{
"NDC": [
{
"NDCCode": "57353-101-53",
"PackageDescription": "1 TUBE in 1 BOX (57353-101-53) > 74 g in 1 TUBE (57353-101-13)",
"NDC11Code": "57353-0101-53",
"ProductNDC": "57353-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Power White 7",
"ProprietaryNameSuffix": "Sensitive",
"NonProprietaryName": "Sodium Fluoride Potassium Nitrate",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20121201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "DENTOVATIONS INC",
"SubstanceName": "SODIUM FLUORIDE; POTASSIUM NITRATE",
"StrengthNumber": ".24; 5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "57353-102-63",
"PackageDescription": "2 BOX in 1 BOX (57353-102-63) > 1 TUBE in 1 BOX (57353-102-53) > 74 g in 1 TUBE (57353-102-13)",
"NDC11Code": "57353-0102-63",
"ProductNDC": "57353-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Power White 7",
"ProprietaryNameSuffix": "Everyday Whitening",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20121201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "DENTOVATIONS INC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".24",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "57353-103-53",
"PackageDescription": "1 TUBE in 1 BOX (57353-103-53) > 113 g in 1 TUBE (57353-103-13) ",
"NDC11Code": "57353-0103-53",
"ProductNDC": "57353-103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Luster Now",
"ProprietaryNameSuffix": "Instant Whitening",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20121201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "DENTOVATIONS INC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".24",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160620",
"SamplePackage": "N",
"IndicationAndUsage": "USES: ANTI-CAVITY."
},
{
"NDCCode": "57353-106-53",
"PackageDescription": "1 TUBE in 1 BOX (57353-106-53) > 113 g in 1 TUBE (57353-106-13) ",
"NDC11Code": "57353-0106-53",
"ProductNDC": "57353-106",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Luster Power White",
"ProprietaryNameSuffix": "Deep Stain Eraser",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "ORAL",
"StartMarketingDate": "20121201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "DENTOVATIONS INC",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": ".88",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20121201",
"SamplePackage": "N",
"IndicationAndUsage": "USE: Helps protect against cavities."
},
{
"NDCCode": "70381-101-53",
"PackageDescription": "1 TUBE in 1 BOX (70381-101-53) > 5 mL in 1 TUBE (70381-101-13) ",
"NDC11Code": "70381-0101-53",
"ProductNDC": "70381-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Murad - Acne Control - Oil And Pore Control Mattifier",
"ProprietaryNameSuffix": "Spf-45",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190513",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Murad, LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 10; 5; 5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190513",
"SamplePackage": "N",
"IndicationAndUsage": "■ helps prevent sunburn. ■ if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "71112-101-53",
"PackageDescription": "1 TUBE in 1 BOX (71112-101-53) > 90 mg in 1 TUBE (71112-101-13) ",
"NDC11Code": "71112-0101-53",
"ProductNDC": "71112-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "White Is Black",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20170129",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "CURADEN AG",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": ".095",
"StrengthUnit": "mg/mg",
"Status": "Deprecated",
"LastUpdate": "2020-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170129",
"SamplePackage": "N"
},
{
"NDCCode": "71610-101-53",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (71610-101-53) ",
"NDC11Code": "71610-0101-53",
"ProductNDC": "71610-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071457",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180726",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "DESCRIPTION. Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is: C16H13ClN2O2 MW = 300.74 Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 15 mg and 30 mg, are for oral administration. 15 mg and 30 mg CapsulesActive Ingredient: temazepam USP 15 mg CapsulesInactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg CapsulesInactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide."
},
{
"NDCCode": "77550-101-53",
"PackageDescription": "250 mL in 1 BOTTLE (77550-101-53) ",
"NDC11Code": "77550-0101-53",
"ProductNDC": "77550-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Hand Sanitizer Gel",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200519",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "MAQAS GROUP GAYRIMENKUL TURIZM SANAYI VE TICARET LIMITED SIRKETI",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200519",
"SamplePackage": "N",
"IndicationAndUsage": "hand sanitizer to decrease bacteria on the skin. recommended for repeated use. for use when soap and water are not available."
},
{
"NDCCode": "78122-101-53",
"PackageDescription": "80 CLOTH in 1 BAG (78122-101-53) ",
"NDC11Code": "78122-0101-53",
"ProductNDC": "78122-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Wipes",
"NonProprietaryName": "Alcohol Wipes",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200526",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Wenzhou Guanshang Paper Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "2.625",
"StrengthUnit": "mL/1",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200526",
"SamplePackage": "N"
},
{
"NDCCode": "78680-101-03",
"PackageDescription": "53 mL in 1 BOTTLE (78680-101-03) ",
"NDC11Code": "78680-0101-03",
"ProductNDC": "78680-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sterilup Antiseptic Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200530",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "OKUYUCULAR KOZMETIK VE SAGLIK URUNLERI TICARET VE SANAYI ANONIM SIRKETI",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200530",
"SamplePackage": "N",
"IndicationAndUsage": " hand sanitizer to decrease bacteria on the skin recommended for repeated use for use when soap and water are not available."
},
{
"NDCCode": "84502-101-53",
"PackageDescription": ".002 g in 1 VIAL, GLASS (84502-101-53) ",
"NDC11Code": "84502-0101-53",
"ProductNDC": "84502-101",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Semaglutide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240702",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Fujian Genohope Biotech Ltd.",
"SubstanceName": "SEMAGLUTIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "02-JUL-24"
},
{
"NDCCode": "43485-101-03",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (43485-101-03) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-101-01) ",
"NDC11Code": "43485-0101-03",
"ProductNDC": "43485-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spritam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20160205",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207958",
"LabelerName": "Aprecia Pharmaceuticals, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "SPRITAM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). SPRITAM is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "SPRITAM (levetiracetam) is an antiepileptic drug available as 250 mg and 500 mg round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). SPRITAM tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. SPRITAM tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. SPRITAM tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed."
},
{
"NDCCode": "43485-101-60",
"PackageDescription": "60 BLISTER PACK in 1 CARTON (43485-101-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-101-01) ",
"NDC11Code": "43485-0101-60",
"ProductNDC": "43485-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spritam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20160205",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207958",
"LabelerName": "Aprecia Pharmaceuticals, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160205",
"SamplePackage": "N",
"IndicationAndUsage": "SPRITAM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). SPRITAM is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "SPRITAM (levetiracetam) is an antiepileptic drug available as 250 mg and 500 mg round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). SPRITAM tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. SPRITAM tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. SPRITAM tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed."
