RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "63868-801-27",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (63868-801-27)  / 9 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "63868-0801-27",
      "ProductNDC": "63868-801",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mucus Relief D Sinus Congestion",
      "NonProprietaryName": "Guaifenesin, Pseudoephedrine Hcl",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200423",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "CHAIN DRUG MARKETING ASSOCIATION INC",
      "SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "400; 40",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-03-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200423",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves sinus congestion and pressure. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive . promotes nasal and/or sinus drainage. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies."
    },
    {
      "NDCCode": "10237-801-27",
      "PackageDescription": "73 g in 1 CANISTER (10237-801-27)",
      "NDC11Code": "10237-0801-27",
      "ProductNDC": "10237-801",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ultramax Invisible Solid",
      "ProprietaryNameSuffix": "Antiperspirant Deodorant Unscented",
      "NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20030619",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
      "StrengthNumber": "19",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-12-24",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "69898-801-27",
      "PackageDescription": "1040988 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (69898-801-27) ",
      "NDC11Code": "69898-0801-27",
      "ProductNDC": "69898-801",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Premium Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200701",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "MD Science Lab LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "80",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200701",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "75111-801-27",
      "PackageDescription": "100 CLOTH in 1 CANISTER (75111-801-27) ",
      "NDC11Code": "75111-0801-27",
      "ProductNDC": "75111-801",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ipa Cleaning Wipe",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Enping Jiaxin Daily Necessities Co., Ltd.",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "1/1001",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N",
      "IndicationAndUsage": "IPA Cleaning Wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "78517-801-27",
      "PackageDescription": "1040988.2 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (78517-801-27) ",
      "NDC11Code": "78517-0801-27",
      "ProductNDC": "78517-801",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pyroxy Liquid-80b",
      "NonProprietaryName": "Alcohol 80%",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Pyrock Chemical",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "80",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "31722-872-27",
      "PackageDescription": "3 BOTTLE in 1 CARTON (31722-872-27)  / 90 TABLET, FILM COATED in 1 BOTTLE (31722-872-90) ",
      "NDC11Code": "31722-0872-27",
      "ProductNDC": "31722-872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pirfenidone",
      "NonProprietaryName": "Pirfenidone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220921",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212674",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "PIRFENIDONE",
      "StrengthNumber": "267",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
      "Status": "Active",
      "LastUpdate": "2023-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220921",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
      "Description": "Pirfenidone tablets belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (white) and 801 mg (red) pirfenidone. Pirfenidone has a molecular formula of C 12H 11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-Methyl-1-phenyl-2-1( H)-pyridone or 5-Methyl-1-phenylpyridin-2(1 H)-one. Pirfenidone is a white to pale yellow colored powder. It is freely soluble in methanol. The melting point is between 106° C and 112° C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, iron oxide red (for 801 mg strength), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide."
    },
    {
      "NDCCode": "42291-491-27",
      "PackageDescription": "3 BOTTLE in 1 CARTON (42291-491-27)  / 90 TABLET, FILM COATED in 1 BOTTLE (42291-491-09) ",
      "NDC11Code": "42291-0491-27",
      "ProductNDC": "42291-491",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pirfenidone",
      "NonProprietaryName": "Pirfenidone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231018",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212570",
      "LabelerName": "AvKARE",
      "SubstanceName": "PIRFENIDONE",
      "StrengthNumber": "267",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231018",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
      "Description": "Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C 12H 11NO and a molecular weight of 185.22 g/mol. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenylpyridin-2-one. Pirfenidone is a white to pale yellow, non-hygroscopic, crystalline powder. It is sparingly soluble in water, freely soluble in ethanol (96%), and slightly soluble in heptane. The melting point range is 107°C to 111°C. Pirfenidone Tablets are available for oral administration, each pirfenidone tablet contains pirfenidone, 267 mg or 801 mg, as active ingredient and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferrosoferric oxide (801 mg), hypromellose, iron oxide red (801 mg), iron oxide yellow (267 mg), lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
    },
    {
      "NDCCode": "42385-801-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42385-801-30) ",
      "NDC11Code": "42385-0801-30",
      "ProductNDC": "42385-801",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Emtricitabine, Rilpivirine And Tenofovir Disoproxil Fumarate",
      "NonProprietaryName": "Emtricitabine, Rilpivirine And Tenofovir Disoproxil Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260305",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA220232",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE",
      "StrengthNumber": "200; 25; 300",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260305",
      "SamplePackage": "N",
      "IndicationAndUsage": "Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg.       as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or.       to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets [see Microbiology (12.4) and Clinical Studies (14)]. Limitations of Use:       More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [see Clinical Studies (14)].",
      "Description": "Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are a fixed-dose combination tablet containing FTC, rilpivirine hydrochloride, and TDF. Emtricitabine, USP (FTC) is a synthetic nucleoside analog of cytidine. Rilpivirine (RPV) is a non-nucleoside reverse transcriptase inhibitor. Tenofovir disoproxil fumarate (TDF) is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are for oral administration. Each tablet contains 200 mg of FTC, 27.5 mg of rilpivirine hydrochloride (equivalent to 25 mg of RPV), and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone K30. The tablets are film coated with a coating material containing polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide. Emtricitabine, USP: The chemical name of FTC is 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Emtricitabine, USP is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder. Freely soluble in methanol and water, practically insoluble in dichloromethane. Rilpivirine: RPV is available as the hydrochloride salt. The chemical name for rilpivirine hydrochloride is 4-[[4-[[4-[(E)-2-cyanoethenyl]-2,6-dimethylphenyl]amino]-2- pyrimidinyl]amino]benzonitrile monohydrochloride. Its molecular formula is C22H18N6  HCl and its molecular weight is 402.88. Rilpivirine hydrochloride has the following structural formula. Rilpivirine hydrochloride is a white to off white solid. Rilpivirine hydrochloride is sparingly soluble in dimethylformamide and practically insoluble in water. Tenofovir DF: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). 9-[(R)-2- [[Bis(isopropoxycarbonyl)oxy]methoxy] phosphinyl] methoxy]propyl]adenine Fumarate (1:1). It has a molecular formula of C19H30N5O10P*C4H4O4 and a molecular weight of 635.52. It has the following structural formula. TDF is a white to off-white powder. Freely soluble in Dimethylformamide and soluble in methanol. All dosages are expressed in terms of TDF except where otherwise noted."
