{
"NDC": [
{
"NDCCode": "57664-005-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-005-88) ",
"NDC11Code": "57664-0005-88",
"ProductNDC": "57664-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole",
"NonProprietaryName": "Pramipexole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"EndMarketingDate": "20181228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091683",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130523",
"EndMarketingDatePackage": "20181228",
"SamplePackage": "N"
},
{
"NDCCode": "57664-005-08",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-005-08) ",
"NDC11Code": "57664-0005-08",
"ProductNDC": "57664-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole",
"NonProprietaryName": "Pramipexole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"EndMarketingDate": "20181228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091683",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130523",
"EndMarketingDatePackage": "20181228",
"SamplePackage": "N"
},
{
"NDCCode": "57664-005-13",
"PackageDescription": "500 TABLET in 1 BOTTLE (57664-005-13) ",
"NDC11Code": "57664-0005-13",
"ProductNDC": "57664-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole",
"NonProprietaryName": "Pramipexole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"EndMarketingDate": "20181228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091683",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130523",
"EndMarketingDatePackage": "20181228",
"SamplePackage": "N"
},
{
"NDCCode": "57664-005-18",
"PackageDescription": "1000 TABLET in 1 BOTTLE (57664-005-18) ",
"NDC11Code": "57664-0005-18",
"ProductNDC": "57664-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole",
"NonProprietaryName": "Pramipexole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"EndMarketingDate": "20181228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091683",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130523",
"EndMarketingDatePackage": "20181228",
"SamplePackage": "N"
},
{
"NDCCode": "57664-005-83",
"PackageDescription": "30 TABLET in 1 BOTTLE (57664-005-83) ",
"NDC11Code": "57664-0005-83",
"ProductNDC": "57664-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole",
"NonProprietaryName": "Pramipexole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"EndMarketingDate": "20181228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091683",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130523",
"EndMarketingDatePackage": "20181228",
"SamplePackage": "N"
},
{
"NDCCode": "41250-005-22",
"PackageDescription": "88 mL in 1 TUBE (41250-005-22)",
"NDC11Code": "41250-0005-22",
"ProductNDC": "41250-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meijer Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "2; 10; 5; 2; 2",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "47335-005-88",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (47335-005-88) ",
"NDC11Code": "47335-0005-88",
"ProductNDC": "47335-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa, Levodopa And Entacapone",
"NonProprietaryName": "Carbidopa, Levodopa And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021485",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA; ENTACAPONE",
"StrengthNumber": "37.5; 150; 200",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20120401",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa, levodopa and entacapone tablets, a combination drug consisting of levodopa, carbidopa (dopa decarboxylase inhibitor), and entacapone (catechol-O-methyltransferase-COMT inhibitor) is indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tabletscan be used: : 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .",
"Description": "Carbidopa, levodopa and entacapone tablets are combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro‑catechol‑structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone is supplied as tablets in 6 strengths:Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg, containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets 18.75 mg/75 mg/200 mg, containing 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets 25 mg/100 mg/200 mg, containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets 31.25 mg/125 mg/200 mg, containing 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets 37.5 mg/150 mg/200 mg, containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets 50 mg/200 mg/200 mg, containing 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone.The inactive ingredients of the carbidopa, levodopa and entacapone tablets are corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg, 25 mg/100 mg/200 mg and 37.5 mg/150 mg/200 mg also contain yellow iron oxide."
},
{
"NDCCode": "47643-005-03",
"PackageDescription": "15.88 kg in 1 PAIL (47643-005-03)",
"NDC11Code": "47643-0005-03",
"ProductNDC": "47643-005",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"StartMarketingDate": "20200630",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Vantage Specialty Ingredients, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "54699-005-02",
"PackageDescription": "88 mL in 1 BOTTLE (54699-005-02) ",
"NDC11Code": "54699-0005-02",
"ProductNDC": "54699-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ultra Defense Sani Smart Hand Sanitizer Fragrance Free With Vitamin E",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200715",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Ouya Cosmetics Co., Ltd of Yiwu",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "69",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200715",
"SamplePackage": "N"
},
{
"NDCCode": "62217-005-09",
"PackageDescription": "88 mL in 1 TUBE (62217-005-09) ",
"NDC11Code": "62217-0005-09",
"ProductNDC": "62217-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth",
"ProprietaryNameSuffix": "Block Up Kids Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140929",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "20; 90; 75; 50; 15; 50",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170330",
"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 agining caused by the sun ."