},
{
"NDCCode": "58443-0583-7",
"PackageDescription": "3785 mL in 1 BOTTLE (58443-0583-7) ",
"NDC11Code": "58443-0583-07",
"ProductNDC": "58443-0583",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Palm Island",
"ProprietaryNameSuffix": "Broad Spectrum Spf 50 Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220210",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "Prime Enterprises Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30.51; 152.53; 50.85; 101.7",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220210",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "58443-0584-8",
"PackageDescription": "3785 mL in 1 BOTTLE (58443-0584-8) ",
"NDC11Code": "58443-0584-08",
"ProductNDC": "58443-0584",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Palm Island",
"ProprietaryNameSuffix": "Broad Spectrum Spf 50 Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220210",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "Prime Enterprises Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30.51; 152.53; 50.85; 101.7",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220210",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "66993-101-60",
"PackageDescription": "60 BLISTER PACK in 1 CARTON (66993-101-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-101-51) ",
"NDC11Code": "66993-0101-60",
"ProductNDC": "66993-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20250120",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA207958",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260116",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets for oral suspension are indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). Levetiracetam tablets for oral suspension are indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam tablets for oral suspension are an antiepileptic drug available as 250 mg and 500 mg, round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. Levetiracetam tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. Levetiracetam tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed."
},
{
"NDCCode": "69639-101-01",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (69639-101-01) / 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "69639-0101-01",
"ProductNDC": "69639-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Akynzeo",
"NonProprietaryName": "Netupitant And Palonosetron",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20141013",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205718",
"LabelerName": "Helsinn Therapeutics (U.S.), Inc.",
"SubstanceName": "NETUPITANT; PALONOSETRON",
"StrengthNumber": "300; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], P-Glycoprotein Inhibitors [MoA], Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC], Substance P/Neurokinin-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141013",
"SamplePackage": "N",
"IndicationAndUsage": "AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. AKYNZEO for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. Limitations of Use AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.",
"Description": "AKYNZEO (300 mg netupitant/0.5 mg palonosetron) capsules are an oral combination product of netupitant, a substance P/neurokinin 1 (NK-1) receptor antagonist, and palonosetron hydrochloride, a serotonin-3 (5-HT3) receptor antagonist. Both netupitant and palonosetron hydrochloride are anti-nausea and anti-emetic agents. Netupitant is chemically described: 2-[3,5-bis(trifluoromethyl)phenyl]-N, 2 dimethyl-N-[4-(2-methylphenyl)-6-(4-methylpiperazin-1-yl)pyridin-3-yl] propanamide. The empirical formula is C30H32F6N4O, with a molecular weight of 578.61. Netupitant exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is chemically described: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1H-benz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Netupitant is white to off-white crystalline powder. It is freely soluble in toluene and acetone, soluble in isopropanol and ethanol, and very slightly soluble in water. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Each AKYNZEO capsule is composed of one white-caramel hard gelatin capsule which contains three tablets each containing 100 mg netupitant and one gelatin capsule containing 0.5 mg palonosetron (equivalent to 0.56 mg palonosetron hydrochloride). The inactive ingredients are butylated hydroxyanisole (BHA), croscarmellose sodium, gelatin, glycerin, magnesium stearate, microcrystalline cellulose, mono- and di-glycerides of capryl/capric acid, polyglyceryl dioleate, povidone K-30, purified water, red iron oxide, silicon dioxide, sodium stearyl fumarate, sorbitol, sucrose fatty acid esters, titanium dioxide and yellow iron oxide. It may contain traces of medium-chain triglycerides, lecithin, and denatured ethanol. AKYNZEO (235 mg fosnetupitant/0.25 mg palonosetron) for injection is a combination product of fosnetupitant, a prodrug of netupitant, which is a substance P/neurokinin 1 (NK-1) receptor antagonist, and palonosetron hydrochloride, a serotonin-3 (5-HT3) receptor antagonist. Fosnetupitant chloride hydrochloride is chemically described as 2-(3,5-bis-trifluoromethylphenyl)-N-methyl-N-[6-(4-methyl-4-O-methylene-phosphatepiperazinium-1-yl)-4-o-tolyl-pyridin-3-yl]-isobutyramide chloride hydrochloride. The empirical formula is C31H36F6N4O5PClHCl, with a molecular weight of 761.53. Fosnetupitant chloride hydrochloride exists as a single isomer and has the following structural formula. Fosnetupitant chloride hydrochloride is white to off-white to yellowish solid or powder. Its solubility is pH dependent: at acidic pH (pH 2), its solubility is 1.4 mg/mL; at basic pH (pH 10), its solubility is 11.5 mg/mL. Palonosetron hydrochloride is described above in this section. AKYNZEO for injection is available for intravenous infusion supplied as a sterile lyophilized powder. Each vial of AKYNZEO for injection contains 235 mg of fosnetupitant (equivalent to 260 mg fosnetupitant chloride hydrochloride) and 0.25 mg of palonosetron (equivalent to 0.28 mg of palonosetron hydrochloride). The inactive ingredients are edetate disodium (6.4 mg), mannitol (760 mg), sodium hydroxide and/or hydrochloric acid (for pH adjustment). AKYNZEO injection is available for intravenous infusion supplied as a sterile solution in a single-dose vial. Each vial of AKYNZEO injection contains 235 mg of fosnetupitant (equivalent to 260 mg fosnetupitant chloride hydrochloride) and 0.25 mg of palonosetron (equivalent to 0.28 mg of palonosetron hydrochloride). The inactive ingredients are edetate disodium (3.2 mg), mannitol (760 mg), water for injection, sodium hydroxide and/or hydrochloric acid (for pH adjustment)."
