{
"NDC": [
{
"NDCCode": "69256-265-31",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (69256-265-31) / 6 TABLET in 1 BLISTER PACK",
"NDC11Code": "69256-0265-31",
"ProductNDC": "69256-265",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-diarrheal/anti-gas",
"NonProprietaryName": "Loperamide Hydrochloride, Simethicone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214541",
"LabelerName": "Harris Teeter, LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE; DIMETHICONE",
"StrengthNumber": "2; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250205",
"SamplePackage": "N",
"IndicationAndUsage": "relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas."
},
{
"NDCCode": "69256-265-33",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (69256-265-33) / 6 TABLET in 1 BLISTER PACK",
"NDC11Code": "69256-0265-33",
"ProductNDC": "69256-265",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-diarrheal/anti-gas",
"NonProprietaryName": "Loperamide Hydrochloride, Simethicone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214541",
"LabelerName": "Harris Teeter, LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE; DIMETHICONE",
"StrengthNumber": "2; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250205",
"SamplePackage": "N",
"IndicationAndUsage": "relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas."
},
{
"NDCCode": "69256-265-73",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (69256-265-73) / 6 TABLET in 1 BLISTER PACK",
"NDC11Code": "69256-0265-73",
"ProductNDC": "69256-265",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-diarrheal/anti-gas",
"NonProprietaryName": "Loperamide Hydrochloride, Simethicone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214541",
"LabelerName": "Harris Teeter, LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE; DIMETHICONE",
"StrengthNumber": "2; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250205",
"SamplePackage": "N",
"IndicationAndUsage": "relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas."
},
{
"NDCCode": "43419-265-31",
"PackageDescription": "1 CONTAINER in 1 CARTON (43419-265-31) / 15 g in 1 CONTAINER",
"NDC11Code": "43419-0265-31",
"ProductNDC": "43419-265",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hera Black Cushion Foundation 31c1",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Amorepacific Corporation",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".9743",
"StrengthUnit": "g/15g",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N"
},
{
"NDCCode": "46708-265-31",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-31) ",
"NDC11Code": "46708-0265-31",
"ProductNDC": "46708-265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202786",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130314",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1).",
"Description": "Ropinirole extended-release tablets contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and one or more of the following: FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc."
},
{
"NDCCode": "52544-265-31",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (52544-265-31) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "52544-0265-31",
"ProductNDC": "52544-265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norinyl",
"NonProprietaryName": "Norethindrone And Mestranol",
"DosageFormName": "KIT",
"StartMarketingDate": "19671117",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016659",
"LabelerName": "Actavis Pharma, Inc.",
"Status": "Deprecated",
"LastUpdate": "2019-01-11",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "69256-292-08",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (69256-292-08) / 237 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "69256-0292-08",
"ProductNDC": "69256-292",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20241210",
"EndMarketingDate": "20260828",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Harris Teeter, LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241210",
"EndMarketingDatePackage": "20260828",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezingrunny nose itchy, watery eyes itching of the nose or throat."
},
{
"NDCCode": "69256-379-34",
"PackageDescription": "1 BOTTLE in 1 CARTON (69256-379-34) > 237 mL in 1 BOTTLE",
"NDC11Code": "69256-0379-34",
"ProductNDC": "69256-379",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Harris Teeter Childrens Allergy",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150624",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Harris Teeter, LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. sneezing. itching of the nose or throat. runny nose. itchy, watery eyes."
},
{
"NDCCode": "29300-316-21",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (29300-316-21) > 3 TABLET in 1 BLISTER PACK (29300-316-31) ",
"NDC11Code": "29300-0316-21",
"ProductNDC": "29300-316",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207836",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170705",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1). Limitations of Use: 1 Use only after clear diagnosis of migraine has been established (1), 2 Not indicated for the prophylactic therapy of migraine (1), 3 Not indicated for the treatment of cluster headache (1).",
"Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25oC. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and magnesium stearate."
},
{
"NDCCode": "29300-316-81",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (29300-316-81) > 3 TABLET in 1 BLISTER PACK (29300-316-31) ",
"NDC11Code": "29300-0316-81",
"ProductNDC": "29300-316",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207836",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170705",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1). Limitations of Use: 1 Use only after clear diagnosis of migraine has been established (1), 2 Not indicated for the prophylactic therapy of migraine (1), 3 Not indicated for the treatment of cluster headache (1).",
"Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25oC. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and magnesium stearate."
