RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "80425-0140-2",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0140-2) ",
      "NDC11Code": "80425-0140-02",
      "ProductNDC": "80425-0140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Etodolac",
      "NonProprietaryName": "Etodolac",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180611",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208834",
      "LabelerName": "Advanced Rx Pharmacy of Tennessee, LLC",
      "SubstanceName": "ETODOLAC",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180611",
      "SamplePackage": "N",
      "IndicationAndUsage": "INDICATIONS AND USAGE. Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac tablets are indicated. For acute and long-term use in the management of signs and symptoms of the following. Osteoarthritis Rheumatoid arthritis. For the management of acute pain.",
      "Description": "Etodolac is member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac, USP for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac, USP is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17 H21 NO3, and it has the following structural formula. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. Each 400 mg tablet also contains iron oxide red and iron oxide yellow. Each 500 mg tablet also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake."
    },
    {
      "NDCCode": "0924-0140-01",
      "PackageDescription": "50 PACKET in 1 CARTON (0924-0140-01)  > 2 TABLET, FILM COATED in 1 PACKET",
      "NDC11Code": "00924-0140-01",
      "ProductNDC": "0924-0140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Physicianscare Cold And Cough",
      "ProprietaryNameSuffix": "Non-drowsy",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120128",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Acme United Corporation",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 15; 200; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-05-02"
    },
    {
      "NDCCode": "0924-0140-03",
      "PackageDescription": "10 PACKET in 1 CARTON (0924-0140-03)  > 2 TABLET, FILM COATED in 1 PACKET",
      "NDC11Code": "00924-0140-03",
      "ProductNDC": "0924-0140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Physicianscare Cold And Cough",
      "ProprietaryNameSuffix": "Non-drowsy",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120128",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Acme United Corporation",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 15; 200; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-05-02"
    },
    {
      "NDCCode": "15631-0140-2",
      "PackageDescription": "400 PELLET in 1 PACKAGE (15631-0140-2) ",
      "NDC11Code": "15631-0140-02",
      "ProductNDC": "15631-0140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cinnamomum",
      "NonProprietaryName": "Cinnamomum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151002",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "CINNAMON",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "20890-0140-2",
      "PackageDescription": "946 mL in 1 BOTTLE, PLASTIC (20890-0140-2) ",
      "NDC11Code": "20890-0140-02",
      "ProductNDC": "20890-0140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare Antibacterial Complete Foaming Hand",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160801",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Abaco Partners LLC DBA Surefil",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "13",
      "StrengthUnit": "mg/10mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20160801",
      "SamplePackage": "N",
      "IndicationAndUsage": "for handwashing, reduces germs on the skin."
    },
    {
      "NDCCode": "37662-0140-2",
      "PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-0140-2) ",
      "NDC11Code": "37662-0140-02",
      "ProductNDC": "37662-0140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Calcarea Sulphurica",
      "NonProprietaryName": "Calcarea Sulphurica",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220525",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "CALCIUM SULFATE ANHYDROUS",
      "StrengthNumber": "500",
      "StrengthUnit": "[hp_C]/1",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2022-05-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220525",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49288-0140-1",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0140-1)",
      "NDC11Code": "49288-0140-01",
      "ProductNDC": "49288-0140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cocklebur",
      "NonProprietaryName": "Cocklebur",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "XANTHIUM STRUMARIUM POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0140-2",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0140-2)",
      "NDC11Code": "49288-0140-02",
      "ProductNDC": "49288-0140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cocklebur",
      "NonProprietaryName": "Cocklebur",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "XANTHIUM STRUMARIUM POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "50332-0140-4",
      "PackageDescription": "40 PACKET in 1 BOX (50332-0140-4)  / 2 TABLET, FILM COATED in 1 PACKET",
      "NDC11Code": "50332-0140-04",
      "ProductNDC": "50332-0140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Backprin",
      "NonProprietaryName": "Magnesium Salicylate Tetrahydrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230109",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M",
      "LabelerName": "HART Health",
      "SubstanceName": "MAGNESIUM SALICYLATE",
      "StrengthNumber": "580",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230109",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. Temporarily relieves minor back pain."
