVA is supplied at a concentration of 25 mg/mL in 1,000 mg single-dose vials. Each vial contains in 40 mL: 1,000 mg obinutuzumab, L-histidine (57.6 mg), L-histidine hydrochloride monohydrate (89.6 mg), trehalose dihydrate (3632 mg), and poloxamer 188 (8 mg). The pH is 6.0."
    },
    {
      "NDCCode": "51060-070-01",
      "PackageDescription": "1 TUBE in 1 BOX (51060-070-01)  > 40 mL in 1 TUBE",
      "NDC11Code": "51060-0070-01",
      "ProductNDC": "51060-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Foundcealer 2-in-1 Foundation And Concealer Broad Spectrum Spf 15 Sunscreen",
      "ProprietaryNameSuffix": "Light-medium",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Tarte, Inc",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "60; 30",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20140101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "61354-070-05",
      "PackageDescription": "1 TUBE in 1 CARTON (61354-070-05)  > 40 mg in 1 TUBE (61354-070-01) ",
      "NDC11Code": "61354-0070-05",
      "ProductNDC": "61354-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cream",
      "NonProprietaryName": "Octinoxate, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210222",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Oxygen Development LLC",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "5; 5",
      "StrengthUnit": "mg/100mg; mg/100mg",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210222",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "61354-070-06",
      "PackageDescription": "1 TUBE in 1 CARTON (61354-070-06)  > 40 mg in 1 TUBE (61354-070-02) ",
      "NDC11Code": "61354-0070-06",
      "ProductNDC": "61354-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cream",
      "NonProprietaryName": "Octinoxate, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210222",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Oxygen Development LLC",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "5; 5",
      "StrengthUnit": "mg/100mg; mg/100mg",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210222",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "61354-070-07",
      "PackageDescription": "1 TUBE in 1 CARTON (61354-070-07)  > 40 mg in 1 TUBE (61354-070-03) ",
      "NDC11Code": "61354-0070-07",
      "ProductNDC": "61354-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cream",
      "NonProprietaryName": "Octinoxate, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210222",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Oxygen Development LLC",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "5; 5",
      "StrengthUnit": "mg/100mg; mg/100mg",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210222",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "61354-070-08",
      "PackageDescription": "1 TUBE in 1 CARTON (61354-070-08)  > 40 mg in 1 TUBE (61354-070-04) ",
      "NDC11Code": "61354-0070-08",
      "ProductNDC": "61354-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cream",
      "NonProprietaryName": "Octinoxate, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210222",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Oxygen Development LLC",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "5; 5",
      "StrengthUnit": "mg/100mg; mg/100mg",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210222",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70567-070-01",
      "PackageDescription": "40 mL in 1 CONTAINER (70567-070-01)",
      "NDC11Code": "70567-0070-01",
      "ProductNDC": "70567-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Grain Timeless Perfection Essence",
      "NonProprietaryName": "Dimethicone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160302",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "KHLEEKOREA",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": ".2",
      "StrengthUnit": "g/40mL",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "IndicationAndUsage": "Indications & Usage: Softly apply cream along the skin texture and pat gently for better absorption. 1. Apply some suitable amount of cream on your skin evenly and rub lightly. 2. Apply to entire face outwards and neck from top-down. 3. Tap gently on the face to absorb with palm of the hand giving light tension to the face."
    },
    {
      "NDCCode": "70991-070-02",
      "PackageDescription": "1 TUBE in 1 CARTON (70991-070-02)  > 40 mL in 1 TUBE (70991-070-01)",
      "NDC11Code": "70991-0070-02",
      "ProductNDC": "70991-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fascy Moisture Bomb Hand Milk 40ml",
      "NonProprietaryName": "Dimethicone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "FASCY Co,.LTD.",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": ".4",
      "StrengthUnit": "g/40mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "How to use: Apply desired amount and massage into the hands."
    },
    {
      "NDCCode": "16571-070-12",
      "PackageDescription": "150 mL in 1 BOTTLE (16571-070-12)",
      "NDC11Code": "16571-0070-12",
      "ProductNDC": "16571-070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cefaclor",
      "NonProprietaryName": "Cefaclor",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121025",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065412",
      "LabelerName": "Pack Pharmaceuticals, LLC",
      "SubstanceName": "CEFACLOR",
      "StrengthNumber": "125",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "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 For Oral Suspension and other antibacterial drugs, Cefaclor For Oral Suspension 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 C15H14ClN3O4SH2O and the molecular weight is 385.82. After mixing, each 5 ml of Cefaclor for Oral Suspension will contain cefaclor monohydrate equivalent to 125 mg (0.34 mmol), 250 mg (0.68 mmol), or 375 mg (1 .0 mmol) anhydrous cefaclor. The suspensions also contain methylcellulose, sodium lauryl sulfate, sucrose, and xanthan gum, FD&C Red No. 40, strawbenry flavor. The color of drug powder in the dry powder state is white to off-white. After reconstitution, it turns to a red suspension."
    },
    {
      "NDCCode": "36800-070-09",
      "PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (36800-070-09)  > 25 g in 1 TUBE, WITH APPLICATOR",
      "NDC11Code": "36800-0070-09",
      "ProductNDC": "36800-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare",
      "ProprietaryNameSuffix": "Miconazole 3 Yeast Infection Relief",
      "NonProprietaryName": "Miconazole Nitrate",
      "DosageFormName": "CREAM",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20050302",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076773",
      "LabelerName": "Topco Associates LLC",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20130116",
      "SamplePackage": "N",
      "IndicationAndUsage": "treats vaginal yeast infections."
