RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "70436-093-04",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70436-093-04) ",
      "NDC11Code": "70436-0093-04",
      "ProductNDC": "70436-093",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lurasidone Hydrochloride",
      "NonProprietaryName": "Lurasidone Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212091",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "LURASIDONE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lurasidone hydrochloride tablets are indicated for: : 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]., 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]., 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].",
      "Description": "Lurasidone hydrochloride tablets are an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, corn starch, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 2 Aluminum Lake."
    },
    {
      "NDCCode": "70436-093-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (70436-093-01) ",
      "NDC11Code": "70436-0093-01",
      "ProductNDC": "70436-093",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lurasidone Hydrochloride",
      "NonProprietaryName": "Lurasidone Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212091",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "LURASIDONE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lurasidone hydrochloride tablets are indicated for: : 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]., 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]., 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].",
      "Description": "Lurasidone hydrochloride tablets are an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, corn starch, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 2 Aluminum Lake."
    },
    {
      "NDCCode": "21922-093-04",
      "PackageDescription": "1 TUBE in 1 CARTON (21922-093-04)  / 14 g in 1 TUBE",
      "NDC11Code": "21922-0093-04",
      "ProductNDC": "21922-093",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Triple Antibiotic",
      "NonProprietaryName": "Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250306",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M004",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
      "StrengthNumber": "400; 3.5; 5000",
      "StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-09-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250306",
      "SamplePackage": "N",
      "IndicationAndUsage": "First aid to help prevent infection in minor : 1 cuts."
    },
    {
      "NDCCode": "33342-093-04",
      "PackageDescription": "12 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-093-04) ",
      "NDC11Code": "33342-0093-04",
      "ProductNDC": "33342-093",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rizatriptan Benzoate",
      "NonProprietaryName": "Rizatriptan Benzoate",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140923",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203146",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "RIZATRIPTAN BENZOATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-03-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230227",
      "SamplePackage": "N",
      "IndicationAndUsage": "Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.Limitations of Use  Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.  Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].  Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks.  Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.",
      "Description": "Rizatriptan benzoate orally disintegrating tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D ) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate orally disintegrating tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, carboxymethyl cellulose calcium, magnesium stearate, mannitol, aspartame, and peppermint flavor. USP Dissolution Test 2."
    },
    {
      "NDCCode": "49884-093-04",
      "PackageDescription": "250 TABLET in 1 BOTTLE (49884-093-04) ",
      "NDC11Code": "49884-0093-04",
      "ProductNDC": "49884-093",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline",
      "NonProprietaryName": "Doxycycline",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001215",
      "EndMarketingDate": "20200831",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065070",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "DOXYCYCLINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20001215",
      "EndMarketingDatePackage": "20200831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "58159-093-04",
      "PackageDescription": "10 kg in 1 DRUM (58159-093-04) ",
      "NDC11Code": "58159-0093-04",
      "ProductNDC": "58159-093",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Trientine Tetrahydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20221020",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "TRIENTINE TETRAHYDROCHLORIDE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2022-11-01",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20-OCT-22"
    },
    {
      "NDCCode": "59779-093-04",
      "PackageDescription": "1 BOTTLE in 1 CARTON (59779-093-04)  > 60 mL in 1 BOTTLE",
      "NDC11Code": "59779-0093-04",
      "ProductNDC": "59779-093",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Childrens",
      "ProprietaryNameSuffix": "Allergy Relief",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076805",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/5mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "63545-093-04",
      "PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (63545-093-04) ",
      "NDC11Code": "63545-0093-04",
      "ProductNDC": "63545-093",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Araneus Diadematus",
      "NonProprietaryName": "Araneus Diadematus",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210225",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, Inc.",
      "SubstanceName": "ARANEUS DIADEMATUS",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_M]/1",
      "Status": "Active",
      "LastUpdate": "2021-02-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210225",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71209-093-04",
      "PackageDescription": "90 TABLET, COATED in 1 BOTTLE (71209-093-04) ",
      "NDC11Code": "71209-0093-04",
      "ProductNDC": "71209-093",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atorvastatin Calcium",
      "NonProprietaryName": "Atorvastatin Calcium",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180706",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212103",
      "LabelerName": "Cadila Pharmaceuticals Limited",
      "SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-06-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180706",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atorvastatin Calcium tablets are indicated. To reduce the risk of.         o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.         o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.         o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in.         o Adults with primary hyperlipidemia.         o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with.         o Primary dysbetalipoproteinemia.         o Hypertriglyceridemia.",
      "Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP, is a white to off-white crystalline powder that is freely soluble in methanol, slightly soluble in ethanol (96 %), very slightly soluble in water, phosphate buffer (pH: 7.4) and acetonitrile. Practically insoluble in methylene chloride and aqueous solution at pH: 4.0. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg or 82.72 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry white, and polysorbate 80. Opadry white contains hypromellose, polyethylene glycol, titanium dioxide, and talc."