    },
    {
      "NDCCode": "50332-0140-7",
      "PackageDescription": "100 PACKET in 1 BOX (50332-0140-7)  / 2 TABLET, FILM COATED in 1 PACKET",
      "NDC11Code": "50332-0140-07",
      "ProductNDC": "50332-0140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Backprin",
      "NonProprietaryName": "Magnesium Salicylate Tetrahydrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230109",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M",
      "LabelerName": "HART Health",
      "SubstanceName": "MAGNESIUM SALICYLATE",
      "StrengthNumber": "580",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230109",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. Temporarily relieves minor back pain."
    },
    {
      "NDCCode": "51532-0140-2",
      "PackageDescription": "2 TABLET in 1 PACKET (51532-0140-2) ",
      "NDC11Code": "51532-0140-02",
      "ProductNDC": "51532-0140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fedrin",
      "NonProprietaryName": "Acetaminophen, Phenylephrine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161025",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Afassco Inc.",
      "SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "500; 5",
      "StrengthUnit": "1/1; 1/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20161025",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. For temporary relief of nasal congestion associated with sinusitis. Temporarily relieves headache and sinus pain."
    },
    {
      "NDCCode": "57955-0140-2",
      "PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0140-2)",
      "NDC11Code": "57955-0140-02",
      "ProductNDC": "57955-0140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nosebleed Relief",
      "NonProprietaryName": "Ambrosia Artemisiaefolia, Arnica Montana, Bovista, Bryonia, Carbo Vegetabilis, Ferrum Phosporicum, Hamamelis Virginian, Ipecacuanha, Mercurius Vivus, Nitricum Acidum, Phosphorus, Trillium Pendulum",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121018",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "King Bio Inc.",
      "SubstanceName": "AMBROSIA ARTEMISIIFOLIA; ARNICA MONTANA; LYCOPERDON UTRIFORME FRUITING BODY; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; FERROSOFERRIC PHOSPHATE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; IPECAC; MERCURY; NITRIC ACID; PHOSPHORUS; TRILLIUM ERECTUM ROOT",
      "StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
      "StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Uses for temporary relief of nosebleeds commonly associated with irritations or strains, colds, coughing, sneezing or menses. Also for nightime nosebleeds. ​."
    },
    {
      "NDCCode": "58468-0140-1",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (58468-0140-1)  > 1.2 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "58468-0140-01",
      "ProductNDC": "58468-0140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mozobil",
      "NonProprietaryName": "Plerixafor",
      "DosageFormName": "SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20081215",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022311",
      "LabelerName": "Genzyme Corporation",
      "SubstanceName": "PLERIXAFOR",
      "StrengthNumber": "24",
      "StrengthUnit": "mg/1.2mL",
      "Pharm_Classes": "Hematopoietic Stem Cell Mobilizer [EPC],Increased Hematopoietic Stem Cell Mobilization [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2018-04-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "67296-0140-2",
      "PackageDescription": "30 TABLET in 1 BOTTLE (67296-0140-2) ",
      "NDC11Code": "67296-0140-02",
      "ProductNDC": "67296-0140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19871101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA085162",
      "LabelerName": "RedPharm Drug Inc.",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20110624",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic diseases: pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory diseases: symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic disorders: idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Nervous system: acute exacerbations of multiple sclerosis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.",
      "Description": "Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone Tablets USP 20 mg also contain FD and C Yellow No. 6."
    },
    {
      "NDCCode": "70518-0140-2",
      "PackageDescription": "180 TABLET in 1 BOTTLE, PLASTIC (70518-0140-2) ",
      "NDC11Code": "70518-0140-02",
      "ProductNDC": "70518-0140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077662",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "800",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-03-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20170125",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71335-0140-2",
      "PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0140-2) ",
      "NDC11Code": "71335-0140-02",
      "ProductNDC": "71335-0140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077336",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20220120",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride USP, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets, USP 500 mg contain the inactive ingredients xanthan gum, hypromellose, sodium carbonate, povidone, talc, colloidal silicon dioxide and magnesium stearate. Metformin hydrochloride extended-release tablets, USP 750 mg contain the inactive ingredients xanthan gum, hypromellose, sodium carbonate, povidone, talc, colloidal silicon dioxide, magnesium stearate and ferric oxide (red). Metformin hydrochloride extended-release tablets meet USP dissolution test 10."
