{
"NDC": [
{
"NDCCode": "72657-124-42",
"PackageDescription": "3 BOTTLE in 1 CARTON (72657-124-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "72657-0124-42",
"ProductNDC": "72657-124",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216349",
"LabelerName": "GLENMARK THERAPEUTICS INC., USA",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230822",
"SamplePackage": "N",
"Description": "Drug Facts. Active ingredient (in each capsule). Esomeprazole 20 mg. (Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate). Purpose. Acid reducer. Uses: 1 treats frequent heartburn (occurs 2 or more days a week), 2 not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "83324-182-42",
"PackageDescription": "124 mL in 1 TUBE (83324-182-42) ",
"NDC11Code": "83324-0182-42",
"ProductNDC": "83324-182",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260722",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Chain Drug Marketing Association",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260722",
"SamplePackage": "N",
"IndicationAndUsage": "for the treatment of acne."
},
{
"NDCCode": "72657-127-42",
"PackageDescription": "3 BOTTLE in 1 CARTON (72657-127-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "72657-0127-42",
"ProductNDC": "72657-127",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216349",
"LabelerName": "GLENMARK THERAPEUTICS INC., USA",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250806",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "72657-159-42",
"PackageDescription": "3 BOTTLE in 1 CARTON (72657-159-42) / 144 SPRAY, METERED in 1 BOTTLE",
"NDC11Code": "72657-0159-42",
"ProductNDC": "72657-159",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fluticasone Propionate",
"ProprietaryNameSuffix": "Allergy Relief",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20260316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218742",
"LabelerName": "GLENMARK THERAPEUTICS INC., USA",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260316",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 itchy nose, 3 runny nose, 4 itchy, watery eyes, 5 sneezing."
},
{
"NDCCode": "0006-5084-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) ",
"NDC11Code": "00006-5084-01",
"ProductNDC": "0006-5084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipfendra",
"NonProprietaryName": "Lipfendra",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220848",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ENLICITIDE DECANOATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260715",
"SamplePackage": "N",
"IndicationAndUsage": "LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.",
"Description": "LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent."
},
{
"NDCCode": "0006-5084-59",
"PackageDescription": "1 BOTTLE in 1 CARTON (0006-5084-59) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5084-58) ",
"NDC11Code": "00006-5084-59",
"ProductNDC": "0006-5084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipfendra",
"NonProprietaryName": "Lipfendra",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220848",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ENLICITIDE DECANOATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260715",
"SamplePackage": "Y",
"IndicationAndUsage": "LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.",
"Description": "LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent."
},
{
"NDCCode": "0245-0215-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (0245-0215-60)",
"NDC11Code": "00245-0215-60",
"ProductNDC": "0245-0215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "B-nexa",
"NonProprietaryName": "Pyridoxine, Folic Acid, Calcium, And Ginger",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120815",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "PYRIDOXINE; FOLIC ACID; CALCIUM; GINGER",
"StrengthNumber": "42; 1.22; 124.23; 100",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-10-26"
},
{
"NDCCode": "41190-124-86",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (41190-124-86) ",
"NDC11Code": "41190-0124-86",
"ProductNDC": "41190-124",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antispetic",
"NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "20090804",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Wakefern Food Corp",
"SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
"StrengthNumber": ".92; .42; .6; .64",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090804",
"SamplePackage": "N",
"IndicationAndUsage": "help control plaque that leads to gingivitis."
},
{
"NDCCode": "53675-154-04",
"PackageDescription": "124 mL in 1 JAR (53675-154-04) ",
"NDC11Code": "53675-0154-04",
"ProductNDC": "53675-154",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aruba Aloe Very Water Resistant Sunscreen - For Faces",
"ProprietaryNameSuffix": "Spf 30",
"NonProprietaryName": "Homosalate, Octinoxate, Padimate O, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110706",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Aruba Aloe Balm NV",
"SubstanceName": "HOMOSALATE; OCTINOXATE; OXYBENZONE; PADIMATE O",
"StrengthNumber": "80; 70; 30; 42",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110706",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 80 minutes of activity in the water or perspiring ."
