RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "76281-558-25",
      "PackageDescription": "177 mL in 1 BOTTLE (76281-558-25) ",
      "NDC11Code": "76281-0558-25",
      "ProductNDC": "76281-558",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Stomach Relief, Maximum Strength",
      "NonProprietaryName": "Bismuth Subsalicylate",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200930",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M008",
      "LabelerName": "AptaPharma Inc.",
      "SubstanceName": "BISMUTH SUBSALICYLATE",
      "StrengthNumber": "1050",
      "StrengthUnit": "mg/30mL",
      "Status": "Active",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200930",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses relieves ■ travelers' diarrhea ■ diarrhea■ upset stomach due to overindulgence of food and drinkincluding: ■ heart burn ■ indigestion ■ nausea ■ gas■ belching."
    },
    {
      "NDCCode": "62157-558-01",
      "PackageDescription": "25 kg in 1 DRUM (62157-558-01)",
      "NDC11Code": "62157-0558-01",
      "ProductNDC": "62157-558",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Streptomycin Sulfate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20180418",
      "MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
      "LabelerName": "AX Pharmaceutical Corp",
      "SubstanceName": "STREPTOMYCIN SULFATE",
      "StrengthNumber": "24.75",
      "StrengthUnit": "kg/25kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "68001-558-55",
      "PackageDescription": "25 TABLET in 1 BOTTLE (68001-558-55) ",
      "NDC11Code": "68001-0558-55",
      "ProductNDC": "68001-558",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylprednisolone",
      "NonProprietaryName": "Methylprednisolone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230131",
      "EndMarketingDate": "20260331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040189",
      "LabelerName": "BluePoint Laboratories",
      "SubstanceName": "METHYLPREDNISOLONE",
      "StrengthNumber": "8",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230131",
      "EndMarketingDatePackage": "20260331",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methylprednisolone Tablets are indicated in the following conditions. 1.Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2.Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Synovitis of osteoarthritis. Acute nonspecific tenosynovitis. Post-traumatic osteoarthritis. Psoriatic arthritis. Epicondylitis. Acute gouty arthritis. 3.Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. 4.Dermatologic Diseases. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Severe seborrheic dermatitis. Exfoliative dermatitis. Mycosis fungoides. Pemphigus. Severe psoriasis. 5.Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Serum sickness. Contact dermatitis. Bronchial asthma. Atopic dermatitis. 6.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. Keratitis. Optic neuritis. Allergic conjunctivitis. Chorioretinitis. Iritis and iridocyclitis. 7.Respiratory Diseases. Symptomatic sarcoidosis. Berylliosis. Loeffler’s syndrome not manageable by other means. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. 8.Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 9.Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10.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. 11.Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. 12.Nervous System. Acute exacerbations of multiple sclerosis. 13.Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.",
      "Description": "Methylprednisolone Tablets, USP contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6- methyl-,(6α,11β)- and the molecular weight is 374.48. The structural formula is represented below. C 22H 30O 5. Methylprednisolone Tablets, USP for oral administration, are available as scored tablets in the following strength: 4 mg, 8 mg, 16 mg, and 32 mg. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous (4 mg and 8 mg), lactose monohydrate (16 mg and 32 mg), magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate."
    },
    {
      "NDCCode": "69733-558-03",
      "PackageDescription": "25 POUCH in 1 PACKAGE (69733-558-03)  > .00297 g in 1 POUCH",
      "NDC11Code": "69733-0558-03",
      "ProductNDC": "69733-558",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Moist Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "SWAB",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150415",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "JIANGSU TERRA MEDICAL TECHNOLOGY CO LTD",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2015-05-15"
    },
    {
      "NDCCode": "76281-306-25",
      "PackageDescription": "177 mL in 1 BOTTLE, PLASTIC (76281-306-25) ",
      "NDC11Code": "76281-0306-25",
      "ProductNDC": "76281-306",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Xl-3 Day Time",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "AptaPharma Inc.",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 10; 5",
      "StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180901",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves common cold and flu symptoms: nasal congestion  cough due to minor throat and bronchialirritation  sore throat  headache  minor aches and pains  fever."
    },
    {
      "NDCCode": "76281-307-25",
      "PackageDescription": "177 mL in 1 BOTTLE (76281-307-25) ",
      "NDC11Code": "76281-0307-25",
      "ProductNDC": "76281-307",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Xl-3 Xtreme",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "AptaPharma Inc.",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
      "StrengthNumber": "650; 30; 12.5",
      "StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
      "Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180901",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves cold/flu symptoms:  sore throatheadache  minor aches and pain  fever  runny nose andsneezing  cough due to minor throat and bronchial irritation."
