{
"NDC": [
{
"NDCCode": "64842-1020-1",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (64842-1020-1) ",
"NDC11Code": "64842-1020-01",
"ProductNDC": "64842-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lonsurf",
"NonProprietaryName": "Trifluridine And Tipiracil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150922",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207981",
"LabelerName": "Taiho Pharmaceutical Co., Ltd.",
"SubstanceName": "TRIFLURIDINE; TIPIRACIL HYDROCHLORIDE",
"StrengthNumber": "20; 8.19",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151007",
"SamplePackage": "N",
"IndicationAndUsage": "LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: 1 metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. (1.1), 2 metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. (1.2).",
"Description": "LONSURF contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5. Trifluridine. Trifluridine, a nucleoside metabolic inhibitor, is described chemically as 2’-deoxy-5-(trifluoromethyl) uridine and has the following structural formula. Trifluridine has a molecular formula C10H11F3N2O5 and a molecular weight of 296.20. Trifluridine is a white crystalline powder, soluble in water, ethanol, 0.01 mol/L hydrochloric acid, 0.01 mol/L sodium hydroxide solution; freely soluble in methanol, acetone; sparingly soluble in 2-propanol, acetonitrile; slightly soluble in diethyl ether; and very slightly soluble in isopropyl ether. Tipiracil hydrochloride. Tipiracil hydrochloride, a thymidine phosphorylase inhibitor, is described chemically as 5-chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4-(1H,3H)-dione monohydrochloride or 2,4(1H,3H)-Pyrimidinedione, 5-chloro-6-[(2-imino-1-pyrrolidinyl)methyl]-, hydrochloride (1:1) and has the following structural formula. Tipiracil hydrochloride has a molecular formula C9H11ClN4O2HCl and a molecular weight of 279.12. Tipiracil hydrochloride is a white crystalline powder, soluble in water, 0.01 mol/L hydrochloric acid, and 0.01 mol/L sodium hydroxide; slightly soluble in methanol; very slightly soluble in ethanol; and practically insoluble in acetonitrile, 2-propanol, acetone, diisopropyl ether, and diethyl ether. LONSURF (trifluridine and tipiracil) tablets for oral use contain 15 mg of trifluridine and 6.14 mg of tipiracil equivalent to 7.065 mg of tipiracil hydrochloride or 20 mg of trifluridine and 8.19 mg of tipiracil equivalent to 9.420 mg of tipiracil hydrochloride. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide, and magnesium stearate. The tablets are imprinted with ink containing shellac, ferric oxide red, ferric oxide yellow, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, carnauba wax, and talc."
},
{
"NDCCode": "64842-1020-2",
"PackageDescription": "40 TABLET, FILM COATED in 1 BOTTLE (64842-1020-2) ",
"NDC11Code": "64842-1020-02",
"ProductNDC": "64842-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lonsurf",
"NonProprietaryName": "Trifluridine And Tipiracil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150922",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207981",
"LabelerName": "Taiho Pharmaceutical Co., Ltd.",
"SubstanceName": "TRIFLURIDINE; TIPIRACIL HYDROCHLORIDE",
"StrengthNumber": "20; 8.19",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151111",
"SamplePackage": "N",
"IndicationAndUsage": "LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: 1 metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. (1.1), 2 metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. (1.2).",
"Description": "LONSURF contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5. Trifluridine. Trifluridine, a nucleoside metabolic inhibitor, is described chemically as 2’-deoxy-5-(trifluoromethyl) uridine and has the following structural formula. Trifluridine has a molecular formula C10H11F3N2O5 and a molecular weight of 296.20. Trifluridine is a white crystalline powder, soluble in water, ethanol, 0.01 mol/L hydrochloric acid, 0.01 mol/L sodium hydroxide solution; freely soluble in methanol, acetone; sparingly soluble in 2-propanol, acetonitrile; slightly soluble in diethyl ether; and very slightly soluble in isopropyl ether. Tipiracil hydrochloride. Tipiracil hydrochloride, a thymidine phosphorylase inhibitor, is described chemically as 5-chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4-(1H,3H)-dione monohydrochloride or 2,4(1H,3H)-Pyrimidinedione, 5-chloro-6-[(2-imino-1-pyrrolidinyl)methyl]-, hydrochloride (1:1) and has the following structural formula. Tipiracil hydrochloride has a molecular formula C9H11ClN4O2HCl and a molecular weight of 279.12. Tipiracil hydrochloride is a white crystalline powder, soluble in water, 0.01 mol/L hydrochloric acid, and 0.01 mol/L sodium hydroxide; slightly soluble in methanol; very slightly soluble in ethanol; and practically insoluble in acetonitrile, 2-propanol, acetone, diisopropyl ether, and diethyl ether. LONSURF (trifluridine and tipiracil) tablets for oral use contain 15 mg of trifluridine and 6.14 mg of tipiracil equivalent to 7.065 mg of tipiracil hydrochloride or 20 mg of trifluridine and 8.19 mg of tipiracil equivalent to 9.420 mg of tipiracil hydrochloride. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide, and magnesium stearate. The tablets are imprinted with ink containing shellac, ferric oxide red, ferric oxide yellow, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, carnauba wax, and talc."
},
{
"NDCCode": "64842-1020-3",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (64842-1020-3) ",
"NDC11Code": "64842-1020-03",
"ProductNDC": "64842-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lonsurf",
"NonProprietaryName": "Trifluridine And Tipiracil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150922",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207981",
"LabelerName": "Taiho Pharmaceutical Co., Ltd.",
"SubstanceName": "TRIFLURIDINE; TIPIRACIL HYDROCHLORIDE",
"StrengthNumber": "20; 8.19",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151021",
"SamplePackage": "N",
"IndicationAndUsage": "LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: 1 metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. (1.1), 2 metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. (1.2).",
"Description": "LONSURF contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5. Trifluridine. Trifluridine, a nucleoside metabolic inhibitor, is described chemically as 2’-deoxy-5-(trifluoromethyl) uridine and has the following structural formula. Trifluridine has a molecular formula C10H11F3N2O5 and a molecular weight of 296.20. Trifluridine is a white crystalline powder, soluble in water, ethanol, 0.01 mol/L hydrochloric acid, 0.01 mol/L sodium hydroxide solution; freely soluble in methanol, acetone; sparingly soluble in 2-propanol, acetonitrile; slightly soluble in diethyl ether; and very slightly soluble in isopropyl ether. Tipiracil hydrochloride. Tipiracil hydrochloride, a thymidine phosphorylase inhibitor, is described chemically as 5-chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4-(1H,3H)-dione monohydrochloride or 2,4(1H,3H)-Pyrimidinedione, 5-chloro-6-[(2-imino-1-pyrrolidinyl)methyl]-, hydrochloride (1:1) and has the following structural formula. Tipiracil hydrochloride has a molecular formula C9H11ClN4O2HCl and a molecular weight of 279.12. Tipiracil hydrochloride is a white crystalline powder, soluble in water, 0.01 mol/L hydrochloric acid, and 0.01 mol/L sodium hydroxide; slightly soluble in methanol; very slightly soluble in ethanol; and practically insoluble in acetonitrile, 2-propanol, acetone, diisopropyl ether, and diethyl ether. LONSURF (trifluridine and tipiracil) tablets for oral use contain 15 mg of trifluridine and 6.14 mg of tipiracil equivalent to 7.065 mg of tipiracil hydrochloride or 20 mg of trifluridine and 8.19 mg of tipiracil equivalent to 9.420 mg of tipiracil hydrochloride. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide, and magnesium stearate. The tablets are imprinted with ink containing shellac, ferric oxide red, ferric oxide yellow, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, carnauba wax, and talc."