    },
    {
      "NDCCode": "43593-801-02",
      "PackageDescription": "28005 CAPSULE in 1 DRUM (43593-801-02) ",
      "NDC11Code": "43593-0801-02",
      "ProductNDC": "43593-801",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Ozanimod Hydrochloride",
      "DosageFormName": "CAPSULE",
      "StartMarketingDate": "20200327",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Celgene International Sarl",
      "SubstanceName": "OZANIMOD HYDROCHLORIDE",
      "StrengthNumber": ".46",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2026-01-12",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "27-MAR-20"
    },
    {
      "NDCCode": "44567-801-10",
      "PackageDescription": "10 VIAL in 1 BOX (44567-801-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
      "NDC11Code": "44567-0801-10",
      "ProductNDC": "44567-801",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Piperacillin And Tazobactam",
      "NonProprietaryName": "Piperacillin Sodium,tazobactam Sodium",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091013",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065523",
      "LabelerName": "WG Critical Care, LLC",
      "SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
      "StrengthNumber": "2; .25",
      "StrengthUnit": "g/1; g/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20091013",
      "SamplePackage": "N",
      "IndicationAndUsage": "Piperacillin and tazobactam for injection, for intravenous use is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor indicated for the treatment of: : 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5)To reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam for injection and other antibacterial drugs, piperacillin and tazobactam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.6).",
      "Description": "Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin.  The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.  The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5.  The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone.  Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylate-4,4-dioxide.  The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3.  The chemical structure of tazobactam sodium is. Piperacillin and Tazobactam for Injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Piperacillin and Tazobactam for Injection, USP is a white to off-white sterile, lyophilized powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials.  This product does not contain excipients or preservatives. : 1 Each Piperacillin and Tazobactam for Injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 gram of tazobactam.  Each vial contains 4.69 mEq (108 mg) of sodium., 2 Each Piperacillin and Tazobactam for Injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 gram of tazobactam.  Each vial contains 7.04 mEq (162 mg) of sodium., 3 Each Piperacillin and Tazobactam for Injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 gram of tazobactam.  Each vial contains 9.39 mEq (216 mg) of sodium."
    },
    {
      "NDCCode": "46708-479-27",
      "PackageDescription": "270 TABLET, COATED in 1 BOTTLE (46708-479-27) ",
      "NDC11Code": "46708-0479-27",
      "ProductNDC": "46708-479",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pirfenidone",
      "NonProprietaryName": "Pirfenidone",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220610",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212708",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "PIRFENIDONE",
      "StrengthNumber": "267",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
      "Status": "Active",
      "LastUpdate": "2023-04-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221122",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
      "Description": "Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.22. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white or pale yellow crystalline, non-hygroscopic powder. It is sparingly soluble in water, freely soluble in ethanol (96 percent), slightly soluble in heptane. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: microcrystalline cellulose, povidone,croscarmellose sodium,colloidal silicon dioxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow (267 mg) and ferrosoferric oxide (801 mg), iron oxide red (801 mg)."
    },
    {
      "NDCCode": "51079-801-20",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-801-20)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-801-01) ",
      "NDC11Code": "51079-0801-20",
      "ProductNDC": "51079-801",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Tartrate",
      "NonProprietaryName": "Metoprolol Tartrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19940503",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076704",
      "LabelerName": "Mylan Institutional Inc.",
      "SubstanceName": "METOPROLOL TARTRATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19940503",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3) .",
      "Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients:anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake."
    },
    {
      "NDCCode": "51407-913-27",
      "PackageDescription": "270 TABLET in 1 BOTTLE (51407-913-27) ",
      "NDC11Code": "51407-0913-27",
      "ProductNDC": "51407-913",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pirfenidone",
      "NonProprietaryName": "Pirfenidone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212709",
      "LabelerName": "Golden State Medical Supply, Inc.",
      "SubstanceName": "PIRFENIDONE",
      "StrengthNumber": "267",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
      "Description": "Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C 12H 11NO and a molecular weight of 185.22 g/mol. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1­ phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridinone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is freely soluble in methanol, ethyl alcohol, acetone and chloroform. Sparingly soluble in 1 N hydrochloric acid, water and 0.1 N sodium hydroxide. The melting point is approximately 106°C to 112°C. Pirfenidone tablets, USP contain pirfenidone and the following inactive ingredients: colloidal silicon dioxide, ferric ferrous oxide (801 mg only), ferric oxide red (801 mg only), ferric oxide yellow (267 mg only), hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide."
    },
    {
      "NDCCode": "55444-011-01",
      "PackageDescription": "80 CLOTH in 1 PACKET (55444-011-01) ",
      "NDC11Code": "55444-0011-01",
      "ProductNDC": "55444-011",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Blue Cedar Alcohol Wipes",
      "NonProprietaryName": "Disinfecting Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200527",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Anhui Kiwi Biotech Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "120",
      "StrengthUnit": "mL/801",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200527",
      "SamplePackage": "N",
      "IndicationAndUsage": "open packet, unfold and use as a washcloth. Allow hands to dry without wiping."