    },
    {
      "NDCCode": "76281-501-25",
      "PackageDescription": "177 mL in 1 BOTTLE (76281-501-25) ",
      "NDC11Code": "76281-0501-25",
      "ProductNDC": "76281-501",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nite-time",
      "ProprietaryNameSuffix": "Cold/flu Medicine",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180309",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "AptaPharma Inc.",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
      "StrengthNumber": "650; 30; 12.5",
      "StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
      "Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180309",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses temporarily relieves cold/flu symptoms: 1 sore throat, 2 minor aches and pain, 3 runny nose and sneezing, 4 cough due to minor sore throat and bronchial irritation, 5 headache, 6 fever."
    },
    {
      "NDCCode": "76281-502-25",
      "PackageDescription": "177 mL in 1 BOTTLE (76281-502-25) ",
      "NDC11Code": "76281-0502-25",
      "ProductNDC": "76281-502",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nite-time",
      "ProprietaryNameSuffix": "Cold/flu Medicine Cherry",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "AptaPharma Inc.",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
      "StrengthNumber": "650; 30; 12.5",
      "StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
      "Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses temporarily relieves cold/flu symptoms: 1 sore throat   , 2 minor aches and pain, 3 runny nose and sneezing, 4 cough due to minor sore throat and bronchial irritation, 5 headache, 6 fever ."
    },
    {
      "NDCCode": "76281-506-25",
      "PackageDescription": "177 mL in 1 BOTTLE (76281-506-25) ",
      "NDC11Code": "76281-0506-25",
      "ProductNDC": "76281-506",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Day-time Cold/flu Relief",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "AptaPharma Inc.",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 10; 5",
      "StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these common cold/flu symptoms:■ minor aches and pains ■ headache ■ sore throat ■ fever■ nasal congestion ■ cough due to minor throat and bronchial irritation."
    },
    {
      "NDCCode": "76281-515-25",
      "PackageDescription": "177 mL in 1 BOTTLE (76281-515-25) ",
      "NDC11Code": "76281-0515-25",
      "ProductNDC": "76281-515",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Maximum Strength Max Cold And Sinus",
      "NonProprietaryName": "Acetaminophen, Guaifenesin, Phenylephrine Hcl",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240130",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "AptaPharma Inc.",
      "SubstanceName": "ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "650; 400; 10",
      "StrengthUnit": "mg/20mL; mg/20mL; mg/20mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. temporarily relieves these common cold and flu symptoms: nasal congestion sinus congestion and pressure minor aches and pains sore throat headache fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes."
    },
    {
      "NDCCode": "76281-517-25",
      "PackageDescription": "177 mL in 1 BOTTLE (76281-517-25) ",
      "NDC11Code": "76281-0517-25",
      "ProductNDC": "76281-517",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Severe Congestion And Cough Max",
      "NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240130",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "AptaPharma Inc.",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "20; 400; 10",
      "StrengthUnit": "mg/20mL; mg/20mL; mg/20mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses● helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes● temporarily relieves these symptoms occurring with a cold:      ● cough due to minor throat and bronchial irritation      ● nasal congestion."
    },
    {
      "NDCCode": "76281-522-25",
      "PackageDescription": "177 mL in 1 BOTTLE (76281-522-25) ",
      "NDC11Code": "76281-0522-25",
      "ProductNDC": "76281-522",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nighttime Sleep-aid",
      "ProprietaryNameSuffix": "Non-habit Forming",
      "NonProprietaryName": "Diphenhydramine Hci",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "AptaPharma Inc.",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/30mL",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "■ reduces time to fall asleep if you have difficulty falling asleep■ for relief of occasional sleeplessness."
    },
    {
      "NDCCode": "76281-537-25",
      "PackageDescription": "177 mL in 1 BOTTLE (76281-537-25) ",
      "NDC11Code": "76281-0537-25",
      "ProductNDC": "76281-537",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Stomach Relief - Regular Strength",
      "NonProprietaryName": "Bismuth Subsalicylate",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181001",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M008",
      "LabelerName": "AptaPharma Inc.",
      "SubstanceName": "BISMUTH SUBSALICYLATE",
      "StrengthNumber": "525",
      "StrengthUnit": "mg/30mL",
      "Status": "Active",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses relieves ■ travelers' diarrhea ■ diarrhea■ upset stomach due to overindulgence of food and drinkincluding: ■ heart burn ■ indigestion ■ nausea ■ gas■ belching."