},
{
"NDCCode": "64842-0120-4",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (64842-0120-4) / 21 TABLET in 1 BLISTER PACK",
"NDC11Code": "64842-0120-04",
"ProductNDC": "64842-0120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lytgobi",
"NonProprietaryName": "Futibatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230203",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214801",
"LabelerName": "TAIHO PHARMACEUTICAL CO., LTD.",
"SubstanceName": "FUTIBATINIB",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Fibroblast Growth Factor Receptor Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230203",
"SamplePackage": "N",
"IndicationAndUsage": "LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "Futibatinib is a kinase inhibitor with the chemical name 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]- 1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]prop-2-en-1-one. Futibatinib has a molecular formula of C22H22N6O3 and molecular mass of 418.45 g/mole. Futibatinib has the following chemical structure. Futibatinib is a white crystalline powder. The solubility of futibatinib is pH dependent with decreasing solubility with increasing pH, being practically insoluble at pH 3 or higher. Futibatinib is insoluble in water and poorly soluble in common solvents. LYTGOBI is supplied as 4 mg and 16 mg film-coated tablets for oral administration. Each tablet contains inactive ingredients of corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate. The film coating material contains hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "64842-0120-5",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (64842-0120-5) / 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "64842-0120-05",
"ProductNDC": "64842-0120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lytgobi",
"NonProprietaryName": "Futibatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230203",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214801",
"LabelerName": "TAIHO PHARMACEUTICAL CO., LTD.",
"SubstanceName": "FUTIBATINIB",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Fibroblast Growth Factor Receptor Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230203",
"SamplePackage": "N",
"IndicationAndUsage": "LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "Futibatinib is a kinase inhibitor with the chemical name 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]- 1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]prop-2-en-1-one. Futibatinib has a molecular formula of C22H22N6O3 and molecular mass of 418.45 g/mole. Futibatinib has the following chemical structure. Futibatinib is a white crystalline powder. The solubility of futibatinib is pH dependent with decreasing solubility with increasing pH, being practically insoluble at pH 3 or higher. Futibatinib is insoluble in water and poorly soluble in common solvents. LYTGOBI is supplied as 4 mg and 16 mg film-coated tablets for oral administration. Each tablet contains inactive ingredients of corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate. The film coating material contains hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "64842-0120-6",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (64842-0120-6) / 35 TABLET in 1 BLISTER PACK",
"NDC11Code": "64842-0120-06",
"ProductNDC": "64842-0120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lytgobi",
"NonProprietaryName": "Futibatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230203",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214801",
"LabelerName": "TAIHO PHARMACEUTICAL CO., LTD.",
"SubstanceName": "FUTIBATINIB",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Fibroblast Growth Factor Receptor Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230203",
"SamplePackage": "N",
"IndicationAndUsage": "LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "Futibatinib is a kinase inhibitor with the chemical name 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]- 1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]prop-2-en-1-one. Futibatinib has a molecular formula of C22H22N6O3 and molecular mass of 418.45 g/mole. Futibatinib has the following chemical structure. Futibatinib is a white crystalline powder. The solubility of futibatinib is pH dependent with decreasing solubility with increasing pH, being practically insoluble at pH 3 or higher. Futibatinib is insoluble in water and poorly soluble in common solvents. LYTGOBI is supplied as 4 mg and 16 mg film-coated tablets for oral administration. Each tablet contains inactive ingredients of corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate. The film coating material contains hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "64842-0127-7",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (64842-0127-7) / 7 TABLET in 1 BLISTER PACK",
"NDC11Code": "64842-0127-07",
"ProductNDC": "64842-0127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lytgobi",
"NonProprietaryName": "Futibatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214801",
"LabelerName": "TAIHO PHARMACEUTICAL CO., LTD.",
"SubstanceName": "FUTIBATINIB",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Fibroblast Growth Factor Receptor Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"IndicationAndUsage": "LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "Futibatinib is a kinase inhibitor with the chemical name 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]- 1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]prop-2-en-1-one. Futibatinib has a molecular formula of C22H22N6O3 and molecular mass of 418.45 g/mole. Futibatinib has the following chemical structure. Futibatinib is a white crystalline powder. The solubility of futibatinib is pH dependent with decreasing solubility with increasing pH, being practically insoluble at pH 3 or higher. Futibatinib is insoluble in water and poorly soluble in common solvents. LYTGOBI is supplied as 4 mg and 16 mg film-coated tablets for oral administration. Each tablet contains inactive ingredients of corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate. The film coating material contains hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "64842-0128-8",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (64842-0128-8) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "64842-0128-08",
"ProductNDC": "64842-0128",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lytgobi",
"NonProprietaryName": "Lytgobi",
"DosageFormName": "KIT",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214801",
"LabelerName": "TAIHO PHARMACEUTICAL CO., LTD.",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"IndicationAndUsage": "LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "Futibatinib is a kinase inhibitor with the chemical name 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]- 1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]prop-2-en-1-one. Futibatinib has a molecular formula of C22H22N6O3 and molecular mass of 418.45 g/mole. Futibatinib has the following chemical structure. Futibatinib is a white crystalline powder. The solubility of futibatinib is pH dependent with decreasing solubility with increasing pH, being practically insoluble at pH 3 or higher. Futibatinib is insoluble in water and poorly soluble in common solvents. LYTGOBI is supplied as 4 mg and 16 mg film-coated tablets for oral administration. Each tablet contains inactive ingredients of corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate. The film coating material contains hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "64842-0727-9",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (64842-0727-9) / 5 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64842-0727-09",
"ProductNDC": "64842-0727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inqovi",
"NonProprietaryName": "Cedazuridine And Decitabine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200707",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212576",
"LabelerName": "Taiho Pharmaceutical Co., Ltd.",
"SubstanceName": "CEDAZURIDINE; DECITABINE",
"StrengthNumber": "100; 35",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200825",
"SamplePackage": "N",
"IndicationAndUsage": "INQOVI is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor, indicated: 1 For treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. (1.1), 2 In combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2).",
"Description": "Decitabine. Decitabine is a nucleoside metabolic inhibitor. Decitabine is a white to off-white solid with the molecular formula of C8H12N4O4 and a molecular weight of 228.21 daltons. Its international union of pure and applied chemistry (IUPAC) chemical name is 4-amino-1-[(2R,4S,5R)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-1,3,5-triazin-2(1H)-one and it has the following structural formula. Cedazuridine. Cedazuridine is a cytidine deaminase inhibitor. Cedazuridine is a white to off-white solid with the molecular formula of C9H14F2N2O5 and a molecular weight of 268.21 daltons. Its IUPAC chemical name is (4R)-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-4-hydroxy-1,3-diazinan-2-one and it has the following structural formula. INQOVI. INQOVI (decitabine and cedazuridine) tablets, for oral use contain 35 mg decitabine and 100 mg cedazuridine. The tablets are biconvex, oval-shaped, film-coated, red and debossed with “H35” on one side. Each film-coated tablet contains the following inactive ingredients: lactose monohydrate, hypromellose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating material contains polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red."