    },
    {
      "NDCCode": "37012-070-09",
      "PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (37012-070-09)  > 25 g in 1 TUBE, WITH APPLICATOR",
      "NDC11Code": "37012-0070-09",
      "ProductNDC": "37012-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Miconazole 3",
      "NonProprietaryName": "Miconazole Nitrate",
      "DosageFormName": "CREAM",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20050302",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076773",
      "LabelerName": "Shopko Stores Operating Co., LLC",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "treats vaginal yeast infections."
    },
    {
      "NDCCode": "42254-070-14",
      "PackageDescription": "14 CAPSULE in 1 BOTTLE (42254-070-14)",
      "NDC11Code": "42254-0070-14",
      "ProductNDC": "42254-070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrofurantoin Macrocrystals",
      "NonProprietaryName": "Nitrofurantoin Macrocrystals",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110919",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA073652",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "NITROFURANTOIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitrofurans [CS],Nitrofuran Antibacterial [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Nitrofurantoin macrocrystals is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin macrocrystals and other antibacterial drugs, nitrofurantoin macrocrystals 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin macrocrystals are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin macrocrystals, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin macrocrystals, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
      "Description": "Nitrofurantoin macrocrystals is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin macrocrystals is an antibacterial agent for specific urinary tract infections. It is chemically designated as 1-[[(5-nitro-2-furanyl)methylene]amino]-2,4-imidazolidinedione and has the following structural formula. C8H6N4O5 M.W. 238.16. Each capsule, for oral administration, contains 50 mg or 100 mg of nitrofurantoin macrocrystals. In addition, each capsule contains the following inactive ingredients: corn starch, edible black ink (black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol, shellac glaze), gelatin, lactose monohydrate, silicon dioxide, sodium lauryl sulfate, talc, titanium dioxide and colorant D&C Red No. 33."
    },
    {
      "NDCCode": "42291-070-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (42291-070-30) ",
      "NDC11Code": "42291-0070-30",
      "ProductNDC": "42291-070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atomoxetine",
      "NonProprietaryName": "Atomoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220412",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079022",
      "LabelerName": "AvKARE",
      "SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-01-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220412",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (  1.1).",
      "Description": "Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl, USP is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)- N-methyl-3-phenyl-3-( o-tolyoxy)-propylamine hydrochloride. The chemical structure is:. C 17H 21NOHCl M.W. 291.82. Atomoxetine HCl, USP is a white to practically white powder, which has a solubility of 27.8 mg/mL in water. Atomoxetine Capsules USP are intended for oral administration only. Each capsule contains atomoxetine HCl, USP equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain black iron oxide, gelatin, potassium hydroxide, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. Additionally the 18 mg and 60 mg capsules contain D&C yellow #10; the 25 mg, 40 mg, and 60 mg capsules contain FD&C blue #1; and the 80 mg and 100 mg capsules contain red iron oxide and yellow iron oxide."
    },
    {
      "NDCCode": "42411-070-03",
      "PackageDescription": "425 L in 1 CYLINDER (42411-070-03)",
      "NDC11Code": "42411-0070-03",
      "ProductNDC": "42411-070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Helium Oxygen Mixture",
      "NonProprietaryName": "Helium Oxygen Mixture",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19600101",
      "MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
      "LabelerName": "Air Liquide America Specialty Gases LLC",
      "SubstanceName": "HELIUM; OXYGEN",
      "StrengthNumber": "60; 40",
      "StrengthUnit": "L/100L; L/100L",
      "Status": "Deprecated",
      "LastUpdate": "2014-10-17"
    },
    {
      "NDCCode": "42411-070-04",
      "PackageDescription": "708 L in 1 CYLINDER (42411-070-04)",
      "NDC11Code": "42411-0070-04",
      "ProductNDC": "42411-070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Helium Oxygen Mixture",
      "NonProprietaryName": "Helium Oxygen Mixture",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19600101",
      "MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
      "LabelerName": "Air Liquide America Specialty Gases LLC",
      "SubstanceName": "HELIUM; OXYGEN",
      "StrengthNumber": "60; 40",
      "StrengthUnit": "L/100L; L/100L",
      "Status": "Deprecated",
      "LastUpdate": "2014-10-17"
    },
    {
      "NDCCode": "42411-070-05",
      "PackageDescription": "3540 L in 1 CYLINDER (42411-070-05)",
      "NDC11Code": "42411-0070-05",
      "ProductNDC": "42411-070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Helium Oxygen Mixture",
      "NonProprietaryName": "Helium Oxygen Mixture",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19600101",
      "MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
      "LabelerName": "Air Liquide America Specialty Gases LLC",
      "SubstanceName": "HELIUM; OXYGEN",
      "StrengthNumber": "60; 40",
      "StrengthUnit": "L/100L; L/100L",
      "Status": "Deprecated",
      "LastUpdate": "2014-10-17"
    },
    {
      "NDCCode": "42411-070-06",
      "PackageDescription": "6514 L in 1 CYLINDER (42411-070-06)",
      "NDC11Code": "42411-0070-06",
      "ProductNDC": "42411-070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Helium Oxygen Mixture",
      "NonProprietaryName": "Helium Oxygen Mixture",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19600101",
      "MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
      "LabelerName": "Air Liquide America Specialty Gases LLC",
      "SubstanceName": "HELIUM; OXYGEN",
      "StrengthNumber": "60; 40",
      "StrengthUnit": "L/100L; L/100L",
      "Status": "Deprecated",
      "LastUpdate": "2014-10-17"
    },
    {
      "NDCCode": "42708-070-28",
      "PackageDescription": "28 CAPSULE in 1 BOTTLE (42708-070-28) ",
      "NDC11Code": "42708-0070-28",
      "ProductNDC": "42708-070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110119",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090836",
      "LabelerName": "QPharma Inc",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180918",
      "SamplePackage": "Y",
      "IndicationAndUsage": "Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria.  To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6).",
      "Description": "Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin has the following structural formula:. Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of cephalexin. The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD & C Blue No. 1, D & C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD & C Red No. 40; 333 mg and 750 mg Capsules contains FD & C Yellow No. 6. The imprinting ink contains; shellac, propylene glycol, strong ammonia solution and potassium hydroxide. Also black Iron oxide is used in 250mg, 333mg and 500mg and titanium dioxide is used in 750mg."
