{
"NDC": [
{
"NDCCode": "63736-211-40",
"PackageDescription": "1 BOTTLE in 1 BOX (63736-211-40) > 40 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "63736-0211-40",
"ProductNDC": "63736-211",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anacin",
"ProprietaryNameSuffix": "Es",
"NonProprietaryName": "Aspirin And Caffeine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090707",
"EndMarketingDate": "20200731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "500; 32",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090707",
"EndMarketingDatePackage": "20200731",
"SamplePackage": "N"
},
{
"NDCCode": "63736-211-75",
"PackageDescription": "1 BOTTLE in 1 BOX (63736-211-75) > 75 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "63736-0211-75",
"ProductNDC": "63736-211",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anacin",
"ProprietaryNameSuffix": "Es",
"NonProprietaryName": "Aspirin And Caffeine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090707",
"EndMarketingDate": "20200731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "500; 32",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090707",
"EndMarketingDatePackage": "20200731",
"SamplePackage": "N"
},
{
"NDCCode": "11673-211-40",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (11673-211-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "11673-0211-40",
"ProductNDC": "11673-211",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Cetirizine Hcl",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20140930",
"EndMarketingDate": "20211230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022429",
"LabelerName": "TARGET Corporation",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140930",
"EndMarketingDatePackage": "20211230",
"SamplePackage": "N"
},
{
"NDCCode": "30142-211-40",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (30142-211-40) > 40 CAPSULE in 1 BOTTLE, PLASTIC",
"NDC11Code": "30142-0211-40",
"ProductNDC": "30142-211",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "All Day Allergy",
"NonProprietaryName": "Cetirizine Hcl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20131230",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022429",
"LabelerName": "The Kroger Co.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131230",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat ."
},
{
"NDCCode": "66326-211-03",
"PackageDescription": "40 kg in 1 DRUM (66326-211-03)",
"NDC11Code": "66326-0211-03",
"ProductNDC": "66326-211",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dimethicone, Silicon Dioxide",
"DosageFormName": "GRANULE",
"StartMarketingDate": "20200325",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Sri Krishna Pharmaceuticals Ltd. Unit I",
"SubstanceName": "SILICON DIOXIDE; DIMETHICONE",
"StrengthNumber": "16.5; 283.5",
"StrengthUnit": "g/kg; g/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "70108-211-01",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (70108-211-01) / 40 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "70108-0211-01",
"ProductNDC": "70108-211",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Care Champagne Toast Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250807",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Ashtel Studios, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250807",
"SamplePackage": "N",
"IndicationAndUsage": "Decreases bacteria on skin."
},
{
"NDCCode": "87302-211-01",
"PackageDescription": "40 mL in 1 BOTTLE, SPRAY (87302-211-01) ",
"NDC11Code": "87302-0211-01",
"ProductNDC": "87302-211",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fresh Feels Hand Sanitizer Mist Pineapple Sundae Scent",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Amber Glow Cosmetics Limited",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260107",
"SamplePackage": "N",
"IndicationAndUsage": " To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use."
},
{
"NDCCode": "63736-015-18",
"PackageDescription": "3 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-18) / 5 g in 1 TUBE, WITH APPLICATOR",
"NDC11Code": "63736-0015-18",
"ProductNDC": "63736-015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Monistat 3",
"ProprietaryNameSuffix": "3 Day",
"NonProprietaryName": "Miconazole Nitrate",
"DosageFormName": "CREAM",
"RouteName": "VAGINAL",
"StartMarketingDate": "19980330",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020827",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980330",
"SamplePackage": "N",
"IndicationAndUsage": "treats vaginal yeast infections."
},
{
"NDCCode": "63736-015-25",
"PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-25) / 25 g in 1 TUBE, WITH APPLICATOR",
"NDC11Code": "63736-0015-25",
"ProductNDC": "63736-015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Monistat 3",
"ProprietaryNameSuffix": "3 Day",
"NonProprietaryName": "Miconazole Nitrate",
"DosageFormName": "CREAM",
"RouteName": "VAGINAL",
"StartMarketingDate": "19980330",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020827",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980330",
"SamplePackage": "N",
"IndicationAndUsage": "treats vaginal yeast infections."
},
{
"NDCCode": "0270-7025-40",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CASE (0270-7025-40) / 7.5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00270-7025-40",
"ProductNDC": "0270-7025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vueway",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2."
},
{
"NDCCode": "10544-211-10",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (10544-211-10)",
"NDC11Code": "10544-0211-10",
"ProductNDC": "10544-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088237",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis and serum sickness.",
"Description": "Dexamethasone Tablets 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg are for oral administration. Each tablet contains 0.5 mg, 0.75 mg, 1.5 mg, 4 mg or 6 mg of dexamethasone. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β, 17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. Each tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid. In addition, the 0.5 mg tablet contains D&C Yellow #10 and FD&C Yellow #5. The 0.75 mg tablet contains D&C Yellow #10 and FD&C Blue #1. The 1.5 mg tablet contains FD&C Red #40. The 6 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6."