},
{
"NDCCode": "54766-894-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (54766-894-03) ",
"NDC11Code": "54766-0894-03",
"ProductNDC": "54766-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lotronex",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160711",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021107",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160711",
"SamplePackage": "N",
"IndicationAndUsage": "LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.",
"Description": "The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT 3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C 17H 18N 4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. LOTRONEX Tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine."
},
{
"NDCCode": "54766-895-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (54766-895-03) ",
"NDC11Code": "54766-0895-03",
"ProductNDC": "54766-895",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lotronex",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160711",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021107",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160711",
"SamplePackage": "N",
"IndicationAndUsage": "LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.",
"Description": "The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT 3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C 17H 18N 4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. LOTRONEX Tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine."
},
{
"NDCCode": "58657-105-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (58657-105-60)",
"NDC11Code": "58657-0105-60",
"ProductNDC": "58657-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Focalgin B",
"NonProprietaryName": "Pyridoxine Hydrochloride, Folic Acid, Calcium, And Ginger",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "CALCIUM; FOLIC ACID; GINGER; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "124.23; 1.22; 100; 42",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "63629-2517-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (63629-2517-1) ",
"NDC11Code": "63629-2517-01",
"ProductNDC": "63629-2517",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron",
"NonProprietaryName": "Alosetron",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213614",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220429",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.",
"Description": "The active ingredient in alosetron tablets USP, is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP, are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, and titanium dioxide. The blue film coat for the 1 mg tablet contains hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue #2 - Aluminum Lake and Iron Oxide Yellow."
},
{
"NDCCode": "63629-2518-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (63629-2518-1) ",
"NDC11Code": "63629-2518-01",
"ProductNDC": "63629-2518",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron",
"NonProprietaryName": "Alosetron",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213614",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210329",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.",
"Description": "The active ingredient in alosetron tablets USP, is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP, are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, and titanium dioxide. The blue film coat for the 1 mg tablet contains hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue #2 - Aluminum Lake and Iron Oxide Yellow."
},
{
"NDCCode": "64980-453-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (64980-453-03) ",
"NDC11Code": "64980-0453-03",
"ProductNDC": "64980-453",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209180",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190114",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.",
"Description": "The active ingredient in alosetron hydrochloride tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron hydrochloride tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine."
},
{
"NDCCode": "64980-453-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (64980-453-50) ",
"NDC11Code": "64980-0453-50",
"ProductNDC": "64980-453",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209180",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190114",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.",
"Description": "The active ingredient in alosetron hydrochloride tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron hydrochloride tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine."
},
{
"NDCCode": "64980-454-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (64980-454-03) ",
"NDC11Code": "64980-0454-03",
"ProductNDC": "64980-454",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209180",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190114",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.",
"Description": "The active ingredient in alosetron hydrochloride tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron hydrochloride tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine."
},
{
"NDCCode": "64980-454-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (64980-454-50) ",
"NDC11Code": "64980-0454-50",
"ProductNDC": "64980-454",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209180",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190114",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.",
"Description": "The active ingredient in alosetron hydrochloride tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron hydrochloride tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine."