    },
    {
      "NDCCode": "43386-071-83",
      "PackageDescription": "1 KIT in 1 KIT (43386-071-83)  *  1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43386-010-61)  *  2 L in 1 BOTTLE (43386-070-17) ",
      "NDC11Code": "43386-0071-83",
      "ProductNDC": "43386-071",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gavilyte-h And Bisacodyl",
      "NonProprietaryName": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride And Bisacodyl Delayed-release Tablet",
      "DosageFormName": "KIT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150421",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202217",
      "LabelerName": "Lupin Pharmaceuticals, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-01-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150421",
      "SamplePackage": "N",
      "IndicationAndUsage": "GaviLyte - H and bisacodyl delayed-release tablet, USP is indicated for cleansing of the colon as a preparation for colonoscopy in adults.",
      "Description": "GaviLyte - H and bisacodyl delayed-release tablet, USP consists of PEG-3350, an osmotic laxative and bisacodyl, a stimulant laxative. Each GaviLyte - H and 5 mg bisacodyl delayed-release tablet, USP (Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet) consists of one 2 liter bottle of GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and one 5 mg bisacodyl, delayed-release tablet, USP. : 1 Bisacodyl delayed-release tablet, USP: Each pink, round, enteric coated bisacodyl delayed-release tablet, USP (debossed “N1”) contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40. Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, D&C red # 27/phloxine aluminum lake, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, FD&C blue # 2/indigo carmine aluminum lake and FD&C yellow # 6/sunset yellow FCF aluminum lake. The bisacodyl delayed-release tablet, USP is administered orally prior to drinking the GaviLyte - H [see Dosage and Administration ( 2)] ., 2 GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution): A white powder for reconstitution containing 210 grams of PEG-3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride and 2 grams of flavoring ingredients (if applicable). Flavor Packs are available in Cherry (containing artificial cherry flavor powder, maltodextrin and sodium saccharin), Lemon (containing natural lemon flavor powder, maltodextrin and sodium saccharin),  and Orange (containing natural and artificial orange flavor powder, maltodextrin and sodium saccharin). This preparation can be used without the addition of a Flavor Pack. When dissolved in water to a volume of 2 liters, the GaviLyte - H solution is isosmotic, clear, and colorless. The GaviLyte - H solution is administered orally after taking the one bisacodyl delayed-release tablet, USP [see Dosage and Administration ( 2)] ."
    },
    {
      "NDCCode": "50066-070-01",
      "PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (50066-070-01)  / 25 g in 1 TUBE, WITH APPLICATOR",
      "NDC11Code": "50066-0070-01",
      "ProductNDC": "50066-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lagicam",
      "ProprietaryNameSuffix": "Antifungal",
      "NonProprietaryName": "Miconazole Nitrate",
      "DosageFormName": "CREAM",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20050302",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076773",
      "LabelerName": "Genomma Lab USA, Inc.",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Active",
      "LastUpdate": "2025-07-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230911",
      "SamplePackage": "N",
      "IndicationAndUsage": "treats vaginal yeast infections."
    },
    {
      "NDCCode": "50066-070-03",
      "PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (50066-070-03)  / 25 g in 1 TUBE, WITH APPLICATOR",
      "NDC11Code": "50066-0070-03",
      "ProductNDC": "50066-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lagicam",
      "ProprietaryNameSuffix": "Antifungal",
      "NonProprietaryName": "Miconazole Nitrate",
      "DosageFormName": "CREAM",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20050302",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076773",
      "LabelerName": "Genomma Lab USA, Inc.",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Active",
      "LastUpdate": "2025-07-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20131018",
      "SamplePackage": "N",
      "IndicationAndUsage": "treats vaginal yeast infections."
    },
    {
      "NDCCode": "51655-070-52",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (51655-070-52) ",
      "NDC11Code": "51655-0070-52",
      "ProductNDC": "51655-070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pravastatin Sodium",
      "NonProprietaryName": "Pravastatin Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220928",
      "EndMarketingDate": "20260331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076056",
      "LabelerName": "Northwind Health Company, LLC",
      "SubstanceName": "PRAVASTATIN SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20220928",
      "EndMarketingDatePackage": "20260331",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
      "Description": "Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. C 23H 35NaO 7M.W. 446.52. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP for oral use contain 10 mg, 20 mg and 40 mg pravastatin sodium USP, which is equivalent to 9.50 mg, 19.01 mg and 38.03 mg of pravastatin, respectively. Inactive ingredients include: calcium phosphate dibasic anhydrous, croscarmellose sodium, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone and sodium stearyl fumarate. Additionally, the 10 mg tablet contains ferric oxide red; the 20 mg tablet contains ferric oxide yellow; and the 40 mg tablet contains FD&C Blue No. 1 Aluminum Lake and D&C Yellow No.10."