},
{
"NDCCode": "15014-211-21",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (15014-211-21) > 21 TABLET in 1 BLISTER PACK",
"NDC11Code": "15014-0211-21",
"ProductNDC": "15014-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hidex 6-day",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088237",
"LabelerName": "Gentex Pharma, Llc",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190222",
"SamplePackage": "N",
"IndicationAndUsage": "Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness.",
"Description": "HiDex contains dexamethasone tablets USP, 1.5mg for oral administration. Each tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid. In addition, the 1.5 mg tablet contains FD&C Red #40. HiDex 6-Day contains dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water."
},
{
"NDCCode": "21695-211-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (21695-211-15)",
"NDC11Code": "21695-0211-15",
"ProductNDC": "21695-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ambien",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019908",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
"Description": "Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a]pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Ambien tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80."
},
{
"NDCCode": "21695-211-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (21695-211-30)",
"NDC11Code": "21695-0211-30",
"ProductNDC": "21695-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ambien",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019908",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
"Description": "Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a]pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Ambien tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80."
},
{
"NDCCode": "27241-211-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (27241-211-01) ",
"NDC11Code": "27241-0211-01",
"ProductNDC": "27241-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213897",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2021-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201223",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25 mg, 50 mg, and 75 mg for oral administration. Clomipramine hydrochloride, USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Molecular Formula = C19H23ClN2 ● HCl. Molecular Weight = 351.31. Clomipramine hydrochloride, USP is a white or slightly yellow crystalline powder. It is freely soluble in water and in methylene chloride, soluble in alcohol and practically insoluble in ethyl ether and in hexane. Each capsule contains clomipramine hydrochloride, USP 25 mg, 50 mg and 75 mg and inactive ingredients pregelatinized starch, colloidal silicon dioxide and magnesium stearate. Additionally hard gelatin capsule shell contains FD&C Red 40 (25 mg), FD&C Blue 1 (50 mg), titanium dioxide, gelatin, D&C Yellow 10 and FD& Yellow 6 (25 mg, 50 mg and 75 mg). The capsule is imprinted with black pharmaceutical ink which contains shellac, propylene glycol, ammonia, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "27241-211-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (27241-211-30) ",
"NDC11Code": "27241-0211-30",
"ProductNDC": "27241-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213897",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2021-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201223",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25 mg, 50 mg, and 75 mg for oral administration. Clomipramine hydrochloride, USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Molecular Formula = C19H23ClN2 ● HCl. Molecular Weight = 351.31. Clomipramine hydrochloride, USP is a white or slightly yellow crystalline powder. It is freely soluble in water and in methylene chloride, soluble in alcohol and practically insoluble in ethyl ether and in hexane. Each capsule contains clomipramine hydrochloride, USP 25 mg, 50 mg and 75 mg and inactive ingredients pregelatinized starch, colloidal silicon dioxide and magnesium stearate. Additionally hard gelatin capsule shell contains FD&C Red 40 (25 mg), FD&C Blue 1 (50 mg), titanium dioxide, gelatin, D&C Yellow 10 and FD& Yellow 6 (25 mg, 50 mg and 75 mg). The capsule is imprinted with black pharmaceutical ink which contains shellac, propylene glycol, ammonia, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "33358-211-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (33358-211-30)",
"NDC11Code": "33358-0211-30",
"ProductNDC": "33358-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077321",
"LabelerName": "RxChange Co.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lisinopril tablets USP are indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 lisinopril. 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 1 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. Lisinopril tablets USP may be administered alone or with other antihypertensive agents.",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5(2H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, starch. 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, red iron oxide, starch. 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, starch, yellow iron oxide."
},
{
"NDCCode": "42043-211-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (42043-211-01) ",
"NDC11Code": "42043-0211-01",
"ProductNDC": "42043-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zaleplon",
"NonProprietaryName": "Zaleplon",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090374",
"LabelerName": "OrchidPharma Inc",
"SubstanceName": "ZALEPLON",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Agonists [MoA], gamma-Aminobutyric Acid A Receptor Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180620",
"SamplePackage": "N",
"IndicationAndUsage": "Zaleplon capsules are indicated for the short-term treatment of insomnia. Zaleplon capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY). It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.",
"Description": "Zaleplon, USP is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. The chemical name of zaleplon, USP is N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide. Its empirical formula is C17H15N5O, and its molecular weight is 305.34. The structural formula is shown below. Zaleplon, USP is a white to off-white powder that is practically insoluble in water and sparingly soluble in alcohol or propylene glycol. Its partition coefficient in octanol/water is constant (log PC = 1.23) over the pH range of 1 to 7. Zaleplon capsules, USP contain zaleplon, USP as the active ingredient. Inactive ingredients consist of lactose monohydrate, pregelatinized starch, microcrystalline cellulose, silicon dioxide, magnesium stearate, gelatin, titanium dioxide, FD&C blue #1, FD&C red #40, and FD&C yellow #5. Ink constituents are: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Complies with USP dissolution Test 2."
},
{
"NDCCode": "46708-211-10",
"PackageDescription": "100 TABLET in 1 CARTON (46708-211-10) ",
"NDC11Code": "46708-0211-10",
"ProductNDC": "46708-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan And Hydrochlorothiazide",
"NonProprietaryName": "Telmisartan And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203010",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "TELMISARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "80; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2023-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140314",
"SamplePackage": "N",
"IndicationAndUsage": "Telmisartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).",
"Description": "Telmisartan and hydrochlorothiazide. tablets, USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.Telmisartan, a non-peptide molecule, is chemically described as 4’-[(1,4’-dimethyl-2’-propyl[2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H. -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate, lactose monohydrate, magnesium stearate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture."