},
{
"NDCCode": "29300-317-21",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (29300-317-21) > 3 TABLET in 1 BLISTER PACK (29300-317-31) ",
"NDC11Code": "29300-0317-21",
"ProductNDC": "29300-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207836",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170705",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1). Limitations of Use: 1 Use only after clear diagnosis of migraine has been established (1), 2 Not indicated for the prophylactic therapy of migraine (1), 3 Not indicated for the treatment of cluster headache (1).",
"Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25oC. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and magnesium stearate."
},
{
"NDCCode": "29300-317-81",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (29300-317-81) > 3 TABLET in 1 BLISTER PACK (29300-317-31) ",
"NDC11Code": "29300-0317-81",
"ProductNDC": "29300-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207836",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170705",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1). Limitations of Use: 1 Use only after clear diagnosis of migraine has been established (1), 2 Not indicated for the prophylactic therapy of migraine (1), 3 Not indicated for the treatment of cluster headache (1).",
"Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25oC. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and magnesium stearate."
},
{
"NDCCode": "46708-265-10",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (46708-265-10) ",
"NDC11Code": "46708-0265-10",
"ProductNDC": "46708-265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202786",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130314",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1).",
"Description": "Ropinirole extended-release tablets contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and one or more of the following: FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc."
},
{
"NDCCode": "46708-265-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-30) ",
"NDC11Code": "46708-0265-30",
"ProductNDC": "46708-265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202786",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130314",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1).",
"Description": "Ropinirole extended-release tablets contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and one or more of the following: FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc."
},
{
"NDCCode": "46708-265-71",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-71) ",
"NDC11Code": "46708-0265-71",
"ProductNDC": "46708-265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202786",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130314",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1).",
"Description": "Ropinirole extended-release tablets contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and one or more of the following: FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc."
},
{
"NDCCode": "46708-265-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-90) ",
"NDC11Code": "46708-0265-90",
"ProductNDC": "46708-265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202786",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130314",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1).",
"Description": "Ropinirole extended-release tablets contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and one or more of the following: FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc."
},
{
"NDCCode": "46708-265-91",
"PackageDescription": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-91) ",
"NDC11Code": "46708-0265-91",
"ProductNDC": "46708-265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202786",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130314",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1).",
"Description": "Ropinirole extended-release tablets contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and one or more of the following: FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc."
},
{
"NDCCode": "50090-8038-0",
"PackageDescription": "3 FILM in 1 BOTTLE (50090-8038-0) ",
"NDC11Code": "50090-8038-00",
"ProductNDC": "50090-8038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizafilm",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "FILM",
"RouteName": "ORAL",
"StartMarketingDate": "20260427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205394",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260826",
"SamplePackage": "N",
"IndicationAndUsage": "RizaFilm is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age. Limitations of Use: 1 RizaFilm should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with RizaFilm, the diagnosis of migraine should be reconsidered before RizaFilm is administered to treat any subsequent attacks., 2 RizaFilm is not indicated for the preventive treatment of migraine., 3 Safety and effectiveness of RizaFilm have not been established for cluster headache.",
"Description": "RizaFilm contains rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1 H-1,2,4-triazol-1-ylmethyl)-1 H-indole-3-ethanamine monobenzoate and its structural formula is:. Its empirical formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. RizaFilm oral film is available for oral administration in a 5 mg and 10 mg strength (equivalent to 7.265 mg and 14.53 mg rizatriptan benzoate respectively). Each oral film contains the following inactive ingredients: ammonium glycyrrhizate, butylated hydroxytoluene, copovidone, cupric chloride, ethylcellulose, FD&C Blue No. 1, hydroxypropyl cellulose, isopropyl alcohol, levomenthol, methyl ethyl ketone, sodium acetate, sucralose, titanium dioxide, and triacetin."
