{
"NDC": [
{
"NDCCode": "61874-075-08",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (61874-075-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "61874-0075-08",
"ProductNDC": "61874-075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viberzi",
"NonProprietaryName": "Eluxadoline",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206940",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "ELUXADOLINE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid mu-Receptor Agonists [MoA], mu-Opioid Receptor Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151001",
"SamplePackage": "Y",
"IndicationAndUsage": "VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).",
"Description": "The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist. The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid. Eluxadoline has a molecular weight of 569.65 and a molecular formula of C32H35N5O5. The chemical structure of eluxadoline is. VIBERZI is available as 75 mg and 100 mg tablets for oral administration. In addition to the active ingredient, eluxadoline, each tablet contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red)."
},
{
"NDCCode": "61874-075-16",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (61874-075-16) / 8 TABLET, FILM COATED in 1 BLISTER PACK (61874-075-08) ",
"NDC11Code": "61874-0075-16",
"ProductNDC": "61874-075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viberzi",
"NonProprietaryName": "Eluxadoline",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206940",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "ELUXADOLINE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid mu-Receptor Agonists [MoA], mu-Opioid Receptor Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "Y",
"IndicationAndUsage": "VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).",
"Description": "The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist. The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid. Eluxadoline has a molecular weight of 569.65 and a molecular formula of C32H35N5O5. The chemical structure of eluxadoline is. VIBERZI is available as 75 mg and 100 mg tablets for oral administration. In addition to the active ingredient, eluxadoline, each tablet contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red)."
},
{
"NDCCode": "61874-075-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (61874-075-60) / 60 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "61874-0075-60",
"ProductNDC": "61874-075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viberzi",
"NonProprietaryName": "Eluxadoline",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206940",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "ELUXADOLINE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid mu-Receptor Agonists [MoA], mu-Opioid Receptor Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151001",
"SamplePackage": "N",
"IndicationAndUsage": "VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).",
"Description": "The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist. The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid. Eluxadoline has a molecular weight of 569.65 and a molecular formula of C32H35N5O5. The chemical structure of eluxadoline is. VIBERZI is available as 75 mg and 100 mg tablets for oral administration. In addition to the active ingredient, eluxadoline, each tablet contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red)."
},
{
"NDCCode": "61874-100-08",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (61874-100-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "61874-0100-08",
"ProductNDC": "61874-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viberzi",
"NonProprietaryName": "Eluxadoline",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206940",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "ELUXADOLINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid mu-Receptor Agonists [MoA], mu-Opioid Receptor Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151001",
"SamplePackage": "Y",
"IndicationAndUsage": "VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).",
"Description": "The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist. The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid. Eluxadoline has a molecular weight of 569.65 and a molecular formula of C32H35N5O5. The chemical structure of eluxadoline is. VIBERZI is available as 75 mg and 100 mg tablets for oral administration. In addition to the active ingredient, eluxadoline, each tablet contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red)."
},
{
"NDCCode": "61874-100-16",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (61874-100-16) / 8 TABLET, FILM COATED in 1 BLISTER PACK (61874-100-08) ",
"NDC11Code": "61874-0100-16",
"ProductNDC": "61874-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viberzi",
"NonProprietaryName": "Eluxadoline",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206940",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "ELUXADOLINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid mu-Receptor Agonists [MoA], mu-Opioid Receptor Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "Y",
"IndicationAndUsage": "VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).",
"Description": "The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist. The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid. Eluxadoline has a molecular weight of 569.65 and a molecular formula of C32H35N5O5. The chemical structure of eluxadoline is. VIBERZI is available as 75 mg and 100 mg tablets for oral administration. In addition to the active ingredient, eluxadoline, each tablet contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red)."
},
{
"NDCCode": "61874-170-08",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (61874-170-08) / 1 KIT in 1 BLISTER PACK * 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK * 6 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "61874-0170-08",
"ProductNDC": "61874-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N",
"IndicationAndUsage": "VRAYLAR® is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies (14.1)], 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies (14.2)], 3 Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults [see Clinical Studies (14.3)], 4 Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains a white to off-white powder of cariprazine HCl, which is equivalent to 1.5, 3, 4.5, or 6 mg of cariprazine base. In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (1.5, 3, and 6 mg), FD&C Blue 1 (3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (3 and 4.5 mg)."