    },
    {
      "NDCCode": "76281-315-26",
      "PackageDescription": "237 mL in 1 BOTTLE (76281-315-26) ",
      "NDC11Code": "76281-0315-26",
      "ProductNDC": "76281-315",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Childrens Nighttime Cold And Cough",
      "NonProprietaryName": "Diphenhydramine Hcl, Phenylephrine Hcl",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180801",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "AptaPharma Inc.",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "6.25; 2.5",
      "StrengthUnit": "mg/5mL; mg/5mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20180801",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "76281-603-03",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (76281-603-03)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "76281-0603-03",
      "ProductNDC": "76281-603",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Night Time Cold And Flu Relief Liquid Filled Softgels",
      "NonProprietaryName": "Acetaminophen,dextromethrophan Hbr,doxylamine Succinate",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "AptaPharma Inc.",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
      "StrengthNumber": "325; 15; 6.25",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-05-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260101",
      "SamplePackage": "N",
      "IndicationAndUsage": "UsesTemporarily relieves common cold/flu symptoms."
    },
    {
      "NDCCode": "0093-5002-56",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0093-5002-56) ",
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      "ProductNDC": "0093-5002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202491",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "40; 10; 25",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
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      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets for oral administration are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[2'-(1H-tetrazole-5-yl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4-ylmethyl ester. The amlodipine besylate, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 2-[(2-Amino-ethoxy)methyl]- ]-4-(2-chloro-phenyl)-6-methyl-1,4-dihydro-pyridine-3,5-dicarboxilic acid –3-ethyl ester 5- methyl ester, compound with benzonesulfonic acid. The hydrochlorothiazide, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 6-Chloro-3,4 dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. The structural formula for olmesartan medoxomil, USP is. C29H30N6O6 M.W. 558.59. The structural formula for amlodipine besylate, USP is. C20H25ClN2O5  C6H6O3S M.W. 567.1. The structural formula for hydrochlorothiazide, USP is. C7H8ClN3O4S2 M.W. 297.74. Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets contain olmesartan medoxomil, USP, a white to off-white crystalline powder, amlodipine besylate, USP, a white or almost white powder, and hydrochlorothiazide, USP, a white or practically white, practically odorless crystalline powder. Olmesartan medoxomil, USP is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate, USP is sparingly soluble in ethanol, slightly soluble in water and 2-propanol and freely soluble in methanol. Hydrochlorothiazide, USP is slightly soluble in water, freely soluble in hydroxide solution, in n-butylamine and in dimethylformamide (DMF), sparingly soluble in methanol and insoluble in ether, in chloroform and in dilute mineral acids. Each olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablet also contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol (part hydrolyzed), povidone, silicon dioxide, sodium starch glycolate, talc, and titanium dioxide. In addition:20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, and 40 mg/10 mg/25 mg strengths contain FD&C red #40 aluminum lake and iron oxide black,40 mg/10 mg/12.5 mg and 40 mg/10 mg/25 mg strengths contain FD&C yellow #6 aluminum lake,40 mg/5 mg/12.5 mg and 40 mg/5 mg/25 mg strengths contain D&C yellow #10 aluminum lake,20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg , and 40 mg/5 mg/25 mg strengths contain iron oxide yellow."