},
{
"NDCCode": "50090-8038-1",
"PackageDescription": "9 FILM in 1 BOTTLE (50090-8038-1) ",
"NDC11Code": "50090-8038-01",
"ProductNDC": "50090-8038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizafilm",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "FILM",
"RouteName": "ORAL",
"StartMarketingDate": "20260427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205394",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260826",
"SamplePackage": "N",
"IndicationAndUsage": "RizaFilm is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age. Limitations of Use: 1 RizaFilm should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with RizaFilm, the diagnosis of migraine should be reconsidered before RizaFilm is administered to treat any subsequent attacks., 2 RizaFilm is not indicated for the preventive treatment of migraine., 3 Safety and effectiveness of RizaFilm have not been established for cluster headache.",
"Description": "RizaFilm contains rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1 H-1,2,4-triazol-1-ylmethyl)-1 H-indole-3-ethanamine monobenzoate and its structural formula is:. Its empirical formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. RizaFilm oral film is available for oral administration in a 5 mg and 10 mg strength (equivalent to 7.265 mg and 14.53 mg rizatriptan benzoate respectively). Each oral film contains the following inactive ingredients: ammonium glycyrrhizate, butylated hydroxytoluene, copovidone, cupric chloride, ethylcellulose, FD&C Blue No. 1, hydroxypropyl cellulose, isopropyl alcohol, levomenthol, methyl ethyl ketone, sodium acetate, sucralose, titanium dioxide, and triacetin."
},
{
"NDCCode": "51991-354-78",
"PackageDescription": "18 BLISTER PACK in 1 CARTON (51991-354-78) > 6 TABLET in 1 BLISTER PACK (51991-354-99) ",
"NDC11Code": "51991-0354-78",
"ProductNDC": "51991-354",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121231",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200482",
"LabelerName": "Breckenridge Pharmaceutical, Inc.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121231",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.",
"Description": "Rizatriptan Benzoate Tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its empirical formula is C15H19N5∙C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan Benzoate Tablets, USP are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: ferric oxide (red), lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch."
},
{
"NDCCode": "51991-355-78",
"PackageDescription": "18 BLISTER PACK in 1 CARTON (51991-355-78) > 6 TABLET in 1 BLISTER PACK (51991-355-99) ",
"NDC11Code": "51991-0355-78",
"ProductNDC": "51991-355",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121231",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200482",
"LabelerName": "Breckenridge Pharmaceutical, Inc.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121231",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.",
"Description": "Rizatriptan Benzoate Tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its empirical formula is C15H19N5∙C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan Benzoate Tablets, USP are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: ferric oxide (red), lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch."
},
{
"NDCCode": "54340-265-12",
"PackageDescription": "12 PACKET in 1 PACKAGE (54340-265-12) / 113 g in 1 PACKET",
"NDC11Code": "54340-0265-12",
"ProductNDC": "54340-265",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dial Complete",
"ProprietaryNameSuffix": "White Antibacterial",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210722",
"EndMarketingDate": "20241228",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Henkel Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210722",
"EndMarketingDatePackage": "20241228",
"SamplePackage": "N",
"IndicationAndUsage": "Use For washing to decrease bacteria on the skin."
},
{
"NDCCode": "68071-2635-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (68071-2635-9) ",
"NDC11Code": "68071-2635-09",
"ProductNDC": "68071-2635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076921",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220201",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine tablets, USP contain mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture:. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine USP, and unscored film-coated tablets containing 7.5 or 45 mg of mirtazapine USP. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, and titanium dioxide. In addition, the 15 mg contains iron oxide yellow and 30 mg contains iron oxide red, iron oxide black, and iron oxide yellow."
},
{
"NDCCode": "70518-2819-2",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2819-2) ",
"NDC11Code": "70518-2819-02",
"ProductNDC": "70518-2819",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076921",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230712",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine tablets, USP contain mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture:. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine USP, and unscored film-coated tablets containing 7.5 or 45 mg of mirtazapine USP. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, and titanium dioxide. In addition, the 15 mg contains iron oxide yellow and 30 mg contains iron oxide red, iron oxide black, and iron oxide yellow."
},
{
"NDCCode": "71335-1352-1",
"PackageDescription": "10 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-1) ",
"NDC11Code": "71335-1352-01",
"ProductNDC": "71335-1352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan",
"NonProprietaryName": "Rizatriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203147",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220919",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.",
"Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate."
},
{
"NDCCode": "71335-1352-2",
"PackageDescription": "6 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-2) ",
"NDC11Code": "71335-1352-02",
"ProductNDC": "71335-1352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan",
"NonProprietaryName": "Rizatriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203147",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210308",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.",
"Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate."
},
{
"NDCCode": "71335-1352-3",
"PackageDescription": "90 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-3) ",
"NDC11Code": "71335-1352-03",
"ProductNDC": "71335-1352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan",
"NonProprietaryName": "Rizatriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203147",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220919",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.",
"Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate."
},
{
"NDCCode": "71335-1352-4",
"PackageDescription": "9 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-4) ",
"NDC11Code": "71335-1352-04",
"ProductNDC": "71335-1352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan",
"NonProprietaryName": "Rizatriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203147",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.",
"Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate."