    },
    {
      "NDCCode": "71611-093-04",
      "PackageDescription": "45 mL in 1 BOTTLE (71611-093-04) ",
      "NDC11Code": "71611-0093-04",
      "ProductNDC": "71611-093",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Wish Hand Sanitizer White Jsamine",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240628",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "CLICK PRODUCTS LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240628",
      "SamplePackage": "N",
      "IndicationAndUsage": "USE: · Hand sanitizer to help reduce bacteria on the skin that may cause disease."
    },
    {
      "NDCCode": "72524-093-04",
      "PackageDescription": "118 mL in 1 BOTTLE, SPRAY (72524-093-04) ",
      "NDC11Code": "72524-0093-04",
      "ProductNDC": "72524-093",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ay Bendito Hemp",
      "NonProprietaryName": "Menthol, Camphor",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251220",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "AY BENDITO INTERNATIONAL, INC",
      "SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL",
      "StrengthNumber": "5.3; 3.6",
      "StrengthUnit": "g/100mL; g/100mL",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251220",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of minor pains on muscles or joints."
    },
    {
      "NDCCode": "75054-093-04",
      "PackageDescription": "30 mL in 1 BOTTLE, SPRAY (75054-093-04) ",
      "NDC11Code": "75054-0093-04",
      "ProductNDC": "75054-093",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Covaguard Mask",
      "NonProprietaryName": "Antimicrobial Sanitizer With Benzalkonium Chloride",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200430",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Covalon Technologies Ltd.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".13",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-11-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200430",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "84778-093-04",
      "PackageDescription": "8 PATCH in 1 BOX (84778-093-04)  / 60 mg in 1 PATCH",
      "NDC11Code": "84778-0093-04",
      "ProductNDC": "84778-093",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Esokalli Testosterone Booster Oral Dissolving Film",
      "NonProprietaryName": "Esokalli Testosterone Booster Oral Dissolving Film",
      "DosageFormName": "FILM, SOLUBLE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250824",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Guangzhou Yixin Cross-border E-commerce Co., Ltd.",
      "SubstanceName": "TADALAFIL; VARDENAFIL",
      "StrengthNumber": "40; 20",
      "StrengthUnit": "mg/100mg; mg/100mg",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250824",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the treatment of erectile dysfunction (ED)."