    },
    {
      "NDCCode": "0093-5003-56",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0093-5003-56) ",
      "NDC11Code": "00093-5003-56",
      "ProductNDC": "0093-5003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202491",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "40; 10; 12.5",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets for oral administration are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[2'-(1H-tetrazole-5-yl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4-ylmethyl ester. The amlodipine besylate, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 2-[(2-Amino-ethoxy)methyl]- ]-4-(2-chloro-phenyl)-6-methyl-1,4-dihydro-pyridine-3,5-dicarboxilic acid –3-ethyl ester 5- methyl ester, compound with benzonesulfonic acid. The hydrochlorothiazide, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 6-Chloro-3,4 dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. The structural formula for olmesartan medoxomil, USP is. C29H30N6O6 M.W. 558.59. The structural formula for amlodipine besylate, USP is. C20H25ClN2O5  C6H6O3S M.W. 567.1. The structural formula for hydrochlorothiazide, USP is. C7H8ClN3O4S2 M.W. 297.74. Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets contain olmesartan medoxomil, USP, a white to off-white crystalline powder, amlodipine besylate, USP, a white or almost white powder, and hydrochlorothiazide, USP, a white or practically white, practically odorless crystalline powder. Olmesartan medoxomil, USP is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate, USP is sparingly soluble in ethanol, slightly soluble in water and 2-propanol and freely soluble in methanol. Hydrochlorothiazide, USP is slightly soluble in water, freely soluble in hydroxide solution, in n-butylamine and in dimethylformamide (DMF), sparingly soluble in methanol and insoluble in ether, in chloroform and in dilute mineral acids. Each olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablet also contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol (part hydrolyzed), povidone, silicon dioxide, sodium starch glycolate, talc, and titanium dioxide. In addition:20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, and 40 mg/10 mg/25 mg strengths contain FD&C red #40 aluminum lake and iron oxide black,40 mg/10 mg/12.5 mg and 40 mg/10 mg/25 mg strengths contain FD&C yellow #6 aluminum lake,40 mg/5 mg/12.5 mg and 40 mg/5 mg/25 mg strengths contain D&C yellow #10 aluminum lake,20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg , and 40 mg/5 mg/25 mg strengths contain iron oxide yellow."
    },
    {
      "NDCCode": "0093-5004-56",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0093-5004-56) ",
      "NDC11Code": "00093-5004-56",
      "ProductNDC": "0093-5004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202491",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "40; 5; 25",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets for oral administration are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[2'-(1H-tetrazole-5-yl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4-ylmethyl ester. The amlodipine besylate, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 2-[(2-Amino-ethoxy)methyl]- ]-4-(2-chloro-phenyl)-6-methyl-1,4-dihydro-pyridine-3,5-dicarboxilic acid –3-ethyl ester 5- methyl ester, compound with benzonesulfonic acid. The hydrochlorothiazide, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 6-Chloro-3,4 dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. The structural formula for olmesartan medoxomil, USP is. C29H30N6O6 M.W. 558.59. The structural formula for amlodipine besylate, USP is. C20H25ClN2O5  C6H6O3S M.W. 567.1. The structural formula for hydrochlorothiazide, USP is. C7H8ClN3O4S2 M.W. 297.74. Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets contain olmesartan medoxomil, USP, a white to off-white crystalline powder, amlodipine besylate, USP, a white or almost white powder, and hydrochlorothiazide, USP, a white or practically white, practically odorless crystalline powder. Olmesartan medoxomil, USP is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate, USP is sparingly soluble in ethanol, slightly soluble in water and 2-propanol and freely soluble in methanol. Hydrochlorothiazide, USP is slightly soluble in water, freely soluble in hydroxide solution, in n-butylamine and in dimethylformamide (DMF), sparingly soluble in methanol and insoluble in ether, in chloroform and in dilute mineral acids. Each olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablet also contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol (part hydrolyzed), povidone, silicon dioxide, sodium starch glycolate, talc, and titanium dioxide. In addition:20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, and 40 mg/10 mg/25 mg strengths contain FD&C red #40 aluminum lake and iron oxide black,40 mg/10 mg/12.5 mg and 40 mg/10 mg/25 mg strengths contain FD&C yellow #6 aluminum lake,40 mg/5 mg/12.5 mg and 40 mg/5 mg/25 mg strengths contain D&C yellow #10 aluminum lake,20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg , and 40 mg/5 mg/25 mg strengths contain iron oxide yellow."