},
{
"NDCCode": "46708-211-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (46708-211-30) ",
"NDC11Code": "46708-0211-30",
"ProductNDC": "46708-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan And Hydrochlorothiazide",
"NonProprietaryName": "Telmisartan And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203010",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "TELMISARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "80; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2023-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140314",
"SamplePackage": "N",
"IndicationAndUsage": "Telmisartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).",
"Description": "Telmisartan and hydrochlorothiazide. tablets, USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.Telmisartan, a non-peptide molecule, is chemically described as 4’-[(1,4’-dimethyl-2’-propyl[2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H. -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate, lactose monohydrate, magnesium stearate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture."
},
{
"NDCCode": "46708-211-91",
"PackageDescription": "1000 TABLET in 1 BOTTLE (46708-211-91) ",
"NDC11Code": "46708-0211-91",
"ProductNDC": "46708-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan And Hydrochlorothiazide",
"NonProprietaryName": "Telmisartan And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203010",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "TELMISARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "80; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2023-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140314",
"SamplePackage": "N",
"IndicationAndUsage": "Telmisartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).",
"Description": "Telmisartan and hydrochlorothiazide. tablets, USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.Telmisartan, a non-peptide molecule, is chemically described as 4’-[(1,4’-dimethyl-2’-propyl[2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H. -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate, lactose monohydrate, magnesium stearate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture."
},
{
"NDCCode": "49884-211-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-211-01) ",
"NDC11Code": "49884-0211-01",
"ProductNDC": "49884-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078540",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "425",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110103",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone HCl Extended Release Capsules, USP are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: : 1 The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules to control ventricular rate during AF. , 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see BOXED WARNING].",
"Description": "Propafenone Hydrochloride Extended Release Capsule, USP is an antiarrhythmic drug supplied in extended-release capsules of 225mg, 325mg and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3‑phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20ºC), chloroform, and ethanol. Propafenone ER capsules are filled with granules containing the following inactive ingredients: ethylcellulose, lactose anhydrous, magnesium stearate and povidone. Each capsule contains titanium dioxide and gelatin. In addition the 325 mg capsule also contains FD&C Blue No. 1, D&C Yellow No. 10 and FD&C Red No. 40 and the 425 mg capsule contains FD&C Blue No. 1, FD&C Red No. 40 and FD&C Yellow No. 6. The black ink consists of D&C Yellow No.10, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1 and shellac glaze~45% (20% esterfied) in ethanol."
},
{
"NDCCode": "49884-211-02",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-211-02) ",
"NDC11Code": "49884-0211-02",
"ProductNDC": "49884-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078540",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "425",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110103",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone HCl Extended Release Capsules, USP are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: : 1 The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules to control ventricular rate during AF. , 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see BOXED WARNING].",
"Description": "Propafenone Hydrochloride Extended Release Capsule, USP is an antiarrhythmic drug supplied in extended-release capsules of 225mg, 325mg and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3‑phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20ºC), chloroform, and ethanol. Propafenone ER capsules are filled with granules containing the following inactive ingredients: ethylcellulose, lactose anhydrous, magnesium stearate and povidone. Each capsule contains titanium dioxide and gelatin. In addition the 325 mg capsule also contains FD&C Blue No. 1, D&C Yellow No. 10 and FD&C Red No. 40 and the 425 mg capsule contains FD&C Blue No. 1, FD&C Red No. 40 and FD&C Yellow No. 6. The black ink consists of D&C Yellow No.10, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1 and shellac glaze~45% (20% esterfied) in ethanol."
},
{
"NDCCode": "49884-211-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-211-05) ",
"NDC11Code": "49884-0211-05",
"ProductNDC": "49884-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078540",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "425",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110103",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone HCl Extended Release Capsules, USP are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: : 1 The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules to control ventricular rate during AF. , 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see BOXED WARNING].",
"Description": "Propafenone Hydrochloride Extended Release Capsule, USP is an antiarrhythmic drug supplied in extended-release capsules of 225mg, 325mg and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3‑phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20ºC), chloroform, and ethanol. Propafenone ER capsules are filled with granules containing the following inactive ingredients: ethylcellulose, lactose anhydrous, magnesium stearate and povidone. Each capsule contains titanium dioxide and gelatin. In addition the 325 mg capsule also contains FD&C Blue No. 1, D&C Yellow No. 10 and FD&C Red No. 40 and the 425 mg capsule contains FD&C Blue No. 1, FD&C Red No. 40 and FD&C Yellow No. 6. The black ink consists of D&C Yellow No.10, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1 and shellac glaze~45% (20% esterfied) in ethanol."