    },
    {
      "NDCCode": "55444-012-01",
      "PackageDescription": "80 CLOTH in 1 PAIL (55444-012-01) ",
      "NDC11Code": "55444-0012-01",
      "ProductNDC": "55444-012",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Blue Cedar Alcohol Wipes",
      "NonProprietaryName": "Disinfecting Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200527",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Anhui Kiwi Biotech Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "120",
      "StrengthUnit": "mL/801",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200527",
      "SamplePackage": "N",
      "IndicationAndUsage": "open packet, unfold and use as a washcloth. Allow hands to dry without wiping."
    },
    {
      "NDCCode": "59651-238-27",
      "PackageDescription": "3 BOTTLE in 1 CARTON (59651-238-27)  / 90 TABLET in 1 BOTTLE (59651-238-90) ",
      "NDC11Code": "59651-0238-27",
      "ProductNDC": "59651-238",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pirfenidone",
      "NonProprietaryName": "Pirfenidone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250811",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212596",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "PIRFENIDONE",
      "StrengthNumber": "267",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
      "Status": "Active",
      "LastUpdate": "2025-08-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250811",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
      "Description": "Pirfenidone belongs to the chemical class of pyridone. Pirfenidone Tablets, USP are available as tablets containing 267 mg (yellow) and 801 mg (pink) pirfenidone, USP. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone, USP is a white to pale yellow, crystalline, non-hygroscopic powder. It is sparingly to slightly soluble in water, freely soluble in ethanol (96 %), slightly to very slightly soluble in n-Heptane. The melting point is approximately 109°C. Pirfenidone tablets, USP contain pirfenidone, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, and sodium stearyl fumarate. In addition, 267 mg tablets contains yellow iron oxide and 801 mg tablets contains red iron oxide."
    },
    {
      "NDCCode": "60687-801-21",
      "PackageDescription": "30 BLISTER PACK in 1 CARTON (60687-801-21)  / 1 TABLET in 1 BLISTER PACK (60687-801-11) ",
      "NDC11Code": "60687-0801-21",
      "ProductNDC": "60687-801",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Buspirone Hydrochloride",
      "NonProprietaryName": "Buspirone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240221",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078888",
      "LabelerName": "American Health Packaging",
      "SubstanceName": "BUSPIRONE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2024-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240221",
      "SamplePackage": "N",
      "IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. , 2 Autonomic hyperactivity Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. , 3 Apprehensive expectation Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. , 4 Vigilance and scanning Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience. .",
      "Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C 21H 31N 5O 2HCl is represented by the following structural formula:. Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 7.5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 6.85 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet)."
    },
    {
      "NDCCode": "62007-801-16",
      "PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (62007-801-16) ",
      "NDC11Code": "62007-0801-16",
      "ProductNDC": "62007-801",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pcxx Banana Berry Apf G",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL",
      "RouteName": "DENTAL; TOPICAL",
      "StartMarketingDate": "20190204",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Ross Healthcare Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "27.2",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20190204",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "62332-479-27",
      "PackageDescription": "270 TABLET, COATED in 1 BOTTLE (62332-479-27) ",
      "NDC11Code": "62332-0479-27",
      "ProductNDC": "62332-479",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pirfenidone",
      "NonProprietaryName": "Pirfenidone",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220610",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212708",
      "LabelerName": "Alembic Pharmaceuticals Inc.",
      "SubstanceName": "PIRFENIDONE",
      "StrengthNumber": "267",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
      "Status": "Active",
      "LastUpdate": "2023-12-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221122",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
      "Description": "Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.22. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white or pale yellow crystalline, non-hygroscopic powder. It is sparingly soluble in water, freely soluble in ethanol (96 percent), slightly soluble in heptane. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: microcrystalline cellulose, povidone,croscarmellose sodium,colloidal silicon dioxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow (267 mg) and ferrosoferric oxide (801 mg), iron oxide red (801 mg)."
    },
    {
      "NDCCode": "67984-003-01",
      "PackageDescription": "80 CLOTH in 1 PACKAGE (67984-003-01) ",
      "NDC11Code": "67984-0003-01",
      "ProductNDC": "67984-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanitizing Wipes",
      "NonProprietaryName": "Sanitizing Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200429",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "XIAMEN EASEPAL ENTERPRISES LIMITED",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "291.18",
      "StrengthUnit": "mL/801",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200429",
      "SamplePackage": "N",
      "IndicationAndUsage": "Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in."
    },
    {
      "NDCCode": "67984-003-02",
      "PackageDescription": "10 CLOTH in 1 PACKAGE (67984-003-02) ",
      "NDC11Code": "67984-0003-02",
      "ProductNDC": "67984-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanitizing Wipes",
      "NonProprietaryName": "Sanitizing Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200429",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "XIAMEN EASEPAL ENTERPRISES LIMITED",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "291.18",
      "StrengthUnit": "mL/801",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200429",
      "SamplePackage": "N",
      "IndicationAndUsage": "Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in."
    },
    {
      "NDCCode": "67984-003-03",
      "PackageDescription": "20 CLOTH in 1 PACKAGE (67984-003-03) ",
      "NDC11Code": "67984-0003-03",
      "ProductNDC": "67984-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanitizing Wipes",
      "NonProprietaryName": "Sanitizing Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200429",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "XIAMEN EASEPAL ENTERPRISES LIMITED",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "291.18",
      "StrengthUnit": "mL/801",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200429",
      "SamplePackage": "N",
      "IndicationAndUsage": "Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in."