    },
    {
      "NDCCode": "0093-5005-56",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0093-5005-56) ",
      "NDC11Code": "00093-5005-56",
      "ProductNDC": "0093-5005",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202491",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 5; 12.5",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
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      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161114",
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      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets for oral administration are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[2'-(1H-tetrazole-5-yl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4-ylmethyl ester. The amlodipine besylate, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 2-[(2-Amino-ethoxy)methyl]- ]-4-(2-chloro-phenyl)-6-methyl-1,4-dihydro-pyridine-3,5-dicarboxilic acid –3-ethyl ester 5- methyl ester, compound with benzonesulfonic acid. The hydrochlorothiazide, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 6-Chloro-3,4 dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. The structural formula for olmesartan medoxomil, USP is. C29H30N6O6 M.W. 558.59. The structural formula for amlodipine besylate, USP is. C20H25ClN2O5  C6H6O3S M.W. 567.1. The structural formula for hydrochlorothiazide, USP is. C7H8ClN3O4S2 M.W. 297.74. Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets contain olmesartan medoxomil, USP, a white to off-white crystalline powder, amlodipine besylate, USP, a white or almost white powder, and hydrochlorothiazide, USP, a white or practically white, practically odorless crystalline powder. Olmesartan medoxomil, USP is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate, USP is sparingly soluble in ethanol, slightly soluble in water and 2-propanol and freely soluble in methanol. Hydrochlorothiazide, USP is slightly soluble in water, freely soluble in hydroxide solution, in n-butylamine and in dimethylformamide (DMF), sparingly soluble in methanol and insoluble in ether, in chloroform and in dilute mineral acids. Each olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablet also contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol (part hydrolyzed), povidone, silicon dioxide, sodium starch glycolate, talc, and titanium dioxide. In addition:20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, and 40 mg/10 mg/25 mg strengths contain FD&C red #40 aluminum lake and iron oxide black,40 mg/10 mg/12.5 mg and 40 mg/10 mg/25 mg strengths contain FD&C yellow #6 aluminum lake,40 mg/5 mg/12.5 mg and 40 mg/5 mg/25 mg strengths contain D&C yellow #10 aluminum lake,20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg , and 40 mg/5 mg/25 mg strengths contain iron oxide yellow."
    },
    {
      "NDCCode": "0093-5006-56",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0093-5006-56) ",
      "NDC11Code": "00093-5006-56",
      "ProductNDC": "0093-5006",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202491",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "40; 5; 12.5",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets for oral administration are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[2'-(1H-tetrazole-5-yl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4-ylmethyl ester. The amlodipine besylate, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 2-[(2-Amino-ethoxy)methyl]- ]-4-(2-chloro-phenyl)-6-methyl-1,4-dihydro-pyridine-3,5-dicarboxilic acid –3-ethyl ester 5- methyl ester, compound with benzonesulfonic acid. The hydrochlorothiazide, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 6-Chloro-3,4 dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. The structural formula for olmesartan medoxomil, USP is. C29H30N6O6 M.W. 558.59. The structural formula for amlodipine besylate, USP is. C20H25ClN2O5  C6H6O3S M.W. 567.1. The structural formula for hydrochlorothiazide, USP is. C7H8ClN3O4S2 M.W. 297.74. Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets contain olmesartan medoxomil, USP, a white to off-white crystalline powder, amlodipine besylate, USP, a white or almost white powder, and hydrochlorothiazide, USP, a white or practically white, practically odorless crystalline powder. Olmesartan medoxomil, USP is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate, USP is sparingly soluble in ethanol, slightly soluble in water and 2-propanol and freely soluble in methanol. Hydrochlorothiazide, USP is slightly soluble in water, freely soluble in hydroxide solution, in n-butylamine and in dimethylformamide (DMF), sparingly soluble in methanol and insoluble in ether, in chloroform and in dilute mineral acids. Each olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablet also contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol (part hydrolyzed), povidone, silicon dioxide, sodium starch glycolate, talc, and titanium dioxide. In addition:20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, and 40 mg/10 mg/25 mg strengths contain FD&C red #40 aluminum lake and iron oxide black,40 mg/10 mg/12.5 mg and 40 mg/10 mg/25 mg strengths contain FD&C yellow #6 aluminum lake,40 mg/5 mg/12.5 mg and 40 mg/5 mg/25 mg strengths contain D&C yellow #10 aluminum lake,20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg , and 40 mg/5 mg/25 mg strengths contain iron oxide yellow."