},
{
"NDCCode": "71798-005-03",
"PackageDescription": "88.7 mg in 1 JAR (71798-005-03) ",
"NDC11Code": "71798-0005-03",
"ProductNDC": "71798-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ps",
"NonProprietaryName": "Menthol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "New Leaf Pharmaceutical, LLC",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "16",
"StrengthUnit": "g/16mg",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N"
},
{
"NDCCode": "73386-005-03",
"PackageDescription": "88.5 mL in 1 BOTTLE (73386-005-03) ",
"NDC11Code": "73386-0005-03",
"ProductNDC": "73386-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sanar - Arnica Roll On",
"NonProprietaryName": "Camphor",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210927",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "SANVALL ENTERPRISES, INC",
"SubstanceName": "CAMPHOR (SYNTHETIC)",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210927",
"SamplePackage": "N",
"IndicationAndUsage": "Aid for temporary local relief of minor pain in muscles or joints."
},
{
"NDCCode": "75455-005-07",
"PackageDescription": "354.88 mL in 1 BOTTLE (75455-005-07) ",
"NDC11Code": "75455-0005-07",
"ProductNDC": "75455-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jet Kleen Hsg-e70",
"NonProprietaryName": "Gel Hand Sanitizer, Ethanol 70%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200528",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Chemject International, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200528",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "81683-005-02",
"PackageDescription": "1 BOTTLE in 1 BOX (81683-005-02) / 88.5 mL in 1 BOTTLE",
"NDC11Code": "81683-0005-02",
"ProductNDC": "81683-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rocksauce Warming Massage Roll-on",
"NonProprietaryName": "Menthol, Methyl Salicylate",
"DosageFormName": "CREAM, AUGMENTED",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Implus Footcare, LLC",
"SubstanceName": "METHYL SALICYLATE; MENTHOL",
"StrengthNumber": "200; 100",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250501",
"SamplePackage": "N",
"IndicationAndUsage": "Provides soothing heat to sore muscles and joints."
},
{
"NDCCode": "57664-001-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-001-88) ",
"NDC11Code": "57664-0001-88",
"ProductNDC": "57664-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole",
"NonProprietaryName": "Pramipexole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"EndMarketingDate": "20181228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091683",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130523",
"EndMarketingDatePackage": "20181228",
"SamplePackage": "N"
},
{
"NDCCode": "57664-002-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-002-88) ",
"NDC11Code": "57664-0002-88",
"ProductNDC": "57664-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole",
"NonProprietaryName": "Pramipexole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"EndMarketingDate": "20181228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091683",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130523",
"EndMarketingDatePackage": "20181228",
"SamplePackage": "N"
},
{
"NDCCode": "57664-003-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-003-88) ",
"NDC11Code": "57664-0003-88",
"ProductNDC": "57664-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole",
"NonProprietaryName": "Pramipexole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"EndMarketingDate": "20181228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091683",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130523",
"EndMarketingDatePackage": "20181228",
"SamplePackage": "N"
},
{
"NDCCode": "57664-004-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-004-88) ",
"NDC11Code": "57664-0004-88",
"ProductNDC": "57664-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole",
"NonProprietaryName": "Pramipexole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"EndMarketingDate": "20181228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091683",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130523",
"EndMarketingDatePackage": "20181228",
"SamplePackage": "N"
},
{
"NDCCode": "57664-046-88",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (57664-046-88) ",
"NDC11Code": "57664-0046-88",
"ProductNDC": "57664-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214484",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .",
"Description": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor."