    },
    {
      "NDCCode": "53217-070-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (53217-070-30)",
      "NDC11Code": "53217-0070-30",
      "ProductNDC": "53217-070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxepin Hydrochloride",
      "NonProprietaryName": "Doxepin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121018",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070791",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "DOXEPIN HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Doxepin is recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.",
      "Description": "Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO  HCl having a molecular weight of 316. It is a white crystalline solid readily soluble in water, lower alcohols and chloroform. It may be represented by the following structural formula. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[b,e]oxepin-11 (6H )ylidene-N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
    },
    {
      "NDCCode": "60760-070-07",
      "PackageDescription": "7 TABLET in 1 BOTTLE, PLASTIC (60760-070-07) ",
      "NDC11Code": "60760-0070-07",
      "ProductNDC": "60760-070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Famotidine",
      "NonProprietaryName": "Famotidine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078916",
      "LabelerName": "St. Mary's Medical Park Pharmacy",
      "SubstanceName": "FAMOTIDINE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20191203",
      "SamplePackage": "N",
      "IndicationAndUsage": "Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: : 1 active duodenal ulcer (DU). , 2 active gastric ulcer (GU). , 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by biopsy. .",
      "Description": "The active ingredient in famotidine tablets, USP is a histamine-2 (H 2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3 and its molecular weight is 337.43. Its structural formula is:. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: colloidal silicon dioxide, yellow iron oxide and red iron oxide, Lecithin, macrogel/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
    },
    {
      "NDCCode": "60760-070-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (60760-070-60) ",
      "NDC11Code": "60760-0070-60",
      "ProductNDC": "60760-070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Famotidine",
      "NonProprietaryName": "Famotidine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078916",
      "LabelerName": "St. Mary's Medical Park Pharmacy",
      "SubstanceName": "FAMOTIDINE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20190227",
      "SamplePackage": "N",
      "IndicationAndUsage": "Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: : 1 active duodenal ulcer (DU). , 2 active gastric ulcer (GU). , 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by biopsy. .",
      "Description": "The active ingredient in famotidine tablets, USP is a histamine-2 (H 2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3 and its molecular weight is 337.43. Its structural formula is:. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: colloidal silicon dioxide, yellow iron oxide and red iron oxide, Lecithin, macrogel/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
    },
    {
      "NDCCode": "61715-070-09",
      "PackageDescription": "9 PLASTER in 1 PACKET (61715-070-09) ",
      "NDC11Code": "61715-0070-09",
      "ProductNDC": "61715-070",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kpp Ultra Thin Corn Removers",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "PLASTER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19951031",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part358F",
      "LabelerName": "Cardinal Health",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "40",
      "StrengthUnit": "1/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-10-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "19951031",
      "SamplePackage": "N"
    }
  ]
}
                    

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<NDCList>
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    <NDCCode>74728-070-40</NDCCode>
    <PackageDescription>10 mL in 1 BOTTLE (74728-070-40) </PackageDescription>
    <NDC11Code>74728-0070-40</NDC11Code>
    <ProductNDC>74728-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Emurgent Usa Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210212</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>EmUrgent USA LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
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    <NDCCode>74728-070-30</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, PLASTIC (74728-070-30) </PackageDescription>
    <NDC11Code>74728-0070-30</NDC11Code>
    <ProductNDC>74728-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Emurgent Usa Hand Sanitizer</ProprietaryName>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>EmUrgent USA LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>37000-070-40</NDCCode>
    <PackageDescription>400 mL in 1 BOTTLE, PUMP (37000-070-40) </PackageDescription>
    <NDC11Code>37000-0070-40</NDC11Code>
    <ProductNDC>37000-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Head And Shoulders 2in1</ProprietaryName>
    <ProprietaryNameSuffix>Classic Clean</ProprietaryNameSuffix>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>LOTION/SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130901</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240201</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50242-070-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-070-01)  / 40 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>50242-0070-01</NDC11Code>
    <ProductNDC>50242-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gazyva</ProprietaryName>
    <NonProprietaryName>Obinutuzumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20131101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125486</ApplicationNumber>
    <LabelerName>Genentech, Inc.</LabelerName>
    <SubstanceName>OBINUTUZUMAB</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/40mL</StrengthUnit>
    <Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GAZYVA is a CD20-directed cytolytic antibody indicated: 1 in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). (1.1, 14), 2 in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. (1.2, 14), 3 in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. (1.2, 14), 4 for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy (1.3, 14), 5 to reduce the risk of relapse in adult and pediatric patients 2 years of age and older with frequently relapsing or steroid dependent childhood-onset idiopathic nephrotic syndrome who are in complete remission. (1.4, 14).</IndicationAndUsage>
    <Description>Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B cells. The molecular mass of the antibody is approximately 150 kDa. GAZYVA (obinutuzumab) injection is produced by mammalian cell (CHO) suspension culture. GAZYVA was engineered to have reduced fucose content as compared to a typical IgG1 produced in CHO cells. GAZYVA is a sterile, clear, colorless to slightly brown, preservative-free liquid concentrate for intravenous use. GAZYVA is supplied at a concentration of 25 mg/mL in 1,000 mg single-dose vials. Each vial contains in 40 mL: 1,000 mg obinutuzumab, L-histidine (57.6 mg), L-histidine hydrochloride monohydrate (89.6 mg), trehalose dihydrate (3632 mg), and poloxamer 188 (8 mg). The pH is 6.0.</Description>