},
{
"NDCCode": "64842-1025-1",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (64842-1025-1) ",
"NDC11Code": "64842-1025-01",
"ProductNDC": "64842-1025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lonsurf",
"NonProprietaryName": "Trifluridine And Tipiracil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150922",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207981",
"LabelerName": "Taiho Pharmaceutical Co., Ltd.",
"SubstanceName": "TRIFLURIDINE; TIPIRACIL HYDROCHLORIDE",
"StrengthNumber": "15; 6.14",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151007",
"SamplePackage": "N",
"IndicationAndUsage": "LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: 1 metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. (1.1), 2 metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. (1.2).",
"Description": "LONSURF contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5. Trifluridine. Trifluridine, a nucleoside metabolic inhibitor, is described chemically as 2’-deoxy-5-(trifluoromethyl) uridine and has the following structural formula. Trifluridine has a molecular formula C10H11F3N2O5 and a molecular weight of 296.20. Trifluridine is a white crystalline powder, soluble in water, ethanol, 0.01 mol/L hydrochloric acid, 0.01 mol/L sodium hydroxide solution; freely soluble in methanol, acetone; sparingly soluble in 2-propanol, acetonitrile; slightly soluble in diethyl ether; and very slightly soluble in isopropyl ether. Tipiracil hydrochloride. Tipiracil hydrochloride, a thymidine phosphorylase inhibitor, is described chemically as 5-chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4-(1H,3H)-dione monohydrochloride or 2,4(1H,3H)-Pyrimidinedione, 5-chloro-6-[(2-imino-1-pyrrolidinyl)methyl]-, hydrochloride (1:1) and has the following structural formula. Tipiracil hydrochloride has a molecular formula C9H11ClN4O2HCl and a molecular weight of 279.12. Tipiracil hydrochloride is a white crystalline powder, soluble in water, 0.01 mol/L hydrochloric acid, and 0.01 mol/L sodium hydroxide; slightly soluble in methanol; very slightly soluble in ethanol; and practically insoluble in acetonitrile, 2-propanol, acetone, diisopropyl ether, and diethyl ether. LONSURF (trifluridine and tipiracil) tablets for oral use contain 15 mg of trifluridine and 6.14 mg of tipiracil equivalent to 7.065 mg of tipiracil hydrochloride or 20 mg of trifluridine and 8.19 mg of tipiracil equivalent to 9.420 mg of tipiracil hydrochloride. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide, and magnesium stearate. The tablets are imprinted with ink containing shellac, ferric oxide red, ferric oxide yellow, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, carnauba wax, and talc."
},
{
"NDCCode": "64842-1025-2",
"PackageDescription": "40 TABLET, FILM COATED in 1 BOTTLE (64842-1025-2) ",
"NDC11Code": "64842-1025-02",
"ProductNDC": "64842-1025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lonsurf",
"NonProprietaryName": "Trifluridine And Tipiracil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150922",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207981",
"LabelerName": "Taiho Pharmaceutical Co., Ltd.",
"SubstanceName": "TRIFLURIDINE; TIPIRACIL HYDROCHLORIDE",
"StrengthNumber": "15; 6.14",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151111",
"SamplePackage": "N",
"IndicationAndUsage": "LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: 1 metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. (1.1), 2 metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. (1.2).",
"Description": "LONSURF contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5. Trifluridine. Trifluridine, a nucleoside metabolic inhibitor, is described chemically as 2’-deoxy-5-(trifluoromethyl) uridine and has the following structural formula. Trifluridine has a molecular formula C10H11F3N2O5 and a molecular weight of 296.20. Trifluridine is a white crystalline powder, soluble in water, ethanol, 0.01 mol/L hydrochloric acid, 0.01 mol/L sodium hydroxide solution; freely soluble in methanol, acetone; sparingly soluble in 2-propanol, acetonitrile; slightly soluble in diethyl ether; and very slightly soluble in isopropyl ether. Tipiracil hydrochloride. Tipiracil hydrochloride, a thymidine phosphorylase inhibitor, is described chemically as 5-chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4-(1H,3H)-dione monohydrochloride or 2,4(1H,3H)-Pyrimidinedione, 5-chloro-6-[(2-imino-1-pyrrolidinyl)methyl]-, hydrochloride (1:1) and has the following structural formula. Tipiracil hydrochloride has a molecular formula C9H11ClN4O2HCl and a molecular weight of 279.12. Tipiracil hydrochloride is a white crystalline powder, soluble in water, 0.01 mol/L hydrochloric acid, and 0.01 mol/L sodium hydroxide; slightly soluble in methanol; very slightly soluble in ethanol; and practically insoluble in acetonitrile, 2-propanol, acetone, diisopropyl ether, and diethyl ether. LONSURF (trifluridine and tipiracil) tablets for oral use contain 15 mg of trifluridine and 6.14 mg of tipiracil equivalent to 7.065 mg of tipiracil hydrochloride or 20 mg of trifluridine and 8.19 mg of tipiracil equivalent to 9.420 mg of tipiracil hydrochloride. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide, and magnesium stearate. The tablets are imprinted with ink containing shellac, ferric oxide red, ferric oxide yellow, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, carnauba wax, and talc."
},
{
"NDCCode": "64842-1025-3",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (64842-1025-3) ",
"NDC11Code": "64842-1025-03",
"ProductNDC": "64842-1025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lonsurf",
"NonProprietaryName": "Trifluridine And Tipiracil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150922",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207981",
"LabelerName": "Taiho Pharmaceutical Co., Ltd.",
"SubstanceName": "TRIFLURIDINE; TIPIRACIL HYDROCHLORIDE",
"StrengthNumber": "15; 6.14",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151021",
"SamplePackage": "N",
"IndicationAndUsage": "LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: 1 metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. (1.1), 2 metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. (1.2).",
"Description": "LONSURF contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5. Trifluridine. Trifluridine, a nucleoside metabolic inhibitor, is described chemically as 2’-deoxy-5-(trifluoromethyl) uridine and has the following structural formula. Trifluridine has a molecular formula C10H11F3N2O5 and a molecular weight of 296.20. Trifluridine is a white crystalline powder, soluble in water, ethanol, 0.01 mol/L hydrochloric acid, 0.01 mol/L sodium hydroxide solution; freely soluble in methanol, acetone; sparingly soluble in 2-propanol, acetonitrile; slightly soluble in diethyl ether; and very slightly soluble in isopropyl ether. Tipiracil hydrochloride. Tipiracil hydrochloride, a thymidine phosphorylase inhibitor, is described chemically as 5-chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4-(1H,3H)-dione monohydrochloride or 2,4(1H,3H)-Pyrimidinedione, 5-chloro-6-[(2-imino-1-pyrrolidinyl)methyl]-, hydrochloride (1:1) and has the following structural formula. Tipiracil hydrochloride has a molecular formula C9H11ClN4O2HCl and a molecular weight of 279.12. Tipiracil hydrochloride is a white crystalline powder, soluble in water, 0.01 mol/L hydrochloric acid, and 0.01 mol/L sodium hydroxide; slightly soluble in methanol; very slightly soluble in ethanol; and practically insoluble in acetonitrile, 2-propanol, acetone, diisopropyl ether, and diethyl ether. LONSURF (trifluridine and tipiracil) tablets for oral use contain 15 mg of trifluridine and 6.14 mg of tipiracil equivalent to 7.065 mg of tipiracil hydrochloride or 20 mg of trifluridine and 8.19 mg of tipiracil equivalent to 9.420 mg of tipiracil hydrochloride. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide, and magnesium stearate. The tablets are imprinted with ink containing shellac, ferric oxide red, ferric oxide yellow, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, carnauba wax, and talc."