},
{
"NDCCode": "10565-075-08",
"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (10565-075-08) ",
"NDC11Code": "10565-0075-08",
"ProductNDC": "10565-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Hand Sanitizer Unscented",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120321",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Hydrox Laboratories",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120321",
"SamplePackage": "N",
"IndicationAndUsage": "hand sanitizer to help reduce bacteria on the skin that could cause disease."
},
{
"NDCCode": "61715-075-08",
"PackageDescription": "236 mL in 1 BOTTLE (61715-075-08)",
"NDC11Code": "61715-0075-08",
"ProductNDC": "61715-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough And Sore Throat Nighttime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20060828",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Kinray LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "500; 15; 6.25",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "sore throat . headache . minor aches and pains. fever. runny nose and sneezing, cough."
},
{
"NDCCode": "71919-075-08",
"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-075-08) ",
"NDC11Code": "71919-0075-08",
"ProductNDC": "71919-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arbutus Andrachne",
"NonProprietaryName": "Arbutus Andrachne Leafy Shoot",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140319",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARBUTUS ANDRACHNE LEAFY SHOOT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140319",
"SamplePackage": "N"
},
{
"NDCCode": "74235-075-08",
"PackageDescription": "240 mL in 1 BOTTLE (74235-075-08) ",
"NDC11Code": "74235-0075-08",
"ProductNDC": "74235-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clean Rx",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200406",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Quality Innovations Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200406",
"SamplePackage": "N",
"IndicationAndUsage": "Helps decrease bacteria on skin. Recommended for repeated use."
},
{
"NDCCode": "74783-075-08",
"PackageDescription": "236 mL in 1 BOTTLE, DISPENSING (74783-075-08) ",
"NDC11Code": "74783-0075-08",
"ProductNDC": "74783-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200410",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Georgia Pallet Design, LLC",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200410",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "75030-075-08",
"PackageDescription": "236 mL in 1 BOTTLE (75030-075-08) ",
"NDC11Code": "75030-0075-08",
"ProductNDC": "75030-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200430",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Maple Holistics, LLC",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200430",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "75204-075-08",
"PackageDescription": "236 mL in 1 BOTTLE (75204-075-08) ",
"NDC11Code": "75204-0075-08",
"ProductNDC": "75204-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dispotouch",
"ProprietaryNameSuffix": "Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200510",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Martinni Beauty Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200510",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "75404-075-08",
"PackageDescription": "227 mL in 1 BOTTLE, PLASTIC (75404-075-08) ",
"NDC11Code": "75404-0075-08",
"ProductNDC": "75404-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Cloud Nine Vapor LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "75460-075-08",
"PackageDescription": ".238 L in 1 PACKAGE (75460-075-08) ",
"NDC11Code": "75460-0075-08",
"ProductNDC": "75460-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cavalry",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200427",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "CAVALRY SANITIZERS, L.L.C.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200716",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77999-075-08",
"PackageDescription": "236 mL in 1 BOTTLE, SPRAY (77999-075-08) ",
"NDC11Code": "77999-0075-08",
"ProductNDC": "77999-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cleand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"EndMarketingDate": "20230601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "AlphaMicron Inc.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200330",
"EndMarketingDatePackage": "20230601",
"SamplePackage": "N"
},
{
"NDCCode": "78710-075-08",
"PackageDescription": "250 mL in 1 BOTTLE (78710-075-08) ",
"NDC11Code": "78710-0075-08",
"ProductNDC": "78710-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Regal Care",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200604",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SERVICE TOOL COMPANY, L.L.C.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200604",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79903-075-08",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (79903-075-08) / 24 TABLET in 1 BLISTER PACK (79903-075-43) ",
"NDC11Code": "79903-0075-08",
"ProductNDC": "79903-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinus Pe And Allergy",
"NonProprietaryName": "Chlorpheniramine Maleate, Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "WALMART INC.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
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"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:itchy, watery eyesrunny noseitching of the nose or throatnasal congestionsneezingsinus congestion and pressure."