},
{
"NDCCode": "57664-047-88",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (57664-047-88) ",
"NDC11Code": "57664-0047-88",
"ProductNDC": "57664-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214484",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .",
"Description": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor."
},
{
"NDCCode": "57664-048-88",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (57664-048-88) ",
"NDC11Code": "57664-0048-88",
"ProductNDC": "57664-048",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214484",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .",
"Description": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor."
},
{
"NDCCode": "57664-049-88",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (57664-049-88) ",
"NDC11Code": "57664-0049-88",
"ProductNDC": "57664-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214484",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .",
"Description": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor."
},
{
"NDCCode": "57664-050-88",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (57664-050-88) ",
"NDC11Code": "57664-0050-88",
"ProductNDC": "57664-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214484",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .",
"Description": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor."
},
{
"NDCCode": "57664-051-88",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (57664-051-88) ",
"NDC11Code": "57664-0051-88",
"ProductNDC": "57664-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214484",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .",
"Description": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor."
},
{
"NDCCode": "57664-052-88",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (57664-052-88) ",
"NDC11Code": "57664-0052-88",
"ProductNDC": "57664-052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214484",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .",
"Description": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor."
},
{
"NDCCode": "57664-058-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-058-88) ",
"NDC11Code": "57664-0058-88",
"ProductNDC": "57664-058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levorphanol Tartrate",
"NonProprietaryName": "Levorphanol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213906",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LEVORPHANOL TARTRATE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240615",
"SamplePackage": "N",
"IndicationAndUsage": "Levorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at any dosage or duration, and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including levorphanol tartrate tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Levorphanol tartrate tablets USP, contain levorphanol, an opioid agonist with a molecular formula of C 17H 23NO C 4H 6O 6 2H 2O and molecular weight 443.5. Each milligram of levorphanol tartrate is equivalent to 0.58 mg levorphanol base. Levorphanol's chemical name is levo-3-hydroxy-N-methylmorphinan. The USP nomenclature is 17- methylmorphinan 3-ol tartrate (1:1) (Salt) dihydrate. The material has 3 asymmetric carbon atoms. The chemical structure is:. Levorphanol tartrate, USP is a white crystalline powder, soluble in water and ether, but insoluble in chloroform. Levorphanol tartrate tablets, USP, for oral administration, are available in two strengths. 2 mg tablet: white to off-white, flat face beveled edge tablet, bisect scored on one side and debossed with “762” on other side. 3 mg tablet: white to off-white, oval tablet, debossed with “058” on one side. In addition, each tablet contains microcrystalline cellulose, anhydrous lactose, pregelatinized starch, and magnesium stearate."
},
{
"NDCCode": "57664-062-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-062-88) ",
"NDC11Code": "57664-0062-88",
"ProductNDC": "57664-062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphetamine Sulfate",
"NonProprietaryName": "Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214574",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "AMPHETAMINE SULFATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210127",
"SamplePackage": "N",
"IndicationAndUsage": "Amphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy, 2 Attention Deficit-Disorder with Hyperactivityas an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability , and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. , 3 Exogenous Obesityas a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. .",
"Description": "Amphetamine sulfate, USP is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5.0 to 6.0. It is freely soluble in water and slightly soluble in alcohol. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate, USP. Each tablet also contains the following inactive ingredients: crospovidone, povidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&C Blue #1. Structural Formula."
},
{
"NDCCode": "57664-075-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-075-88) ",
"NDC11Code": "57664-0075-88",
"ProductNDC": "57664-075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphetamine Sulfate",
"NonProprietaryName": "Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214574",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "AMPHETAMINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210127",
"SamplePackage": "N",
"IndicationAndUsage": "Amphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy, 2 Attention Deficit-Disorder with Hyperactivityas an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability , and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. , 3 Exogenous Obesityas a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. .",
"Description": "Amphetamine sulfate, USP is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5.0 to 6.0. It is freely soluble in water and slightly soluble in alcohol. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate, USP. Each tablet also contains the following inactive ingredients: crospovidone, povidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&C Blue #1. Structural Formula."