},
{
"NDCCode": "65162-248-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (65162-248-03) ",
"NDC11Code": "65162-0248-03",
"ProductNDC": "65162-248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206647",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170102",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .",
"Description": "The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (light blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USPequivalent to 0.5 mg alosetron and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USPequivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. The light blue film coat for the 1 mg tablet contains FD&C blue #2, hypromellose, macrogol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "65162-248-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65162-248-50) ",
"NDC11Code": "65162-0248-50",
"ProductNDC": "65162-248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206647",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170102",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .",
"Description": "The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (light blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USPequivalent to 0.5 mg alosetron and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USPequivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. The light blue film coat for the 1 mg tablet contains FD&C blue #2, hypromellose, macrogol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "65162-249-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (65162-249-03) ",
"NDC11Code": "65162-0249-03",
"ProductNDC": "65162-249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206647",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170102",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .",
"Description": "The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (light blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USPequivalent to 0.5 mg alosetron and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USPequivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. The light blue film coat for the 1 mg tablet contains FD&C blue #2, hypromellose, macrogol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "65162-249-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65162-249-50) ",
"NDC11Code": "65162-0249-50",
"ProductNDC": "65162-249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206647",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170102",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .",
"Description": "The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (light blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USPequivalent to 0.5 mg alosetron and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USPequivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. The light blue film coat for the 1 mg tablet contains FD&C blue #2, hypromellose, macrogol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "65483-894-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (65483-894-03)",
"NDC11Code": "65483-0894-03",
"ProductNDC": "65483-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lotronex",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090209",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021107",
"LabelerName": "Prometheus Laboratories Inc.",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .",
"Description": "The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. LOTRONEX Tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine."
},
{
"NDCCode": "65483-895-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (65483-895-03)",
"NDC11Code": "65483-0895-03",
"ProductNDC": "65483-895",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lotronex",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090209",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021107",
"LabelerName": "Prometheus Laboratories Inc.",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .",
"Description": "The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. LOTRONEX Tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine."
},
{
"NDCCode": "70756-701-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (70756-701-30) ",
"NDC11Code": "70756-0701-30",
"ProductNDC": "70756-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron",
"NonProprietaryName": "Alosetron",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213614",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200914",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.",
"Description": "The active ingredient in alosetron tablets USP, is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP, are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, and titanium dioxide. The blue film coat for the 1 mg tablet contains hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue #2 - Aluminum Lake and Iron Oxide Yellow."
},
{
"NDCCode": "70756-702-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (70756-702-30) ",
"NDC11Code": "70756-0702-30",
"ProductNDC": "70756-702",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron",
"NonProprietaryName": "Alosetron",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213614",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200914",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.",
"Description": "The active ingredient in alosetron tablets USP, is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP, are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, and titanium dioxide. The blue film coat for the 1 mg tablet contains hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue #2 - Aluminum Lake and Iron Oxide Yellow."
},
{
"NDCCode": "76162-124-86",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (76162-124-86) ",
"NDC11Code": "76162-0124-86",
"ProductNDC": "76162-124",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antispetic",
"NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "20090804",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "TOPCO ASSOCIATES LLC",
"SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
"StrengthNumber": ".92; .42; .6; .64",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090804",
"SamplePackage": "N",
"IndicationAndUsage": "help control plaque that leads to gingivitis."
},
{
"NDCCode": "83107-012-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (83107-012-30) ",
"NDC11Code": "83107-0012-30",
"ProductNDC": "83107-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lotronex",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021107",
"LabelerName": "Legacy Pharma USA Inc.",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "N",
"IndicationAndUsage": "LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.",
"Description": "The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT 3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C 17H 18N 4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. LOTRONEX Tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine."
},
{
"NDCCode": "83107-013-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (83107-013-30) ",
"NDC11Code": "83107-0013-30",
"ProductNDC": "83107-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lotronex",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021107",
"LabelerName": "Legacy Pharma USA Inc.",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "N",
"IndicationAndUsage": "LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.",
"Description": "The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT 3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C 17H 18N 4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. LOTRONEX Tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine."