    },
    {
      "NDCCode": "67984-003-04",
      "PackageDescription": "30 CLOTH in 1 PACKAGE (67984-003-04) ",
      "NDC11Code": "67984-0003-04",
      "ProductNDC": "67984-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanitizing Wipes",
      "NonProprietaryName": "Sanitizing Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200429",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "XIAMEN EASEPAL ENTERPRISES LIMITED",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "291.18",
      "StrengthUnit": "mL/801",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200429",
      "SamplePackage": "N",
      "IndicationAndUsage": "Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in."
    },
    {
      "NDCCode": "67984-003-05",
      "PackageDescription": "40 CLOTH in 1 PACKAGE (67984-003-05) ",
      "NDC11Code": "67984-0003-05",
      "ProductNDC": "67984-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanitizing Wipes",
      "NonProprietaryName": "Sanitizing Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200429",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "XIAMEN EASEPAL ENTERPRISES LIMITED",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "291.18",
      "StrengthUnit": "mL/801",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200429",
      "SamplePackage": "N",
      "IndicationAndUsage": "Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in."
    },
    {
      "NDCCode": "67984-003-06",
      "PackageDescription": "50 CLOTH in 1 PACKAGE (67984-003-06) ",
      "NDC11Code": "67984-0003-06",
      "ProductNDC": "67984-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanitizing Wipes",
      "NonProprietaryName": "Sanitizing Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200429",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "XIAMEN EASEPAL ENTERPRISES LIMITED",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "291.18",
      "StrengthUnit": "mL/801",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200429",
      "SamplePackage": "N",
      "IndicationAndUsage": "Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in."
    },
    {
      "NDCCode": "67984-003-07",
      "PackageDescription": "60 CLOTH in 1 PACKAGE (67984-003-07) ",
      "NDC11Code": "67984-0003-07",
      "ProductNDC": "67984-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanitizing Wipes",
      "NonProprietaryName": "Sanitizing Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200429",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "XIAMEN EASEPAL ENTERPRISES LIMITED",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "291.18",
      "StrengthUnit": "mL/801",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200429",
      "SamplePackage": "N",
      "IndicationAndUsage": "Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in."
    },
    {
      "NDCCode": "67984-003-08",
      "PackageDescription": "70 CLOTH in 1 PACKAGE (67984-003-08) ",
      "NDC11Code": "67984-0003-08",
      "ProductNDC": "67984-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanitizing Wipes",
      "NonProprietaryName": "Sanitizing Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200429",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "XIAMEN EASEPAL ENTERPRISES LIMITED",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "291.18",
      "StrengthUnit": "mL/801",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200429",
      "SamplePackage": "N",
      "IndicationAndUsage": "Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in."
    },
    {
      "NDCCode": "67984-003-09",
      "PackageDescription": "90 CLOTH in 1 PACKAGE (67984-003-09) ",
      "NDC11Code": "67984-0003-09",
      "ProductNDC": "67984-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanitizing Wipes",
      "NonProprietaryName": "Sanitizing Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200429",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "XIAMEN EASEPAL ENTERPRISES LIMITED",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "291.18",
      "StrengthUnit": "mL/801",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200429",
      "SamplePackage": "N",
      "IndicationAndUsage": "Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in."
    },
    {
      "NDCCode": "67984-003-10",
      "PackageDescription": "100 CLOTH in 1 PACKAGE (67984-003-10) ",
      "NDC11Code": "67984-0003-10",
      "ProductNDC": "67984-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanitizing Wipes",
      "NonProprietaryName": "Sanitizing Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200429",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "XIAMEN EASEPAL ENTERPRISES LIMITED",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "291.18",
      "StrengthUnit": "mL/801",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200429",
      "SamplePackage": "N",
      "IndicationAndUsage": "Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in."
    },
    {
      "NDCCode": "69539-119-26",
      "PackageDescription": "3 BOTTLE in 1 CARTON (69539-119-26)  / 90 TABLET, FILM COATED in 1 BOTTLE (69539-119-90) ",
      "NDC11Code": "69539-0119-26",
      "ProductNDC": "69539-119",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pirfenidone",
      "NonProprietaryName": "Pirfenidone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220524",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212772",
      "LabelerName": "MSN LABORATORIES PRIVATE LIMITED",
      "SubstanceName": "PIRFENIDONE",
      "StrengthNumber": "267",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220908",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pirfenidone tablet is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
      "Description": "Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as film-coated tablets containing 267 mg and 801 mg pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1­ phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is freely soluble in dichloromethane, methanol, soluble in ethanol and practically insoluble in water. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol) and talc."