},
{
"NDCCode": "71335-1352-5",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-5) ",
"NDC11Code": "71335-1352-05",
"ProductNDC": "71335-1352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan",
"NonProprietaryName": "Rizatriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203147",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210903",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.",
"Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate."
},
{
"NDCCode": "71335-1352-6",
"PackageDescription": "18 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-6) ",
"NDC11Code": "71335-1352-06",
"ProductNDC": "71335-1352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan",
"NonProprietaryName": "Rizatriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203147",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191011",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.",
"Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>69256-265-31</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (69256-265-31) / 6 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69256-0265-31</NDC11Code>
<ProductNDC>69256-265</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-diarrheal/anti-gas</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride, Simethicone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214541</ApplicationNumber>
<LabelerName>Harris Teeter, LLC</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>2; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69256-265-33</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (69256-265-33) / 6 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69256-0265-33</NDC11Code>
<ProductNDC>69256-265</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-diarrheal/anti-gas</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride, Simethicone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214541</ApplicationNumber>
<LabelerName>Harris Teeter, LLC</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>2; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69256-265-73</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (69256-265-73) / 6 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69256-0265-73</NDC11Code>
<ProductNDC>69256-265</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-diarrheal/anti-gas</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride, Simethicone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214541</ApplicationNumber>
<LabelerName>Harris Teeter, LLC</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>2; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43419-265-31</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (43419-265-31) / 15 g in 1 CONTAINER</PackageDescription>
<NDC11Code>43419-0265-31</NDC11Code>
<ProductNDC>43419-265</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hera Black Cushion Foundation 31c1</ProprietaryName>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Amorepacific Corporation</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.9743</StrengthNumber>
<StrengthUnit>g/15g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46708-265-31</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-31) </PackageDescription>
<NDC11Code>46708-0265-31</NDC11Code>
<ProductNDC>46708-265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202786</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1).</IndicationAndUsage>
<Description>Ropinirole extended-release tablets contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and one or more of the following: FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc.</Description>
</NDC>
<NDC>
<NDCCode>52544-265-31</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (52544-265-31) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>52544-0265-31</NDC11Code>
<ProductNDC>52544-265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norinyl</ProprietaryName>
<NonProprietaryName>Norethindrone And Mestranol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19671117</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016659</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-01-11</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69256-292-08</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (69256-292-08) / 237 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69256-0292-08</NDC11Code>
<ProductNDC>69256-292</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<EndMarketingDate>20260828</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Harris Teeter, LLC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<EndMarketingDatePackage>20260828</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezingrunny nose itchy, watery eyes itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69256-379-34</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69256-379-34) > 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69256-0379-34</NDC11Code>
<ProductNDC>69256-379</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Harris Teeter Childrens Allergy</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150624</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Harris Teeter, LLC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. sneezing. itching of the nose or throat. runny nose. itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>29300-316-21</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (29300-316-21) > 3 TABLET in 1 BLISTER PACK (29300-316-31) </PackageDescription>
<NDC11Code>29300-0316-21</NDC11Code>
<ProductNDC>29300-316</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207836</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1). Limitations of Use: 1 Use only after clear diagnosis of migraine has been established (1), 2 Not indicated for the prophylactic therapy of migraine (1), 3 Not indicated for the treatment of cluster headache (1).</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25oC. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>29300-316-81</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (29300-316-81) > 3 TABLET in 1 BLISTER PACK (29300-316-31) </PackageDescription>
<NDC11Code>29300-0316-81</NDC11Code>
<ProductNDC>29300-316</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207836</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1). Limitations of Use: 1 Use only after clear diagnosis of migraine has been established (1), 2 Not indicated for the prophylactic therapy of migraine (1), 3 Not indicated for the treatment of cluster headache (1).</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25oC. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>29300-317-21</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (29300-317-21) > 3 TABLET in 1 BLISTER PACK (29300-317-31) </PackageDescription>