},
{
"NDCCode": "57664-083-88",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE (57664-083-88) ",
"NDC11Code": "57664-0083-88",
"ProductNDC": "57664-083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214134",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .",
"Description": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor."
},
{
"NDCCode": "57664-084-88",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE (57664-084-88) ",
"NDC11Code": "57664-0084-88",
"ProductNDC": "57664-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214134",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .",
"Description": "Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor."
}
]
}
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<NDC11Code>57664-0005-88</NDC11Code>
<ProductNDC>57664-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole</ProprietaryName>
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<Status>Deprecated</Status>
<LastUpdate>2018-12-29</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130523</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>57664-005-08</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-005-08) </PackageDescription>
<NDC11Code>57664-0005-08</NDC11Code>
<ProductNDC>57664-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole</ProprietaryName>
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<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130523</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>57664-005-13</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (57664-005-13) </PackageDescription>
<NDC11Code>57664-0005-13</NDC11Code>
<ProductNDC>57664-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole</ProprietaryName>
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<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130523</StartMarketingDatePackage>
<EndMarketingDatePackage>20181228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>57664-005-18</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (57664-005-18) </PackageDescription>
<NDC11Code>57664-0005-18</NDC11Code>
<ProductNDC>57664-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole</ProprietaryName>
<NonProprietaryName>Pramipexole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<EndMarketingDate>20181228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091683</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130523</StartMarketingDatePackage>
<EndMarketingDatePackage>20181228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57664-005-83</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (57664-005-83) </PackageDescription>
<NDC11Code>57664-0005-83</NDC11Code>
<ProductNDC>57664-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<EndMarketingDate>20181228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091683</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130523</StartMarketingDatePackage>
<EndMarketingDatePackage>20181228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41250-005-22</NDCCode>
<PackageDescription>88 mL in 1 TUBE (41250-005-22)</PackageDescription>
<NDC11Code>41250-0005-22</NDC11Code>
<ProductNDC>41250-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Meijer Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>2; 10; 5; 2; 2</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47335-005-88</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (47335-005-88) </PackageDescription>
<NDC11Code>47335-0005-88</NDC11Code>
<ProductNDC>47335-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa, Levodopa And Entacapone</ProprietaryName>
<NonProprietaryName>Carbidopa, Levodopa And Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120401</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021485</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA; ENTACAPONE</SubstanceName>
<StrengthNumber>37.5; 150; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa, levodopa and entacapone tablets, a combination drug consisting of levodopa, carbidopa (dopa decarboxylase inhibitor), and entacapone (catechol-O-methyltransferase-COMT inhibitor) is indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tabletscan be used: : 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .</IndicationAndUsage>
<Description>Carbidopa, levodopa and entacapone tablets are combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro‑catechol‑structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone is supplied as tablets in 6 strengths:Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg, containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets 18.75 mg/75 mg/200 mg, containing 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets 25 mg/100 mg/200 mg, containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets 31.25 mg/125 mg/200 mg, containing 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets 37.5 mg/150 mg/200 mg, containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets 50 mg/200 mg/200 mg, containing 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone.The inactive ingredients of the carbidopa, levodopa and entacapone tablets are corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg, 25 mg/100 mg/200 mg and 37.5 mg/150 mg/200 mg also contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>47643-005-03</NDCCode>
<PackageDescription>15.88 kg in 1 PAIL (47643-005-03)</PackageDescription>
<NDC11Code>47643-0005-03</NDC11Code>
<ProductNDC>47643-005</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<StartMarketingDate>20200630</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Vantage Specialty Ingredients, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54699-005-02</NDCCode>
<PackageDescription>88 mL in 1 BOTTLE (54699-005-02) </PackageDescription>
<NDC11Code>54699-0005-02</NDC11Code>