},
{
"NDCCode": "69639-101-04",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (69639-101-04) / 2 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "69639-0101-04",
"ProductNDC": "69639-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Akynzeo",
"NonProprietaryName": "Netupitant And Palonosetron",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20141013",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205718",
"LabelerName": "Helsinn Therapeutics (U.S.), Inc.",
"SubstanceName": "NETUPITANT; PALONOSETRON",
"StrengthNumber": "300; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], P-Glycoprotein Inhibitors [MoA], Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC], Substance P/Neurokinin-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141013",
"SamplePackage": "N",
"IndicationAndUsage": "AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. AKYNZEO for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. Limitations of Use AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.",
"Description": "AKYNZEO (300 mg netupitant/0.5 mg palonosetron) capsules are an oral combination product of netupitant, a substance P/neurokinin 1 (NK-1) receptor antagonist, and palonosetron hydrochloride, a serotonin-3 (5-HT3) receptor antagonist. Both netupitant and palonosetron hydrochloride are anti-nausea and anti-emetic agents. Netupitant is chemically described: 2-[3,5-bis(trifluoromethyl)phenyl]-N, 2 dimethyl-N-[4-(2-methylphenyl)-6-(4-methylpiperazin-1-yl)pyridin-3-yl] propanamide. The empirical formula is C30H32F6N4O, with a molecular weight of 578.61. Netupitant exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is chemically described: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1H-benz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Netupitant is white to off-white crystalline powder. It is freely soluble in toluene and acetone, soluble in isopropanol and ethanol, and very slightly soluble in water. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Each AKYNZEO capsule is composed of one white-caramel hard gelatin capsule which contains three tablets each containing 100 mg netupitant and one gelatin capsule containing 0.5 mg palonosetron (equivalent to 0.56 mg palonosetron hydrochloride). The inactive ingredients are butylated hydroxyanisole (BHA), croscarmellose sodium, gelatin, glycerin, magnesium stearate, microcrystalline cellulose, mono- and di-glycerides of capryl/capric acid, polyglyceryl dioleate, povidone K-30, purified water, red iron oxide, silicon dioxide, sodium stearyl fumarate, sorbitol, sucrose fatty acid esters, titanium dioxide and yellow iron oxide. It may contain traces of medium-chain triglycerides, lecithin, and denatured ethanol. AKYNZEO (235 mg fosnetupitant/0.25 mg palonosetron) for injection is a combination product of fosnetupitant, a prodrug of netupitant, which is a substance P/neurokinin 1 (NK-1) receptor antagonist, and palonosetron hydrochloride, a serotonin-3 (5-HT3) receptor antagonist. Fosnetupitant chloride hydrochloride is chemically described as 2-(3,5-bis-trifluoromethylphenyl)-N-methyl-N-[6-(4-methyl-4-O-methylene-phosphatepiperazinium-1-yl)-4-o-tolyl-pyridin-3-yl]-isobutyramide chloride hydrochloride. The empirical formula is C31H36F6N4O5PClHCl, with a molecular weight of 761.53. Fosnetupitant chloride hydrochloride exists as a single isomer and has the following structural formula. Fosnetupitant chloride hydrochloride is white to off-white to yellowish solid or powder. Its solubility is pH dependent: at acidic pH (pH 2), its solubility is 1.4 mg/mL; at basic pH (pH 10), its solubility is 11.5 mg/mL. Palonosetron hydrochloride is described above in this section. AKYNZEO for injection is available for intravenous infusion supplied as a sterile lyophilized powder. Each vial of AKYNZEO for injection contains 235 mg of fosnetupitant (equivalent to 260 mg fosnetupitant chloride hydrochloride) and 0.25 mg of palonosetron (equivalent to 0.28 mg of palonosetron hydrochloride). The inactive ingredients are edetate disodium (6.4 mg), mannitol (760 mg), sodium hydroxide and/or hydrochloric acid (for pH adjustment). AKYNZEO injection is available for intravenous infusion supplied as a sterile solution in a single-dose vial. Each vial of AKYNZEO injection contains 235 mg of fosnetupitant (equivalent to 260 mg fosnetupitant chloride hydrochloride) and 0.25 mg of palonosetron (equivalent to 0.28 mg of palonosetron hydrochloride). The inactive ingredients are edetate disodium (3.2 mg), mannitol (760 mg), water for injection, sodium hydroxide and/or hydrochloric acid (for pH adjustment)."
},
{
"NDCCode": "71860-101-01",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (71860-101-01) / .8 mL in 1 SYRINGE, GLASS",
"NDC11Code": "71860-0101-01",
"ProductNDC": "71860-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tryngolza",
"NonProprietaryName": "Olezarsen Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20241219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218614",
"LabelerName": "Ionis Pharmaceuticals, Inc.",
"SubstanceName": "OLEZARSEN SODIUM",
"StrengthNumber": "80",
"StrengthUnit": "mg/.8mL",
"Pharm_Classes": "APOC-III-directed RNA Interaction [EPC], Antisense Oligonucleotide [EPC], Antisense [CS], Increased RNA Degradation [PE]",
"Status": "Active",
"LastUpdate": "2026-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241219",
"SamplePackage": "N",
"IndicationAndUsage": "TRYNGOLZA ®is indicated as an adjunct to diet: : 1 To reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS)., 2 To reduce TG and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL).",
"Description": "Olezarsen is an ASO directed inhibitor of apolipoprotein C-III (apoC-III) mRNA, conjugated to a ligand containing three GalNAc residues to enable delivery of the ASO to hepatocytes. TRYNGOLZA contains olezarsen sodium as the active ingredient. Olezarsen sodium is a white to yellow solid and it is freely soluble in water and in phosphate buffer. The molecular formula of olezarsen sodium is C 296H 419N 71O 154P 20S 19Na 20 and the molecular weight is 9124.48 daltons. The chemical name of olezarsen sodium is DNA, d(P-thio) ([2'- O-(2-methoxyethyl)] rA-[2'- O-(2-methoxyethyl)] rG-[2'- O-(2-methoxyethyl)] m5rC-[2'- O-(2-methoxyethyl)] m5rU-[2'- O-(2-methoxyethyl)] m5rU-m5C-T-T-G-T-m5C-m5C-A-G-m5C-[2'- O-(2-methoxyethyl)] m5rU-[2'- O-(2-methoxyethyl)] m5rU-[2'- O-(2-methoxyethyl)] m5rU-[2'- O-(2-methoxyethyl)] rA-[2'- O-(2-methoxyethyl)]m5rU), 5'-[26-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]-14,14-bis[[3-[[6-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]hexyl]amino]-3-oxopropoxy]methyl]-8,12,19-trioxo-16-oxa-7,13,20-triazahexacos-1-yl hydrogen phosphate], sodium salt (1:20). The structure of olezarsen sodium is presented below. TRYNGOLZA is a sterile, preservative-free solution for subcutaneous injection. Each single-dose autoinjector contains 50 mg olezarsen (equivalent to 53 mg of olezarsen sodium) in 0.8 mL of solution or 80 mg olezarsen (equivalent to 84 mg of olezarsen sodium) in 0.8 mL of solution. The solution also contains the following inactive ingredients: disodium hydrogen phosphate, sodium chloride, sodium dihydrogen phosphate to maintain pH and provide tonicity, and water for injection. The solution may include hydrochloric acid and/or sodium hydroxide for pH adjustment between 6.9 to 7.9. Each 50 mg dose of TRYNGOLZA injection contains 4 mg of phosphorous and 4 mg of sodium. Each 80 mg dose of TRYNGOLZA injection contains 6 mg of phosphorous and 5 mg of sodium."
},
{
"NDCCode": "72789-101-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (72789-101-01) ",
"NDC11Code": "72789-0101-01",
"ProductNDC": "72789-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076164",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200715",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP, are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch."