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"PackageDescription": "100 PACKAGE in 1 CANISTER (80443-075-01) > 3.08 mL in 1 PACKAGE",
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"ProductTypeName": "HUMAN OTC DRUG",
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{
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"PackageDescription": "7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-07) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
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"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
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"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
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"StartMarketingDatePackage": "20160301",
"SamplePackage": "Y",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
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{
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"PackageDescription": "1 BLISTER PACK in 1 CARTON (61874-115-17) / 7 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
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"ProductNDC": "61874-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
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"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
},
{
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"PackageDescription": "2 BLISTER PACK in 1 CARTON (61874-115-20) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-11) ",
"NDC11Code": "61874-0115-20",
"ProductNDC": "61874-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
},
{
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"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (61874-115-30) ",
"NDC11Code": "61874-0115-30",
"ProductNDC": "61874-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
},
{
"NDCCode": "61874-130-07",
"PackageDescription": "7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-130-07) ",
"NDC11Code": "61874-0130-07",
"ProductNDC": "61874-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "Y",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
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{
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"PackageDescription": "2 BLISTER PACK in 1 CARTON (61874-130-20) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-130-11) ",
"NDC11Code": "61874-0130-20",
"ProductNDC": "61874-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
},
{
"NDCCode": "61874-130-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (61874-130-30) ",
"NDC11Code": "61874-0130-30",
"ProductNDC": "61874-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
},
{
"NDCCode": "61874-145-07",
"PackageDescription": "7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-145-07) ",
"NDC11Code": "61874-0145-07",
"ProductNDC": "61874-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "4.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "Y",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
},
{
"NDCCode": "61874-145-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (61874-145-30) ",
"NDC11Code": "61874-0145-30",
"ProductNDC": "61874-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "4.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
},
{
"NDCCode": "61874-160-07",
"PackageDescription": "7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-160-07) ",
"NDC11Code": "61874-0160-07",
"ProductNDC": "61874-160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "Y",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
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"LabelerName": "Allergan, Inc.",
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"StrengthUnit": "mg/1",
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"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
}
]
}
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<PackageDescription>1 BLISTER PACK in 1 CARTON (61874-075-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).</IndicationAndUsage>
<Description>The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist. The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid. Eluxadoline has a molecular weight of 569.65 and a molecular formula of C32H35N5O5. The chemical structure of eluxadoline is. VIBERZI is available as 75 mg and 100 mg tablets for oral administration. In addition to the active ingredient, eluxadoline, each tablet contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red).</Description>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).</IndicationAndUsage>
<Description>The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist. The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid. Eluxadoline has a molecular weight of 569.65 and a molecular formula of C32H35N5O5. The chemical structure of eluxadoline is. VIBERZI is available as 75 mg and 100 mg tablets for oral administration. In addition to the active ingredient, eluxadoline, each tablet contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red).</Description>
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<NDC>
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<PackageDescription>1 BOTTLE in 1 CARTON (61874-075-60) / 60 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>61874-0075-60</NDC11Code>
<ProductNDC>61874-075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viberzi</ProprietaryName>
<NonProprietaryName>Eluxadoline</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206940</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
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<DEASchedule>CIV</DEASchedule>
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<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).</IndicationAndUsage>
<Description>The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist. The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid. Eluxadoline has a molecular weight of 569.65 and a molecular formula of C32H35N5O5. The chemical structure of eluxadoline is. VIBERZI is available as 75 mg and 100 mg tablets for oral administration. In addition to the active ingredient, eluxadoline, each tablet contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red).</Description>
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<NDC>
<NDCCode>61874-100-08</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (61874-100-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>61874-0100-08</NDC11Code>
<ProductNDC>61874-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viberzi</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206940</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid mu-Receptor Agonists [MoA], mu-Opioid Receptor Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151001</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).</IndicationAndUsage>
<Description>The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist. The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid. Eluxadoline has a molecular weight of 569.65 and a molecular formula of C32H35N5O5. The chemical structure of eluxadoline is. VIBERZI is available as 75 mg and 100 mg tablets for oral administration. In addition to the active ingredient, eluxadoline, each tablet contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red).</Description>
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<ProductNDC>61874-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viberzi</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
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<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Allergan, Inc.</LabelerName>
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<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).</IndicationAndUsage>
<Description>The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist. The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid. Eluxadoline has a molecular weight of 569.65 and a molecular formula of C32H35N5O5. The chemical structure of eluxadoline is. VIBERZI is available as 75 mg and 100 mg tablets for oral administration. In addition to the active ingredient, eluxadoline, each tablet contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red).</Description>