<ProductNDC>54699-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ultra Defense Sani Smart Hand Sanitizer Fragrance Free With Vitamin E</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Ouya Cosmetics Co., Ltd of Yiwu</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>69</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62217-005-09</NDCCode>
<PackageDescription>88 mL in 1 TUBE (62217-005-09) </PackageDescription>
<NDC11Code>62217-0005-09</NDC11Code>
<ProductNDC>62217-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth</ProprietaryName>
<ProprietaryNameSuffix>Block Up Kids Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140929</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>20; 90; 75; 50; 15; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170330</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 agining caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>88.7 mg in 1 JAR (71798-005-03) </PackageDescription>
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<LabelerName>New Leaf Pharmaceutical, LLC</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
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<StrengthUnit>g/16mg</StrengthUnit>
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<LastUpdate>2022-01-04</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<NDCCode>73386-005-03</NDCCode>
<PackageDescription>88.5 mL in 1 BOTTLE (73386-005-03) </PackageDescription>
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<ProductNDC>73386-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sanar - Arnica Roll On</ProprietaryName>
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<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210927</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>SANVALL ENTERPRISES, INC</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC)</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aid for temporary local relief of minor pain in muscles or joints.</IndicationAndUsage>
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<NDC>
<NDCCode>75455-005-07</NDCCode>
<PackageDescription>354.88 mL in 1 BOTTLE (75455-005-07) </PackageDescription>
<NDC11Code>75455-0005-07</NDC11Code>
<ProductNDC>75455-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Jet Kleen Hsg-e70</ProprietaryName>
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<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200528</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Chemject International, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81683-005-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (81683-005-02) / 88.5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>81683-0005-02</NDC11Code>
<ProductNDC>81683-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rocksauce Warming Massage Roll-on</ProprietaryName>
<NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName>
<DosageFormName>CREAM, AUGMENTED</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Implus Footcare, LLC</LabelerName>
<SubstanceName>METHYL SALICYLATE; MENTHOL</SubstanceName>
<StrengthNumber>200; 100</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Provides soothing heat to sore muscles and joints.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57664-001-88</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-001-88) </PackageDescription>
<NDC11Code>57664-0001-88</NDC11Code>
<ProductNDC>57664-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole</ProprietaryName>
<NonProprietaryName>Pramipexole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<EndMarketingDate>20181228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091683</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130523</StartMarketingDatePackage>
<EndMarketingDatePackage>20181228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57664-002-88</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-002-88) </PackageDescription>
<NDC11Code>57664-0002-88</NDC11Code>
<ProductNDC>57664-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole</ProprietaryName>
<NonProprietaryName>Pramipexole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<EndMarketingDate>20181228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091683</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130523</StartMarketingDatePackage>
<EndMarketingDatePackage>20181228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57664-003-88</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-003-88) </PackageDescription>
<NDC11Code>57664-0003-88</NDC11Code>
<ProductNDC>57664-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole</ProprietaryName>
<NonProprietaryName>Pramipexole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<EndMarketingDate>20181228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091683</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130523</StartMarketingDatePackage>
<EndMarketingDatePackage>20181228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57664-004-88</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-004-88) </PackageDescription>
<NDC11Code>57664-0004-88</NDC11Code>
<ProductNDC>57664-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole</ProprietaryName>
<NonProprietaryName>Pramipexole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<EndMarketingDate>20181228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091683</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130523</StartMarketingDatePackage>
<EndMarketingDatePackage>20181228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57664-046-88</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (57664-046-88) </PackageDescription>
<NDC11Code>57664-0046-88</NDC11Code>
<ProductNDC>57664-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214484</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor.</Description>
</NDC>
<NDC>
<NDCCode>57664-047-88</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (57664-047-88) </PackageDescription>
<NDC11Code>57664-0047-88</NDC11Code>
<ProductNDC>57664-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214484</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor.</Description>
</NDC>