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  <NDC>
    <NDCCode>50242-070-86</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-070-86)  / 40 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>50242-0070-86</NDC11Code>
    <ProductNDC>50242-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gazyva</ProprietaryName>
    <NonProprietaryName>Obinutuzumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20131101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125486</ApplicationNumber>
    <LabelerName>Genentech, Inc.</LabelerName>
    <SubstanceName>OBINUTUZUMAB</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/40mL</StrengthUnit>
    <Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131104</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>GAZYVA is a CD20-directed cytolytic antibody indicated: 1 in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). (1.1, 14), 2 in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. (1.2, 14), 3 in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. (1.2, 14), 4 for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy (1.3, 14).</IndicationAndUsage>
    <Description>Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B cells. The molecular mass of the antibody is approximately 150 kDa. GAZYVA (obinutuzumab) injection is produced by mammalian cell (CHO) suspension culture. GAZYVA was engineered to have reduced fucose content as compared to a typical IgG1 produced in CHO cells. GAZYVA is a sterile, clear, colorless to slightly brown, preservative-free liquid concentrate for intravenous use. GAZYVA is supplied at a concentration of 25 mg/mL in 1,000 mg single-dose vials. Each vial contains in 40 mL: 1,000 mg obinutuzumab, L-histidine (57.6 mg), L-histidine hydrochloride monohydrate (89.6 mg), trehalose dihydrate (3632 mg), and poloxamer 188 (8 mg). The pH is 6.0.</Description>
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  <NDC>
    <NDCCode>51060-070-01</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (51060-070-01)  &gt; 40 mL in 1 TUBE</PackageDescription>
    <NDC11Code>51060-0070-01</NDC11Code>
    <ProductNDC>51060-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Foundcealer 2-in-1 Foundation And Concealer Broad Spectrum Spf 15 Sunscreen</ProprietaryName>
    <ProprietaryNameSuffix>Light-medium</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Tarte, Inc</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>60; 30</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>61354-070-05</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (61354-070-05)  &gt; 40 mg in 1 TUBE (61354-070-01) </PackageDescription>
    <NDC11Code>61354-0070-05</NDC11Code>
    <ProductNDC>61354-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cream</ProprietaryName>
    <NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210222</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Oxygen Development LLC</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>5; 5</StrengthNumber>
    <StrengthUnit>mg/100mg; mg/100mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>61354-070-06</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (61354-070-06)  &gt; 40 mg in 1 TUBE (61354-070-02) </PackageDescription>
    <NDC11Code>61354-0070-06</NDC11Code>
    <ProductNDC>61354-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cream</ProprietaryName>
    <NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210222</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Oxygen Development LLC</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>5; 5</StrengthNumber>
    <StrengthUnit>mg/100mg; mg/100mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>61354-070-07</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (61354-070-07)  &gt; 40 mg in 1 TUBE (61354-070-03) </PackageDescription>
    <NDC11Code>61354-0070-07</NDC11Code>
    <ProductNDC>61354-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cream</ProprietaryName>
    <NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210222</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Oxygen Development LLC</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>5; 5</StrengthNumber>
    <StrengthUnit>mg/100mg; mg/100mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>61354-070-08</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (61354-070-08)  &gt; 40 mg in 1 TUBE (61354-070-04) </PackageDescription>
    <NDC11Code>61354-0070-08</NDC11Code>
    <ProductNDC>61354-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cream</ProprietaryName>
    <NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210222</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Oxygen Development LLC</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>5; 5</StrengthNumber>
    <StrengthUnit>mg/100mg; mg/100mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70567-070-01</NDCCode>
    <PackageDescription>40 mL in 1 CONTAINER (70567-070-01)</PackageDescription>
    <NDC11Code>70567-0070-01</NDC11Code>
    <ProductNDC>70567-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Grain Timeless Perfection Essence</ProprietaryName>
    <NonProprietaryName>Dimethicone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160302</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>KHLEEKOREA</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>g/40mL</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Indications &amp; Usage: Softly apply cream along the skin texture and pat gently for better absorption. 1. Apply some suitable amount of cream on your skin evenly and rub lightly. 2. Apply to entire face outwards and neck from top-down. 3. Tap gently on the face to absorb with palm of the hand giving light tension to the face.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70991-070-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (70991-070-02)  &gt; 40 mL in 1 TUBE (70991-070-01)</PackageDescription>
    <NDC11Code>70991-0070-02</NDC11Code>
    <ProductNDC>70991-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fascy Moisture Bomb Hand Milk 40ml</ProprietaryName>
    <NonProprietaryName>Dimethicone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>FASCY Co,.LTD.</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>.4</StrengthNumber>
    <StrengthUnit>g/40mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>How to use: Apply desired amount and massage into the hands.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16571-070-12</NDCCode>
    <PackageDescription>150 mL in 1 BOTTLE (16571-070-12)</PackageDescription>
    <NDC11Code>16571-0070-12</NDC11Code>
    <ProductNDC>16571-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefaclor</ProprietaryName>
    <NonProprietaryName>Cefaclor</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121025</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065412</ApplicationNumber>
    <LabelerName>Pack Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>CEFACLOR</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <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 For Oral Suspension and other antibacterial drugs, Cefaclor For Oral Suspension 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 C15H14ClN3O4SH2O and the molecular weight is 385.82. After mixing, each 5 ml of Cefaclor for Oral Suspension will contain cefaclor monohydrate equivalent to 125 mg (0.34 mmol), 250 mg (0.68 mmol), or 375 mg (1 .0 mmol) anhydrous cefaclor. The suspensions also contain methylcellulose, sodium lauryl sulfate, sucrose, and xanthan gum, FD&amp;C Red No. 40, strawbenry flavor. The color of drug powder in the dry powder state is white to off-white. After reconstitution, it turns to a red suspension.</Description>