    },
    {
      "NDCCode": "70436-007-04",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70436-007-04) ",
      "NDC11Code": "70436-0007-04",
      "ProductNDC": "70436-007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cinacalcet Hydrochloride",
      "NonProprietaryName": "Cinacalcet Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190306",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210207",
      "LabelerName": "Slate Run Pharmaceuticals",
      "SubstanceName": "CINACALCET HYDROCHLORIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20190306",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cinacalcet tablets are a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1), 2  Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis , 3 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2), 4 Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. (1.3).",
      "Description": "Cinacalcet Tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C22H22F3N·HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white, crystalline solid that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Cinacalcet tablets are formulated as light-green, oval-shaped, film-coated, tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive IngredientsThe following are the inactive ingredients in cinacalcet tablets: colloidal silicon dioxide, corn/maize starch, crospovidone, FD&C Blue #2/Indigo carmine AL, iron oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pre-gelatinized starch, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "70436-008-04",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70436-008-04) ",
      "NDC11Code": "70436-0008-04",
      "ProductNDC": "70436-008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cinacalcet Hydrochloride",
      "NonProprietaryName": "Cinacalcet Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190306",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210207",
      "LabelerName": "Slate Run Pharmaceuticals",
      "SubstanceName": "CINACALCET HYDROCHLORIDE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20190306",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cinacalcet tablets are a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1), 2  Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis , 3 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2), 4 Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. (1.3).",
      "Description": "Cinacalcet Tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C22H22F3N·HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white, crystalline solid that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Cinacalcet tablets are formulated as light-green, oval-shaped, film-coated, tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive IngredientsThe following are the inactive ingredients in cinacalcet tablets: colloidal silicon dioxide, corn/maize starch, crospovidone, FD&C Blue #2/Indigo carmine AL, iron oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pre-gelatinized starch, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "70436-009-04",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70436-009-04) ",
      "NDC11Code": "70436-0009-04",
      "ProductNDC": "70436-009",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cinacalcet Hydrochloride",
      "NonProprietaryName": "Cinacalcet Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190306",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210207",
      "LabelerName": "Slate Run Pharmaceuticals",
      "SubstanceName": "CINACALCET HYDROCHLORIDE",
      "StrengthNumber": "90",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20190306",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cinacalcet tablets are a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1), 2  Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis , 3 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2), 4 Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. (1.3).",
      "Description": "Cinacalcet Tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C22H22F3N·HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white, crystalline solid that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Cinacalcet tablets are formulated as light-green, oval-shaped, film-coated, tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive IngredientsThe following are the inactive ingredients in cinacalcet tablets: colloidal silicon dioxide, corn/maize starch, crospovidone, FD&C Blue #2/Indigo carmine AL, iron oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pre-gelatinized starch, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "70436-010-04",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-010-04) ",
      "NDC11Code": "70436-0010-04",
      "ProductNDC": "70436-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupropion Hydrochloride",
      "ProprietaryNameSuffix": "Xl",
      "NonProprietaryName": "Bupropion Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210015",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "BUPROPION HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for:    treatment of major de pressive disorder (MDD) (   1.1)    prevention of seasonal affective disorder (SAD) (   1.2).",
      "Description": "Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used."
    },
    {
      "NDCCode": "70436-011-04",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-04) ",
      "NDC11Code": "70436-0011-04",
      "ProductNDC": "70436-011",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupropion Hydrochloride",
      "ProprietaryNameSuffix": "Xl",
      "NonProprietaryName": "Bupropion Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210015",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "BUPROPION HYDROCHLORIDE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for:    treatment of major de pressive disorder (MDD) (   1.1)    prevention of seasonal affective disorder (SAD) (   1.2).",
      "Description": "Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used."