},
{
"NDCCode": "49884-211-10",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-211-10) ",
"NDC11Code": "49884-0211-10",
"ProductNDC": "49884-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078540",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "425",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110103",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone HCl Extended Release Capsules, USP are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: : 1 The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules to control ventricular rate during AF. , 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see BOXED WARNING].",
"Description": "Propafenone Hydrochloride Extended Release Capsule, USP is an antiarrhythmic drug supplied in extended-release capsules of 225mg, 325mg and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3‑phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20ºC), chloroform, and ethanol. Propafenone ER capsules are filled with granules containing the following inactive ingredients: ethylcellulose, lactose anhydrous, magnesium stearate and povidone. Each capsule contains titanium dioxide and gelatin. In addition the 325 mg capsule also contains FD&C Blue No. 1, D&C Yellow No. 10 and FD&C Red No. 40 and the 425 mg capsule contains FD&C Blue No. 1, FD&C Red No. 40 and FD&C Yellow No. 6. The black ink consists of D&C Yellow No.10, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1 and shellac glaze~45% (20% esterfied) in ethanol."
},
{
"NDCCode": "50261-211-05",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (50261-211-05) / 5 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "50261-0211-05",
"ProductNDC": "50261-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bijuva",
"NonProprietaryName": "Estradiol And Progesterone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190403",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210132",
"LabelerName": "Mayne Pharma LLC",
"SubstanceName": "ESTRADIOL; PROGESTERONE",
"StrengthNumber": "1; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190403",
"SamplePackage": "Y",
"IndicationAndUsage": "BIJUVA is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause. (1.1).",
"Description": "BIJUVA (estradiol and progesterone) is an oval shaped opaque capsule in which the estradiol is solubilized and the progesterone is micronized and suspended in the mixture of medium chain mono and di-glycerides and lauroyl polyoxyl-32 glycerides. Each 0.5 mg/100 mg capsule is light pink on one side, dark pink on the other side, and printed with \"5C1\" in white ink. Each 1 mg/100 mg capsule is light pink on one side, dark pink on the other side, and printed with \"1C1\" in white ink. Estradiol (estra-1,3,5 (10)-triene-3,17β-diol), an estrogen, has a molecular weight of 272.38, and chemical formula C18H24O2. Progesterone (pregn-4-ene-3, 20-dione) has a molecular weight of 314.47, and chemical formula C21H30O2. The structural formulas are as follows. Each BIJUVA (estradiol and progesterone) capsule contains the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, FD&C Red #40, gelatin, glycerin, hydrolyzed gelatin, isopropyl alcohol, lauroyl polyoxyl-32 glycerides, lecithin, medium chain mono and di- glycerides, medium chain triglycerides, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, purified water, and titanium dioxide."
},
{
"NDCCode": "50261-211-30",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (50261-211-30) / 30 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "50261-0211-30",
"ProductNDC": "50261-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bijuva",
"NonProprietaryName": "Estradiol And Progesterone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190403",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210132",
"LabelerName": "Mayne Pharma LLC",
"SubstanceName": "ESTRADIOL; PROGESTERONE",
"StrengthNumber": "1; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190403",
"SamplePackage": "N",
"IndicationAndUsage": "BIJUVA is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause. (1.1).",
"Description": "BIJUVA (estradiol and progesterone) is an oval shaped opaque capsule in which the estradiol is solubilized and the progesterone is micronized and suspended in the mixture of medium chain mono and di-glycerides and lauroyl polyoxyl-32 glycerides. Each 0.5 mg/100 mg capsule is light pink on one side, dark pink on the other side, and printed with \"5C1\" in white ink. Each 1 mg/100 mg capsule is light pink on one side, dark pink on the other side, and printed with \"1C1\" in white ink. Estradiol (estra-1,3,5 (10)-triene-3,17β-diol), an estrogen, has a molecular weight of 272.38, and chemical formula C18H24O2. Progesterone (pregn-4-ene-3, 20-dione) has a molecular weight of 314.47, and chemical formula C21H30O2. The structural formulas are as follows. Each BIJUVA (estradiol and progesterone) capsule contains the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, FD&C Red #40, gelatin, glycerin, hydrolyzed gelatin, isopropyl alcohol, lauroyl polyoxyl-32 glycerides, lecithin, medium chain mono and di-glycerides, medium chain triglycerides, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, purified water, and titanium dioxide."
},
{
"NDCCode": "50390-211-30",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50390-211-30) / 30 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "50390-0211-30",
"ProductNDC": "50390-211",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Artistry Exact Fit Longwearing Foundation Shade Cappuccino",
"ProprietaryNameSuffix": "L5w1",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Amway Corp",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "40.25",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2023-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "51079-211-03",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (51079-211-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-211-01) ",
"NDC11Code": "51079-0211-03",
"ProductNDC": "51079-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091226",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140123",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 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)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemiaHypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is Calcium ( βR, δR)-2-( p-fluorophenyl)- β, δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl) pyrrole-1-heptanoate (1:2), trihydrate. The molecular formula of atorvastatin calcium is C 66H 68CaF 2N 4O 103H 2O and its molecular weight is 1209. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.84 mg, 21.69 mg, 43.38 mg, or 86.75 mg atorvastatin calcium trihydrate) and the following inactive ingredients: anhydrous lactose, anhydrous sodium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, L-Arginine, magnesium stearate and microcrystalline cellulose. The film coating of the tablets contains polyvinyl alcohol, talc and titanium dioxide, and may contain polyethylene glycol or lecithin and xanthan gum. Meets USP Dissolution Test 4."