  </NDC>
  <NDC>
    <NDCCode>36800-070-09</NDCCode>
    <PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (36800-070-09)  &gt; 25 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>36800-0070-09</NDC11Code>
    <ProductNDC>36800-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Topcare</ProprietaryName>
    <ProprietaryNameSuffix>Miconazole 3 Yeast Infection Relief</ProprietaryNameSuffix>
    <NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20050302</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076773</ApplicationNumber>
    <LabelerName>Topco Associates LLC</LabelerName>
    <SubstanceName>MICONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats vaginal yeast infections.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>37012-070-09</NDCCode>
    <PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (37012-070-09)  &gt; 25 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>37012-0070-09</NDC11Code>
    <ProductNDC>37012-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Miconazole 3</ProprietaryName>
    <NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20050302</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076773</ApplicationNumber>
    <LabelerName>Shopko Stores Operating Co., LLC</LabelerName>
    <SubstanceName>MICONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>treats vaginal yeast infections.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42254-070-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE (42254-070-14)</PackageDescription>
    <NDC11Code>42254-0070-14</NDC11Code>
    <ProductNDC>42254-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrofurantoin Macrocrystals</ProprietaryName>
    <NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110919</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA073652</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>NITROFURANTOIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitrofurans [CS],Nitrofuran Antibacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Nitrofurantoin macrocrystals is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin macrocrystals and other antibacterial drugs, nitrofurantoin macrocrystals 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin macrocrystals are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin macrocrystals, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin macrocrystals, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
    <Description>Nitrofurantoin macrocrystals is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin macrocrystals is an antibacterial agent for specific urinary tract infections. It is chemically designated as 1-[[(5-nitro-2-furanyl)methylene]amino]-2,4-imidazolidinedione and has the following structural formula. C8H6N4O5 M.W. 238.16. Each capsule, for oral administration, contains 50 mg or 100 mg of nitrofurantoin macrocrystals. In addition, each capsule contains the following inactive ingredients: corn starch, edible black ink (black iron oxide, D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, propylene glycol, shellac glaze), gelatin, lactose monohydrate, silicon dioxide, sodium lauryl sulfate, talc, titanium dioxide and colorant D&amp;C Red No. 33.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-070-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (42291-070-30) </PackageDescription>
    <NDC11Code>42291-0070-30</NDC11Code>
    <ProductNDC>42291-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atomoxetine</ProprietaryName>
    <NonProprietaryName>Atomoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220412</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079022</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (  1.1).</IndicationAndUsage>
    <Description>Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl, USP is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)- N-methyl-3-phenyl-3-( o-tolyoxy)-propylamine hydrochloride. The chemical structure is:. C 17H 21NOHCl M.W. 291.82. Atomoxetine HCl, USP is a white to practically white powder, which has a solubility of 27.8 mg/mL in water. Atomoxetine Capsules USP are intended for oral administration only. Each capsule contains atomoxetine HCl, USP equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain black iron oxide, gelatin, potassium hydroxide, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. Additionally the 18 mg and 60 mg capsules contain D&amp;C yellow #10; the 25 mg, 40 mg, and 60 mg capsules contain FD&amp;C blue #1; and the 80 mg and 100 mg capsules contain red iron oxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42411-070-03</NDCCode>
    <PackageDescription>425 L in 1 CYLINDER (42411-070-03)</PackageDescription>
    <NDC11Code>42411-0070-03</NDC11Code>
    <ProductNDC>42411-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Helium Oxygen Mixture</ProprietaryName>
    <NonProprietaryName>Helium Oxygen Mixture</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19600101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Air Liquide America Specialty Gases LLC</LabelerName>
    <SubstanceName>HELIUM; OXYGEN</SubstanceName>
    <StrengthNumber>60; 40</StrengthNumber>
    <StrengthUnit>L/100L; L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-10-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>42411-070-04</NDCCode>
    <PackageDescription>708 L in 1 CYLINDER (42411-070-04)</PackageDescription>
    <NDC11Code>42411-0070-04</NDC11Code>
    <ProductNDC>42411-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Helium Oxygen Mixture</ProprietaryName>
    <NonProprietaryName>Helium Oxygen Mixture</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19600101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Air Liquide America Specialty Gases LLC</LabelerName>
    <SubstanceName>HELIUM; OXYGEN</SubstanceName>
    <StrengthNumber>60; 40</StrengthNumber>
    <StrengthUnit>L/100L; L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-10-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>42411-070-05</NDCCode>
    <PackageDescription>3540 L in 1 CYLINDER (42411-070-05)</PackageDescription>
    <NDC11Code>42411-0070-05</NDC11Code>
    <ProductNDC>42411-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Helium Oxygen Mixture</ProprietaryName>
    <NonProprietaryName>Helium Oxygen Mixture</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19600101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Air Liquide America Specialty Gases LLC</LabelerName>
    <SubstanceName>HELIUM; OXYGEN</SubstanceName>
    <StrengthNumber>60; 40</StrengthNumber>
    <StrengthUnit>L/100L; L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-10-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>42411-070-06</NDCCode>
    <PackageDescription>6514 L in 1 CYLINDER (42411-070-06)</PackageDescription>
    <NDC11Code>42411-0070-06</NDC11Code>
    <ProductNDC>42411-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Helium Oxygen Mixture</ProprietaryName>
    <NonProprietaryName>Helium Oxygen Mixture</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19600101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Air Liquide America Specialty Gases LLC</LabelerName>
    <SubstanceName>HELIUM; OXYGEN</SubstanceName>
    <StrengthNumber>60; 40</StrengthNumber>
    <StrengthUnit>L/100L; L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-10-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>42708-070-28</NDCCode>