<NDC11Code>29300-0317-21</NDC11Code>
<ProductNDC>29300-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207836</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1). Limitations of Use: 1 Use only after clear diagnosis of migraine has been established (1), 2 Not indicated for the prophylactic therapy of migraine (1), 3 Not indicated for the treatment of cluster headache (1).</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25oC. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>29300-317-81</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (29300-317-81) > 3 TABLET in 1 BLISTER PACK (29300-317-31) </PackageDescription>
<NDC11Code>29300-0317-81</NDC11Code>
<ProductNDC>29300-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207836</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1). Limitations of Use: 1 Use only after clear diagnosis of migraine has been established (1), 2 Not indicated for the prophylactic therapy of migraine (1), 3 Not indicated for the treatment of cluster headache (1).</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25oC. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>46708-265-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (46708-265-10) </PackageDescription>
<NDC11Code>46708-0265-10</NDC11Code>
<ProductNDC>46708-265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202786</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1).</IndicationAndUsage>
<Description>Ropinirole extended-release tablets contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and one or more of the following: FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc.</Description>
</NDC>
<NDC>
<NDCCode>46708-265-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-30) </PackageDescription>
<NDC11Code>46708-0265-30</NDC11Code>
<ProductNDC>46708-265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202786</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1).</IndicationAndUsage>
<Description>Ropinirole extended-release tablets contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and one or more of the following: FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc.</Description>
</NDC>
<NDC>
<NDCCode>46708-265-71</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-71) </PackageDescription>
<NDC11Code>46708-0265-71</NDC11Code>
<ProductNDC>46708-265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202786</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1).</IndicationAndUsage>
<Description>Ropinirole extended-release tablets contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and one or more of the following: FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc.</Description>
</NDC>
<NDC>
<NDCCode>46708-265-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-90) </PackageDescription>
<NDC11Code>46708-0265-90</NDC11Code>
<ProductNDC>46708-265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202786</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1).</IndicationAndUsage>
<Description>Ropinirole extended-release tablets contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and one or more of the following: FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc.</Description>
</NDC>
<NDC>
<NDCCode>46708-265-91</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-91) </PackageDescription>
<NDC11Code>46708-0265-91</NDC11Code>
<ProductNDC>46708-265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202786</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1).</IndicationAndUsage>
<Description>Ropinirole extended-release tablets contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and one or more of the following: FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc.</Description>
</NDC>
<NDC>
<NDCCode>50090-8038-0</NDCCode>
<PackageDescription>3 FILM in 1 BOTTLE (50090-8038-0) </PackageDescription>
<NDC11Code>50090-8038-00</NDC11Code>
<ProductNDC>50090-8038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizafilm</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205394</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RizaFilm is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age. Limitations of Use: 1 RizaFilm should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with RizaFilm, the diagnosis of migraine should be reconsidered before RizaFilm is administered to treat any subsequent attacks., 2 RizaFilm is not indicated for the preventive treatment of migraine., 3 Safety and effectiveness of RizaFilm have not been established for cluster headache.</IndicationAndUsage>
<Description>RizaFilm contains rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1 H-1,2,4-triazol-1-ylmethyl)-1 H-indole-3-ethanamine monobenzoate and its structural formula is:. Its empirical formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. RizaFilm oral film is available for oral administration in a 5 mg and 10 mg strength (equivalent to 7.265 mg and 14.53 mg rizatriptan benzoate respectively). Each oral film contains the following inactive ingredients: ammonium glycyrrhizate, butylated hydroxytoluene, copovidone, cupric chloride, ethylcellulose, FD&C Blue No. 1, hydroxypropyl cellulose, isopropyl alcohol, levomenthol, methyl ethyl ketone, sodium acetate, sucralose, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>50090-8038-1</NDCCode>
<PackageDescription>9 FILM in 1 BOTTLE (50090-8038-1) </PackageDescription>
<NDC11Code>50090-8038-01</NDC11Code>
<ProductNDC>50090-8038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizafilm</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205394</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RizaFilm is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age. Limitations of Use: 1 RizaFilm should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with RizaFilm, the diagnosis of migraine should be reconsidered before RizaFilm is administered to treat any subsequent attacks., 2 RizaFilm is not indicated for the preventive treatment of migraine., 3 Safety and effectiveness of RizaFilm have not been established for cluster headache.</IndicationAndUsage>
<Description>RizaFilm contains rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1 H-1,2,4-triazol-1-ylmethyl)-1 H-indole-3-ethanamine monobenzoate and its structural formula is:. Its empirical formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. RizaFilm oral film is available for oral administration in a 5 mg and 10 mg strength (equivalent to 7.265 mg and 14.53 mg rizatriptan benzoate respectively). Each oral film contains the following inactive ingredients: ammonium glycyrrhizate, butylated hydroxytoluene, copovidone, cupric chloride, ethylcellulose, FD&C Blue No. 1, hydroxypropyl cellulose, isopropyl alcohol, levomenthol, methyl ethyl ketone, sodium acetate, sucralose, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>51991-354-78</NDCCode>