},
{
"NDCCode": "80705-101-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (80705-101-02) / 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "80705-0101-02",
"ProductNDC": "80705-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elepsia Xr 1500 Mg",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210212",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204417",
"LabelerName": "TRIPOINT THERAPEUTICS, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "1500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-03-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210929",
"SamplePackage": "N",
"IndicationAndUsage": "ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older.",
"Description": "ELEPSIA XR contains levetiracetam, an antiepileptic drug, as extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL), and practically insoluble in n-hexane. Each extended-release tablet contains 1000 mg or 1500 mg of levetiracetam. Inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, dibutyl sebacate, ethyl cellulose, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 20, polysorbate 80, polyvinyl alcohol, povidone, silicified microcrystalline cellulose, sodium lauryl sulfate, talc, and triethyl citrate. The imprinting ink contains ammonium hydroxide, iron oxide black, N-butyl alcohol, propylene glycol, and shellac glaze. ELEPSIA XR is a bilayer coated tablet. The medication is present in core of tablet and release controlling polymers are present in core and coating of tablet. The biologically inert components of core tablet and/or coating may occasionally remain intact during GI transit and may be eliminated in feces as inert fragments of coating and/or soft, hydrated mass."
},
{
"NDCCode": "80705-101-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80705-101-30) ",
"NDC11Code": "80705-0101-30",
"ProductNDC": "80705-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elepsia Xr 1500 Mg",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210212",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204417",
"LabelerName": "TRIPOINT THERAPEUTICS, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "1500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-03-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210212",
"SamplePackage": "N",
"IndicationAndUsage": "ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older.",
"Description": "ELEPSIA XR contains levetiracetam, an antiepileptic drug, as extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL), and practically insoluble in n-hexane. Each extended-release tablet contains 1000 mg or 1500 mg of levetiracetam. Inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, dibutyl sebacate, ethyl cellulose, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 20, polysorbate 80, polyvinyl alcohol, povidone, silicified microcrystalline cellulose, sodium lauryl sulfate, talc, and triethyl citrate. The imprinting ink contains ammonium hydroxide, iron oxide black, N-butyl alcohol, propylene glycol, and shellac glaze. ELEPSIA XR is a bilayer coated tablet. The medication is present in core of tablet and release controlling polymers are present in core and coating of tablet. The biologically inert components of core tablet and/or coating may occasionally remain intact during GI transit and may be eliminated in feces as inert fragments of coating and/or soft, hydrated mass."
},
{
"NDCCode": "80705-101-99",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (80705-101-99) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "80705-0101-99",
"ProductNDC": "80705-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elepsia Xr 1500 Mg",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210212",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204417",
"LabelerName": "TRIPOINT THERAPEUTICS, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "1500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-03-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210212",
"SamplePackage": "N",
"IndicationAndUsage": "ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older.",
"Description": "ELEPSIA XR contains levetiracetam, an antiepileptic drug, as extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL), and practically insoluble in n-hexane. Each extended-release tablet contains 1000 mg or 1500 mg of levetiracetam. Inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, dibutyl sebacate, ethyl cellulose, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 20, polysorbate 80, polyvinyl alcohol, povidone, silicified microcrystalline cellulose, sodium lauryl sulfate, talc, and triethyl citrate. The imprinting ink contains ammonium hydroxide, iron oxide black, N-butyl alcohol, propylene glycol, and shellac glaze. ELEPSIA XR is a bilayer coated tablet. The medication is present in core of tablet and release controlling polymers are present in core and coating of tablet. The biologically inert components of core tablet and/or coating may occasionally remain intact during GI transit and may be eliminated in feces as inert fragments of coating and/or soft, hydrated mass."
},
{
"NDCCode": "81665-101-12",
"PackageDescription": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-101-12) ",
"NDC11Code": "81665-0101-12",
"ProductNDC": "81665-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230505",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212688",
"LabelerName": "Omnivium Pharmaceuticals LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20230505",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.",
"Description": "Levetiracetam extended-release tablets are an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: hypromellose, magnesium stearate, colloidal silicon dioxide, titanium dioxide, and triacetin. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "81665-101-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-101-60) ",
"NDC11Code": "81665-0101-60",
"ProductNDC": "81665-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230505",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212688",
"LabelerName": "Omnivium Pharmaceuticals LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230505",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.",
"Description": "Levetiracetam extended-release tablets are an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: hypromellose, magnesium stearate, colloidal silicon dioxide, titanium dioxide, and triacetin. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "57353-103-31",
"PackageDescription": "3 TUBE in 1 BOX (57353-103-31) > 42 g in 1 TUBE (57353-103-11) ",
"NDC11Code": "57353-0103-31",
"ProductNDC": "57353-103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Luster Now",
"ProprietaryNameSuffix": "Instant Whitening",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20121201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "DENTOVATIONS INC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".24",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160620",
"SamplePackage": "N",
"IndicationAndUsage": "USES: ANTI-CAVITY."
},
{
"NDCCode": "57353-104-24",
"PackageDescription": "1 TUBE in 1 BOX (57353-104-24) > 113 g in 1 TUBE (57353-104-14)",
"NDC11Code": "57353-0104-24",
"ProductNDC": "57353-104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Power White",
"ProprietaryNameSuffix": "Deep Stain Eraser",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20121201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "DENTOVATIONS INC",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": ".88",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "57353-105-52",
"PackageDescription": "1 TUBE in 1 BOX (57353-105-52) > 45 g in 1 TUBE (57353-105-12) ",
"NDC11Code": "57353-0105-52",
"ProductNDC": "57353-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Electrifying Blue Polish",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20150122",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "DENTOVATIONS INC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".24",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150122",
"SamplePackage": "N",
"IndicationAndUsage": "USES: ANTI-CAVITY."
},
{
"NDCCode": "0002-4483-54",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0002-4483-54) / 14 TABLET in 1 BLISTER PACK",
"NDC11Code": "00002-4483-54",
"ProductNDC": "0002-4483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verzenio",
"NonProprietaryName": "Abemaciclib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208716",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ABEMACICLIB",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171006",
"SamplePackage": "N",
"IndicationAndUsage": "VERZENIO® is a kinase inhibitor indicated: : 1 in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. (1.1, 14.1) , 2 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (1.2) , 3 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (1.2) , 4 as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. (1.2) .",
"Description": "Abemaciclib is a kinase inhibitor for oral administration. It is a white to yellow powder with the empirical formula C27H32F2N8 and a molecular weight 506.59. The chemical name for abemaciclib is 2-Pyrimidinamine, N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl]-. Abemaciclib has the following structure:. VERZENIO (abemaciclib) tablets are provided as immediate-release oval white, beige, or yellow tablets. Inactive ingredients are as follows: Excipients—microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide. Color mixture ingredients—polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red."