},
{
"NDCCode": "0071-1020-01",
"PackageDescription": "473 mL in 1 BOTTLE (0071-1020-01) ",
"NDC11Code": "00071-1020-01",
"ProductNDC": "0071-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyrica",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100104",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022488",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100104",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients."
},
{
"NDCCode": "0143-1020-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0143-1020-01)",
"NDC11Code": "00143-1020-01",
"ProductNDC": "0143-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminophylline",
"NonProprietaryName": "Aminophylline Dihydrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19751126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084540",
"LabelerName": "West-ward Pharmaceutical Corp",
"SubstanceName": "AMINOPHYLLINE DIHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-08"
},
{
"NDCCode": "0143-1020-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0143-1020-10)",
"NDC11Code": "00143-1020-10",
"ProductNDC": "0143-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminophylline",
"NonProprietaryName": "Aminophylline Dihydrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19751126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084540",
"LabelerName": "West-ward Pharmaceutical Corp",
"SubstanceName": "AMINOPHYLLINE DIHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-08"
},
{
"NDCCode": "0143-1020-25",
"PackageDescription": "100 TABLET in 1 BOX, UNIT-DOSE (0143-1020-25)",
"NDC11Code": "00143-1020-25",
"ProductNDC": "0143-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminophylline",
"NonProprietaryName": "Aminophylline Dihydrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19751126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084540",
"LabelerName": "West-ward Pharmaceutical Corp",
"SubstanceName": "AMINOPHYLLINE DIHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-08"
},
{
"NDCCode": "0220-1020-41",
"PackageDescription": "200 [kp_C] in 1 TUBE (0220-1020-41) ",
"NDC11Code": "00220-1020-41",
"ProductNDC": "0220-1020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cajuputum",
"NonProprietaryName": "Cajuput Oil",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "CAJUPUT OIL",
"StrengthNumber": "200",
"StrengthUnit": "[kp_C]/200[kp_C]",
"Status": "Active",
"LastUpdate": "2024-04-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: See symptoms on front panel. Relieves hiccups or heartburn *."
},
{
"NDCCode": "0254-1020-47",
"PackageDescription": "100 mL in 1 BOTTLE (0254-1020-47) ",
"NDC11Code": "00254-1020-47",
"ProductNDC": "0254-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin Ethylsuccinate",
"NonProprietaryName": "Erythromycin Ethylsuccinate",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20191111",
"EndMarketingDate": "20211130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211991",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191111",
"EndMarketingDatePackage": "20211130",
"SamplePackage": "N"
},
{
"NDCCode": "0363-1020-26",
"PackageDescription": "1 TUBE in 1 PACKAGE (0363-1020-26) / 113 g in 1 TUBE",
"NDC11Code": "00363-1020-26",
"ProductNDC": "0363-1020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zinc Oxide",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080324",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Walgreen Co.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080324",
"SamplePackage": "N",
"IndicationAndUsage": "helps treat and prevent diaper rash. protects chafed skin due to the diaper rash and helps seal out wetness."
},
{
"NDCCode": "0378-1020-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1020-05) ",
"NDC11Code": "00378-1020-05",
"ProductNDC": "0378-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nicardipine Hydrochloride",
"NonProprietaryName": "Nicardipine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19960719",
"EndMarketingDate": "20300131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074642",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19960719",
"EndMarketingDatePackage": "20300131",
"SamplePackage": "N"
},
{
"NDCCode": "0378-1020-77",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (0378-1020-77) ",
"NDC11Code": "00378-1020-77",
"ProductNDC": "0378-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nicardipine Hydrochloride",
"NonProprietaryName": "Nicardipine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19960719",
"EndMarketingDate": "20300131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074642",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19960719",
"EndMarketingDatePackage": "20300131",
"SamplePackage": "N"
},
{
"NDCCode": "0469-1020-99",
"PackageDescription": "5 kg in 1 DRUM (0469-1020-99)",
"NDC11Code": "00469-1020-99",
"ProductNDC": "0469-1020",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Isavuconazonium Sulfate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20150306",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Astellas Pharma US, Inc.",
"SubstanceName": "ISAVUCONAZONIUM SULFATE",
"StrengthNumber": ".54",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2018-02-02",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0517-1020-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (0517-1020-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-1020-01) ",
"NDC11Code": "00517-1020-25",
"ProductNDC": "0517-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vasopressin",
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"LabelerName": "American Regent, Inc.",
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"LastUpdate": "2024-11-01",
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"IndicationAndUsage": "Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.",
"Description": "Vasopressin is a polypeptide hormone. Vasopressin injection is a sterile, aqueous solution of synthetic arginine vasopressin for administration. The 1 mL and 10 mL solution contains vasopressin 20 units/mL, chlorobutanol 5 mg, sodium chloride 9 mg, water for injection, and glacial acetic acid to adjust pH to 3.5. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L- Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is. Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23."
},
{
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Strength Gas Relief",
"ProprietaryNameSuffix": "Antiflatulent",
"NonProprietaryName": "Simethicone",
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"LabelerName": "RUGBY LABORATORIES",
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ApplicationNumber": "ANDA078189",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
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"StrengthUnit": "mg/1",
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},
{
"NDCCode": "0603-1020-58",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0603-1020-58)",
"NDC11Code": "00603-1020-58",
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"ApplicationNumber": "ANDA089450",
"LabelerName": "Qualitest Pharmaceuticals",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
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"StrengthUnit": "mg/5mL; mg/5mL",
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},
{
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"PackageDescription": "6 BAG in 1 CARTON (0703-1020-30) > 200 mL in 1 BAG (0703-1020-31)",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
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"RouteName": "INTRAVENOUS",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076837",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "400",
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"Pharm_Classes": "Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-12-19"
},
{
"NDCCode": "0955-1020-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0955-1020-01) / 1 mL in 1 VIAL, GLASS",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
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"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
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"IndicationAndUsage": "Docetaxel is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1) , 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2) , 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer ( 1.3) , 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction ( 1.4) , 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN ( 1.5) .",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N- tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel has the following structural formula:. Docetaxel is a white to almost-white powder with an empirical formula of C 43H 53NO 14∙3H 2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water."