},
{
"NDCCode": "72657-102-17",
"PackageDescription": "1 TUBE in 1 CARTON (72657-102-17) / 15 g in 1 TUBE",
"NDC11Code": "72657-0102-17",
"ProductNDC": "72657-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Adapalene",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091314",
"LabelerName": "GLENMARK THERAPEUTICS INC., USA",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230101",
"EndMarketingDatePackage": "20260301",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of acne."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>72657-124-42</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (72657-124-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>72657-0124-42</NDC11Code>
<ProductNDC>72657-124</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216349</ApplicationNumber>
<LabelerName>GLENMARK THERAPEUTICS INC., USA</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Drug Facts. Active ingredient (in each capsule). Esomeprazole 20 mg. (Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate). Purpose. Acid reducer. Uses: 1 treats frequent heartburn (occurs 2 or more days a week), 2 not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</Description>
</NDC>
<NDC>
<NDCCode>83324-182-42</NDCCode>
<PackageDescription>124 mL in 1 TUBE (83324-182-42) </PackageDescription>
<NDC11Code>83324-0182-42</NDC11Code>
<ProductNDC>83324-182</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salicylic Acid</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260722</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Chain Drug Marketing Association</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72657-127-42</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (72657-127-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>72657-0127-42</NDC11Code>
<ProductNDC>72657-127</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216349</ApplicationNumber>
<LabelerName>GLENMARK THERAPEUTICS INC., USA</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72657-159-42</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (72657-159-42) / 144 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>72657-0159-42</NDC11Code>
<ProductNDC>72657-159</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate</ProprietaryName>
<ProprietaryNameSuffix>Allergy Relief</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20260316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218742</ApplicationNumber>
<LabelerName>GLENMARK THERAPEUTICS INC., USA</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 itchy nose, 3 runny nose, 4 itchy, watery eyes, 5 sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0006-5084-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) </PackageDescription>
<NDC11Code>00006-5084-01</NDC11Code>
<ProductNDC>0006-5084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lipfendra</ProprietaryName>
<NonProprietaryName>Lipfendra</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220848</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>ENLICITIDE DECANOATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.</IndicationAndUsage>
<Description>LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent.</Description>
</NDC>
<NDC>
<NDCCode>0006-5084-59</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0006-5084-59) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5084-58) </PackageDescription>
<NDC11Code>00006-5084-59</NDC11Code>
<ProductNDC>0006-5084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lipfendra</ProprietaryName>
<NonProprietaryName>Lipfendra</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220848</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>ENLICITIDE DECANOATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260715</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.</IndicationAndUsage>
<Description>LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent.</Description>
</NDC>
<NDC>
<NDCCode>0245-0215-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (0245-0215-60)</PackageDescription>
<NDC11Code>00245-0215-60</NDC11Code>
<ProductNDC>0245-0215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>B-nexa</ProprietaryName>
<NonProprietaryName>Pyridoxine, Folic Acid, Calcium, And Ginger</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>PYRIDOXINE; FOLIC ACID; CALCIUM; GINGER</SubstanceName>
<StrengthNumber>42; 1.22; 124.23; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>41190-124-86</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (41190-124-86) </PackageDescription>
<NDC11Code>41190-0124-86</NDC11Code>
<ProductNDC>41190-124</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antispetic</ProprietaryName>
<NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090804</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Wakefern Food Corp</LabelerName>
<SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
<StrengthNumber>.92; .42; .6; .64</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>help control plaque that leads to gingivitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53675-154-04</NDCCode>
<PackageDescription>124 mL in 1 JAR (53675-154-04) </PackageDescription>
<NDC11Code>53675-0154-04</NDC11Code>
<ProductNDC>53675-154</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aruba Aloe Very Water Resistant Sunscreen - For Faces</ProprietaryName>
<ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Homosalate, Octinoxate, Padimate O, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110706</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Aruba Aloe Balm NV</LabelerName>
<SubstanceName>HOMOSALATE; OCTINOXATE; OXYBENZONE; PADIMATE O</SubstanceName>
<StrengthNumber>80; 70; 30; 42</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 80 minutes of activity in the water or perspiring .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54766-894-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (54766-894-03) </PackageDescription>
<NDC11Code>54766-0894-03</NDC11Code>
<ProductNDC>54766-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lotronex</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160711</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021107</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.</IndicationAndUsage>
<Description>The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT 3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C 17H 18N 4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. LOTRONEX Tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>54766-895-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (54766-895-03) </PackageDescription>