    },
    {
      "NDCCode": "70436-012-04",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-012-04) ",
      "NDC11Code": "70436-0012-04",
      "ProductNDC": "70436-012",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desvenlafaxine",
      "NonProprietaryName": "Desvenlafaxine",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210014",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "DESVENLAFAXINE SUCCINATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies ( 14)] .",
      "Description": "Desvenlafaxine Extended-Release Tablets are an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16H 25NO 2 (free base) and C 16H 25NO 2C 4H 6O 4H 2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine Extended-Release Tablets are formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of ferrosoferric oxide, iron oxide red, iron oxide yellow, mono- and di-glycerides, polyethylene glycol polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of iron oxide yellow, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of D&C red #27, FD&C blue #2, FD&C yellow #6, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
    },
    {
      "NDCCode": "70436-013-04",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-013-04) ",
      "NDC11Code": "70436-0013-04",
      "ProductNDC": "70436-013",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desvenlafaxine",
      "NonProprietaryName": "Desvenlafaxine",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210014",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "DESVENLAFAXINE SUCCINATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies ( 14)] .",
      "Description": "Desvenlafaxine Extended-Release Tablets are an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16H 25NO 2 (free base) and C 16H 25NO 2C 4H 6O 4H 2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine Extended-Release Tablets are formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of ferrosoferric oxide, iron oxide red, iron oxide yellow, mono- and di-glycerides, polyethylene glycol polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of iron oxide yellow, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of D&C red #27, FD&C blue #2, FD&C yellow #6, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
    },
    {
      "NDCCode": "70436-014-04",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70436-014-04) ",
      "NDC11Code": "70436-0014-04",
      "ProductNDC": "70436-014",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250515",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210718",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "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": "2025-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250515",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and 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 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 provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
    },
    {
      "NDCCode": "70436-015-04",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70436-015-04) ",
      "NDC11Code": "70436-0015-04",
      "ProductNDC": "70436-015",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250515",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210718",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "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": "2025-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250515",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and 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 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 provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
    },
    {
      "NDCCode": "70436-016-04",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70436-016-04) ",
      "NDC11Code": "70436-0016-04",
      "ProductNDC": "70436-016",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250515",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210718",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "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": "2025-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250515",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and 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 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 provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
    },
    {
      "NDCCode": "70436-017-04",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70436-017-04) ",
      "NDC11Code": "70436-0017-04",
      "ProductNDC": "70436-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250515",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210718",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "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": "2025-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250515",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and 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 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 provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
    },
    {
      "NDCCode": "70436-018-04",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70436-018-04) ",
      "NDC11Code": "70436-0018-04",
      "ProductNDC": "70436-018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250515",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210718",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "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": "2025-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250515",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and 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 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 provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
    },
    {
      "NDCCode": "70436-036-04",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-036-04) ",
      "NDC11Code": "70436-0036-04",
      "ProductNDC": "70436-036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desvenlafaxine",
      "NonProprietaryName": "Desvenlafaxine",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210014",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "DESVENLAFAXINE SUCCINATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210105",
      "SamplePackage": "N",
      "IndicationAndUsage": "Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies ( 14)] .",
      "Description": "Desvenlafaxine Extended-Release Tablets are an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16H 25NO 2 (free base) and C 16H 25NO 2C 4H 6O 4H 2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine Extended-Release Tablets are formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of ferrosoferric oxide, iron oxide red, iron oxide yellow, mono- and di-glycerides, polyethylene glycol polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of iron oxide yellow, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of D&C red #27, FD&C blue #2, FD&C yellow #6, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
    },
    {
      "NDCCode": "70436-054-04",
      "PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-054-04) ",
      "NDC11Code": "70436-0054-04",
      "ProductNDC": "70436-054",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Memantine Hydrochloride",
      "NonProprietaryName": "Memantine Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211100",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "MEMANTINE HYDROCHLORIDE",
      "StrengthNumber": "7",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Memantine Hydrochloride Extended-Release Capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
      "Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a fine white to off-white powder and is soluble in water. Memantine Hydrochloride Extended-Release Capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended release beads with the labeled amount of memantine hydrochloride and the following inactive ingredients: ammonium hydroxide, ethylcellulose, hydroxyethyl cellulose, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, sugar spheres and talc. The capsule shell contains FD&C blue 1 (14 mg, 21 mg, 28 mg), FD&C yellow 6 (14 mg, 21 mg, 28 mg), gelatin, titanium dioxide and yellow iron oxide (7 mg, 14 mg). The imprinting ink contains black iron oxide (7 mg, 14 mg, 21 mg), potassium hydroxide (7 mg, 14 mg, 21 mg), shellac and titanium dioxide (28 mg)."