    <PackageDescription>28 CAPSULE in 1 BOTTLE (42708-070-28) </PackageDescription>
    <NDC11Code>42708-0070-28</NDC11Code>
    <ProductNDC>42708-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090836</ApplicationNumber>
    <LabelerName>QPharma Inc</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180918</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria.  To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6).</IndicationAndUsage>
    <Description>Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin has the following structural formula:. Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of cephalexin. The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD &amp; C Blue No. 1, D &amp; C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD &amp; C Red No. 40; 333 mg and 750 mg Capsules contains FD &amp; C Yellow No. 6. The imprinting ink contains; shellac, propylene glycol, strong ammonia solution and potassium hydroxide. Also black Iron oxide is used in 250mg, 333mg and 500mg and titanium dioxide is used in 750mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-071-83</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (43386-071-83)  *  1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43386-010-61)  *  2 L in 1 BOTTLE (43386-070-17) </PackageDescription>
    <NDC11Code>43386-0071-83</NDC11Code>
    <ProductNDC>43386-071</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gavilyte-h And Bisacodyl</ProprietaryName>
    <NonProprietaryName>Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride And Bisacodyl Delayed-release Tablet</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150421</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202217</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-01-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150421</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GaviLyte - H and bisacodyl delayed-release tablet, USP is indicated for cleansing of the colon as a preparation for colonoscopy in adults.</IndicationAndUsage>
    <Description>GaviLyte - H and bisacodyl delayed-release tablet, USP consists of PEG-3350, an osmotic laxative and bisacodyl, a stimulant laxative. Each GaviLyte - H and 5 mg bisacodyl delayed-release tablet, USP (Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet) consists of one 2 liter bottle of GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and one 5 mg bisacodyl, delayed-release tablet, USP. : 1 Bisacodyl delayed-release tablet, USP: Each pink, round, enteric coated bisacodyl delayed-release tablet, USP (debossed “N1”) contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40. Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, D&amp;C red # 27/phloxine aluminum lake, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, FD&amp;C blue # 2/indigo carmine aluminum lake and FD&amp;C yellow # 6/sunset yellow FCF aluminum lake. The bisacodyl delayed-release tablet, USP is administered orally prior to drinking the GaviLyte - H [see Dosage and Administration ( 2)] ., 2 GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution): A white powder for reconstitution containing 210 grams of PEG-3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride and 2 grams of flavoring ingredients (if applicable). Flavor Packs are available in Cherry (containing artificial cherry flavor powder, maltodextrin and sodium saccharin), Lemon (containing natural lemon flavor powder, maltodextrin and sodium saccharin),  and Orange (containing natural and artificial orange flavor powder, maltodextrin and sodium saccharin). This preparation can be used without the addition of a Flavor Pack. When dissolved in water to a volume of 2 liters, the GaviLyte - H solution is isosmotic, clear, and colorless. The GaviLyte - H solution is administered orally after taking the one bisacodyl delayed-release tablet, USP [see Dosage and Administration ( 2)] .</Description>
  </NDC>
  <NDC>
    <NDCCode>50066-070-01</NDCCode>
    <PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (50066-070-01)  / 25 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>50066-0070-01</NDC11Code>
    <ProductNDC>50066-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lagicam</ProprietaryName>
    <ProprietaryNameSuffix>Antifungal</ProprietaryNameSuffix>
    <NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20050302</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076773</ApplicationNumber>
    <LabelerName>Genomma Lab USA, Inc.</LabelerName>
    <SubstanceName>MICONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230911</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats vaginal yeast infections.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50066-070-03</NDCCode>
    <PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (50066-070-03)  / 25 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>50066-0070-03</NDC11Code>
    <ProductNDC>50066-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lagicam</ProprietaryName>
    <ProprietaryNameSuffix>Antifungal</ProprietaryNameSuffix>
    <NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20050302</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076773</ApplicationNumber>
    <LabelerName>Genomma Lab USA, Inc.</LabelerName>
    <SubstanceName>MICONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats vaginal yeast infections.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51655-070-52</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (51655-070-52) </PackageDescription>
    <NDC11Code>51655-0070-52</NDC11Code>
    <ProductNDC>51655-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pravastatin Sodium</ProprietaryName>
    <NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220928</StartMarketingDate>
    <EndMarketingDate>20260331</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076056</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</LabelerName>
    <SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20220928</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. C 23H 35NaO 7M.W. 446.52. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (&gt;300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP for oral use contain 10 mg, 20 mg and 40 mg pravastatin sodium USP, which is equivalent to 9.50 mg, 19.01 mg and 38.03 mg of pravastatin, respectively. Inactive ingredients include: calcium phosphate dibasic anhydrous, croscarmellose sodium, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone and sodium stearyl fumarate. Additionally, the 10 mg tablet contains ferric oxide red; the 20 mg tablet contains ferric oxide yellow; and the 40 mg tablet contains FD&amp;C Blue No. 1 Aluminum Lake and D&amp;C Yellow No.10.</Description>
  </NDC>
  <NDC>
    <NDCCode>53217-070-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (53217-070-30)</PackageDescription>
    <NDC11Code>53217-0070-30</NDC11Code>
    <ProductNDC>53217-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070791</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Doxepin is recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.</IndicationAndUsage>
    <Description>Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO  HCl having a molecular weight of 316. It is a white crystalline solid readily soluble in water, lower alcohols and chloroform. It may be represented by the following structural formula. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[b,e]oxepin-11 (6H )ylidene-N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain D&amp;C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&amp;C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&amp;C Green No. 3. The imprinting ink contains black iron oxide, D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
