{
"NDC": [
{
"NDCCode": "17772-102-10",
"PackageDescription": "5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-102-10) ",
"NDC11Code": "17772-0102-10",
"ProductNDC": "17772-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20130816",
"SamplePackage": "Y",
"IndicationAndUsage": "TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
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"PackageDescription": "5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-101-10) ",
"NDC11Code": "17772-0101-10",
"ProductNDC": "17772-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130816",
"SamplePackage": "Y",
"IndicationAndUsage": "TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
"NDCCode": "17772-103-10",
"PackageDescription": "5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-10) ",
"NDC11Code": "17772-0103-10",
"ProductNDC": "17772-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130816",
"SamplePackage": "Y",
"IndicationAndUsage": "TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
"NDCCode": "17772-104-10",
"PackageDescription": "5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-104-10) ",
"NDC11Code": "17772-0104-10",
"ProductNDC": "17772-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130816",
"SamplePackage": "Y",
"IndicationAndUsage": "TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
"NDCCode": "17772-121-10",
"PackageDescription": "5 TABLET in 1 BLISTER PACK (17772-121-10) ",
"NDC11Code": "17772-0121-10",
"ProductNDC": "17772-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxtellar Xr",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130117",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202810",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130117",
"SamplePackage": "Y",
"IndicationAndUsage": "Oxtellar XR is indicated for the treatment of partial-onset seizures in patients 6 years of age and older.",
"Description": "Oxtellar XR is an antiepileptic drug (AED). Oxtellar XR extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is off-white to yellow crystalline powder. Oxcarbazepine is sparingly soluble in chloroform (30-100 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 40 mg/L (0.04 g/L) at pH 7.0, 25°C. The molecular formula is C 15H 12N 2O 2and its molecular weight is 252.27. Oxtellar XR tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, yellow iron oxide (150 mg, 300 mg tablets only), red iron oxide (300 mg, 600 mg tablets only), black iron oxide (300 mg tablet only), magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium lauryl sulfate, talc, and titanium dioxide. Each tablet is printed on one side with edible black ink."
},
{
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"PackageDescription": "5 TABLET in 1 BLISTER PACK (17772-122-10) ",
"NDC11Code": "17772-0122-10",
"ProductNDC": "17772-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxtellar Xr",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130117",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202810",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130117",
"SamplePackage": "Y",
"IndicationAndUsage": "Oxtellar XR is indicated for the treatment of partial-onset seizures in patients 6 years of age and older.",
"Description": "Oxtellar XR is an antiepileptic drug (AED). Oxtellar XR extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is off-white to yellow crystalline powder. Oxcarbazepine is sparingly soluble in chloroform (30-100 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 40 mg/L (0.04 g/L) at pH 7.0, 25°C. The molecular formula is C 15H 12N 2O 2and its molecular weight is 252.27. Oxtellar XR tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, yellow iron oxide (150 mg, 300 mg tablets only), red iron oxide (300 mg, 600 mg tablets only), black iron oxide (300 mg tablet only), magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium lauryl sulfate, talc, and titanium dioxide. Each tablet is printed on one side with edible black ink."
},
{
"NDCCode": "17772-123-10",
"PackageDescription": "5 TABLET in 1 BLISTER PACK (17772-123-10) ",
"NDC11Code": "17772-0123-10",
"ProductNDC": "17772-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxtellar Xr",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130117",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202810",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130117",
"SamplePackage": "Y",
"IndicationAndUsage": "Oxtellar XR is indicated for the treatment of partial-onset seizures in patients 6 years of age and older.",
"Description": "Oxtellar XR is an antiepileptic drug (AED). Oxtellar XR extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is off-white to yellow crystalline powder. Oxcarbazepine is sparingly soluble in chloroform (30-100 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 40 mg/L (0.04 g/L) at pH 7.0, 25°C. The molecular formula is C 15H 12N 2O 2and its molecular weight is 252.27. Oxtellar XR tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, yellow iron oxide (150 mg, 300 mg tablets only), red iron oxide (300 mg, 600 mg tablets only), black iron oxide (300 mg tablet only), magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium lauryl sulfate, talc, and titanium dioxide. Each tablet is printed on one side with edible black ink."