    },
    {
      "NDCCode": "71858-0140-1",
      "PackageDescription": "2 POUCH in 1 CARTON (71858-0140-1)  / 5 AMPULE in 1 POUCH (71858-0140-4)  / 1 mL in 1 AMPULE (71858-0140-6) ",
      "NDC11Code": "71858-0140-01",
      "ProductNDC": "71858-0140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tirosint",
      "ProprietaryNameSuffix": "Sol",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190301",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA206977",
      "LabelerName": "IBSA Pharma Inc.",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": "125",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190301",
      "EndMarketingDatePackage": "20260131",
      "SamplePackage": "Y",
      "IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
      "Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
    },
    {
      "NDCCode": "71858-0140-2",
      "PackageDescription": "6 POUCH in 1 CARTON (71858-0140-2)  / 5 AMPULE in 1 POUCH (71858-0140-4)  / 1 mL in 1 AMPULE (71858-0140-6) ",
      "NDC11Code": "71858-0140-02",
      "ProductNDC": "71858-0140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tirosint",
      "ProprietaryNameSuffix": "Sol",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190301",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA206977",
      "LabelerName": "IBSA Pharma Inc.",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": "125",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250725",
      "SamplePackage": "Y",
      "IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
      "Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
    },
    {
      "NDCCode": "73923-0140-2",
      "PackageDescription": "850 g in 1 CONTAINER (73923-0140-2) ",
      "NDC11Code": "73923-0140-02",
      "ProductNDC": "73923-0140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Safever Hand Sanitizing Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201001",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "FIRSTCHAM CO., LTD",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20201001",
      "SamplePackage": "N",
      "IndicationAndUsage": "■ Instant hand antiseptic to decrease bacteria on the skin."
    },
    {
      "NDCCode": "76002-0140-2",
      "PackageDescription": "1 BAG in 1 DRUM (76002-0140-2)  / 20 kg in 1 BAG (76002-0140-1) ",
      "NDC11Code": "76002-0140-02",
      "ProductNDC": "76002-0140",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "StartMarketingDate": "20180718",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Miyoshi America, Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": ".96",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-04-06",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "18-JUL-18"
    },
    {
      "NDCCode": "77382-0140-2",
      "PackageDescription": "25 kg in 1 DRUM (77382-0140-2) ",
      "NDC11Code": "77382-0140-02",
      "ProductNDC": "77382-0140",
      "ProductTypeName": "BULK INGREDIENT - ANIMAL DRUG",
      "NonProprietaryName": "Progesterone",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19980514",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Chemo Biosynthesis s.r.l.",
      "SubstanceName": "PROGESTERONE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "14-MAY-98"
    },
    {
      "NDCCode": "81238-0140-1",
      "PackageDescription": "50 PACKET in 1 BOX (81238-0140-1)  > 2 TABLET in 1 PACKET",
      "NDC11Code": "81238-0140-01",
      "ProductNDC": "81238-0140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aramark Fedrin",
      "NonProprietaryName": "Acetaminophen, Phenylephrine Hcl",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210507",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Western First Aid Safety DBA Aramark",
      "SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "500; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210507",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "81238-0140-2",
      "PackageDescription": "125 PACKET in 1 BOX (81238-0140-2)  > 2 TABLET in 1 PACKET",
      "NDC11Code": "81238-0140-02",
      "ProductNDC": "81238-0140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aramark Fedrin",
      "NonProprietaryName": "Acetaminophen, Phenylephrine Hcl",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210507",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Western First Aid Safety DBA Aramark",
      "SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "500; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210507",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "80425-0003-2",
      "PackageDescription": "20 TABLET in 1 BOTTLE (80425-0003-2) ",
      "NDC11Code": "80425-0003-02",
      "ProductNDC": "80425-0003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "ProprietaryNameSuffix": "Ds",
      "NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100216",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090624",
      "LabelerName": "Advanced Rx Pharmacy of Tennessee, LLC",
      "SubstanceName": "TRIMETHOPRIM; SULFAMETHOXAZOLE",