    },
    {
      "NDCCode": "0276-0501-10",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (0276-0501-10) ",
      "NDC11Code": "00276-0501-10",
      "ProductNDC": "0276-0501",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenoprofen Calcium",
      "NonProprietaryName": "Fenoprofen Calcium",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215548",
      "LabelerName": "Misemer Pharmaceuticals, Inc.",
      "SubstanceName": "FENOPROFEN CALCIUM",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231101",
      "SamplePackage": "N",
      "IndicationAndUsage": "FENOPROFEN CALCIUM is indicated for.  Relief of mild to moderate pain in adults  Relief of the signs and symptoms of rheumatoid arthritis  Relief of the signs and symptoms of osteoarthritis.",
      "Description": "Fenoprofen calcium capsules, USP is a nonsteroidal, anti-inflammatory drug available in 200 mg, 300mg and 400 mg capsule form for oral administration. The 200 mg capsule has a Size \"0\" hard gelatin capsules with light Brown opaque cap imprinted with \"FENO 200\" in black and white opaque body imprinted with \"ZN05\" in black, filled with white to off-white granular powder. The 300 mg capsule has a Size \"0el\" hard gelatin capsules with brown opaque cap · imprinted with 'FENO 300' in black and yellow opaque body imprinted with \"ZN07\" in black, filled with white to off-white granular powder. The 400 mg capsule has a Size \"00\" hard gelatin capsules with green opaque cap imprinted with 'FENO 400' in black and blue opaque body imprinted with \"ZN04\" in white, filled with white to off-white granular powder. The chemical name is Benzeneacetic acid, α-methyl-3-phenoxy-, calcium salt dihydrate, (±)-. The molecular weight is 558.65. Its molecular formula is C 30H 26CaO 62H 2O, and it has the following chemical structure. Fenoprofen calcium is an arylacetic acid derivative. It is a white crystalline powder. At 25°C, it dissolves to a 15 mg/mL solution in alcohol (95%). It is slightly soluble in water and insoluble in benzene. The pKa of fenoprofen calcium is 4.5 at 25°C. Fenoprofen calcium capsules, USP contain fenoprofen calcium as the dihydrate in an amount equivalent to 200 mg (0.826 mmol) or 300 mg (1.24 mmol) or 400 mg (1.65 mmol) of fenoprofen. Inactive ingredients in Fenoprofen calcium capsules are crospovidone, magnesium stearate, sodium lauryl sulfate, and talc. In addition, the 200 mg capsules contain gelatin, titanium dioxide, yellow iron oxide, and the 300 mg capsules contain gelatin, FD&C Yellow #6, FD&C Blue #1, FD&C Red #40, FD&C Yellow #5, and titanium dioxide, and the 400 mg capsules contain gelatin, titanium dioxide, iron oxide yellow and FD&C Blue 2."
    },
    {
      "NDCCode": "0276-0502-10",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (0276-0502-10) ",
      "NDC11Code": "00276-0502-10",
      "ProductNDC": "0276-0502",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenoprofen Calcium",
      "NonProprietaryName": "Fenoprofen Calcium",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215548",
      "LabelerName": "Misemer Pharmaceuticals, Inc.",
      "SubstanceName": "FENOPROFEN CALCIUM",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231101",
      "SamplePackage": "N",
      "IndicationAndUsage": "FENOPROFEN CALCIUM is indicated for.  Relief of mild to moderate pain in adults  Relief of the signs and symptoms of rheumatoid arthritis  Relief of the signs and symptoms of osteoarthritis.",
      "Description": "Fenoprofen calcium capsules, USP is a nonsteroidal, anti-inflammatory drug available in 200 mg, 300mg and 400 mg capsule form for oral administration. The 200 mg capsule has a Size \"0\" hard gelatin capsules with light Brown opaque cap imprinted with \"FENO 200\" in black and white opaque body imprinted with \"ZN05\" in black, filled with white to off-white granular powder. The 300 mg capsule has a Size \"0el\" hard gelatin capsules with brown opaque cap · imprinted with 'FENO 300' in black and yellow opaque body imprinted with \"ZN07\" in black, filled with white to off-white granular powder. The 400 mg capsule has a Size \"00\" hard gelatin capsules with green opaque cap imprinted with 'FENO 400' in black and blue opaque body imprinted with \"ZN04\" in white, filled with white to off-white granular powder. The chemical name is Benzeneacetic acid, α-methyl-3-phenoxy-, calcium salt dihydrate, (±)-. The molecular weight is 558.65. Its molecular formula is C 30H 26CaO 62H 2O, and it has the following chemical structure. Fenoprofen calcium is an arylacetic acid derivative. It is a white crystalline powder. At 25°C, it dissolves to a 15 mg/mL solution in alcohol (95%). It is slightly soluble in water and insoluble in benzene. The pKa of fenoprofen calcium is 4.5 at 25°C. Fenoprofen calcium capsules, USP contain fenoprofen calcium as the dihydrate in an amount equivalent to 200 mg (0.826 mmol) or 300 mg (1.24 mmol) or 400 mg (1.65 mmol) of fenoprofen. Inactive ingredients in Fenoprofen calcium capsules are crospovidone, magnesium stearate, sodium lauryl sulfate, and talc. In addition, the 200 mg capsules contain gelatin, titanium dioxide, yellow iron oxide, and the 300 mg capsules contain gelatin, FD&C Yellow #6, FD&C Blue #1, FD&C Red #40, FD&C Yellow #5, and titanium dioxide, and the 400 mg capsules contain gelatin, titanium dioxide, iron oxide yellow and FD&C Blue 2."