},
{
"NDCCode": "17772-102-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-01) ",
"NDC11Code": "17772-0102-01",
"ProductNDC": "17772-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130816",
"SamplePackage": "N",
"IndicationAndUsage": "TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
"NDCCode": "17772-102-03",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-03) ",
"NDC11Code": "17772-0102-03",
"ProductNDC": "17772-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-03-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130816",
"SamplePackage": "Y"
},
{
"NDCCode": "17772-102-07",
"PackageDescription": "7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-07) ",
"NDC11Code": "17772-0102-07",
"ProductNDC": "17772-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200623",
"SamplePackage": "Y",
"IndicationAndUsage": "TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
"NDCCode": "17772-102-12",
"PackageDescription": "7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-102-12) ",
"NDC11Code": "17772-0102-12",
"ProductNDC": "17772-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130816",
"SamplePackage": "Y",
"IndicationAndUsage": "TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
"NDCCode": "17772-102-15",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-102-15) ",
"NDC11Code": "17772-0102-15",
"ProductNDC": "17772-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130816",
"SamplePackage": "N"
},
{
"NDCCode": "17772-102-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-30) ",
"NDC11Code": "17772-0102-30",
"ProductNDC": "17772-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130816",
"SamplePackage": "N",
"IndicationAndUsage": "TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
"NDCCode": "17772-085-21",
"PackageDescription": "21 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-21) ",
"NDC11Code": "17772-0085-21",
"ProductNDC": "17772-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "68.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "Y",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17N∙HCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "17772-085-60",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-60) ",
"NDC11Code": "17772-0085-60",
"ProductNDC": "17772-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "68.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "N",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17N∙HCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "17772-101-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-101-01) ",
"NDC11Code": "17772-0101-01",
"ProductNDC": "17772-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130816",
"SamplePackage": "N",
"IndicationAndUsage": "TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
"NDCCode": "17772-101-07",
"PackageDescription": "7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-101-07) ",
"NDC11Code": "17772-0101-07",
"ProductNDC": "17772-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200623",
"SamplePackage": "Y",
"IndicationAndUsage": "TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
"NDCCode": "17772-101-12",
"PackageDescription": "7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-101-12) ",
"NDC11Code": "17772-0101-12",
"ProductNDC": "17772-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130816",
"SamplePackage": "Y",
"IndicationAndUsage": "TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
"NDCCode": "17772-101-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-101-30) ",
"NDC11Code": "17772-0101-30",
"ProductNDC": "17772-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130816",
"SamplePackage": "N",
"IndicationAndUsage": "TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
"NDCCode": "17772-103-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-01) ",
"NDC11Code": "17772-0103-01",
"ProductNDC": "17772-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130816",
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"IndicationAndUsage": "TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
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"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
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"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
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"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
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{
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"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
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"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
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"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
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"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Supernus Pharmaceuticals, Inc.",
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"Description": "Oxtellar XR is an antiepileptic drug (AED). Oxtellar XR extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is off-white to yellow crystalline powder. Oxcarbazepine is sparingly soluble in chloroform (30-100 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 40 mg/L (0.04 g/L) at pH 7.0, 25°C. The molecular formula is C 15H 12N 2O 2and its molecular weight is 252.27. Oxtellar XR tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, yellow iron oxide (150 mg, 300 mg tablets only), red iron oxide (300 mg, 600 mg tablets only), black iron oxide (300 mg tablet only), magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium lauryl sulfate, talc, and titanium dioxide. Each tablet is printed on one side with edible black ink."