<PackageDescription>18 BLISTER PACK in 1 CARTON (51991-354-78) > 6 TABLET in 1 BLISTER PACK (51991-354-99) </PackageDescription>
<NDC11Code>51991-0354-78</NDC11Code>
<ProductNDC>51991-354</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121231</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200482</ApplicationNumber>
<LabelerName>Breckenridge Pharmaceutical, Inc.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20121231</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.</IndicationAndUsage>
<Description>Rizatriptan Benzoate Tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its empirical formula is C15H19N5∙C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan Benzoate Tablets, USP are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: ferric oxide (red), lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>51991-355-78</NDCCode>
<PackageDescription>18 BLISTER PACK in 1 CARTON (51991-355-78) > 6 TABLET in 1 BLISTER PACK (51991-355-99) </PackageDescription>
<NDC11Code>51991-0355-78</NDC11Code>
<ProductNDC>51991-355</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121231</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200482</ApplicationNumber>
<LabelerName>Breckenridge Pharmaceutical, Inc.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20121231</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.</IndicationAndUsage>
<Description>Rizatriptan Benzoate Tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its empirical formula is C15H19N5∙C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan Benzoate Tablets, USP are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: ferric oxide (red), lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>54340-265-12</NDCCode>
<PackageDescription>12 PACKET in 1 PACKAGE (54340-265-12) / 113 g in 1 PACKET</PackageDescription>
<NDC11Code>54340-0265-12</NDC11Code>
<ProductNDC>54340-265</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dial Complete</ProprietaryName>
<ProprietaryNameSuffix>White Antibacterial</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210722</StartMarketingDate>
<EndMarketingDate>20241228</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Henkel Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210722</StartMarketingDatePackage>
<EndMarketingDatePackage>20241228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use For washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68071-2635-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68071-2635-9) </PackageDescription>
<NDC11Code>68071-2635-09</NDC11Code>
<ProductNDC>68071-2635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076921</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine tablets, USP contain mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture:. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine USP, and unscored film-coated tablets containing 7.5 or 45 mg of mirtazapine USP. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, and titanium dioxide. In addition, the 15 mg contains iron oxide yellow and 30 mg contains iron oxide red, iron oxide black, and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>70518-2819-2</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2819-2) </PackageDescription>
<NDC11Code>70518-2819-02</NDC11Code>
<ProductNDC>70518-2819</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076921</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine tablets, USP contain mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture:. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine USP, and unscored film-coated tablets containing 7.5 or 45 mg of mirtazapine USP. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, and titanium dioxide. In addition, the 15 mg contains iron oxide yellow and 30 mg contains iron oxide red, iron oxide black, and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>71335-1352-1</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-1) </PackageDescription>
<NDC11Code>71335-1352-01</NDC11Code>
<ProductNDC>71335-1352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan</ProprietaryName>
<NonProprietaryName>Rizatriptan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203147</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>71335-1352-2</NDCCode>
<PackageDescription>6 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-2) </PackageDescription>
<NDC11Code>71335-1352-02</NDC11Code>
<ProductNDC>71335-1352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan</ProprietaryName>
<NonProprietaryName>Rizatriptan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203147</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210308</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>71335-1352-3</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-3) </PackageDescription>
<NDC11Code>71335-1352-03</NDC11Code>
<ProductNDC>71335-1352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan</ProprietaryName>
<NonProprietaryName>Rizatriptan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203147</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>71335-1352-4</NDCCode>
<PackageDescription>9 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-4) </PackageDescription>
<NDC11Code>71335-1352-04</NDC11Code>
<ProductNDC>71335-1352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan</ProprietaryName>
<NonProprietaryName>Rizatriptan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203147</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>71335-1352-5</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-5) </PackageDescription>
<NDC11Code>71335-1352-05</NDC11Code>
<ProductNDC>71335-1352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan</ProprietaryName>
<NonProprietaryName>Rizatriptan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203147</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>71335-1352-6</NDCCode>
<PackageDescription>18 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-6) </PackageDescription>
<NDC11Code>71335-1352-06</NDC11Code>
<ProductNDC>71335-1352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan</ProprietaryName>
<NonProprietaryName>Rizatriptan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203147</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate.</Description>
</NDC>
</NDCList>