<NDC11Code>54766-0895-03</NDC11Code>
<ProductNDC>54766-895</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lotronex</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160711</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021107</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.</IndicationAndUsage>
<Description>The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT 3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C 17H 18N 4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. LOTRONEX Tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>58657-105-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (58657-105-60)</PackageDescription>
<NDC11Code>58657-0105-60</NDC11Code>
<ProductNDC>58657-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Focalgin B</ProprietaryName>
<NonProprietaryName>Pyridoxine Hydrochloride, Folic Acid, Calcium, And Ginger</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CALCIUM; FOLIC ACID; GINGER; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>124.23; 1.22; 100; 42</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>63629-2517-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (63629-2517-1) </PackageDescription>
<NDC11Code>63629-2517-01</NDC11Code>
<ProductNDC>63629-2517</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron</ProprietaryName>
<NonProprietaryName>Alosetron</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213614</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.</IndicationAndUsage>
<Description>The active ingredient in alosetron tablets USP, is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP, are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, and titanium dioxide. The blue film coat for the 1 mg tablet contains hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue #2 - Aluminum Lake and Iron Oxide Yellow.</Description>
</NDC>
<NDC>
<NDCCode>63629-2518-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (63629-2518-1) </PackageDescription>
<NDC11Code>63629-2518-01</NDC11Code>
<ProductNDC>63629-2518</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron</ProprietaryName>
<NonProprietaryName>Alosetron</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213614</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.</IndicationAndUsage>
<Description>The active ingredient in alosetron tablets USP, is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP, are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, and titanium dioxide. The blue film coat for the 1 mg tablet contains hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue #2 - Aluminum Lake and Iron Oxide Yellow.</Description>
</NDC>
<NDC>
<NDCCode>64980-453-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (64980-453-03) </PackageDescription>
<NDC11Code>64980-0453-03</NDC11Code>
<ProductNDC>64980-453</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209180</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.</IndicationAndUsage>
<Description>The active ingredient in alosetron hydrochloride tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron hydrochloride tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>64980-453-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (64980-453-50) </PackageDescription>
<NDC11Code>64980-0453-50</NDC11Code>
<ProductNDC>64980-453</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209180</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.</IndicationAndUsage>
<Description>The active ingredient in alosetron hydrochloride tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron hydrochloride tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>64980-454-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (64980-454-03) </PackageDescription>
<NDC11Code>64980-0454-03</NDC11Code>
<ProductNDC>64980-454</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209180</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.</IndicationAndUsage>
<Description>The active ingredient in alosetron hydrochloride tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron hydrochloride tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>64980-454-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (64980-454-50) </PackageDescription>
<NDC11Code>64980-0454-50</NDC11Code>
<ProductNDC>64980-454</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209180</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.</IndicationAndUsage>
<Description>The active ingredient in alosetron hydrochloride tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron hydrochloride tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>65162-248-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (65162-248-03) </PackageDescription>
<NDC11Code>65162-0248-03</NDC11Code>
<ProductNDC>65162-248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206647</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .</IndicationAndUsage>
<Description>The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (light blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USPequivalent to 0.5 mg alosetron and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USPequivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. The light blue film coat for the 1 mg tablet contains FD&C blue #2, hypromellose, macrogol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65162-248-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65162-248-50) </PackageDescription>
<NDC11Code>65162-0248-50</NDC11Code>
<ProductNDC>65162-248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206647</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .</IndicationAndUsage>
<Description>The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (light blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USPequivalent to 0.5 mg alosetron and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USPequivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. The light blue film coat for the 1 mg tablet contains FD&C blue #2, hypromellose, macrogol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65162-249-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (65162-249-03) </PackageDescription>
<NDC11Code>65162-0249-03</NDC11Code>
<ProductNDC>65162-249</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206647</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .</IndicationAndUsage>