      "StrengthNumber": "160; 800",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100216",
      "SamplePackage": "N",
      "IndicationAndUsage": "INDICATIONS AND USAGE. To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim tablets offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim tablets could offer some advantage over the use of a single antimicrobial agent. Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia: For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler’s Diarrhea in Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
      "Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
    },
    {
      "NDCCode": "80425-0004-2",
      "PackageDescription": "40 CAPSULE in 1 BOTTLE (80425-0004-2) ",
      "NDC11Code": "80425-0004-02",
      "ProductNDC": "80425-0004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220914",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065253",
      "LabelerName": "ADVANCED RX PHARMACY OF TENNESSEE, LLC",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2024-03-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220914",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.1 Respiratory Tract Infections. Cephalexin capsules are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 1.2 Otitis Media. Cephalexin capsules are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. 1.3 Skin and Skin Structure Infections. Cephalexin capsules are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes. 1.4 Bone Infections. Cephalexin capsules are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. 1.5 Genitourinary Tract Infections. Cephalexin capsules are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. 1.6 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and other antibacterial drugs, cephalexin capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, gelatin, magnesium stearate, titanium dioxide, and sodium lauryl sulfate."
    },
    {
      "NDCCode": "80425-0005-2",
      "PackageDescription": "40 CAPSULE in 1 BOTTLE (80425-0005-2) ",
      "NDC11Code": "80425-0005-02",
      "ProductNDC": "80425-0005",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065229",
      "LabelerName": "ADVANCED RX PHARMACY OF TENNESSEE, LLC",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2024-01-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20060111",
      "SamplePackage": "N",
      "IndicationAndUsage": "1 INDICATIONS AND USAGE. 1.1 Respiratory Tract Infections. Cephalexin capsules USP are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 1.2 Otitis Media. Cephalexin capsules USP are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. 1.3 Skin and Skin Structure Infections. Cephalexin capsules USP are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes. 1.4 Bone Infections. Cephalexin capsules USP are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. 1.5 Genitourinary Tract Infections. Cephalexin capsules USP are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. 1.6 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules USP and other antibacterial drugs, cephalexin capsules USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Cephalexin capsules USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7- (D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. Each capsule contains cephalexin USP equivalent to 250 mg, or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&C Yellow 10, FD&C Blue 1, FD&C Green 3, FD&C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide."
    },
    {
      "NDCCode": "80425-0006-2",
      "PackageDescription": "40 CAPSULE in 1 BOTTLE (80425-0006-2) ",
      "NDC11Code": "80425-0006-02",
      "ProductNDC": "80425-0006",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065229",
      "LabelerName": "ADVANCED RX PHARMACY OF TENNESSEE, LLC",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20060111",
      "SamplePackage": "N",
      "IndicationAndUsage": "1 INDICATIONS AND USAGE. 1.1 Respiratory Tract Infections. Cephalexin capsules USP are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 1.2 Otitis Media. Cephalexin capsules USP are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. 1.3 Skin and Skin Structure Infections. Cephalexin capsules USP are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes. 1.4 Bone Infections. Cephalexin capsules USP are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. 1.5 Genitourinary Tract Infections. Cephalexin capsules USP are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. 1.6 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules USP and other antibacterial drugs, cephalexin capsules USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Cephalexin capsules USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7- (D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. Each capsule contains cephalexin USP equivalent to 250 mg, or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&C Yellow 10, FD&C Blue 1, FD&C Green 3, FD&C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide."