},
{
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"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "POWDER",
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"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20140625"
},
{
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"PackageDescription": "1020.58 kg in 1 SUPERSACK (10237-590-10) ",
"NDC11Code": "10237-0590-10",
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"ProductTypeName": "BULK INGREDIENT",
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"Status": "Unfinished",
"LastUpdate": "2024-03-14",
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"StartMarketingDatePackage": "30-JAN-77"
}
]
}
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<IndicationAndUsage>LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: 1 metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. (1.1), 2 metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. (1.2).</IndicationAndUsage>
<Description>LONSURF contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5. Trifluridine. Trifluridine, a nucleoside metabolic inhibitor, is described chemically as 2’-deoxy-5-(trifluoromethyl) uridine and has the following structural formula. Trifluridine has a molecular formula C10H11F3N2O5 and a molecular weight of 296.20. Trifluridine is a white crystalline powder, soluble in water, ethanol, 0.01 mol/L hydrochloric acid, 0.01 mol/L sodium hydroxide solution; freely soluble in methanol, acetone; sparingly soluble in 2-propanol, acetonitrile; slightly soluble in diethyl ether; and very slightly soluble in isopropyl ether. Tipiracil hydrochloride. Tipiracil hydrochloride, a thymidine phosphorylase inhibitor, is described chemically as 5-chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4-(1H,3H)-dione monohydrochloride or 2,4(1H,3H)-Pyrimidinedione, 5-chloro-6-[(2-imino-1-pyrrolidinyl)methyl]-, hydrochloride (1:1) and has the following structural formula. Tipiracil hydrochloride has a molecular formula C9H11ClN4O2HCl and a molecular weight of 279.12. Tipiracil hydrochloride is a white crystalline powder, soluble in water, 0.01 mol/L hydrochloric acid, and 0.01 mol/L sodium hydroxide; slightly soluble in methanol; very slightly soluble in ethanol; and practically insoluble in acetonitrile, 2-propanol, acetone, diisopropyl ether, and diethyl ether. LONSURF (trifluridine and tipiracil) tablets for oral use contain 15 mg of trifluridine and 6.14 mg of tipiracil equivalent to 7.065 mg of tipiracil hydrochloride or 20 mg of trifluridine and 8.19 mg of tipiracil equivalent to 9.420 mg of tipiracil hydrochloride. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide, and magnesium stearate. The tablets are imprinted with ink containing shellac, ferric oxide red, ferric oxide yellow, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, carnauba wax, and talc.</Description>
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<SubstanceName>TRIFLURIDINE; TIPIRACIL HYDROCHLORIDE</SubstanceName>
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<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]</Pharm_Classes>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: 1 metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. (1.1), 2 metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. (1.2).</IndicationAndUsage>
<Description>LONSURF contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5. Trifluridine. Trifluridine, a nucleoside metabolic inhibitor, is described chemically as 2’-deoxy-5-(trifluoromethyl) uridine and has the following structural formula. Trifluridine has a molecular formula C10H11F3N2O5 and a molecular weight of 296.20. Trifluridine is a white crystalline powder, soluble in water, ethanol, 0.01 mol/L hydrochloric acid, 0.01 mol/L sodium hydroxide solution; freely soluble in methanol, acetone; sparingly soluble in 2-propanol, acetonitrile; slightly soluble in diethyl ether; and very slightly soluble in isopropyl ether. Tipiracil hydrochloride. Tipiracil hydrochloride, a thymidine phosphorylase inhibitor, is described chemically as 5-chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4-(1H,3H)-dione monohydrochloride or 2,4(1H,3H)-Pyrimidinedione, 5-chloro-6-[(2-imino-1-pyrrolidinyl)methyl]-, hydrochloride (1:1) and has the following structural formula. Tipiracil hydrochloride has a molecular formula C9H11ClN4O2HCl and a molecular weight of 279.12. Tipiracil hydrochloride is a white crystalline powder, soluble in water, 0.01 mol/L hydrochloric acid, and 0.01 mol/L sodium hydroxide; slightly soluble in methanol; very slightly soluble in ethanol; and practically insoluble in acetonitrile, 2-propanol, acetone, diisopropyl ether, and diethyl ether. LONSURF (trifluridine and tipiracil) tablets for oral use contain 15 mg of trifluridine and 6.14 mg of tipiracil equivalent to 7.065 mg of tipiracil hydrochloride or 20 mg of trifluridine and 8.19 mg of tipiracil equivalent to 9.420 mg of tipiracil hydrochloride. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide, and magnesium stearate. The tablets are imprinted with ink containing shellac, ferric oxide red, ferric oxide yellow, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, carnauba wax, and talc.</Description>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: 1 metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. (1.1), 2 metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. (1.2).</IndicationAndUsage>
<Description>LONSURF contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5. Trifluridine. Trifluridine, a nucleoside metabolic inhibitor, is described chemically as 2’-deoxy-5-(trifluoromethyl) uridine and has the following structural formula. Trifluridine has a molecular formula C10H11F3N2O5 and a molecular weight of 296.20. Trifluridine is a white crystalline powder, soluble in water, ethanol, 0.01 mol/L hydrochloric acid, 0.01 mol/L sodium hydroxide solution; freely soluble in methanol, acetone; sparingly soluble in 2-propanol, acetonitrile; slightly soluble in diethyl ether; and very slightly soluble in isopropyl ether. Tipiracil hydrochloride. Tipiracil hydrochloride, a thymidine phosphorylase inhibitor, is described chemically as 5-chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4-(1H,3H)-dione monohydrochloride or 2,4(1H,3H)-Pyrimidinedione, 5-chloro-6-[(2-imino-1-pyrrolidinyl)methyl]-, hydrochloride (1:1) and has the following structural formula. Tipiracil hydrochloride has a molecular formula C9H11ClN4O2HCl and a molecular weight of 279.12. Tipiracil hydrochloride is a white crystalline powder, soluble in water, 0.01 mol/L hydrochloric acid, and 0.01 mol/L sodium hydroxide; slightly soluble in methanol; very slightly soluble in ethanol; and practically insoluble in acetonitrile, 2-propanol, acetone, diisopropyl ether, and diethyl ether. LONSURF (trifluridine and tipiracil) tablets for oral use contain 15 mg of trifluridine and 6.14 mg of tipiracil equivalent to 7.065 mg of tipiracil hydrochloride or 20 mg of trifluridine and 8.19 mg of tipiracil equivalent to 9.420 mg of tipiracil hydrochloride. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide, and magnesium stearate. The tablets are imprinted with ink containing shellac, ferric oxide red, ferric oxide yellow, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, carnauba wax, and talc.</Description>
</NDC>
<NDC>
<NDCCode>64842-0120-4</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (64842-0120-4) / 21 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64842-0120-04</NDC11Code>
<ProductNDC>64842-0120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lytgobi</ProprietaryName>
<NonProprietaryName>Futibatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230203</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214801</ApplicationNumber>
<LabelerName>TAIHO PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>FUTIBATINIB</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Fibroblast Growth Factor Receptor Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>Futibatinib is a kinase inhibitor with the chemical name 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]- 1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]prop-2-en-1-one. Futibatinib has a molecular formula of C22H22N6O3 and molecular mass of 418.45 g/mole. Futibatinib has the following chemical structure. Futibatinib is a white crystalline powder. The solubility of futibatinib is pH dependent with decreasing solubility with increasing pH, being practically insoluble at pH 3 or higher. Futibatinib is insoluble in water and poorly soluble in common solvents. LYTGOBI is supplied as 4 mg and 16 mg film-coated tablets for oral administration. Each tablet contains inactive ingredients of corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate. The film coating material contains hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
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<NDCCode>64842-0120-5</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (64842-0120-5) / 28 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64842-0120-05</NDC11Code>