    }
  ]
}
                    

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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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    <Status>Deprecated</Status>
    <LastUpdate>2025-03-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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    <IndicationAndUsage>temporarily relieves sinus congestion and pressure. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive . promotes nasal and/or sinus drainage. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies.</IndicationAndUsage>
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  <NDC>
    <NDCCode>10237-801-27</NDCCode>
    <PackageDescription>73 g in 1 CANISTER (10237-801-27)</PackageDescription>
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    <ProductNDC>10237-801</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ultramax Invisible Solid</ProprietaryName>
    <ProprietaryNameSuffix>Antiperspirant Deodorant Unscented</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20030619</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
    <StrengthNumber>19</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-12-24</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
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    <NDCCode>69898-801-27</NDCCode>
    <PackageDescription>1040988 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (69898-801-27) </PackageDescription>
    <NDC11Code>69898-0801-27</NDC11Code>
    <ProductNDC>69898-801</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Premium Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>MD Science Lab LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
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  <NDC>
    <NDCCode>75111-801-27</NDCCode>
    <PackageDescription>100 CLOTH in 1 CANISTER (75111-801-27) </PackageDescription>
    <NDC11Code>75111-0801-27</NDC11Code>
    <ProductNDC>75111-801</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ipa Cleaning Wipe</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Enping Jiaxin Daily Necessities Co., Ltd.</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>1/1001</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>IPA Cleaning Wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>78517-801-27</NDCCode>
    <PackageDescription>1040988.2 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (78517-801-27) </PackageDescription>
    <NDC11Code>78517-0801-27</NDC11Code>
    <ProductNDC>78517-801</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pyroxy Liquid-80b</ProprietaryName>
    <NonProprietaryName>Alcohol 80%</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Pyrock Chemical</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>31722-872-27</NDCCode>
    <PackageDescription>3 BOTTLE in 1 CARTON (31722-872-27)  / 90 TABLET, FILM COATED in 1 BOTTLE (31722-872-90) </PackageDescription>
    <NDC11Code>31722-0872-27</NDC11Code>
    <ProductNDC>31722-872</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220921</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212674</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
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  <NDC>
    <NDCCode>42291-491-27</NDCCode>
    <PackageDescription>3 BOTTLE in 1 CARTON (42291-491-27)  / 90 TABLET, FILM COATED in 1 BOTTLE (42291-491-09) </PackageDescription>
    <NDC11Code>42291-0491-27</NDC11Code>
    <ProductNDC>42291-491</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212570</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C 12H 11NO and a molecular weight of 185.22 g/mol. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenylpyridin-2-one. Pirfenidone is a white to pale yellow, non-hygroscopic, crystalline powder. It is sparingly soluble in water, freely soluble in ethanol (96%), and slightly soluble in heptane. The melting point range is 107°C to 111°C. Pirfenidone Tablets are available for oral administration, each pirfenidone tablet contains pirfenidone, 267 mg or 801 mg, as active ingredient and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferrosoferric oxide (801 mg), hypromellose, iron oxide red (801 mg), iron oxide yellow (267 mg), lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-801-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42385-801-30) </PackageDescription>
    <NDC11Code>42385-0801-30</NDC11Code>
    <ProductNDC>42385-801</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Emtricitabine, Rilpivirine And Tenofovir Disoproxil Fumarate</ProprietaryName>
    <NonProprietaryName>Emtricitabine, Rilpivirine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260305</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA220232</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
    <StrengthNumber>200; 25; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260305</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg.       as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or.       to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets [see Microbiology (12.4) and Clinical Studies (14)]. Limitations of Use:       More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are a fixed-dose combination tablet containing FTC, rilpivirine hydrochloride, and TDF. Emtricitabine, USP (FTC) is a synthetic nucleoside analog of cytidine. Rilpivirine (RPV) is a non-nucleoside reverse transcriptase inhibitor. Tenofovir disoproxil fumarate (TDF) is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are for oral administration. Each tablet contains 200 mg of FTC, 27.5 mg of rilpivirine hydrochloride (equivalent to 25 mg of RPV), and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone K30. The tablets are film coated with a coating material containing polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide. Emtricitabine, USP: The chemical name of FTC is 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Emtricitabine, USP is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder. Freely soluble in methanol and water, practically insoluble in dichloromethane. Rilpivirine: RPV is available as the hydrochloride salt. The chemical name for rilpivirine hydrochloride is 4-[[4-[[4-[(E)-2-cyanoethenyl]-2,6-dimethylphenyl]amino]-2- pyrimidinyl]amino]benzonitrile monohydrochloride. Its molecular formula is C22H18N6  HCl and its molecular weight is 402.88. Rilpivirine hydrochloride has the following structural formula. Rilpivirine hydrochloride is a white to off white solid. Rilpivirine hydrochloride is sparingly soluble in dimethylformamide and practically insoluble in water. Tenofovir DF: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). 9-[(R)-2- [[Bis(isopropoxycarbonyl)oxy]methoxy] phosphinyl] methoxy]propyl]adenine Fumarate (1:1). It has a molecular formula of C19H30N5O10P*C4H4O4 and a molecular weight of 635.52. It has the following structural formula. TDF is a white to off-white powder. Freely soluble in Dimethylformamide and soluble in methanol. All dosages are expressed in terms of TDF except where otherwise noted.</Description>
  </NDC>
  <NDC>
    <NDCCode>43593-801-02</NDCCode>
    <PackageDescription>28005 CAPSULE in 1 DRUM (43593-801-02) </PackageDescription>
    <NDC11Code>43593-0801-02</NDC11Code>