},
{
"NDCCode": "51138-211-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51138-211-30)",
"NDC11Code": "51138-0211-30",
"ProductNDC": "51138-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benicar",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021286",
"LabelerName": "Med-Health Pharma, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Benicar is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Benicar. 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 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 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. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically 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 and its structural formula is. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Benicar is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide."
}
]
}
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<NDC>
<NDCCode>63736-211-40</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (63736-211-40) > 40 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>63736-0211-40</NDC11Code>
<ProductNDC>63736-211</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anacin</ProprietaryName>
<ProprietaryNameSuffix>Es</ProprietaryNameSuffix>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20090707</StartMarketingDate>
<EndMarketingDate>20200731</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
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<LabelerName>Insight Pharmaceuticals LLC</LabelerName>
<SubstanceName>ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>500; 32</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090707</StartMarketingDatePackage>
<EndMarketingDatePackage>20200731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63736-211-75</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (63736-211-75) > 75 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>63736-0211-75</NDC11Code>
<ProductNDC>63736-211</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anacin</ProprietaryName>
<ProprietaryNameSuffix>Es</ProprietaryNameSuffix>
<NonProprietaryName>Aspirin And Caffeine</NonProprietaryName>
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<LabelerName>Insight Pharmaceuticals LLC</LabelerName>
<SubstanceName>ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>500; 32</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090707</StartMarketingDatePackage>
<EndMarketingDatePackage>20200731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>11673-211-40</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (11673-211-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>11673-0211-40</NDC11Code>
<ProductNDC>11673-211</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Cetirizine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140930</StartMarketingDate>
<EndMarketingDate>20211230</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022429</ApplicationNumber>
<LabelerName>TARGET Corporation</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140930</StartMarketingDatePackage>
<EndMarketingDatePackage>20211230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>30142-211-40</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (30142-211-40) > 40 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>30142-0211-40</NDC11Code>
<ProductNDC>30142-211</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>All Day Allergy</ProprietaryName>
<NonProprietaryName>Cetirizine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131230</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022429</ApplicationNumber>
<LabelerName>The Kroger Co.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131230</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66326-211-03</NDCCode>
<PackageDescription>40 kg in 1 DRUM (66326-211-03)</PackageDescription>
<NDC11Code>66326-0211-03</NDC11Code>
<ProductNDC>66326-211</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dimethicone, Silicon Dioxide</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<StartMarketingDate>20200325</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Sri Krishna Pharmaceuticals Ltd. Unit I</LabelerName>
<SubstanceName>SILICON DIOXIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>16.5; 283.5</StrengthNumber>
<StrengthUnit>g/kg; g/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70108-211-01</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (70108-211-01) / 40 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>70108-0211-01</NDC11Code>
<ProductNDC>70108-211</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Care Champagne Toast Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250807</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Ashtel Studios, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Decreases bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>87302-211-01</NDCCode>
<PackageDescription>40 mL in 1 BOTTLE, SPRAY (87302-211-01) </PackageDescription>
<NDC11Code>87302-0211-01</NDC11Code>
<ProductNDC>87302-211</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fresh Feels Hand Sanitizer Mist Pineapple Sundae Scent</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Amber Glow Cosmetics Limited</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63736-015-18</NDCCode>
<PackageDescription>3 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-18) / 5 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
<NDC11Code>63736-0015-18</NDC11Code>
<ProductNDC>63736-015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Monistat 3</ProprietaryName>
<ProprietaryNameSuffix>3 Day</ProprietaryNameSuffix>
<NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>19980330</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020827</ApplicationNumber>
<LabelerName>Insight Pharmaceuticals LLC</LabelerName>
<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats vaginal yeast infections.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63736-015-25</NDCCode>
<PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-25) / 25 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
<NDC11Code>63736-0015-25</NDC11Code>
<ProductNDC>63736-015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Monistat 3</ProprietaryName>
<ProprietaryNameSuffix>3 Day</ProprietaryNameSuffix>
<NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>19980330</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020827</ApplicationNumber>
<LabelerName>Insight Pharmaceuticals LLC</LabelerName>
<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats vaginal yeast infections.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0270-7025-40</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CASE (0270-7025-40) / 7.5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00270-7025-40</NDC11Code>
<ProductNDC>0270-7025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vueway</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>10544-211-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (10544-211-10)</PackageDescription>
<NDC11Code>10544-0211-10</NDC11Code>
<ProductNDC>10544-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone</ProprietaryName>
<NonProprietaryName>Dexamethasone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088237</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>DEXAMETHASONE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis and serum sickness.</IndicationAndUsage>