    },
    {
      "NDCCode": "70436-055-04",
      "PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-055-04) ",
      "NDC11Code": "70436-0055-04",
      "ProductNDC": "70436-055",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Memantine Hydrochloride",
      "NonProprietaryName": "Memantine Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211100",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "MEMANTINE HYDROCHLORIDE",
      "StrengthNumber": "14",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Memantine Hydrochloride Extended-Release Capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
      "Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a fine white to off-white powder and is soluble in water. Memantine Hydrochloride Extended-Release Capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended release beads with the labeled amount of memantine hydrochloride and the following inactive ingredients: ammonium hydroxide, ethylcellulose, hydroxyethyl cellulose, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, sugar spheres and talc. The capsule shell contains FD&C blue 1 (14 mg, 21 mg, 28 mg), FD&C yellow 6 (14 mg, 21 mg, 28 mg), gelatin, titanium dioxide and yellow iron oxide (7 mg, 14 mg). The imprinting ink contains black iron oxide (7 mg, 14 mg, 21 mg), potassium hydroxide (7 mg, 14 mg, 21 mg), shellac and titanium dioxide (28 mg)."
    },
    {
      "NDCCode": "70436-056-04",
      "PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-056-04) ",
      "NDC11Code": "70436-0056-04",
      "ProductNDC": "70436-056",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Memantine Hydrochloride",
      "NonProprietaryName": "Memantine Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211100",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "MEMANTINE HYDROCHLORIDE",
      "StrengthNumber": "21",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Memantine Hydrochloride Extended-Release Capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
      "Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a fine white to off-white powder and is soluble in water. Memantine Hydrochloride Extended-Release Capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended release beads with the labeled amount of memantine hydrochloride and the following inactive ingredients: ammonium hydroxide, ethylcellulose, hydroxyethyl cellulose, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, sugar spheres and talc. The capsule shell contains FD&C blue 1 (14 mg, 21 mg, 28 mg), FD&C yellow 6 (14 mg, 21 mg, 28 mg), gelatin, titanium dioxide and yellow iron oxide (7 mg, 14 mg). The imprinting ink contains black iron oxide (7 mg, 14 mg, 21 mg), potassium hydroxide (7 mg, 14 mg, 21 mg), shellac and titanium dioxide (28 mg)."
    },
    {
      "NDCCode": "70436-057-04",
      "PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-057-04) ",
      "NDC11Code": "70436-0057-04",
      "ProductNDC": "70436-057",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Memantine Hydrochloride",
      "NonProprietaryName": "Memantine Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211100",
      "LabelerName": "Slate Run Pharmaceuticals, LLC",
      "SubstanceName": "MEMANTINE HYDROCHLORIDE",
      "StrengthNumber": "28",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Memantine Hydrochloride Extended-Release Capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
      "Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a fine white to off-white powder and is soluble in water. Memantine Hydrochloride Extended-Release Capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended release beads with the labeled amount of memantine hydrochloride and the following inactive ingredients: ammonium hydroxide, ethylcellulose, hydroxyethyl cellulose, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, sugar spheres and talc. The capsule shell contains FD&C blue 1 (14 mg, 21 mg, 28 mg), FD&C yellow 6 (14 mg, 21 mg, 28 mg), gelatin, titanium dioxide and yellow iron oxide (7 mg, 14 mg). The imprinting ink contains black iron oxide (7 mg, 14 mg, 21 mg), potassium hydroxide (7 mg, 14 mg, 21 mg), shellac and titanium dioxide (28 mg)."