<ProductNDC>64842-0120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lytgobi</ProprietaryName>
<NonProprietaryName>Futibatinib</NonProprietaryName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214801</ApplicationNumber>
<LabelerName>TAIHO PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>FUTIBATINIB</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Fibroblast Growth Factor Receptor Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>Futibatinib is a kinase inhibitor with the chemical name 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]- 1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]prop-2-en-1-one. Futibatinib has a molecular formula of C22H22N6O3 and molecular mass of 418.45 g/mole. Futibatinib has the following chemical structure. Futibatinib is a white crystalline powder. The solubility of futibatinib is pH dependent with decreasing solubility with increasing pH, being practically insoluble at pH 3 or higher. Futibatinib is insoluble in water and poorly soluble in common solvents. LYTGOBI is supplied as 4 mg and 16 mg film-coated tablets for oral administration. Each tablet contains inactive ingredients of corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate. The film coating material contains hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>64842-0120-6</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (64842-0120-6) / 35 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64842-0120-06</NDC11Code>
<ProductNDC>64842-0120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lytgobi</ProprietaryName>
<NonProprietaryName>Futibatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230203</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214801</ApplicationNumber>
<LabelerName>TAIHO PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>FUTIBATINIB</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Fibroblast Growth Factor Receptor Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>Futibatinib is a kinase inhibitor with the chemical name 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]- 1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]prop-2-en-1-one. Futibatinib has a molecular formula of C22H22N6O3 and molecular mass of 418.45 g/mole. Futibatinib has the following chemical structure. Futibatinib is a white crystalline powder. The solubility of futibatinib is pH dependent with decreasing solubility with increasing pH, being practically insoluble at pH 3 or higher. Futibatinib is insoluble in water and poorly soluble in common solvents. LYTGOBI is supplied as 4 mg and 16 mg film-coated tablets for oral administration. Each tablet contains inactive ingredients of corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate. The film coating material contains hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide.</Description>
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<NDC>
<NDCCode>64842-0127-7</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (64842-0127-7) / 7 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64842-0127-07</NDC11Code>
<ProductNDC>64842-0127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lytgobi</ProprietaryName>
<NonProprietaryName>Futibatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214801</ApplicationNumber>
<LabelerName>TAIHO PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>FUTIBATINIB</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Fibroblast Growth Factor Receptor Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>Futibatinib is a kinase inhibitor with the chemical name 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]- 1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]prop-2-en-1-one. Futibatinib has a molecular formula of C22H22N6O3 and molecular mass of 418.45 g/mole. Futibatinib has the following chemical structure. Futibatinib is a white crystalline powder. The solubility of futibatinib is pH dependent with decreasing solubility with increasing pH, being practically insoluble at pH 3 or higher. Futibatinib is insoluble in water and poorly soluble in common solvents. LYTGOBI is supplied as 4 mg and 16 mg film-coated tablets for oral administration. Each tablet contains inactive ingredients of corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate. The film coating material contains hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide.</Description>
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<NDC>
<NDCCode>64842-0128-8</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (64842-0128-8) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64842-0128-08</NDC11Code>
<ProductNDC>64842-0128</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lytgobi</ProprietaryName>
<NonProprietaryName>Lytgobi</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214801</ApplicationNumber>
<LabelerName>TAIHO PHARMACEUTICAL CO., LTD.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>Futibatinib is a kinase inhibitor with the chemical name 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]- 1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]prop-2-en-1-one. Futibatinib has a molecular formula of C22H22N6O3 and molecular mass of 418.45 g/mole. Futibatinib has the following chemical structure. Futibatinib is a white crystalline powder. The solubility of futibatinib is pH dependent with decreasing solubility with increasing pH, being practically insoluble at pH 3 or higher. Futibatinib is insoluble in water and poorly soluble in common solvents. LYTGOBI is supplied as 4 mg and 16 mg film-coated tablets for oral administration. Each tablet contains inactive ingredients of corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate. The film coating material contains hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide.</Description>
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<NDC>
<NDCCode>64842-0727-9</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (64842-0727-9) / 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64842-0727-09</NDC11Code>
<ProductNDC>64842-0727</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inqovi</ProprietaryName>
<NonProprietaryName>Cedazuridine And Decitabine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200707</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212576</ApplicationNumber>
<LabelerName>Taiho Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>CEDAZURIDINE; DECITABINE</SubstanceName>
<StrengthNumber>100; 35</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INQOVI is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor, indicated: 1 For treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. (1.1), 2 In combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2).</IndicationAndUsage>
<Description>Decitabine. Decitabine is a nucleoside metabolic inhibitor. Decitabine is a white to off-white solid with the molecular formula of C8H12N4O4 and a molecular weight of 228.21 daltons. Its international union of pure and applied chemistry (IUPAC) chemical name is 4-amino-1-[(2R,4S,5R)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-1,3,5-triazin-2(1H)-one and it has the following structural formula. Cedazuridine. Cedazuridine is a cytidine deaminase inhibitor. Cedazuridine is a white to off-white solid with the molecular formula of C9H14F2N2O5 and a molecular weight of 268.21 daltons. Its IUPAC chemical name is (4R)-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-4-hydroxy-1,3-diazinan-2-one and it has the following structural formula. INQOVI. INQOVI (decitabine and cedazuridine) tablets, for oral use contain 35 mg decitabine and 100 mg cedazuridine. The tablets are biconvex, oval-shaped, film-coated, red and debossed with “H35” on one side. Each film-coated tablet contains the following inactive ingredients: lactose monohydrate, hypromellose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating material contains polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red.</Description>
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<NDCCode>64842-1025-1</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (64842-1025-1) </PackageDescription>
<NDC11Code>64842-1025-01</NDC11Code>
<ProductNDC>64842-1025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lonsurf</ProprietaryName>
<NonProprietaryName>Trifluridine And Tipiracil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150922</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207981</ApplicationNumber>
<LabelerName>Taiho Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>TRIFLURIDINE; TIPIRACIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 6.14</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: 1 metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. (1.1), 2 metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. (1.2).</IndicationAndUsage>