<Description>Dexamethasone Tablets 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg are for oral administration. Each tablet contains 0.5 mg, 0.75 mg, 1.5 mg, 4 mg or 6 mg of dexamethasone. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β, 17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. Each tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid. In addition, the 0.5 mg tablet contains D&C Yellow #10 and FD&C Yellow #5. The 0.75 mg tablet contains D&C Yellow #10 and FD&C Blue #1. The 1.5 mg tablet contains FD&C Red #40. The 6 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>15014-211-21</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (15014-211-21) > 21 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>15014-0211-21</NDC11Code>
<ProductNDC>15014-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hidex 6-day</ProprietaryName>
<NonProprietaryName>Dexamethasone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088237</ApplicationNumber>
<LabelerName>Gentex Pharma, Llc</LabelerName>
<SubstanceName>DEXAMETHASONE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness.</IndicationAndUsage>
<Description>HiDex contains dexamethasone tablets USP, 1.5mg for oral administration. Each tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid. In addition, the 1.5 mg tablet contains FD&C Red #40. HiDex 6-Day contains dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water.</Description>
</NDC>
<NDC>
<NDCCode>21695-211-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE (21695-211-15)</PackageDescription>
<NDC11Code>21695-0211-15</NDC11Code>
<ProductNDC>21695-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ambien</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090630</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019908</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a]pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Ambien tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>21695-211-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (21695-211-30)</PackageDescription>
<NDC11Code>21695-0211-30</NDC11Code>
<ProductNDC>21695-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ambien</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090630</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019908</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a]pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Ambien tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>27241-211-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (27241-211-01) </PackageDescription>
<NDC11Code>27241-0211-01</NDC11Code>
<ProductNDC>27241-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213897</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25 mg, 50 mg, and 75 mg for oral administration. Clomipramine hydrochloride, USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Molecular Formula = C19H23ClN2 ● HCl. Molecular Weight = 351.31. Clomipramine hydrochloride, USP is a white or slightly yellow crystalline powder. It is freely soluble in water and in methylene chloride, soluble in alcohol and practically insoluble in ethyl ether and in hexane. Each capsule contains clomipramine hydrochloride, USP 25 mg, 50 mg and 75 mg and inactive ingredients pregelatinized starch, colloidal silicon dioxide and magnesium stearate. Additionally hard gelatin capsule shell contains FD&C Red 40 (25 mg), FD&C Blue 1 (50 mg), titanium dioxide, gelatin, D&C Yellow 10 and FD& Yellow 6 (25 mg, 50 mg and 75 mg). The capsule is imprinted with black pharmaceutical ink which contains shellac, propylene glycol, ammonia, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>27241-211-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (27241-211-30) </PackageDescription>
<NDC11Code>27241-0211-30</NDC11Code>
<ProductNDC>27241-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213897</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25 mg, 50 mg, and 75 mg for oral administration. Clomipramine hydrochloride, USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Molecular Formula = C19H23ClN2 ● HCl. Molecular Weight = 351.31. Clomipramine hydrochloride, USP is a white or slightly yellow crystalline powder. It is freely soluble in water and in methylene chloride, soluble in alcohol and practically insoluble in ethyl ether and in hexane. Each capsule contains clomipramine hydrochloride, USP 25 mg, 50 mg and 75 mg and inactive ingredients pregelatinized starch, colloidal silicon dioxide and magnesium stearate. Additionally hard gelatin capsule shell contains FD&C Red 40 (25 mg), FD&C Blue 1 (50 mg), titanium dioxide, gelatin, D&C Yellow 10 and FD& Yellow 6 (25 mg, 50 mg and 75 mg). The capsule is imprinted with black pharmaceutical ink which contains shellac, propylene glycol, ammonia, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>33358-211-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (33358-211-30)</PackageDescription>
<NDC11Code>33358-0211-30</NDC11Code>
<ProductNDC>33358-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077321</ApplicationNumber>
<LabelerName>RxChange Co.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lisinopril tablets USP are indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 lisinopril. 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 1 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. Lisinopril tablets USP may be administered alone or with other antihypertensive agents.</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5(2H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, starch. 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, red iron oxide, starch. 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, starch, yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>42043-211-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (42043-211-01) </PackageDescription>
<NDC11Code>42043-0211-01</NDC11Code>
<ProductNDC>42043-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zaleplon</ProprietaryName>
<NonProprietaryName>Zaleplon</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090374</ApplicationNumber>
<LabelerName>OrchidPharma Inc</LabelerName>
<SubstanceName>ZALEPLON</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Agonists [MoA], gamma-Aminobutyric Acid A Receptor Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zaleplon capsules are indicated for the short-term treatment of insomnia. Zaleplon capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY). It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.</IndicationAndUsage>
<Description>Zaleplon, USP is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. The chemical name of zaleplon, USP is N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide. Its empirical formula is C17H15N5O, and its molecular weight is 305.34. The structural formula is shown below. Zaleplon, USP is a white to off-white powder that is practically insoluble in water and sparingly soluble in alcohol or propylene glycol. Its partition coefficient in octanol/water is constant (log PC = 1.23) over the pH range of 1 to 7. Zaleplon capsules, USP contain zaleplon, USP as the active ingredient. Inactive ingredients consist of lactose monohydrate, pregelatinized starch, microcrystalline cellulose, silicon dioxide, magnesium stearate, gelatin, titanium dioxide, FD&C blue #1, FD&C red #40, and FD&C yellow #5. Ink constituents are: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Complies with USP dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>46708-211-10</NDCCode>
<PackageDescription>100 TABLET in 1 CARTON (46708-211-10) </PackageDescription>
<NDC11Code>46708-0211-10</NDC11Code>