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"70436-093-04","ProprietaryName":"Lurasidone Hydrochloride","NonProprietaryName":"Lurasidone Hydrochloride"},{"NDCCode":"70436-093-01","ProprietaryName":"Lurasidone Hydrochloride","NonProprietaryName":"Lurasidone Hydrochloride"},{"NDCCode":"21922-093-04","ProprietaryName":"Triple Antibiotic","NonProprietaryName":"Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate"},{"NDCCode":"33342-093-04","ProprietaryName":"Rizatriptan Benzoate","NonProprietaryName":"Rizatriptan Benzoate"},{"NDCCode":"49884-093-04","ProprietaryName":"Doxycycline","NonProprietaryName":"Doxycycline"},{"NDCCode":"58159-093-04","NonProprietaryName":"Trientine Tetrahydrochloride"},{"NDCCode":"59779-093-04","ProprietaryName":"Childrens","NonProprietaryName":"Loratadine"},{"NDCCode":"63545-093-04","ProprietaryName":"Araneus Diadematus","NonProprietaryName":"Araneus Diadematus"},{"NDCCode":"71209-093-04","ProprietaryName":"Atorvastatin Calcium","NonProprietaryName":"Atorvastatin Calcium"},{"NDCCode":"71611-093-04","ProprietaryName":"Wish Hand Sanitizer White Jsamine","NonProprietaryName":"Alcohol"},{"NDCCode":"72524-093-04","ProprietaryName":"Ay Bendito Hemp","NonProprietaryName":"Menthol, Camphor"},{"NDCCode":"75054-093-04","ProprietaryName":"Covaguard Mask","NonProprietaryName":"Antimicrobial Sanitizer With Benzalkonium Chloride"},{"NDCCode":"84778-093-04","ProprietaryName":"Esokalli Testosterone Booster Oral Dissolving Film","NonProprietaryName":"Esokalli Testosterone Booster Oral Dissolving Film"},{"NDCCode":"70436-007-04","ProprietaryName":"Cinacalcet Hydrochloride","NonProprietaryName":"Cinacalcet Hydrochloride"},{"NDCCode":"70436-008-04","ProprietaryName":"Cinacalcet Hydrochloride","NonProprietaryName":"Cinacalcet Hydrochloride"},{"NDCCode":"70436-009-04","ProprietaryName":"Cinacalcet Hydrochloride","NonProprietaryName":"Cinacalcet Hydrochloride"},{"NDCCode":"70436-010-04","ProprietaryName":"Bupropion Hydrochloride","NonProprietaryName":"Bupropion Hydrochloride"},{"NDCCode":"70436-011-04","ProprietaryName":"Bupropion Hydrochloride","NonProprietaryName":"Bupropion Hydrochloride"},{"NDCCode":"70436-012-04","ProprietaryName":"Desvenlafaxine","NonProprietaryName":"Desvenlafaxine"},{"NDCCode":"70436-013-04","ProprietaryName":"Desvenlafaxine","NonProprietaryName":"Desvenlafaxine"},{"NDCCode":"70436-014-04","ProprietaryName":"Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide","NonProprietaryName":"Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide"},{"NDCCode":"70436-015-04","ProprietaryName":"Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide","NonProprietaryName":"Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide"},{"NDCCode":"70436-016-04","ProprietaryName":"Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide","NonProprietaryName":"Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide"},{"NDCCode":"70436-017-04","ProprietaryName":"Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide","NonProprietaryName":"Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide"},{"NDCCode":"70436-018-04","ProprietaryName":"Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide","NonProprietaryName":"Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide"},{"NDCCode":"70436-036-04","ProprietaryName":"Desvenlafaxine","NonProprietaryName":"Desvenlafaxine"},{"NDCCode":"70436-054-04","ProprietaryName":"Memantine Hydrochloride","NonProprietaryName":"Memantine Hydrochloride"},{"NDCCode":"70436-055-04","ProprietaryName":"Memantine Hydrochloride","NonProprietaryName":"Memantine Hydrochloride"},{"NDCCode":"70436-056-04","ProprietaryName":"Memantine Hydrochloride","NonProprietaryName":"Memantine Hydrochloride"},{"NDCCode":"70436-057-04","ProprietaryName":"Memantine Hydrochloride","NonProprietaryName":"Memantine Hydrochloride"}]}
                    