},
{
"NDCCode": "0002-4483-62",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0002-4483-62) / 14 TABLET in 1 BLISTER PACK",
"NDC11Code": "00002-4483-62",
"ProductNDC": "0002-4483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verzenio",
"NonProprietaryName": "Abemaciclib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208716",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ABEMACICLIB",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250215",
"SamplePackage": "Y",
"IndicationAndUsage": "VERZENIO® is a kinase inhibitor indicated: : 1 in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. (1.1, 14.1) , 2 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (1.2) , 3 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (1.2) , 4 as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. (1.2) .",
"Description": "Abemaciclib is a kinase inhibitor for oral administration. It is a white to yellow powder with the empirical formula C27H32F2N8 and a molecular weight 506.59. The chemical name for abemaciclib is 2-Pyrimidinamine, N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl]-. Abemaciclib has the following structure:. VERZENIO (abemaciclib) tablets are provided as immediate-release oval white, beige, or yellow tablets. Inactive ingredients are as follows: Excipients—microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide. Color mixture ingredients—polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red."
}
]
}
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<NDCList>
<NDC>
<NDCCode>57353-101-53</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (57353-101-53) > 74 g in 1 TUBE (57353-101-13)</PackageDescription>
<NDC11Code>57353-0101-53</NDC11Code>
<ProductNDC>57353-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Power White 7</ProprietaryName>
<ProprietaryNameSuffix>Sensitive</ProprietaryNameSuffix>
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<DosageFormName>GEL, DENTIFRICE</DosageFormName>
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<StrengthNumber>.24; 5</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>57353-102-63</NDCCode>
<PackageDescription>2 BOX in 1 BOX (57353-102-63) > 1 TUBE in 1 BOX (57353-102-53) > 74 g in 1 TUBE (57353-102-13)</PackageDescription>
<NDC11Code>57353-0102-63</NDC11Code>
<ProductNDC>57353-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Power White 7</ProprietaryName>
<ProprietaryNameSuffix>Everyday Whitening</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20121201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>DENTOVATIONS INC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.24</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>57353-103-53</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (57353-103-53) > 113 g in 1 TUBE (57353-103-13) </PackageDescription>
<NDC11Code>57353-0103-53</NDC11Code>
<ProductNDC>57353-103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Luster Now</ProprietaryName>
<ProprietaryNameSuffix>Instant Whitening</ProprietaryNameSuffix>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>DENTOVATIONS INC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.24</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: ANTI-CAVITY.</IndicationAndUsage>
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<NDC>
<NDCCode>57353-106-53</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (57353-106-53) > 113 g in 1 TUBE (57353-106-13) </PackageDescription>
<NDC11Code>57353-0106-53</NDC11Code>
<ProductNDC>57353-106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Luster Power White</ProprietaryName>
<ProprietaryNameSuffix>Deep Stain Eraser</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
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<LabelerName>DENTOVATIONS INC</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>.88</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USE: Helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70381-101-53</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (70381-101-53) > 5 mL in 1 TUBE (70381-101-13) </PackageDescription>
<NDC11Code>70381-0101-53</NDC11Code>
<ProductNDC>70381-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Murad - Acne Control - Oil And Pore Control Mattifier</ProprietaryName>
<ProprietaryNameSuffix>Spf-45</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190513</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Murad, LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 10; 5; 5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ helps prevent sunburn. ■ if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71112-101-53</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (71112-101-53) > 90 mg in 1 TUBE (71112-101-13) </PackageDescription>
<NDC11Code>71112-0101-53</NDC11Code>
<ProductNDC>71112-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>White Is Black</ProprietaryName>
<NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20170129</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>CURADEN AG</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>.095</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71610-101-53</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (71610-101-53) </PackageDescription>
<NDC11Code>71610-0101-53</NDC11Code>
<ProductNDC>71610-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temazepam</ProprietaryName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071457</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>DESCRIPTION. Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is: C16H13ClN2O2 MW = 300.74 Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 15 mg and 30 mg, are for oral administration. 15 mg and 30 mg CapsulesActive Ingredient: temazepam USP 15 mg CapsulesInactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg CapsulesInactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>77550-101-53</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE (77550-101-53) </PackageDescription>
<NDC11Code>77550-0101-53</NDC11Code>
<ProductNDC>77550-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Hand Sanitizer Gel</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200519</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>MAQAS GROUP GAYRIMENKUL TURIZM SANAYI VE TICARET LIMITED SIRKETI</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>hand sanitizer to decrease bacteria on the skin. recommended for repeated use. for use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78122-101-53</NDCCode>
<PackageDescription>80 CLOTH in 1 BAG (78122-101-53) </PackageDescription>
<NDC11Code>78122-0101-53</NDC11Code>
<ProductNDC>78122-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Alcohol Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200526</StartMarketingDate>
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<LabelerName>Wenzhou Guanshang Paper Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>2.625</StrengthNumber>
<StrengthUnit>mL/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>78680-101-03</NDCCode>
<PackageDescription>53 mL in 1 BOTTLE (78680-101-03) </PackageDescription>
<NDC11Code>78680-0101-03</NDC11Code>
<ProductNDC>78680-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sterilup Antiseptic Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200530</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>OKUYUCULAR KOZMETIK VE SAGLIK URUNLERI TICARET VE SANAYI ANONIM SIRKETI</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> hand sanitizer to decrease bacteria on the skin recommended for repeated use for use when soap and water are not available.</IndicationAndUsage>
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<NDC>
<NDCCode>84502-101-53</NDCCode>
<PackageDescription>.002 g in 1 VIAL, GLASS (84502-101-53) </PackageDescription>
<NDC11Code>84502-0101-53</NDC11Code>
<ProductNDC>84502-101</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Semaglutide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240702</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Fujian Genohope Biotech Ltd.</LabelerName>
<SubstanceName>SEMAGLUTIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JUL-24</StartMarketingDatePackage>
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<NDC>
<NDCCode>43485-101-03</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (43485-101-03) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-101-01) </PackageDescription>
<NDC11Code>43485-0101-03</NDC11Code>
<ProductNDC>43485-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spritam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160205</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207958</ApplicationNumber>