<ProductNDC>46708-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203010</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>TELMISARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>80; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Telmisartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Telmisartan and hydrochlorothiazide. tablets, USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.Telmisartan, a non-peptide molecule, is chemically described as 4’-[(1,4’-dimethyl-2’-propyl[2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H. -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate, lactose monohydrate, magnesium stearate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture.</Description>
</NDC>
<NDC>
<NDCCode>46708-211-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (46708-211-30) </PackageDescription>
<NDC11Code>46708-0211-30</NDC11Code>
<ProductNDC>46708-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203010</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>TELMISARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>80; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Telmisartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Telmisartan and hydrochlorothiazide. tablets, USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.Telmisartan, a non-peptide molecule, is chemically described as 4’-[(1,4’-dimethyl-2’-propyl[2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H. -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate, lactose monohydrate, magnesium stearate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture.</Description>
</NDC>
<NDC>
<NDCCode>46708-211-91</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (46708-211-91) </PackageDescription>
<NDC11Code>46708-0211-91</NDC11Code>
<ProductNDC>46708-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203010</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>TELMISARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>80; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Telmisartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Telmisartan and hydrochlorothiazide. tablets, USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.Telmisartan, a non-peptide molecule, is chemically described as 4’-[(1,4’-dimethyl-2’-propyl[2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H. -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate, lactose monohydrate, magnesium stearate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture.</Description>
</NDC>
<NDC>
<NDCCode>49884-211-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-211-01) </PackageDescription>
<NDC11Code>49884-0211-01</NDC11Code>
<ProductNDC>49884-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078540</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>425</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone HCl Extended Release Capsules, USP are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: : 1 The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules to control ventricular rate during AF. , 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see BOXED WARNING].</IndicationAndUsage>
<Description>Propafenone Hydrochloride Extended Release Capsule, USP is an antiarrhythmic drug supplied in extended-release capsules of 225mg, 325mg and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3‑phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20ºC), chloroform, and ethanol. Propafenone ER capsules are filled with granules containing the following inactive ingredients: ethylcellulose, lactose anhydrous, magnesium stearate and povidone. Each capsule contains titanium dioxide and gelatin. In addition the 325 mg capsule also contains FD&C Blue No. 1, D&C Yellow No. 10 and FD&C Red No. 40 and the 425 mg capsule contains FD&C Blue No. 1, FD&C Red No. 40 and FD&C Yellow No. 6. The black ink consists of D&C Yellow No.10, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1 and shellac glaze~45% (20% esterfied) in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>49884-211-02</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-211-02) </PackageDescription>
<NDC11Code>49884-0211-02</NDC11Code>
<ProductNDC>49884-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078540</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>425</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone HCl Extended Release Capsules, USP are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: : 1 The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules to control ventricular rate during AF. , 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see BOXED WARNING].</IndicationAndUsage>
<Description>Propafenone Hydrochloride Extended Release Capsule, USP is an antiarrhythmic drug supplied in extended-release capsules of 225mg, 325mg and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3‑phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20ºC), chloroform, and ethanol. Propafenone ER capsules are filled with granules containing the following inactive ingredients: ethylcellulose, lactose anhydrous, magnesium stearate and povidone. Each capsule contains titanium dioxide and gelatin. In addition the 325 mg capsule also contains FD&C Blue No. 1, D&C Yellow No. 10 and FD&C Red No. 40 and the 425 mg capsule contains FD&C Blue No. 1, FD&C Red No. 40 and FD&C Yellow No. 6. The black ink consists of D&C Yellow No.10, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1 and shellac glaze~45% (20% esterfied) in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>49884-211-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-211-05) </PackageDescription>
<NDC11Code>49884-0211-05</NDC11Code>
<ProductNDC>49884-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078540</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>425</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone HCl Extended Release Capsules, USP are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: : 1 The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules to control ventricular rate during AF. , 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see BOXED WARNING].</IndicationAndUsage>
<Description>Propafenone Hydrochloride Extended Release Capsule, USP is an antiarrhythmic drug supplied in extended-release capsules of 225mg, 325mg and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3‑phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20ºC), chloroform, and ethanol. Propafenone ER capsules are filled with granules containing the following inactive ingredients: ethylcellulose, lactose anhydrous, magnesium stearate and povidone. Each capsule contains titanium dioxide and gelatin. In addition the 325 mg capsule also contains FD&C Blue No. 1, D&C Yellow No. 10 and FD&C Red No. 40 and the 425 mg capsule contains FD&C Blue No. 1, FD&C Red No. 40 and FD&C Yellow No. 6. The black ink consists of D&C Yellow No.10, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1 and shellac glaze~45% (20% esterfied) in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>49884-211-10</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-211-10) </PackageDescription>
<NDC11Code>49884-0211-10</NDC11Code>
<ProductNDC>49884-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078540</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>425</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone HCl Extended Release Capsules, USP are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: : 1 The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules to control ventricular rate during AF. , 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see BOXED WARNING].</IndicationAndUsage>