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<LabelerName>Allergan, Inc.</LabelerName>
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<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VRAYLAR® is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies (14.1)], 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies (14.2)], 3 Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults [see Clinical Studies (14.3)], 4 Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains a white to off-white powder of cariprazine HCl, which is equivalent to 1.5, 3, 4.5, or 6 mg of cariprazine base. In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (1.5, 3, and 6 mg), FD&C Blue 1 (3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (3 and 4.5 mg).</Description>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
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<NDC11Code>61715-0075-08</NDC11Code>
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<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>sore throat . headache . minor aches and pains. fever. runny nose and sneezing, cough.</IndicationAndUsage>
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<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<Status>Deprecated</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<ApplicationNumber>part333A</ApplicationNumber>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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</NDC>
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<PackageDescription>236 mL in 1 BOTTLE (75204-075-08) </PackageDescription>
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<ProductNDC>75204-075</ProductNDC>
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<LabelerName>Martinni Beauty Inc</LabelerName>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
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<NDCCode>75460-075-08</NDCCode>
<PackageDescription>.238 L in 1 PACKAGE (75460-075-08) </PackageDescription>
<NDC11Code>75460-0075-08</NDC11Code>
<ProductNDC>75460-075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cavalry</ProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>CAVALRY SANITIZERS, L.L.C.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
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<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
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<ProductNDC>77999-075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cleand Sanitizer</ProprietaryName>
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<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<EndMarketingDate>20230601</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>AlphaMicron Inc.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<EndMarketingDatePackage>20230601</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>78710-075-08</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE (78710-075-08) </PackageDescription>
<NDC11Code>78710-0075-08</NDC11Code>
<ProductNDC>78710-075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Regal Care</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200604</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>SERVICE TOOL COMPANY, L.L.C.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79903-075-08</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (79903-075-08) / 24 TABLET in 1 BLISTER PACK (79903-075-43) </PackageDescription>
<NDC11Code>79903-0075-08</NDC11Code>
<ProductNDC>79903-075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinus Pe And Allergy</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>WALMART INC.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:itchy, watery eyesrunny noseitching of the nose or throatnasal congestionsneezingsinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80443-075-01</NDCCode>
<PackageDescription>100 PACKAGE in 1 CANISTER (80443-075-01) > 3.08 mL in 1 PACKAGE</PackageDescription>
<NDC11Code>80443-0075-01</NDC11Code>
<ProductNDC>80443-075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pure X Disinfecting Wipes</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol, Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201007</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Snapsak Ltd</LabelerName>
<SubstanceName>ALCOHOL; BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>75; .1</StrengthNumber>
<StrengthUnit>mL/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> For hand washing in order to sanitize skin with a 99.9% efficiency (hands must air dry).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61874-115-07</NDCCode>
<PackageDescription>7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-07) </PackageDescription>
<NDC11Code>61874-0115-07</NDC11Code>
<ProductNDC>61874-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vraylar</ProprietaryName>
<NonProprietaryName>Cariprazine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150917</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204370</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CARIPRAZINE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
</NDC>
<NDC>
<NDCCode>61874-115-17</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (61874-115-17) / 7 CAPSULE, GELATIN COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>61874-0115-17</NDC11Code>
<ProductNDC>61874-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vraylar</ProprietaryName>
<NonProprietaryName>Cariprazine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150917</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204370</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CARIPRAZINE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
</NDC>
<NDC>
<NDCCode>61874-115-20</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (61874-115-20) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-11) </PackageDescription>
<NDC11Code>61874-0115-20</NDC11Code>
<ProductNDC>61874-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vraylar</ProprietaryName>
<NonProprietaryName>Cariprazine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150917</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204370</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CARIPRAZINE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
</NDC>
<NDC>
<NDCCode>61874-115-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (61874-115-30) </PackageDescription>
<NDC11Code>61874-0115-30</NDC11Code>
<ProductNDC>61874-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vraylar</ProprietaryName>
<NonProprietaryName>Cariprazine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150917</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204370</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CARIPRAZINE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
</NDC>
<NDC>
<NDCCode>61874-130-07</NDCCode>
<PackageDescription>7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-130-07) </PackageDescription>
<NDC11Code>61874-0130-07</NDC11Code>
<ProductNDC>61874-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vraylar</ProprietaryName>
<NonProprietaryName>Cariprazine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150917</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204370</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CARIPRAZINE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
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<IndicationAndUsage>VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
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<IndicationAndUsage>VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
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<LabelerName>Allergan, Inc.</LabelerName>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
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<IndicationAndUsage>VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
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<LabelerName>Allergan, Inc.</LabelerName>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
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<IndicationAndUsage>VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
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