<LabelerName>Aprecia Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPRITAM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). SPRITAM is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>SPRITAM (levetiracetam) is an antiepileptic drug available as 250 mg and 500 mg round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). SPRITAM tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. SPRITAM tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. SPRITAM tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed.</Description>
</NDC>
<NDC>
<NDCCode>43485-101-60</NDCCode>
<PackageDescription>60 BLISTER PACK in 1 CARTON (43485-101-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-101-01) </PackageDescription>
<NDC11Code>43485-0101-60</NDC11Code>
<ProductNDC>43485-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spritam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160205</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207958</ApplicationNumber>
<LabelerName>Aprecia Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPRITAM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). SPRITAM is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>SPRITAM (levetiracetam) is an antiepileptic drug available as 250 mg and 500 mg round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). SPRITAM tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. SPRITAM tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. SPRITAM tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed.</Description>
</NDC>
<NDC>
<NDCCode>58443-0583-7</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE (58443-0583-7) </PackageDescription>
<NDC11Code>58443-0583-07</NDC11Code>
<ProductNDC>58443-0583</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Palm Island</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 50 Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Prime Enterprises Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30.51; 152.53; 50.85; 101.7</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58443-0584-8</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE (58443-0584-8) </PackageDescription>
<NDC11Code>58443-0584-08</NDC11Code>
<ProductNDC>58443-0584</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Palm Island</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 50 Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Prime Enterprises Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30.51; 152.53; 50.85; 101.7</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66993-101-60</NDCCode>
<PackageDescription>60 BLISTER PACK in 1 CARTON (66993-101-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-101-51) </PackageDescription>
<NDC11Code>66993-0101-60</NDC11Code>
<ProductNDC>66993-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250120</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA207958</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets for oral suspension are indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). Levetiracetam tablets for oral suspension are indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam tablets for oral suspension are an antiepileptic drug available as 250 mg and 500 mg, round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. Levetiracetam tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. Levetiracetam tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed.</Description>
</NDC>
<NDC>
<NDCCode>69639-101-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (69639-101-01) / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69639-0101-01</NDC11Code>
<ProductNDC>69639-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Akynzeo</ProprietaryName>
<NonProprietaryName>Netupitant And Palonosetron</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141013</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205718</ApplicationNumber>
<LabelerName>Helsinn Therapeutics (U.S.), Inc.</LabelerName>
<SubstanceName>NETUPITANT; PALONOSETRON</SubstanceName>
<StrengthNumber>300; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], P-Glycoprotein Inhibitors [MoA], Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. AKYNZEO for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. Limitations of Use AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.</IndicationAndUsage>
<Description>AKYNZEO (300 mg netupitant/0.5 mg palonosetron) capsules are an oral combination product of netupitant, a substance P/neurokinin 1 (NK-1) receptor antagonist, and palonosetron hydrochloride, a serotonin-3 (5-HT3) receptor antagonist. Both netupitant and palonosetron hydrochloride are anti-nausea and anti-emetic agents. Netupitant is chemically described: 2-[3,5-bis(trifluoromethyl)phenyl]-N, 2 dimethyl-N-[4-(2-methylphenyl)-6-(4-methylpiperazin-1-yl)pyridin-3-yl] propanamide. The empirical formula is C30H32F6N4O, with a molecular weight of 578.61. Netupitant exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is chemically described: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1H-benz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Netupitant is white to off-white crystalline powder. It is freely soluble in toluene and acetone, soluble in isopropanol and ethanol, and very slightly soluble in water. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Each AKYNZEO capsule is composed of one white-caramel hard gelatin capsule which contains three tablets each containing 100 mg netupitant and one gelatin capsule containing 0.5 mg palonosetron (equivalent to 0.56 mg palonosetron hydrochloride). The inactive ingredients are butylated hydroxyanisole (BHA), croscarmellose sodium, gelatin, glycerin, magnesium stearate, microcrystalline cellulose, mono- and di-glycerides of capryl/capric acid, polyglyceryl dioleate, povidone K-30, purified water, red iron oxide, silicon dioxide, sodium stearyl fumarate, sorbitol, sucrose fatty acid esters, titanium dioxide and yellow iron oxide. It may contain traces of medium-chain triglycerides, lecithin, and denatured ethanol. AKYNZEO (235 mg fosnetupitant/0.25 mg palonosetron) for injection is a combination product of fosnetupitant, a prodrug of netupitant, which is a substance P/neurokinin 1 (NK-1) receptor antagonist, and palonosetron hydrochloride, a serotonin-3 (5-HT3) receptor antagonist. Fosnetupitant chloride hydrochloride is chemically described as 2-(3,5-bis-trifluoromethylphenyl)-N-methyl-N-[6-(4-methyl-4-O-methylene-phosphatepiperazinium-1-yl)-4-o-tolyl-pyridin-3-yl]-isobutyramide chloride hydrochloride. The empirical formula is C31H36F6N4O5PClHCl, with a molecular weight of 761.53. Fosnetupitant chloride hydrochloride exists as a single isomer and has the following structural formula. Fosnetupitant chloride hydrochloride is white to off-white to yellowish solid or powder. Its solubility is pH dependent: at acidic pH (pH 2), its solubility is 1.4 mg/mL; at basic pH (pH 10), its solubility is 11.5 mg/mL. Palonosetron hydrochloride is described above in this section. AKYNZEO for injection is available for intravenous infusion supplied as a sterile lyophilized powder. Each vial of AKYNZEO for injection contains 235 mg of fosnetupitant (equivalent to 260 mg fosnetupitant chloride hydrochloride) and 0.25 mg of palonosetron (equivalent to 0.28 mg of palonosetron hydrochloride). The inactive ingredients are edetate disodium (6.4 mg), mannitol (760 mg), sodium hydroxide and/or hydrochloric acid (for pH adjustment). AKYNZEO injection is available for intravenous infusion supplied as a sterile solution in a single-dose vial. Each vial of AKYNZEO injection contains 235 mg of fosnetupitant (equivalent to 260 mg fosnetupitant chloride hydrochloride) and 0.25 mg of palonosetron (equivalent to 0.28 mg of palonosetron hydrochloride). The inactive ingredients are edetate disodium (3.2 mg), mannitol (760 mg), water for injection, sodium hydroxide and/or hydrochloric acid (for pH adjustment).</Description>
</NDC>
<NDC>
<NDCCode>69639-101-04</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (69639-101-04) / 2 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69639-0101-04</NDC11Code>
<ProductNDC>69639-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Akynzeo</ProprietaryName>
<NonProprietaryName>Netupitant And Palonosetron</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141013</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205718</ApplicationNumber>
<LabelerName>Helsinn Therapeutics (U.S.), Inc.</LabelerName>
<SubstanceName>NETUPITANT; PALONOSETRON</SubstanceName>
<StrengthNumber>300; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], P-Glycoprotein Inhibitors [MoA], Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. AKYNZEO for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. Limitations of Use AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.</IndicationAndUsage>