<Description>Propafenone Hydrochloride Extended Release Capsule, USP is an antiarrhythmic drug supplied in extended-release capsules of 225mg, 325mg and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3‑phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20ºC), chloroform, and ethanol. Propafenone ER capsules are filled with granules containing the following inactive ingredients: ethylcellulose, lactose anhydrous, magnesium stearate and povidone. Each capsule contains titanium dioxide and gelatin. In addition the 325 mg capsule also contains FD&C Blue No. 1, D&C Yellow No. 10 and FD&C Red No. 40 and the 425 mg capsule contains FD&C Blue No. 1, FD&C Red No. 40 and FD&C Yellow No. 6. The black ink consists of D&C Yellow No.10, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1 and shellac glaze~45% (20% esterfied) in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>50261-211-05</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50261-211-05) / 5 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50261-0211-05</NDC11Code>
<ProductNDC>50261-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bijuva</ProprietaryName>
<NonProprietaryName>Estradiol And Progesterone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190403</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210132</ApplicationNumber>
<LabelerName>Mayne Pharma LLC</LabelerName>
<SubstanceName>ESTRADIOL; PROGESTERONE</SubstanceName>
<StrengthNumber>1; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190403</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>BIJUVA is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause. (1.1).</IndicationAndUsage>
<Description>BIJUVA (estradiol and progesterone) is an oval shaped opaque capsule in which the estradiol is solubilized and the progesterone is micronized and suspended in the mixture of medium chain mono and di-glycerides and lauroyl polyoxyl-32 glycerides. Each 0.5 mg/100 mg capsule is light pink on one side, dark pink on the other side, and printed with "5C1" in white ink. Each 1 mg/100 mg capsule is light pink on one side, dark pink on the other side, and printed with "1C1" in white ink. Estradiol (estra-1,3,5 (10)-triene-3,17β-diol), an estrogen, has a molecular weight of 272.38, and chemical formula C18H24O2. Progesterone (pregn-4-ene-3, 20-dione) has a molecular weight of 314.47, and chemical formula C21H30O2. The structural formulas are as follows. Each BIJUVA (estradiol and progesterone) capsule contains the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, FD&C Red #40, gelatin, glycerin, hydrolyzed gelatin, isopropyl alcohol, lauroyl polyoxyl-32 glycerides, lecithin, medium chain mono and di- glycerides, medium chain triglycerides, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, purified water, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50261-211-30</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50261-211-30) / 30 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50261-0211-30</NDC11Code>
<ProductNDC>50261-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bijuva</ProprietaryName>
<NonProprietaryName>Estradiol And Progesterone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190403</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210132</ApplicationNumber>
<LabelerName>Mayne Pharma LLC</LabelerName>
<SubstanceName>ESTRADIOL; PROGESTERONE</SubstanceName>
<StrengthNumber>1; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BIJUVA is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause. (1.1).</IndicationAndUsage>
<Description>BIJUVA (estradiol and progesterone) is an oval shaped opaque capsule in which the estradiol is solubilized and the progesterone is micronized and suspended in the mixture of medium chain mono and di-glycerides and lauroyl polyoxyl-32 glycerides. Each 0.5 mg/100 mg capsule is light pink on one side, dark pink on the other side, and printed with "5C1" in white ink. Each 1 mg/100 mg capsule is light pink on one side, dark pink on the other side, and printed with "1C1" in white ink. Estradiol (estra-1,3,5 (10)-triene-3,17β-diol), an estrogen, has a molecular weight of 272.38, and chemical formula C18H24O2. Progesterone (pregn-4-ene-3, 20-dione) has a molecular weight of 314.47, and chemical formula C21H30O2. The structural formulas are as follows. Each BIJUVA (estradiol and progesterone) capsule contains the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, FD&C Red #40, gelatin, glycerin, hydrolyzed gelatin, isopropyl alcohol, lauroyl polyoxyl-32 glycerides, lecithin, medium chain mono and di-glycerides, medium chain triglycerides, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, purified water, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50390-211-30</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50390-211-30) / 30 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50390-0211-30</NDC11Code>
<ProductNDC>50390-211</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Artistry Exact Fit Longwearing Foundation Shade Cappuccino</ProprietaryName>
<ProprietaryNameSuffix>L5w1</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Amway Corp</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>40.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51079-211-03</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (51079-211-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-211-01) </PackageDescription>
<NDC11Code>51079-0211-03</NDC11Code>
<ProductNDC>51079-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091226</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 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)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemiaHypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is Calcium ( βR, δR)-2-( p-fluorophenyl)- β, δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl) pyrrole-1-heptanoate (1:2), trihydrate. The molecular formula of atorvastatin calcium is C 66H 68CaF 2N 4O 103H 2O and its molecular weight is 1209. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.84 mg, 21.69 mg, 43.38 mg, or 86.75 mg atorvastatin calcium trihydrate) and the following inactive ingredients: anhydrous lactose, anhydrous sodium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, L-Arginine, magnesium stearate and microcrystalline cellulose. The film coating of the tablets contains polyvinyl alcohol, talc and titanium dioxide, and may contain polyethylene glycol or lecithin and xanthan gum. Meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>51138-211-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51138-211-30)</PackageDescription>
<NDC11Code>51138-0211-30</NDC11Code>
<ProductNDC>51138-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benicar</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021286</ApplicationNumber>
<LabelerName>Med-Health Pharma, LLC</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Benicar is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Benicar. 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 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 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. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically 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 and its structural formula is. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Benicar is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide.</Description>
</NDC>
</NDCList>