<NDC>
<NDCCode>57664-048-88</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (57664-048-88) </PackageDescription>
<NDC11Code>57664-0048-88</NDC11Code>
<ProductNDC>57664-048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214484</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor.</Description>
</NDC>
<NDC>
<NDCCode>57664-049-88</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (57664-049-88) </PackageDescription>
<NDC11Code>57664-0049-88</NDC11Code>
<ProductNDC>57664-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214484</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor.</Description>
</NDC>
<NDC>
<NDCCode>57664-050-88</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (57664-050-88) </PackageDescription>
<NDC11Code>57664-0050-88</NDC11Code>
<ProductNDC>57664-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214484</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor.</Description>
</NDC>
<NDC>
<NDCCode>57664-051-88</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (57664-051-88) </PackageDescription>
<NDC11Code>57664-0051-88</NDC11Code>
<ProductNDC>57664-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214484</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor.</Description>
</NDC>
<NDC>
<NDCCode>57664-052-88</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (57664-052-88) </PackageDescription>
<NDC11Code>57664-0052-88</NDC11Code>
<ProductNDC>57664-052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214484</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor.</Description>
</NDC>
<NDC>
<NDCCode>57664-058-88</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-058-88) </PackageDescription>
<NDC11Code>57664-0058-88</NDC11Code>
<ProductNDC>57664-058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levorphanol Tartrate</ProprietaryName>
<NonProprietaryName>Levorphanol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213906</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LEVORPHANOL TARTRATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at any dosage or duration, and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including levorphanol tartrate tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Levorphanol tartrate tablets USP, contain levorphanol, an opioid agonist with a molecular formula of C 17H 23NO C 4H 6O 6 2H 2O and molecular weight 443.5. Each milligram of levorphanol tartrate is equivalent to 0.58 mg levorphanol base. Levorphanol's chemical name is levo-3-hydroxy-N-methylmorphinan. The USP nomenclature is 17- methylmorphinan 3-ol tartrate (1:1) (Salt) dihydrate. The material has 3 asymmetric carbon atoms. The chemical structure is:. Levorphanol tartrate, USP is a white crystalline powder, soluble in water and ether, but insoluble in chloroform. Levorphanol tartrate tablets, USP, for oral administration, are available in two strengths. 2 mg tablet: white to off-white, flat face beveled edge tablet, bisect scored on one side and debossed with “762” on other side. 3 mg tablet: white to off-white, oval tablet, debossed with “058” on one side. In addition, each tablet contains microcrystalline cellulose, anhydrous lactose, pregelatinized starch, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>57664-062-88</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-062-88) </PackageDescription>
<NDC11Code>57664-0062-88</NDC11Code>
<ProductNDC>57664-062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214574</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy, 2 Attention Deficit-Disorder with Hyperactivityas an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability , and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. , 3 Exogenous Obesityas a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. .</IndicationAndUsage>
<Description>Amphetamine sulfate, USP is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5.0 to 6.0. It is freely soluble in water and slightly soluble in alcohol. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate, USP. Each tablet also contains the following inactive ingredients: crospovidone, povidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&C Blue #1. Structural Formula.</Description>
</NDC>
<NDC>
<NDCCode>57664-075-88</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-075-88) </PackageDescription>
<NDC11Code>57664-0075-88</NDC11Code>
<ProductNDC>57664-075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214574</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy, 2 Attention Deficit-Disorder with Hyperactivityas an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability , and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. , 3 Exogenous Obesityas a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. .</IndicationAndUsage>
<Description>Amphetamine sulfate, USP is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5.0 to 6.0. It is freely soluble in water and slightly soluble in alcohol. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate, USP. Each tablet also contains the following inactive ingredients: crospovidone, povidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&C Blue #1. Structural Formula.</Description>
</NDC>
<NDC>
<NDCCode>57664-083-88</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE (57664-083-88) </PackageDescription>
<NDC11Code>57664-0083-88</NDC11Code>
<ProductNDC>57664-083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214134</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor.</Description>
</NDC>
<NDC>
<NDCCode>57664-084-88</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE (57664-084-88) </PackageDescription>
<NDC11Code>57664-0084-88</NDC11Code>
<ProductNDC>57664-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214134</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following: FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets. Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor.</Description>
</NDC>
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