<Description>AKYNZEO (300 mg netupitant/0.5 mg palonosetron) capsules are an oral combination product of netupitant, a substance P/neurokinin 1 (NK-1) receptor antagonist, and palonosetron hydrochloride, a serotonin-3 (5-HT3) receptor antagonist. Both netupitant and palonosetron hydrochloride are anti-nausea and anti-emetic agents. Netupitant is chemically described: 2-[3,5-bis(trifluoromethyl)phenyl]-N, 2 dimethyl-N-[4-(2-methylphenyl)-6-(4-methylpiperazin-1-yl)pyridin-3-yl] propanamide. The empirical formula is C30H32F6N4O, with a molecular weight of 578.61. Netupitant exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is chemically described: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1H-benz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Netupitant is white to off-white crystalline powder. It is freely soluble in toluene and acetone, soluble in isopropanol and ethanol, and very slightly soluble in water. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Each AKYNZEO capsule is composed of one white-caramel hard gelatin capsule which contains three tablets each containing 100 mg netupitant and one gelatin capsule containing 0.5 mg palonosetron (equivalent to 0.56 mg palonosetron hydrochloride). The inactive ingredients are butylated hydroxyanisole (BHA), croscarmellose sodium, gelatin, glycerin, magnesium stearate, microcrystalline cellulose, mono- and di-glycerides of capryl/capric acid, polyglyceryl dioleate, povidone K-30, purified water, red iron oxide, silicon dioxide, sodium stearyl fumarate, sorbitol, sucrose fatty acid esters, titanium dioxide and yellow iron oxide. It may contain traces of medium-chain triglycerides, lecithin, and denatured ethanol. AKYNZEO (235 mg fosnetupitant/0.25 mg palonosetron) for injection is a combination product of fosnetupitant, a prodrug of netupitant, which is a substance P/neurokinin 1 (NK-1) receptor antagonist, and palonosetron hydrochloride, a serotonin-3 (5-HT3) receptor antagonist. Fosnetupitant chloride hydrochloride is chemically described as 2-(3,5-bis-trifluoromethylphenyl)-N-methyl-N-[6-(4-methyl-4-O-methylene-phosphatepiperazinium-1-yl)-4-o-tolyl-pyridin-3-yl]-isobutyramide chloride hydrochloride. The empirical formula is C31H36F6N4O5PClHCl, with a molecular weight of 761.53. Fosnetupitant chloride hydrochloride exists as a single isomer and has the following structural formula. Fosnetupitant chloride hydrochloride is white to off-white to yellowish solid or powder. Its solubility is pH dependent: at acidic pH (pH 2), its solubility is 1.4 mg/mL; at basic pH (pH 10), its solubility is 11.5 mg/mL. Palonosetron hydrochloride is described above in this section. AKYNZEO for injection is available for intravenous infusion supplied as a sterile lyophilized powder. Each vial of AKYNZEO for injection contains 235 mg of fosnetupitant (equivalent to 260 mg fosnetupitant chloride hydrochloride) and 0.25 mg of palonosetron (equivalent to 0.28 mg of palonosetron hydrochloride). The inactive ingredients are edetate disodium (6.4 mg), mannitol (760 mg), sodium hydroxide and/or hydrochloric acid (for pH adjustment). AKYNZEO injection is available for intravenous infusion supplied as a sterile solution in a single-dose vial. Each vial of AKYNZEO injection contains 235 mg of fosnetupitant (equivalent to 260 mg fosnetupitant chloride hydrochloride) and 0.25 mg of palonosetron (equivalent to 0.28 mg of palonosetron hydrochloride). The inactive ingredients are edetate disodium (3.2 mg), mannitol (760 mg), water for injection, sodium hydroxide and/or hydrochloric acid (for pH adjustment).</Description>
</NDC>
<NDC>
<NDCCode>71860-101-01</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (71860-101-01) / .8 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>71860-0101-01</NDC11Code>
<ProductNDC>71860-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tryngolza</ProprietaryName>
<NonProprietaryName>Olezarsen Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20241219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218614</ApplicationNumber>
<LabelerName>Ionis Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OLEZARSEN SODIUM</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/.8mL</StrengthUnit>
<Pharm_Classes>APOC-III-directed RNA Interaction [EPC], Antisense Oligonucleotide [EPC], Antisense [CS], Increased RNA Degradation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRYNGOLZA ®is indicated as an adjunct to diet: : 1 To reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS)., 2 To reduce TG and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL).</IndicationAndUsage>
<Description>Olezarsen is an ASO directed inhibitor of apolipoprotein C-III (apoC-III) mRNA, conjugated to a ligand containing three GalNAc residues to enable delivery of the ASO to hepatocytes. TRYNGOLZA contains olezarsen sodium as the active ingredient. Olezarsen sodium is a white to yellow solid and it is freely soluble in water and in phosphate buffer. The molecular formula of olezarsen sodium is C 296H 419N 71O 154P 20S 19Na 20 and the molecular weight is 9124.48 daltons. The chemical name of olezarsen sodium is DNA, d(P-thio) ([2'- O-(2-methoxyethyl)] rA-[2'- O-(2-methoxyethyl)] rG-[2'- O-(2-methoxyethyl)] m5rC-[2'- O-(2-methoxyethyl)] m5rU-[2'- O-(2-methoxyethyl)] m5rU-m5C-T-T-G-T-m5C-m5C-A-G-m5C-[2'- O-(2-methoxyethyl)] m5rU-[2'- O-(2-methoxyethyl)] m5rU-[2'- O-(2-methoxyethyl)] m5rU-[2'- O-(2-methoxyethyl)] rA-[2'- O-(2-methoxyethyl)]m5rU), 5'-[26-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]-14,14-bis[[3-[[6-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]hexyl]amino]-3-oxopropoxy]methyl]-8,12,19-trioxo-16-oxa-7,13,20-triazahexacos-1-yl hydrogen phosphate], sodium salt (1:20). The structure of olezarsen sodium is presented below. TRYNGOLZA is a sterile, preservative-free solution for subcutaneous injection. Each single-dose autoinjector contains 50 mg olezarsen (equivalent to 53 mg of olezarsen sodium) in 0.8 mL of solution or 80 mg olezarsen (equivalent to 84 mg of olezarsen sodium) in 0.8 mL of solution. The solution also contains the following inactive ingredients: disodium hydrogen phosphate, sodium chloride, sodium dihydrogen phosphate to maintain pH and provide tonicity, and water for injection. The solution may include hydrochloric acid and/or sodium hydroxide for pH adjustment between 6.9 to 7.9. Each 50 mg dose of TRYNGOLZA injection contains 4 mg of phosphorous and 4 mg of sodium. Each 80 mg dose of TRYNGOLZA injection contains 6 mg of phosphorous and 5 mg of sodium.</Description>
</NDC>
<NDC>
<NDCCode>72789-101-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (72789-101-01) </PackageDescription>
<NDC11Code>72789-0101-01</NDC11Code>
<ProductNDC>72789-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076164</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP, are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch.</Description>
</NDC>
<NDC>
<NDCCode>80705-101-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (80705-101-02) / 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>80705-0101-02</NDC11Code>
<ProductNDC>80705-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elepsia Xr 1500 Mg</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210212</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204417</ApplicationNumber>
<LabelerName>TRIPOINT THERAPEUTICS, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>1500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older.</IndicationAndUsage>
<Description>ELEPSIA XR contains levetiracetam, an antiepileptic drug, as extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL), and practically insoluble in n-hexane. Each extended-release tablet contains 1000 mg or 1500 mg of levetiracetam. Inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, dibutyl sebacate, ethyl cellulose, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 20, polysorbate 80, polyvinyl alcohol, povidone, silicified microcrystalline cellulose, sodium lauryl sulfate, talc, and triethyl citrate. The imprinting ink contains ammonium hydroxide, iron oxide black, N-butyl alcohol, propylene glycol, and shellac glaze. ELEPSIA XR is a bilayer coated tablet. The medication is present in core of tablet and release controlling polymers are present in core and coating of tablet. The biologically inert components of core tablet and/or coating may occasionally remain intact during GI transit and may be eliminated in feces as inert fragments of coating and/or soft, hydrated mass.</Description>
</NDC>
<NDC>