    <ProductNDC>43593-801</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Ozanimod Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20200327</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Celgene International Sarl</LabelerName>
    <SubstanceName>OZANIMOD HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.46</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-01-12</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>27-MAR-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>44567-801-10</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (44567-801-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>44567-0801-10</NDC11Code>
    <ProductNDC>44567-801</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
    <NonProprietaryName>Piperacillin Sodium,tazobactam Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20091013</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065523</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
    <StrengthNumber>2; .25</StrengthNumber>
    <StrengthUnit>g/1; g/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Piperacillin and tazobactam for injection, for intravenous use is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor indicated for the treatment of: : 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5)To reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam for injection and other antibacterial drugs, piperacillin and tazobactam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.6).</IndicationAndUsage>
    <Description>Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin.  The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.  The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5.  The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone.  Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylate-4,4-dioxide.  The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3.  The chemical structure of tazobactam sodium is. Piperacillin and Tazobactam for Injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Piperacillin and Tazobactam for Injection, USP is a white to off-white sterile, lyophilized powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials.  This product does not contain excipients or preservatives. : 1 Each Piperacillin and Tazobactam for Injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 gram of tazobactam.  Each vial contains 4.69 mEq (108 mg) of sodium., 2 Each Piperacillin and Tazobactam for Injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 gram of tazobactam.  Each vial contains 7.04 mEq (162 mg) of sodium., 3 Each Piperacillin and Tazobactam for Injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 gram of tazobactam.  Each vial contains 9.39 mEq (216 mg) of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-479-27</NDCCode>
    <PackageDescription>270 TABLET, COATED in 1 BOTTLE (46708-479-27) </PackageDescription>
    <NDC11Code>46708-0479-27</NDC11Code>
    <ProductNDC>46708-479</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220610</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212708</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.22. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white or pale yellow crystalline, non-hygroscopic powder. It is sparingly soluble in water, freely soluble in ethanol (96 percent), slightly soluble in heptane. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: microcrystalline cellulose, povidone,croscarmellose sodium,colloidal silicon dioxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow (267 mg) and ferrosoferric oxide (801 mg), iron oxide red (801 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>51079-801-20</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (51079-801-20)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-801-01) </PackageDescription>
    <NDC11Code>51079-0801-20</NDC11Code>
    <ProductNDC>51079-801</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Tartrate</ProprietaryName>
    <NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19940503</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076704</ApplicationNumber>
    <LabelerName>Mylan Institutional Inc.</LabelerName>
    <SubstanceName>METOPROLOL TARTRATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19940503</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3) .</IndicationAndUsage>
    <Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients:anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&amp;C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&amp;C Blue No. 2 Aluminum Lake, D&amp;C Red No. 27 Aluminum Lake and FD&amp;C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&amp;C Blue No. 2 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>51407-913-27</NDCCode>
    <PackageDescription>270 TABLET in 1 BOTTLE (51407-913-27) </PackageDescription>
    <NDC11Code>51407-0913-27</NDC11Code>
    <ProductNDC>51407-913</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230531</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212709</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C 12H 11NO and a molecular weight of 185.22 g/mol. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1­ phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridinone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is freely soluble in methanol, ethyl alcohol, acetone and chloroform. Sparingly soluble in 1 N hydrochloric acid, water and 0.1 N sodium hydroxide. The melting point is approximately 106°C to 112°C. Pirfenidone tablets, USP contain pirfenidone and the following inactive ingredients: colloidal silicon dioxide, ferric ferrous oxide (801 mg only), ferric oxide red (801 mg only), ferric oxide yellow (267 mg only), hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55444-011-01</NDCCode>
    <PackageDescription>80 CLOTH in 1 PACKET (55444-011-01) </PackageDescription>
    <NDC11Code>55444-0011-01</NDC11Code>
    <ProductNDC>55444-011</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Blue Cedar Alcohol Wipes</ProprietaryName>
    <NonProprietaryName>Disinfecting Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200527</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Anhui Kiwi Biotech Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mL/801</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>open packet, unfold and use as a washcloth. Allow hands to dry without wiping.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55444-012-01</NDCCode>
    <PackageDescription>80 CLOTH in 1 PAIL (55444-012-01) </PackageDescription>
    <NDC11Code>55444-0012-01</NDC11Code>
    <ProductNDC>55444-012</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Blue Cedar Alcohol Wipes</ProprietaryName>
    <NonProprietaryName>Disinfecting Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200527</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Anhui Kiwi Biotech Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mL/801</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>open packet, unfold and use as a washcloth. Allow hands to dry without wiping.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59651-238-27</NDCCode>
    <PackageDescription>3 BOTTLE in 1 CARTON (59651-238-27)  / 90 TABLET in 1 BOTTLE (59651-238-90) </PackageDescription>
    <NDC11Code>59651-0238-27</NDC11Code>