    },
    {
      "NDCCode": "0276-0503-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (0276-0503-90) ",
      "NDC11Code": "00276-0503-90",
      "ProductNDC": "0276-0503",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenoprofen Calcium",
      "NonProprietaryName": "Fenoprofen Calcium",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215548",
      "LabelerName": "Misemer Pharmaceuticals, Inc.",
      "SubstanceName": "FENOPROFEN CALCIUM",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231101",
      "SamplePackage": "N",
      "IndicationAndUsage": "FENOPROFEN CALCIUM is indicated for.  Relief of mild to moderate pain in adults  Relief of the signs and symptoms of rheumatoid arthritis  Relief of the signs and symptoms of osteoarthritis.",
      "Description": "Fenoprofen calcium capsules, USP is a nonsteroidal, anti-inflammatory drug available in 200 mg, 300mg and 400 mg capsule form for oral administration. The 200 mg capsule has a Size \"0\" hard gelatin capsules with light Brown opaque cap imprinted with \"FENO 200\" in black and white opaque body imprinted with \"ZN05\" in black, filled with white to off-white granular powder. The 300 mg capsule has a Size \"0el\" hard gelatin capsules with brown opaque cap · imprinted with 'FENO 300' in black and yellow opaque body imprinted with \"ZN07\" in black, filled with white to off-white granular powder. The 400 mg capsule has a Size \"00\" hard gelatin capsules with green opaque cap imprinted with 'FENO 400' in black and blue opaque body imprinted with \"ZN04\" in white, filled with white to off-white granular powder. The chemical name is Benzeneacetic acid, α-methyl-3-phenoxy-, calcium salt dihydrate, (±)-. The molecular weight is 558.65. Its molecular formula is C 30H 26CaO 62H 2O, and it has the following chemical structure. Fenoprofen calcium is an arylacetic acid derivative. It is a white crystalline powder. At 25°C, it dissolves to a 15 mg/mL solution in alcohol (95%). It is slightly soluble in water and insoluble in benzene. The pKa of fenoprofen calcium is 4.5 at 25°C. Fenoprofen calcium capsules, USP contain fenoprofen calcium as the dihydrate in an amount equivalent to 200 mg (0.826 mmol) or 300 mg (1.24 mmol) or 400 mg (1.65 mmol) of fenoprofen. Inactive ingredients in Fenoprofen calcium capsules are crospovidone, magnesium stearate, sodium lauryl sulfate, and talc. In addition, the 200 mg capsules contain gelatin, titanium dioxide, yellow iron oxide, and the 300 mg capsules contain gelatin, FD&C Yellow #6, FD&C Blue #1, FD&C Red #40, FD&C Yellow #5, and titanium dioxide, and the 400 mg capsules contain gelatin, titanium dioxide, iron oxide yellow and FD&C Blue 2."
    },
    {
      "NDCCode": "0713-0863-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0863-30) ",
      "NDC11Code": "00713-0863-30",
      "ProductNDC": "0713-0863",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benicar Hct",
      "NonProprietaryName": "Olmesartan Medoxomil-hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021532",
      "LabelerName": "Cosette Pharmaceuticals, Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2023-07-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220901",
      "SamplePackage": "N",
      "IndicationAndUsage": "BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure.  BENICAR HCT is not indicated for the initial therapy of hypertension [seeDosage and Administration (2)]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with BENICAR HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. BENICAR HCT may be used alone, or in combination with other antihypertensive drugs.",
      "Description": "BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is a combination of an angiotensin II receptor antagonist (AT 1subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2and its structural formula is:. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. BENICAR HCT is available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropylcellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide and yellow iron oxide."