},
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<IndicationAndUsage>TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF.</Description>
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<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-03-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<SamplePackage>Y</SamplePackage>
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<NDC>
<NDCCode>17772-102-07</NDCCode>
<PackageDescription>7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-07) </PackageDescription>
<NDC11Code>17772-0102-07</NDC11Code>
<ProductNDC>17772-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Supernus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
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<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200623</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF.</Description>
</NDC>
<NDC>
<NDCCode>17772-102-12</NDCCode>
<PackageDescription>7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-102-12) </PackageDescription>
<NDC11Code>17772-0102-12</NDC11Code>
<ProductNDC>17772-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trokendi Xr</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201635</ApplicationNumber>
<LabelerName>Supernus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130816</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF.</Description>
</NDC>
<NDC>
<NDCCode>17772-102-15</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-102-15) </PackageDescription>
<NDC11Code>17772-0102-15</NDC11Code>
<ProductNDC>17772-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trokendi Xr</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201635</ApplicationNumber>
<LabelerName>Supernus Pharmaceuticals</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>17772-102-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-30) </PackageDescription>
<NDC11Code>17772-0102-30</NDC11Code>
<ProductNDC>17772-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trokendi Xr</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201635</ApplicationNumber>
<LabelerName>Supernus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF.</Description>
</NDC>
<NDC>
<NDCCode>17772-085-21</NDCCode>
<PackageDescription>21 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-21) </PackageDescription>
<NDC11Code>17772-0085-21</NDC11Code>
<ProductNDC>17772-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gocovri</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208944</ApplicationNumber>
<LabelerName>Supernus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMANTADINE</SubstanceName>
<StrengthNumber>68.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170824</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17N∙HCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
</NDC>
<NDC>
<NDCCode>17772-085-60</NDCCode>
<PackageDescription>60 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-60) </PackageDescription>
<NDC11Code>17772-0085-60</NDC11Code>
<ProductNDC>17772-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gocovri</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208944</ApplicationNumber>
<LabelerName>Supernus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMANTADINE</SubstanceName>
<StrengthNumber>68.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17N∙HCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
</NDC>
<NDC>
<NDCCode>17772-101-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-101-01) </PackageDescription>
<NDC11Code>17772-0101-01</NDC11Code>
<ProductNDC>17772-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trokendi Xr</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201635</ApplicationNumber>
<LabelerName>Supernus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF.</Description>
</NDC>
<NDC>
<NDCCode>17772-101-07</NDCCode>
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<NDC11Code>17772-0101-07</NDC11Code>
<ProductNDC>17772-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
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<LabelerName>Supernus Pharmaceuticals, Inc.</LabelerName>
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<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200623</StartMarketingDatePackage>
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<IndicationAndUsage>TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
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<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF.</Description>
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<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF.</Description>
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<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF.</Description>
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<IndicationAndUsage>TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF.</Description>
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<IndicationAndUsage>TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF.</Description>
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<IndicationAndUsage>TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF.</Description>
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<IndicationAndUsage>Oxtellar XR is indicated for the treatment of partial-onset seizures in patients 6 years of age and older.</IndicationAndUsage>
<Description>Oxtellar XR is an antiepileptic drug (AED). Oxtellar XR extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is off-white to yellow crystalline powder. Oxcarbazepine is sparingly soluble in chloroform (30-100 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 40 mg/L (0.04 g/L) at pH 7.0, 25°C. The molecular formula is C 15H 12N 2O 2and its molecular weight is 252.27. Oxtellar XR tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, yellow iron oxide (150 mg, 300 mg tablets only), red iron oxide (300 mg, 600 mg tablets only), black iron oxide (300 mg tablet only), magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium lauryl sulfate, talc, and titanium dioxide. Each tablet is printed on one side with edible black ink.</Description>
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<IndicationAndUsage>Oxtellar XR is indicated for the treatment of partial-onset seizures in patients 6 years of age and older.</IndicationAndUsage>
<Description>Oxtellar XR is an antiepileptic drug (AED). Oxtellar XR extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is off-white to yellow crystalline powder. Oxcarbazepine is sparingly soluble in chloroform (30-100 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 40 mg/L (0.04 g/L) at pH 7.0, 25°C. The molecular formula is C 15H 12N 2O 2and its molecular weight is 252.27. Oxtellar XR tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, yellow iron oxide (150 mg, 300 mg tablets only), red iron oxide (300 mg, 600 mg tablets only), black iron oxide (300 mg tablet only), magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium lauryl sulfate, talc, and titanium dioxide. Each tablet is printed on one side with edible black ink.</Description>
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<IndicationAndUsage>Oxtellar XR is indicated for the treatment of partial-onset seizures in patients 6 years of age and older.</IndicationAndUsage>
<Description>Oxtellar XR is an antiepileptic drug (AED). Oxtellar XR extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is off-white to yellow crystalline powder. Oxcarbazepine is sparingly soluble in chloroform (30-100 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 40 mg/L (0.04 g/L) at pH 7.0, 25°C. The molecular formula is C 15H 12N 2O 2and its molecular weight is 252.27. Oxtellar XR tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, yellow iron oxide (150 mg, 300 mg tablets only), red iron oxide (300 mg, 600 mg tablets only), black iron oxide (300 mg tablet only), magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium lauryl sulfate, talc, and titanium dioxide. Each tablet is printed on one side with edible black ink.</Description>
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