    <ProductNDC>59651-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250811</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212596</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250811</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone Tablets, USP are available as tablets containing 267 mg (yellow) and 801 mg (pink) pirfenidone, USP. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone, USP is a white to pale yellow, crystalline, non-hygroscopic powder. It is sparingly to slightly soluble in water, freely soluble in ethanol (96 %), slightly to very slightly soluble in n-Heptane. The melting point is approximately 109°C. Pirfenidone tablets, USP contain pirfenidone, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, and sodium stearyl fumarate. In addition, 267 mg tablets contains yellow iron oxide and 801 mg tablets contains red iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60687-801-21</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (60687-801-21)  / 1 TABLET in 1 BLISTER PACK (60687-801-11) </PackageDescription>
    <NDC11Code>60687-0801-21</NDC11Code>
    <ProductNDC>60687-801</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240221</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078888</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. , 2 Autonomic hyperactivity Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. , 3 Apprehensive expectation Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. , 4 Vigilance and scanning Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience. .</IndicationAndUsage>
    <Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C 21H 31N 5O 2HCl is represented by the following structural formula:. Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 7.5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 6.85 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet).</Description>
  </NDC>
  <NDC>
    <NDCCode>62007-801-16</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE, PLASTIC (62007-801-16) </PackageDescription>
    <NDC11Code>62007-0801-16</NDC11Code>
    <ProductNDC>62007-801</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pcxx Banana Berry Apf G</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>DENTAL; TOPICAL</RouteName>
    <StartMarketingDate>20190204</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Ross Healthcare Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>27.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62332-479-27</NDCCode>
    <PackageDescription>270 TABLET, COATED in 1 BOTTLE (62332-479-27) </PackageDescription>
    <NDC11Code>62332-0479-27</NDC11Code>
    <ProductNDC>62332-479</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220610</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212708</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.22. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white or pale yellow crystalline, non-hygroscopic powder. It is sparingly soluble in water, freely soluble in ethanol (96 percent), slightly soluble in heptane. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: microcrystalline cellulose, povidone,croscarmellose sodium,colloidal silicon dioxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow (267 mg) and ferrosoferric oxide (801 mg), iron oxide red (801 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>67984-003-01</NDCCode>
    <PackageDescription>80 CLOTH in 1 PACKAGE (67984-003-01) </PackageDescription>
    <NDC11Code>67984-0003-01</NDC11Code>
    <ProductNDC>67984-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sanitizing Wipes</ProprietaryName>
    <NonProprietaryName>Sanitizing Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200429</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>XIAMEN EASEPAL ENTERPRISES LIMITED</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>291.18</StrengthNumber>
    <StrengthUnit>mL/801</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67984-003-02</NDCCode>
    <PackageDescription>10 CLOTH in 1 PACKAGE (67984-003-02) </PackageDescription>
    <NDC11Code>67984-0003-02</NDC11Code>
    <ProductNDC>67984-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sanitizing Wipes</ProprietaryName>
    <NonProprietaryName>Sanitizing Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200429</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>XIAMEN EASEPAL ENTERPRISES LIMITED</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>291.18</StrengthNumber>
    <StrengthUnit>mL/801</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67984-003-03</NDCCode>
    <PackageDescription>20 CLOTH in 1 PACKAGE (67984-003-03) </PackageDescription>
    <NDC11Code>67984-0003-03</NDC11Code>
    <ProductNDC>67984-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sanitizing Wipes</ProprietaryName>
    <NonProprietaryName>Sanitizing Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200429</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>XIAMEN EASEPAL ENTERPRISES LIMITED</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>291.18</StrengthNumber>
    <StrengthUnit>mL/801</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67984-003-04</NDCCode>
    <PackageDescription>30 CLOTH in 1 PACKAGE (67984-003-04) </PackageDescription>
    <NDC11Code>67984-0003-04</NDC11Code>
    <ProductNDC>67984-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sanitizing Wipes</ProprietaryName>
    <NonProprietaryName>Sanitizing Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200429</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>XIAMEN EASEPAL ENTERPRISES LIMITED</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>291.18</StrengthNumber>
    <StrengthUnit>mL/801</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67984-003-05</NDCCode>
    <PackageDescription>40 CLOTH in 1 PACKAGE (67984-003-05) </PackageDescription>
    <NDC11Code>67984-0003-05</NDC11Code>
    <ProductNDC>67984-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sanitizing Wipes</ProprietaryName>
    <NonProprietaryName>Sanitizing Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200429</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>XIAMEN EASEPAL ENTERPRISES LIMITED</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>291.18</StrengthNumber>
    <StrengthUnit>mL/801</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67984-003-06</NDCCode>
    <PackageDescription>50 CLOTH in 1 PACKAGE (67984-003-06) </PackageDescription>
    <NDC11Code>67984-0003-06</NDC11Code>
    <ProductNDC>67984-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sanitizing Wipes</ProprietaryName>
    <NonProprietaryName>Sanitizing Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200429</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>XIAMEN EASEPAL ENTERPRISES LIMITED</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>291.18</StrengthNumber>
    <StrengthUnit>mL/801</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67984-003-07</NDCCode>
    <PackageDescription>60 CLOTH in 1 PACKAGE (67984-003-07) </PackageDescription>
    <NDC11Code>67984-0003-07</NDC11Code>
    <ProductNDC>67984-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sanitizing Wipes</ProprietaryName>
    <NonProprietaryName>Sanitizing Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200429</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>XIAMEN EASEPAL ENTERPRISES LIMITED</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>291.18</StrengthNumber>
    <StrengthUnit>mL/801</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67984-003-08</NDCCode>