    },
    {
      "NDCCode": "0713-0864-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0864-30) ",
      "NDC11Code": "00713-0864-30",
      "ProductNDC": "0713-0864",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benicar Hct",
      "NonProprietaryName": "Olmesartan Medoxomil-hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021532",
      "LabelerName": "Cosette Pharmaceuticals, Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "40; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2023-07-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220901",
      "SamplePackage": "N",
      "IndicationAndUsage": "BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure.  BENICAR HCT is not indicated for the initial therapy of hypertension [seeDosage and Administration (2)]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with BENICAR HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. BENICAR HCT may be used alone, or in combination with other antihypertensive drugs.",
      "Description": "BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is a combination of an angiotensin II receptor antagonist (AT 1subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2and its structural formula is:. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. BENICAR HCT is available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropylcellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide and yellow iron oxide."
    },
    {
      "NDCCode": "0713-0865-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0865-30) ",
      "NDC11Code": "00713-0865-30",
      "ProductNDC": "0713-0865",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benicar Hct",
      "NonProprietaryName": "Olmesartan Medoxomil-hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021532",
      "LabelerName": "Cosette Pharmaceuticals, Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "40; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2023-07-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220901",
      "SamplePackage": "N",
      "IndicationAndUsage": "BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure.  BENICAR HCT is not indicated for the initial therapy of hypertension [seeDosage and Administration (2)]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with BENICAR HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. BENICAR HCT may be used alone, or in combination with other antihypertensive drugs.",
      "Description": "BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is a combination of an angiotensin II receptor antagonist (AT 1subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2and its structural formula is:. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. BENICAR HCT is available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropylcellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide and yellow iron oxide."
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      "NDC11Code": "00713-0943-30",
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      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benicar Hct",
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      "StartMarketingDate": "20260401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021532",
      "LabelerName": "Cosette Pharmaceuticals, Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
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      "StartMarketingDatePackage": "20260401",
      "SamplePackage": "N",
      "IndicationAndUsage": "BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure.  BENICAR HCT is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with BENICAR HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. BENICAR HCT may be used alone, or in combination with other antihypertensive drugs.",
      "Description": "BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is a combination of an angiotensin II receptor antagonist (AT 1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6 and its structural formula is:. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2 and its structural formula is:. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. BENICAR HCT is available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropylcellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide and yellow iron oxide."
    },
    {
      "NDCCode": "0713-0944-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0944-30) ",
      "NDC11Code": "00713-0944-30",
      "ProductNDC": "0713-0944",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benicar Hct",
      "NonProprietaryName": "Olmesartan Medoxomil-hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260303",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021532",
      "LabelerName": "Cosette Pharmaceuticals, Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "40; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-11",
      "PackageNdcExcludeFlag": "N",
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      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260303",
      "SamplePackage": "N",
      "IndicationAndUsage": "BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure.  BENICAR HCT is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with BENICAR HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. BENICAR HCT may be used alone, or in combination with other antihypertensive drugs.",
      "Description": "BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is a combination of an angiotensin II receptor antagonist (AT 1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6 and its structural formula is:. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2 and its structural formula is:. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. BENICAR HCT is available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropylcellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide and yellow iron oxide."
    },
    {
      "NDCCode": "0713-0945-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0945-30) ",
      "NDC11Code": "00713-0945-30",
      "ProductNDC": "0713-0945",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benicar Hct",
      "NonProprietaryName": "Olmesartan Medoxomil-hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021532",
      "LabelerName": "Cosette Pharmaceuticals, Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "40; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-01",
      "PackageNdcExcludeFlag": "N",
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      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260401",
      "SamplePackage": "N",
      "IndicationAndUsage": "BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure.  BENICAR HCT is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with BENICAR HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. BENICAR HCT may be used alone, or in combination with other antihypertensive drugs.",
      "Description": "BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is a combination of an angiotensin II receptor antagonist (AT 1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6 and its structural formula is:. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2 and its structural formula is:. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. BENICAR HCT is available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropylcellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide and yellow iron oxide."
    },
    {
      "NDCCode": "13668-251-01",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (13668-251-01) ",
      "NDC11Code": "13668-0251-01",
      "ProductNDC": "13668-251",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide 20/12.5",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170424",
      "EndMarketingDate": "20240531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206515",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "12.5; 20",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170424",
      "EndMarketingDatePackage": "20240531",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of olmesartan, an angiotensin II receptor blocker and hydrochlorothiazide, a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1).",
      "Description": "Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil, USP is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. Additionally, the 40 mg/25 mg tablets contain ferric oxide red. The 20 mg/12.5 mg and 40 mg/12.5 mg tablets contain ferric oxide red and ferric oxide yellow."
    }
  ]
}
                    

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