    },
    {
      "NDCCode": "80425-0007-2",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0007-2) ",
      "NDC11Code": "80425-0007-02",
      "ProductNDC": "80425-0007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150119",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202801",
      "LabelerName": "ADVANCED RX PHARMACY OF TENNESSEE, LLC",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150119",
      "SamplePackage": "N",
      "IndicationAndUsage": "1 INDICATIONS & USAGE. 1.1 Nosocomial Pneumonia. Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli,Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)]. MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.3)]. 1.4 Complicated Skin and Skin Structure Infections. Levofloxacin tablets are indicated in adult patients for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)]. 1.5 Uncomplicated Skin and Skin Structure Infections. Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes. 1.6 Chronic Bacterial Prostatitis. Levofloxacin tablets are indicated in adult patients for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)]. 1.7 Inhalational Anthrax (Post-Exposure). Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis in adults and pediatric patients, 6 months of age and older [see Dosage and Administration (2.2)].The effectiveness of levofloxacin tablets is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablets have not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk [see Clinical Studies (14.9)]. 1.8 Plague. Levofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older [see Dosage and Administration (2.2)]. Efficacy studies of levofloxacin tablets could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Clinical Studies (14.10)]. 1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)]. 1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)]. 1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies (14.7, 14.8)]. 1.12 Uncomplicated Urinary Tract Infections. Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. Because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5.1to 5.15)] and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment. options. 1.13 Acute Bacterial Exacerbation of Chronic Bronchitis. Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. Because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5.1to 5.15)] and for some patients ABECB is self-limiting, reserve levofloxacin tablets for treatment of ABECB in patients who have no alternative treatment options. 1.14 Acute Bacterial Sinusitis: 5-day and 10 to 14 day Treatment Regimens. Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)]. Because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5.1to 5.15)] and for some patients ABS is self-limiting, reserve levofloxacin tablets for treatment of ABS in patients who have no alternative treatment options. 1.15 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4)] . Therapy with levofloxacin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.",
      "Description": "Levofloxacin tablets, USP are synthetic antibacterial agents for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin, USP. The molecular formula is C18H20FN3O4  1⁄2 H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish-white to yellow-white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin, USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Levofloxacin Tablets, USP are available as film-coated tablets and contain the following inactive ingredients:  250 mg: croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide.  500 mg: croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide.  750 mg: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Levofloxacin tablets, USP meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "80425-0008-2",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0008-2) ",
      "NDC11Code": "80425-0008-02",
      "ProductNDC": "80425-0008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110620",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201043",
      "LabelerName": "Advanced Rx of Tennessee, LLC",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110620",
      "SamplePackage": "N",
      "IndicationAndUsage": "1 INDICATIONS AND USAGE. 1.1 Nosocomial Pneumonia. Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see CLINICAL STUDIES (14.1)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see DOSAGE AND ADMINISTRATION (2.1) and CLINICAL STUDIES (14.2)]. MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see DOSAGE AND ADMINISTRATION (2.1) and CLINICAL STUDIES (14.3)]. 1.4 Complicated Skin and Skin Structure Infections. Levofloxacin tablets are indicated in adult patients for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see CLINICAL STUDIES (14.5)]. 1.5 Uncomplicated Skin and Skin Structure Infections. Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes. 1.6 Chronic Bacterial Prostatitis. Levofloxacin tablets are indicated in adult patients for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see CLINICAL STUDIES (14.6)]. 1.7 Inhalational Anthrax (Post-Exposure). Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis in adults and pediatric patients, 6 months of age and older [see DOSAGE AND ADMINISTRATION (2.2)]. The effectiveness of levofloxacin tablets is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablets have not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk [see CLINICAL STUDIES (14.9)]. 1.8 Plague. Levofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older [see DOSAGE AND ADMINISTRATION (2.2)]. Efficacy studies of levofloxacin tablets could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see CLINICAL STUDIES (14.10)]. 1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see CLINICAL STUDIES (14.7)]. 1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see CLINICAL STUDIES (14.8)]. 1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see CLINICAL STUDIES (14.7, 14.8)]. 1.12 Uncomplicated Urinary Tract Infections. Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. Because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see WARNINGS AND PRECAUTIONS (5.1 TO 5.15)] and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin tablets for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options. 