    <PackageDescription>70 CLOTH in 1 PACKAGE (67984-003-08) </PackageDescription>
    <NDC11Code>67984-0003-08</NDC11Code>
    <ProductNDC>67984-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sanitizing Wipes</ProprietaryName>
    <NonProprietaryName>Sanitizing Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200429</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>XIAMEN EASEPAL ENTERPRISES LIMITED</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>291.18</StrengthNumber>
    <StrengthUnit>mL/801</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67984-003-09</NDCCode>
    <PackageDescription>90 CLOTH in 1 PACKAGE (67984-003-09) </PackageDescription>
    <NDC11Code>67984-0003-09</NDC11Code>
    <ProductNDC>67984-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sanitizing Wipes</ProprietaryName>
    <NonProprietaryName>Sanitizing Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200429</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>XIAMEN EASEPAL ENTERPRISES LIMITED</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>291.18</StrengthNumber>
    <StrengthUnit>mL/801</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67984-003-10</NDCCode>
    <PackageDescription>100 CLOTH in 1 PACKAGE (67984-003-10) </PackageDescription>
    <NDC11Code>67984-0003-10</NDC11Code>
    <ProductNDC>67984-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sanitizing Wipes</ProprietaryName>
    <NonProprietaryName>Sanitizing Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200429</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>XIAMEN EASEPAL ENTERPRISES LIMITED</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>291.18</StrengthNumber>
    <StrengthUnit>mL/801</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Peel back flap on front to pul out a towelette and wipe away. Reseal the flap to keep moisture sealed in.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69539-119-26</NDCCode>
    <PackageDescription>3 BOTTLE in 1 CARTON (69539-119-26)  / 90 TABLET, FILM COATED in 1 BOTTLE (69539-119-90) </PackageDescription>
    <NDC11Code>69539-0119-26</NDC11Code>
    <ProductNDC>69539-119</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212772</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220908</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablet is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as film-coated tablets containing 267 mg and 801 mg pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1­ phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is freely soluble in dichloromethane, methanol, soluble in ethanol and practically insoluble in water. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol) and talc.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>63868-801-27</NDCCode><ProprietaryName>Mucus Relief D Sinus Congestion</ProprietaryName><NonProprietaryName>Guaifenesin, Pseudoephedrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>10237-801-27</NDCCode><ProprietaryName>Ultramax Invisible Solid</ProprietaryName><NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName></NDC><NDC><NDCCode>69898-801-27</NDCCode><ProprietaryName>Premium Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>75111-801-27</NDCCode><ProprietaryName>Ipa Cleaning Wipe</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>78517-801-27</NDCCode><ProprietaryName>Pyroxy Liquid-80b</ProprietaryName><NonProprietaryName>Alcohol 80%</NonProprietaryName></NDC><NDC><NDCCode>31722-872-27</NDCCode><ProprietaryName>Pirfenidone</ProprietaryName><NonProprietaryName>Pirfenidone</NonProprietaryName></NDC><NDC><NDCCode>42291-491-27</NDCCode><ProprietaryName>Pirfenidone</ProprietaryName><NonProprietaryName>Pirfenidone</NonProprietaryName></NDC><NDC><NDCCode>42385-801-30</NDCCode><ProprietaryName>Emtricitabine, Rilpivirine And Tenofovir Disoproxil Fumarate</ProprietaryName><NonProprietaryName>Emtricitabine, Rilpivirine And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>43593-801-02</NDCCode><NonProprietaryName>Ozanimod Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>44567-801-10</NDCCode><ProprietaryName>Piperacillin And Tazobactam</ProprietaryName><NonProprietaryName>Piperacillin Sodium,tazobactam Sodium</NonProprietaryName></NDC><NDC><NDCCode>46708-479-27</NDCCode><ProprietaryName>Pirfenidone</ProprietaryName><NonProprietaryName>Pirfenidone</NonProprietaryName></NDC><NDC><NDCCode>51079-801-20</NDCCode><ProprietaryName>Metoprolol Tartrate</ProprietaryName><NonProprietaryName>Metoprolol Tartrate</NonProprietaryName></NDC><NDC><NDCCode>51407-913-27</NDCCode><ProprietaryName>Pirfenidone</ProprietaryName><NonProprietaryName>Pirfenidone</NonProprietaryName></NDC><NDC><NDCCode>55444-011-01</NDCCode><ProprietaryName>Blue Cedar Alcohol Wipes</ProprietaryName><NonProprietaryName>Disinfecting Wipes</NonProprietaryName></NDC><NDC><NDCCode>55444-012-01</NDCCode><ProprietaryName>Blue Cedar Alcohol Wipes</ProprietaryName><NonProprietaryName>Disinfecting Wipes</NonProprietaryName></NDC><NDC><NDCCode>59651-238-27</NDCCode><ProprietaryName>Pirfenidone</ProprietaryName><NonProprietaryName>Pirfenidone</NonProprietaryName></NDC><NDC><NDCCode>60687-801-21</NDCCode><ProprietaryName>Buspirone Hydrochloride</ProprietaryName><NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>62007-801-16</NDCCode><ProprietaryName>Pcxx Banana Berry Apf G</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>62332-479-27</NDCCode><ProprietaryName>Pirfenidone</ProprietaryName><NonProprietaryName>Pirfenidone</NonProprietaryName></NDC><NDC><NDCCode>67984-003-01</NDCCode><ProprietaryName>Sanitizing Wipes</ProprietaryName><NonProprietaryName>Sanitizing Wipes</NonProprietaryName></NDC><NDC><NDCCode>67984-003-02</NDCCode><ProprietaryName>Sanitizing Wipes</ProprietaryName><NonProprietaryName>Sanitizing Wipes</NonProprietaryName></NDC><NDC><NDCCode>67984-003-03</NDCCode><ProprietaryName>Sanitizing Wipes</ProprietaryName><NonProprietaryName>Sanitizing Wipes</NonProprietaryName></NDC><NDC><NDCCode>67984-003-04</NDCCode><ProprietaryName>Sanitizing Wipes</ProprietaryName><NonProprietaryName>Sanitizing Wipes</NonProprietaryName></NDC><NDC><NDCCode>67984-003-05</NDCCode><ProprietaryName>Sanitizing Wipes</ProprietaryName><NonProprietaryName>Sanitizing Wipes</NonProprietaryName></NDC><NDC><NDCCode>67984-003-06</NDCCode><ProprietaryName>Sanitizing Wipes</ProprietaryName><NonProprietaryName>Sanitizing Wipes</NonProprietaryName></NDC><NDC><NDCCode>67984-003-07</NDCCode><ProprietaryName>Sanitizing Wipes</ProprietaryName><NonProprietaryName>Sanitizing Wipes</NonProprietaryName></NDC><NDC><NDCCode>67984-003-08</NDCCode><ProprietaryName>Sanitizing Wipes</ProprietaryName><NonProprietaryName>Sanitizing Wipes</NonProprietaryName></NDC><NDC><NDCCode>67984-003-09</NDCCode><ProprietaryName>Sanitizing Wipes</ProprietaryName><NonProprietaryName>Sanitizing Wipes</NonProprietaryName></NDC><NDC><NDCCode>67984-003-10</NDCCode><ProprietaryName>Sanitizing Wipes</ProprietaryName><NonProprietaryName>Sanitizing Wipes</NonProprietaryName></NDC><NDC><NDCCode>69539-119-26</NDCCode><ProprietaryName>Pirfenidone</ProprietaryName><NonProprietaryName>Pirfenidone</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

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

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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