<Description>The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (light blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USPequivalent to 0.5 mg alosetron and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USPequivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. The light blue film coat for the 1 mg tablet contains FD&C blue #2, hypromellose, macrogol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65162-249-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65162-249-50) </PackageDescription>
<NDC11Code>65162-0249-50</NDC11Code>
<ProductNDC>65162-249</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206647</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .</IndicationAndUsage>
<Description>The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (light blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USPequivalent to 0.5 mg alosetron and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USPequivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. The light blue film coat for the 1 mg tablet contains FD&C blue #2, hypromellose, macrogol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65483-894-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (65483-894-03)</PackageDescription>
<NDC11Code>65483-0894-03</NDC11Code>
<ProductNDC>65483-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lotronex</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090209</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021107</ApplicationNumber>
<LabelerName>Prometheus Laboratories Inc.</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .</IndicationAndUsage>
<Description>The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. LOTRONEX Tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>65483-895-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (65483-895-03)</PackageDescription>
<NDC11Code>65483-0895-03</NDC11Code>
<ProductNDC>65483-895</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lotronex</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090209</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021107</ApplicationNumber>
<LabelerName>Prometheus Laboratories Inc.</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .</IndicationAndUsage>
<Description>The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. LOTRONEX Tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>70756-701-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70756-701-30) </PackageDescription>
<NDC11Code>70756-0701-30</NDC11Code>
<ProductNDC>70756-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron</ProprietaryName>
<NonProprietaryName>Alosetron</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213614</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.</IndicationAndUsage>
<Description>The active ingredient in alosetron tablets USP, is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP, are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, and titanium dioxide. The blue film coat for the 1 mg tablet contains hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue #2 - Aluminum Lake and Iron Oxide Yellow.</Description>
</NDC>
<NDC>
<NDCCode>70756-702-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70756-702-30) </PackageDescription>
<NDC11Code>70756-0702-30</NDC11Code>
<ProductNDC>70756-702</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron</ProprietaryName>
<NonProprietaryName>Alosetron</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213614</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.</IndicationAndUsage>
<Description>The active ingredient in alosetron tablets USP, is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP, are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, and titanium dioxide. The blue film coat for the 1 mg tablet contains hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue #2 - Aluminum Lake and Iron Oxide Yellow.</Description>
</NDC>
<NDC>
<NDCCode>76162-124-86</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (76162-124-86) </PackageDescription>
<NDC11Code>76162-0124-86</NDC11Code>
<ProductNDC>76162-124</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antispetic</ProprietaryName>
<NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090804</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>TOPCO ASSOCIATES LLC</LabelerName>
<SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
<StrengthNumber>.92; .42; .6; .64</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>help control plaque that leads to gingivitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83107-012-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (83107-012-30) </PackageDescription>
<NDC11Code>83107-0012-30</NDC11Code>
<ProductNDC>83107-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lotronex</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021107</ApplicationNumber>
<LabelerName>Legacy Pharma USA Inc.</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.</IndicationAndUsage>
<Description>The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT 3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C 17H 18N 4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. LOTRONEX Tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>83107-013-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (83107-013-30) </PackageDescription>
<NDC11Code>83107-0013-30</NDC11Code>
<ProductNDC>83107-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lotronex</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021107</ApplicationNumber>
<LabelerName>Legacy Pharma USA Inc.</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.</IndicationAndUsage>
<Description>The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT 3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C 17H 18N 4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. LOTRONEX Tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>72657-102-17</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72657-102-17) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>72657-0102-17</NDC11Code>
<ProductNDC>72657-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Adapalene</ProprietaryName>
<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091314</ApplicationNumber>
<LabelerName>GLENMARK THERAPEUTICS INC., USA</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230101</StartMarketingDatePackage>
<EndMarketingDatePackage>20260301</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of acne.</IndicationAndUsage>
</NDC>
</NDCList>