<NDCList><NDC><NDCCode>70436-093-04</NDCCode><ProprietaryName>Lurasidone Hydrochloride</ProprietaryName><NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70436-093-01</NDCCode><ProprietaryName>Lurasidone Hydrochloride</ProprietaryName><NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>21922-093-04</NDCCode><ProprietaryName>Triple Antibiotic</ProprietaryName><NonProprietaryName>Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate</NonProprietaryName></NDC><NDC><NDCCode>33342-093-04</NDCCode><ProprietaryName>Rizatriptan Benzoate</ProprietaryName><NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName></NDC><NDC><NDCCode>49884-093-04</NDCCode><ProprietaryName>Doxycycline</ProprietaryName><NonProprietaryName>Doxycycline</NonProprietaryName></NDC><NDC><NDCCode>58159-093-04</NDCCode><NonProprietaryName>Trientine Tetrahydrochloride</NonProprietaryName></NDC><NDC><NDCCode>59779-093-04</NDCCode><ProprietaryName>Childrens</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>63545-093-04</NDCCode><ProprietaryName>Araneus Diadematus</ProprietaryName><NonProprietaryName>Araneus Diadematus</NonProprietaryName></NDC><NDC><NDCCode>71209-093-04</NDCCode><ProprietaryName>Atorvastatin Calcium</ProprietaryName><NonProprietaryName>Atorvastatin Calcium</NonProprietaryName></NDC><NDC><NDCCode>71611-093-04</NDCCode><ProprietaryName>Wish Hand Sanitizer White Jsamine</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>72524-093-04</NDCCode><ProprietaryName>Ay Bendito Hemp</ProprietaryName><NonProprietaryName>Menthol, Camphor</NonProprietaryName></NDC><NDC><NDCCode>75054-093-04</NDCCode><ProprietaryName>Covaguard Mask</ProprietaryName><NonProprietaryName>Antimicrobial Sanitizer With Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>84778-093-04</NDCCode><ProprietaryName>Esokalli Testosterone Booster Oral Dissolving Film</ProprietaryName><NonProprietaryName>Esokalli Testosterone Booster Oral Dissolving Film</NonProprietaryName></NDC><NDC><NDCCode>70436-007-04</NDCCode><ProprietaryName>Cinacalcet Hydrochloride</ProprietaryName><NonProprietaryName>Cinacalcet Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70436-008-04</NDCCode><ProprietaryName>Cinacalcet Hydrochloride</ProprietaryName><NonProprietaryName>Cinacalcet Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70436-009-04</NDCCode><ProprietaryName>Cinacalcet Hydrochloride</ProprietaryName><NonProprietaryName>Cinacalcet Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70436-010-04</NDCCode><ProprietaryName>Bupropion Hydrochloride</ProprietaryName><NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70436-011-04</NDCCode><ProprietaryName>Bupropion Hydrochloride</ProprietaryName><NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70436-012-04</NDCCode><ProprietaryName>Desvenlafaxine</ProprietaryName><NonProprietaryName>Desvenlafaxine</NonProprietaryName></NDC><NDC><NDCCode>70436-013-04</NDCCode><ProprietaryName>Desvenlafaxine</ProprietaryName><NonProprietaryName>Desvenlafaxine</NonProprietaryName></NDC><NDC><NDCCode>70436-014-04</NDCCode><ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>70436-015-04</NDCCode><ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>70436-016-04</NDCCode><ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>70436-017-04</NDCCode><ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>70436-018-04</NDCCode><ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>70436-036-04</NDCCode><ProprietaryName>Desvenlafaxine</ProprietaryName><NonProprietaryName>Desvenlafaxine</NonProprietaryName></NDC><NDC><NDCCode>70436-054-04</NDCCode><ProprietaryName>Memantine Hydrochloride</ProprietaryName><NonProprietaryName>Memantine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70436-055-04</NDCCode><ProprietaryName>Memantine Hydrochloride</ProprietaryName><NonProprietaryName>Memantine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70436-056-04</NDCCode><ProprietaryName>Memantine Hydrochloride</ProprietaryName><NonProprietaryName>Memantine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70436-057-04</NDCCode><ProprietaryName>Memantine Hydrochloride</ProprietaryName><NonProprietaryName>Memantine Hydrochloride</NonProprietaryName></NDC></NDCList>