  </NDC>
  <NDC>
    <NDCCode>60760-070-07</NDCCode>
    <PackageDescription>7 TABLET in 1 BOTTLE, PLASTIC (60760-070-07) </PackageDescription>
    <NDC11Code>60760-0070-07</NDC11Code>
    <ProductNDC>60760-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078916</ApplicationNumber>
    <LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: : 1 active duodenal ulcer (DU). , 2 active gastric ulcer (GU). , 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by biopsy. .</IndicationAndUsage>
    <Description>The active ingredient in famotidine tablets, USP is a histamine-2 (H 2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3 and its molecular weight is 337.43. Its structural formula is:. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: colloidal silicon dioxide, yellow iron oxide and red iron oxide, Lecithin, macrogel/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>60760-070-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (60760-070-60) </PackageDescription>
    <NDC11Code>60760-0070-60</NDC11Code>
    <ProductNDC>60760-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078916</ApplicationNumber>
    <LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: : 1 active duodenal ulcer (DU). , 2 active gastric ulcer (GU). , 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by biopsy. .</IndicationAndUsage>
    <Description>The active ingredient in famotidine tablets, USP is a histamine-2 (H 2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3 and its molecular weight is 337.43. Its structural formula is:. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: colloidal silicon dioxide, yellow iron oxide and red iron oxide, Lecithin, macrogel/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>61715-070-09</NDCCode>
    <PackageDescription>9 PLASTER in 1 PACKET (61715-070-09) </PackageDescription>
    <NDC11Code>61715-0070-09</NDC11Code>
    <ProductNDC>61715-070</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kpp Ultra Thin Corn Removers</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>PLASTER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19951031</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358F</ApplicationNumber>
    <LabelerName>Cardinal Health</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>1/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19951031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>74728-070-40</NDCCode><ProprietaryName>Emurgent Usa Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>74728-070-30</NDCCode><ProprietaryName>Emurgent Usa Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>37000-070-40</NDCCode><ProprietaryName>Head And Shoulders 2in1</ProprietaryName><NonProprietaryName>Pyrithione Zinc</NonProprietaryName></NDC><NDC><NDCCode>50242-070-01</NDCCode><ProprietaryName>Gazyva</ProprietaryName><NonProprietaryName>Obinutuzumab</NonProprietaryName></NDC><NDC><NDCCode>50242-070-86</NDCCode><ProprietaryName>Gazyva</ProprietaryName><NonProprietaryName>Obinutuzumab</NonProprietaryName></NDC><NDC><NDCCode>51060-070-01</NDCCode><ProprietaryName>Foundcealer 2-in-1 Foundation And Concealer Broad Spectrum Spf 15 Sunscreen</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>61354-070-05</NDCCode><ProprietaryName>Cream</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>61354-070-06</NDCCode><ProprietaryName>Cream</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>61354-070-07</NDCCode><ProprietaryName>Cream</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>61354-070-08</NDCCode><ProprietaryName>Cream</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>70567-070-01</NDCCode><ProprietaryName>Grain Timeless Perfection Essence</ProprietaryName><NonProprietaryName>Dimethicone</NonProprietaryName></NDC><NDC><NDCCode>70991-070-02</NDCCode><ProprietaryName>Fascy Moisture Bomb Hand Milk 40ml</ProprietaryName><NonProprietaryName>Dimethicone</NonProprietaryName></NDC><NDC><NDCCode>16571-070-12</NDCCode><ProprietaryName>Cefaclor</ProprietaryName><NonProprietaryName>Cefaclor</NonProprietaryName></NDC><NDC><NDCCode>36800-070-09</NDCCode><ProprietaryName>Topcare</ProprietaryName><NonProprietaryName>Miconazole Nitrate</NonProprietaryName></NDC><NDC><NDCCode>37012-070-09</NDCCode><ProprietaryName>Miconazole 3</ProprietaryName><NonProprietaryName>Miconazole Nitrate</NonProprietaryName></NDC><NDC><NDCCode>42254-070-14</NDCCode><ProprietaryName>Nitrofurantoin Macrocrystals</ProprietaryName><NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName></NDC><NDC><NDCCode>42291-070-30</NDCCode><ProprietaryName>Atomoxetine</ProprietaryName><NonProprietaryName>Atomoxetine</NonProprietaryName></NDC><NDC><NDCCode>42411-070-03</NDCCode><ProprietaryName>Helium Oxygen Mixture</ProprietaryName><NonProprietaryName>Helium Oxygen Mixture</NonProprietaryName></NDC><NDC><NDCCode>42411-070-04</NDCCode><ProprietaryName>Helium Oxygen Mixture</ProprietaryName><NonProprietaryName>Helium Oxygen Mixture</NonProprietaryName></NDC><NDC><NDCCode>42411-070-05</NDCCode><ProprietaryName>Helium Oxygen Mixture</ProprietaryName><NonProprietaryName>Helium Oxygen Mixture</NonProprietaryName></NDC><NDC><NDCCode>42411-070-06</NDCCode><ProprietaryName>Helium Oxygen Mixture</ProprietaryName><NonProprietaryName>Helium Oxygen Mixture</NonProprietaryName></NDC><NDC><NDCCode>42708-070-28</NDCCode><ProprietaryName>Cephalexin</ProprietaryName><NonProprietaryName>Cephalexin</NonProprietaryName></NDC><NDC><NDCCode>43386-071-83</NDCCode><ProprietaryName>Gavilyte-h And Bisacodyl</ProprietaryName><NonProprietaryName>Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride And Bisacodyl Delayed-release Tablet</NonProprietaryName></NDC><NDC><NDCCode>50066-070-01</NDCCode><ProprietaryName>Lagicam</ProprietaryName><NonProprietaryName>Miconazole Nitrate</NonProprietaryName></NDC><NDC><NDCCode>50066-070-03</NDCCode><ProprietaryName>Lagicam</ProprietaryName><NonProprietaryName>Miconazole Nitrate</NonProprietaryName></NDC><NDC><NDCCode>51655-070-52</NDCCode><ProprietaryName>Pravastatin Sodium</ProprietaryName><NonProprietaryName>Pravastatin Sodium</NonProprietaryName></NDC><NDC><NDCCode>53217-070-30</NDCCode><ProprietaryName>Doxepin Hydrochloride</ProprietaryName><NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>60760-070-07</NDCCode><ProprietaryName>Famotidine</ProprietaryName><NonProprietaryName>Famotidine</NonProprietaryName></NDC><NDC><NDCCode>60760-070-60</NDCCode><ProprietaryName>Famotidine</ProprietaryName><NonProprietaryName>Famotidine</NonProprietaryName></NDC><NDC><NDCCode>61715-070-09</NDCCode><ProprietaryName>Kpp Ultra Thin Corn Removers</ProprietaryName><NonProprietaryName>Salicylic Acid</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",
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      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
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      "PracticeLocationAddressCountryCode": "US",
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      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
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      "TaxonomyCode1": "175T00000X",
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      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
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  ]
}
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