1.13 Acute Bacterial Exacerbation of Chronic Bronchitis. Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. Because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see WARNINGS AND PRECAUTIONS (5.1 TO 5.15)] and for some patients ABECB is self-limiting, reserve levofloxacin tablets for treatment of ABECB in patients who have no alternative treatment options. 1.14 Acute Bacterial Sinusitis: 5-day and 10 to 14 day Treatment Regimens. Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see CLINICAL STUDIES (14.4)]. Because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see WARNINGS AND PRECAUTIONS (5.1 TO 5.15)] and for some patients ABS is self-limiting, reserve levofloxacin tablets for treatment of ABS in patients who have no alternative treatment options. 1.15 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Culture and susceptibility testing. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see MICROBIOLOGY (12.4)]. Therapy with levofloxacin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.",
      "Description": "Levofloxacin tablets are synthetic antibacterial agents for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The molecular formula is C18H20FN3O4  ½ H2O and the molecular weight is 370.38. Levofloxacin USP is a pale or bright yellow, crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin USP is essentially constant (approximately 100 mg/mL). Levofloxacin USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Levofloxacin tablets USP are available as film-coated tablets and contain the following inactive ingredients: 250 mg, 500 mg and 750 mg (as expressed in the anhydrous form): croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, and titanium dioxide. In addition 250 mg contains iron oxide red and 500 mg contains iron oxide red and iron oxide yellow. Meets USP dissolution test 4."
    },
    {
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      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0009-2) ",
      "NDC11Code": "80425-0009-02",
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      "ProprietaryName": "Levofloxacin",
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      "RouteName": "ORAL",
      "StartMarketingDate": "20120322",
      "EndMarketingDate": "20250731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200839",
      "LabelerName": "Advanced Rx of Tennessee, LLC",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
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      "SamplePackage": "N",
      "IndicationAndUsage": "1 INDICATIONS & USAGE. 1.1 Nosocomial Pneumonia. Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillinsusceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an antipseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multidrug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)]. MDRSP isolates are strains resistant to two or more of the following antibacterials: penicillin (MIC ≥2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration (2.1)and Clinical Studies (14.3)]. 1.4 Complicated Skin and Skin Structure Infections. Levofloxacin tablets are indicated in adult patients for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)]. 1.5 Uncomplicated Skin and Skin Structure Infections. Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes. 1.6 Chronic Bacterial Prostatitis. Levofloxacin tablets are indicated in adult patients for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)]. 1.7 Inhalational Anthrax (Post-Exposure). Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis in adults and pediatric patients, 6 months of age and older [see Dosage and Administration (2.2)]. . The effectiveness of levofloxacin tablets are based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablets has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk [see Clinical Studies (14.9)]. 1.8 Plague. Levofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older [see Dosage and Administration (2.2)]. Efficacy studies of levofloxacin tablets could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Clinical Studies (14.10)]. 1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)]. 1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)]. 1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen. Levofloxacin tablets are indicated in adult patients for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies (14.7, 14.8)]. 1.12 Uncomplicated Urinary Tract Infections. Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.15)] and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin tablets for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options. 1.13 Acute Bacterial Exacerbation of Chronic Bhronchitis. Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.15)] and for some patients ABECB is self-limiting, reserve levofloxacin tablets, USP for treatment of ABECB in patients who have no alternative treatment options. 1.14 Acute Bacterial Sinusitis: 5-day and 10-14day Treatment Regimens. Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)]. Because fluoroquinolones, including levofloxacin have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.15)] and for some patients ABS is self-limiting, reserve levofloxacin tablets for treatment of ABS in patients who have no alternative treatment options. 1.15 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4)]. Therapy with levofloxacin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.",
      "Description": "Levofloxacin USP are synthetic antibacterial agents for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (--(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Levofloxacin USP is available as film-coated tablets and contain the following inactive ingredients. 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide. 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides. 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80. USP dissolution test 4."
    }
  ]
}
                    

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