<NDCCode>80705-101-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80705-101-30) </PackageDescription>
<NDC11Code>80705-0101-30</NDC11Code>
<ProductNDC>80705-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elepsia Xr 1500 Mg</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210212</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204417</ApplicationNumber>
<LabelerName>TRIPOINT THERAPEUTICS, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>1500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older.</IndicationAndUsage>
<Description>ELEPSIA XR contains levetiracetam, an antiepileptic drug, as extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL), and practically insoluble in n-hexane. Each extended-release tablet contains 1000 mg or 1500 mg of levetiracetam. Inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, dibutyl sebacate, ethyl cellulose, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 20, polysorbate 80, polyvinyl alcohol, povidone, silicified microcrystalline cellulose, sodium lauryl sulfate, talc, and triethyl citrate. The imprinting ink contains ammonium hydroxide, iron oxide black, N-butyl alcohol, propylene glycol, and shellac glaze. ELEPSIA XR is a bilayer coated tablet. The medication is present in core of tablet and release controlling polymers are present in core and coating of tablet. The biologically inert components of core tablet and/or coating may occasionally remain intact during GI transit and may be eliminated in feces as inert fragments of coating and/or soft, hydrated mass.</Description>
</NDC>
<NDC>
<NDCCode>80705-101-99</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (80705-101-99) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>80705-0101-99</NDC11Code>
<ProductNDC>80705-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elepsia Xr 1500 Mg</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210212</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204417</ApplicationNumber>
<LabelerName>TRIPOINT THERAPEUTICS, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>1500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older.</IndicationAndUsage>
<Description>ELEPSIA XR contains levetiracetam, an antiepileptic drug, as extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL), and practically insoluble in n-hexane. Each extended-release tablet contains 1000 mg or 1500 mg of levetiracetam. Inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, dibutyl sebacate, ethyl cellulose, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 20, polysorbate 80, polyvinyl alcohol, povidone, silicified microcrystalline cellulose, sodium lauryl sulfate, talc, and triethyl citrate. The imprinting ink contains ammonium hydroxide, iron oxide black, N-butyl alcohol, propylene glycol, and shellac glaze. ELEPSIA XR is a bilayer coated tablet. The medication is present in core of tablet and release controlling polymers are present in core and coating of tablet. The biologically inert components of core tablet and/or coating may occasionally remain intact during GI transit and may be eliminated in feces as inert fragments of coating and/or soft, hydrated mass.</Description>
</NDC>
<NDC>
<NDCCode>81665-101-12</NDCCode>
<PackageDescription>120 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-101-12) </PackageDescription>
<NDC11Code>81665-0101-12</NDC11Code>
<ProductNDC>81665-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230505</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212688</ApplicationNumber>
<LabelerName>Omnivium Pharmaceuticals LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.</IndicationAndUsage>
<Description>Levetiracetam extended-release tablets are an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: hypromellose, magnesium stearate, colloidal silicon dioxide, titanium dioxide, and triacetin. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>81665-101-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-101-60) </PackageDescription>
<NDC11Code>81665-0101-60</NDC11Code>
<ProductNDC>81665-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230505</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212688</ApplicationNumber>
<LabelerName>Omnivium Pharmaceuticals LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.</IndicationAndUsage>
<Description>Levetiracetam extended-release tablets are an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: hypromellose, magnesium stearate, colloidal silicon dioxide, titanium dioxide, and triacetin. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>57353-103-31</NDCCode>
<PackageDescription>3 TUBE in 1 BOX (57353-103-31) > 42 g in 1 TUBE (57353-103-11) </PackageDescription>
<NDC11Code>57353-0103-31</NDC11Code>
<ProductNDC>57353-103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>DENTOVATIONS INC</LabelerName>
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<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: ANTI-CAVITY.</IndicationAndUsage>
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<LabelerName>DENTOVATIONS INC</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>.88</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
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<PackageDescription>1 TUBE in 1 BOX (57353-105-52) > 45 g in 1 TUBE (57353-105-12) </PackageDescription>
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<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>DENTOVATIONS INC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.24</StrengthNumber>
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<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: ANTI-CAVITY.</IndicationAndUsage>
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<NDC>
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<PackageDescription>1 BLISTER PACK in 1 CARTON (0002-4483-54) / 14 TABLET in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>0002-4483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verzenio</ProprietaryName>
<NonProprietaryName>Abemaciclib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208716</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ABEMACICLIB</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VERZENIO® is a kinase inhibitor indicated: : 1 in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. (1.1, 14.1) , 2 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (1.2) , 3 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (1.2) , 4 as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. (1.2) .</IndicationAndUsage>
<Description>Abemaciclib is a kinase inhibitor for oral administration. It is a white to yellow powder with the empirical formula C27H32F2N8 and a molecular weight 506.59. The chemical name for abemaciclib is 2-Pyrimidinamine, N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl]-. Abemaciclib has the following structure:. VERZENIO (abemaciclib) tablets are provided as immediate-release oval white, beige, or yellow tablets. Inactive ingredients are as follows: Excipients—microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide. Color mixture ingredients—polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red.</Description>
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<ProductNDC>0002-4483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verzenio</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
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<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208716</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
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<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250215</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>VERZENIO® is a kinase inhibitor indicated: : 1 in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. (1.1, 14.1) , 2 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (1.2) , 3 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (1.2) , 4 as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. (1.2) .</IndicationAndUsage>
<Description>Abemaciclib is a kinase inhibitor for oral administration. It is a white to yellow powder with the empirical formula C27H32F2N8 and a molecular weight 506.59. The chemical name for abemaciclib is 2-Pyrimidinamine, N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl]-. Abemaciclib has the following structure:. VERZENIO (abemaciclib) tablets are provided as immediate-release oval white, beige, or yellow tablets. Inactive ingredients are as follows: Excipients—microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide. Color mixture ingredients—polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red.</Description>
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