<Description>LONSURF contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5. Trifluridine. Trifluridine, a nucleoside metabolic inhibitor, is described chemically as 2’-deoxy-5-(trifluoromethyl) uridine and has the following structural formula. Trifluridine has a molecular formula C10H11F3N2O5 and a molecular weight of 296.20. Trifluridine is a white crystalline powder, soluble in water, ethanol, 0.01 mol/L hydrochloric acid, 0.01 mol/L sodium hydroxide solution; freely soluble in methanol, acetone; sparingly soluble in 2-propanol, acetonitrile; slightly soluble in diethyl ether; and very slightly soluble in isopropyl ether. Tipiracil hydrochloride. Tipiracil hydrochloride, a thymidine phosphorylase inhibitor, is described chemically as 5-chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4-(1H,3H)-dione monohydrochloride or 2,4(1H,3H)-Pyrimidinedione, 5-chloro-6-[(2-imino-1-pyrrolidinyl)methyl]-, hydrochloride (1:1) and has the following structural formula. Tipiracil hydrochloride has a molecular formula C9H11ClN4O2HCl and a molecular weight of 279.12. Tipiracil hydrochloride is a white crystalline powder, soluble in water, 0.01 mol/L hydrochloric acid, and 0.01 mol/L sodium hydroxide; slightly soluble in methanol; very slightly soluble in ethanol; and practically insoluble in acetonitrile, 2-propanol, acetone, diisopropyl ether, and diethyl ether. LONSURF (trifluridine and tipiracil) tablets for oral use contain 15 mg of trifluridine and 6.14 mg of tipiracil equivalent to 7.065 mg of tipiracil hydrochloride or 20 mg of trifluridine and 8.19 mg of tipiracil equivalent to 9.420 mg of tipiracil hydrochloride. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide, and magnesium stearate. The tablets are imprinted with ink containing shellac, ferric oxide red, ferric oxide yellow, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, carnauba wax, and talc.</Description>
</NDC>
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<NDCCode>64842-1025-2</NDCCode>
<PackageDescription>40 TABLET, FILM COATED in 1 BOTTLE (64842-1025-2) </PackageDescription>
<NDC11Code>64842-1025-02</NDC11Code>
<ProductNDC>64842-1025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lonsurf</ProprietaryName>
<NonProprietaryName>Trifluridine And Tipiracil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150922</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207981</ApplicationNumber>
<LabelerName>Taiho Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>TRIFLURIDINE; TIPIRACIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 6.14</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: 1 metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. (1.1), 2 metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. (1.2).</IndicationAndUsage>
<Description>LONSURF contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5. Trifluridine. Trifluridine, a nucleoside metabolic inhibitor, is described chemically as 2’-deoxy-5-(trifluoromethyl) uridine and has the following structural formula. Trifluridine has a molecular formula C10H11F3N2O5 and a molecular weight of 296.20. Trifluridine is a white crystalline powder, soluble in water, ethanol, 0.01 mol/L hydrochloric acid, 0.01 mol/L sodium hydroxide solution; freely soluble in methanol, acetone; sparingly soluble in 2-propanol, acetonitrile; slightly soluble in diethyl ether; and very slightly soluble in isopropyl ether. Tipiracil hydrochloride. Tipiracil hydrochloride, a thymidine phosphorylase inhibitor, is described chemically as 5-chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4-(1H,3H)-dione monohydrochloride or 2,4(1H,3H)-Pyrimidinedione, 5-chloro-6-[(2-imino-1-pyrrolidinyl)methyl]-, hydrochloride (1:1) and has the following structural formula. Tipiracil hydrochloride has a molecular formula C9H11ClN4O2HCl and a molecular weight of 279.12. Tipiracil hydrochloride is a white crystalline powder, soluble in water, 0.01 mol/L hydrochloric acid, and 0.01 mol/L sodium hydroxide; slightly soluble in methanol; very slightly soluble in ethanol; and practically insoluble in acetonitrile, 2-propanol, acetone, diisopropyl ether, and diethyl ether. LONSURF (trifluridine and tipiracil) tablets for oral use contain 15 mg of trifluridine and 6.14 mg of tipiracil equivalent to 7.065 mg of tipiracil hydrochloride or 20 mg of trifluridine and 8.19 mg of tipiracil equivalent to 9.420 mg of tipiracil hydrochloride. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide, and magnesium stearate. The tablets are imprinted with ink containing shellac, ferric oxide red, ferric oxide yellow, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, carnauba wax, and talc.</Description>
</NDC>
<NDC>
<NDCCode>64842-1025-3</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (64842-1025-3) </PackageDescription>
<NDC11Code>64842-1025-03</NDC11Code>
<ProductNDC>64842-1025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lonsurf</ProprietaryName>
<NonProprietaryName>Trifluridine And Tipiracil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150922</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207981</ApplicationNumber>
<LabelerName>Taiho Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>TRIFLURIDINE; TIPIRACIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 6.14</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: 1 metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. (1.1), 2 metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. (1.2).</IndicationAndUsage>
<Description>LONSURF contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5. Trifluridine. Trifluridine, a nucleoside metabolic inhibitor, is described chemically as 2’-deoxy-5-(trifluoromethyl) uridine and has the following structural formula. Trifluridine has a molecular formula C10H11F3N2O5 and a molecular weight of 296.20. Trifluridine is a white crystalline powder, soluble in water, ethanol, 0.01 mol/L hydrochloric acid, 0.01 mol/L sodium hydroxide solution; freely soluble in methanol, acetone; sparingly soluble in 2-propanol, acetonitrile; slightly soluble in diethyl ether; and very slightly soluble in isopropyl ether. Tipiracil hydrochloride. Tipiracil hydrochloride, a thymidine phosphorylase inhibitor, is described chemically as 5-chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4-(1H,3H)-dione monohydrochloride or 2,4(1H,3H)-Pyrimidinedione, 5-chloro-6-[(2-imino-1-pyrrolidinyl)methyl]-, hydrochloride (1:1) and has the following structural formula. Tipiracil hydrochloride has a molecular formula C9H11ClN4O2HCl and a molecular weight of 279.12. Tipiracil hydrochloride is a white crystalline powder, soluble in water, 0.01 mol/L hydrochloric acid, and 0.01 mol/L sodium hydroxide; slightly soluble in methanol; very slightly soluble in ethanol; and practically insoluble in acetonitrile, 2-propanol, acetone, diisopropyl ether, and diethyl ether. LONSURF (trifluridine and tipiracil) tablets for oral use contain 15 mg of trifluridine and 6.14 mg of tipiracil equivalent to 7.065 mg of tipiracil hydrochloride or 20 mg of trifluridine and 8.19 mg of tipiracil equivalent to 9.420 mg of tipiracil hydrochloride. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide, and magnesium stearate. The tablets are imprinted with ink containing shellac, ferric oxide red, ferric oxide yellow, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, carnauba wax, and talc.</Description>
</NDC>
<NDC>
<NDCCode>0071-1020-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (0071-1020-01) </PackageDescription>
<NDC11Code>00071-1020-01</NDC11Code>
<ProductNDC>0071-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyrica</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100104</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022488</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100104</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0143-1020-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0143-1020-01)</PackageDescription>
<NDC11Code>00143-1020-01</NDC11Code>
<ProductNDC>0143-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminophylline</ProprietaryName>
<NonProprietaryName>Aminophylline Dihydrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19751126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084540</ApplicationNumber>
<LabelerName>West-ward Pharmaceutical Corp</LabelerName>
<SubstanceName>AMINOPHYLLINE DIHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>0143-1020-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0143-1020-10)</PackageDescription>
<NDC11Code>00143-1020-10</NDC11Code>
<ProductNDC>0143-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminophylline</ProprietaryName>
<NonProprietaryName>Aminophylline Dihydrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19751126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084540</ApplicationNumber>
<LabelerName>West-ward Pharmaceutical Corp</LabelerName>
<SubstanceName>AMINOPHYLLINE DIHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>0143-1020-25</NDCCode>
<PackageDescription>100 TABLET in 1 BOX, UNIT-DOSE (0143-1020-25)</PackageDescription>
<NDC11Code>00143-1020-25</NDC11Code>
<ProductNDC>0143-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminophylline</ProprietaryName>
<NonProprietaryName>Aminophylline Dihydrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19751126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084540</ApplicationNumber>
<LabelerName>West-ward Pharmaceutical Corp</LabelerName>
<SubstanceName>AMINOPHYLLINE DIHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>0220-1020-41</NDCCode>
<PackageDescription>200 [kp_C] in 1 TUBE (0220-1020-41) </PackageDescription>
<NDC11Code>00220-1020-41</NDC11Code>
<ProductNDC>0220-1020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cajuputum</ProprietaryName>
<NonProprietaryName>Cajuput Oil</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>CAJUPUT OIL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[kp_C]/200[kp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-04-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: See symptoms on front panel. Relieves hiccups or heartburn *.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0254-1020-47</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (0254-1020-47) </PackageDescription>
<NDC11Code>00254-1020-47</NDC11Code>
<ProductNDC>0254-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin Ethylsuccinate</ProprietaryName>
<NonProprietaryName>Erythromycin Ethylsuccinate</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191111</StartMarketingDate>
<EndMarketingDate>20211130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211991</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ERYTHROMYCIN ETHYLSUCCINATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191111</StartMarketingDatePackage>
<EndMarketingDatePackage>20211130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0363-1020-26</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (0363-1020-26) / 113 g in 1 TUBE</PackageDescription>
<NDC11Code>00363-1020-26</NDC11Code>
<ProductNDC>0363-1020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zinc Oxide</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080324</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Walgreen Co.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps treat and prevent diaper rash. protects chafed skin due to the diaper rash and helps seal out wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0378-1020-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1020-05) </PackageDescription>
<NDC11Code>00378-1020-05</NDC11Code>
<ProductNDC>0378-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nicardipine Hydrochloride</ProprietaryName>
<NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960719</StartMarketingDate>
<EndMarketingDate>20300131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074642</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19960719</StartMarketingDatePackage>
<EndMarketingDatePackage>20300131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-1020-77</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (0378-1020-77) </PackageDescription>
<NDC11Code>00378-1020-77</NDC11Code>
<ProductNDC>0378-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nicardipine Hydrochloride</ProprietaryName>
<NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960719</StartMarketingDate>
<EndMarketingDate>20300131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074642</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19960719</StartMarketingDatePackage>
<EndMarketingDatePackage>20300131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0469-1020-99</NDCCode>
<PackageDescription>5 kg in 1 DRUM (0469-1020-99)</PackageDescription>
<NDC11Code>00469-1020-99</NDC11Code>
<ProductNDC>0469-1020</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Isavuconazonium Sulfate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20150306</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Astellas Pharma US, Inc.</LabelerName>
<SubstanceName>ISAVUCONAZONIUM SULFATE</SubstanceName>
<StrengthNumber>.54</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2018-02-02</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0517-1020-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (0517-1020-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-1020-01) </PackageDescription>
<NDC11Code>00517-1020-25</NDC11Code>
<ProductNDC>0517-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vasopressin</ProprietaryName>
<NonProprietaryName>Vasopressin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220203</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212593</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>VASOPRESSIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.</IndicationAndUsage>
<Description>Vasopressin is a polypeptide hormone. Vasopressin injection is a sterile, aqueous solution of synthetic arginine vasopressin for administration. The 1 mL and 10 mL solution contains vasopressin 20 units/mL, chlorobutanol 5 mg, sodium chloride 9 mg, water for injection, and glacial acetic acid to adjust pH to 3.5. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L- Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is. Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23.</Description>
</NDC>
<NDC>
<NDCCode>0536-1020-08</NDCCode>
<PackageDescription>60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0536-1020-08) </PackageDescription>
<NDC11Code>00536-1020-08</NDC11Code>
<ProductNDC>0536-1020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Maximum Strength Gas Relief</ProprietaryName>
<ProprietaryNameSuffix>Antiflatulent</ProprietaryNameSuffix>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140527</StartMarketingDate>
<EndMarketingDate>20200131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part332</ApplicationNumber>
<LabelerName>RUGBY LABORATORIES</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140527</StartMarketingDatePackage>
<EndMarketingDatePackage>20200131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0555-1020-01</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0555-1020-01)</PackageDescription>
<NDC11Code>00555-1020-01</NDC11Code>
<ProductNDC>0555-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galantamine</ProprietaryName>
<NonProprietaryName>Galantamine</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081014</StartMarketingDate>
<EndMarketingDate>20171031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078189</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>0603-1020-58</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (0603-1020-58)</PackageDescription>
<NDC11Code>00603-1020-58</NDC11Code>
<ProductNDC>0603-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089450</ApplicationNumber>
<LabelerName>Qualitest Pharmaceuticals</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>120; 12</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-04-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>0703-1020-30</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0703-1020-30) > 200 mL in 1 BAG (0703-1020-31)</PackageDescription>
<NDC11Code>00703-1020-30</NDC11Code>
<ProductNDC>0703-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076837</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/200mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-12-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>0955-1020-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (0955-1020-01) / 1 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00955-1020-01</NDC11Code>
<ProductNDC>0955-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20101021</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020449</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Docetaxel is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1) , 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2) , 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer ( 1.3) , 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction ( 1.4) , 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN ( 1.5) .</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N- tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel has the following structural formula:. Docetaxel is a white to almost-white powder with an empirical formula of C 43H 53NO 14∙3H 2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water.</Description>
</NDC>
<NDC>
<NDCCode>10237-588-10</NDCCode>
<PackageDescription>1020.58 kg in 1 SUPERSACK (10237-588-10)</PackageDescription>
<NDC11Code>10237-0588-10</NDC11Code>
<ProductNDC>10237-588</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19770130</StartMarketingDate>
<EndMarketingDate>20140625</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20140625</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10237-590-10</NDCCode>
<PackageDescription>1020.58 kg in 1 SUPERSACK (10237-590-10) </PackageDescription>
<NDC11Code>10237-0590-10</NDC11Code>
<ProductNDC>10237-590</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19770130</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-03-14</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-JAN-77</StartMarketingDatePackage>
</NDC>
</NDCList>