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"Description": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in five strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, or 60 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate."
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"Description": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate."
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"Description": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in five strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, or 60 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate."
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"IndicationAndUsage": "XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). , 3 For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s) (1.2). .",
"Description": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in five strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, or 60 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate."
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"IndicationAndUsage": "XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .",
"Description": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate."
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"Description": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate."
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"IndicationAndUsage": "XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). , 3 For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s) (1.2). .",
"Description": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in five strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, or 60 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate."
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"IndicationAndUsage": "XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). , 3 For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s) (1.2). .",
"Description": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in five strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, or 60 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate."
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"IndicationAndUsage": "XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .",
"Description": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate."
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"IndicationAndUsage": "XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .",
"Description": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate."
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"IndicationAndUsage": "XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .",
"Description": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate."
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{
"NDCCode": "72237-104-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (72237-104-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (72237-104-11) ",
"NDC11Code": "72237-0104-01",
"ProductNDC": "72237-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xpovio",
"NonProprietaryName": "Selinexor",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210519",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212306",
"LabelerName": "Karyopharm Therapeutics Inc.",
"SubstanceName": "SELINEXOR",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nuclear Export Inhibitor [EPC], Nuclear Export Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210519",
"SamplePackage": "N",
"IndicationAndUsage": "XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .",
"Description": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate."
},
{
"NDCCode": "72237-105-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (72237-105-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (72237-105-11) ",
"NDC11Code": "72237-0105-01",
"ProductNDC": "72237-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xpovio",
"NonProprietaryName": "Selinexor",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260105",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212306",
"LabelerName": "Karyopharm Therapeutics Inc.",
"SubstanceName": "SELINEXOR",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nuclear Export Inhibitor [EPC], Nuclear Export Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260105",
"SamplePackage": "N",
"IndicationAndUsage": "XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .",
"Description": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate."
},
{
"NDCCode": "72237-106-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (72237-106-01) / 4 TABLET, FILM COATED in 1 BLISTER PACK (72237-106-11) ",
"NDC11Code": "72237-0106-01",
"ProductNDC": "72237-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xpovio",
"NonProprietaryName": "Selinexor",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250310",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212306",
"LabelerName": "Karyopharm Therapeutics Inc.",
"SubstanceName": "SELINEXOR",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nuclear Export Inhibitor [EPC], Nuclear Export Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250310",
"SamplePackage": "N",
"IndicationAndUsage": "XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .",
"Description": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate."
},
{
"NDCCode": "10842-101-05",
"PackageDescription": "946 mL in 1 JUG (10842-101-05) ",
"NDC11Code": "10842-0101-05",
"ProductNDC": "10842-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Doctor Hoys Natural Pain Relief",
"NonProprietaryName": "Camphor",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050510",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "DOCTOR HOY'S, LLC",
"SubstanceName": "CAMPHOR (NATURAL)",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150805",
"SamplePackage": "N"
},
{
"NDCCode": "10927-101-05",
"PackageDescription": "1300 L in 1 CYLINDER (10927-101-05)",
"NDC11Code": "10927-0101-05",
"ProductNDC": "10927-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19381020",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "PURITY CYLINDER GASES INC",
"SubstanceName": "NITROGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "13310-101-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (13310-101-05)",
"NDC11Code": "13310-0101-05",
"ProductNDC": "13310-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fibricor",
"NonProprietaryName": "Fenofibric Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090814",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022418",
"LabelerName": "AR Scientific, Inc.",
"SubstanceName": "FENOFIBRIC ACID",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FIBRICOR is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: 1 to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (≥ 500 mg/dL) (1.1)., 2 to reduce elevated total cholesterol (TC), low-density-lipoprotein cholesterol (LDL-C), TG and apolipoprotein (Apo) B and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.2).",
"Description": "FIBRICOR is a lipid regulating agent available as tablets for oral administration. Each tablet contains 35 mg or 105 mg of fenofibric acid. The chemical name for fenofibric acid is 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid with the following structural formula. Fenofibric acid is a white to almost white crystalline powder that is stable under ordinary conditions, and has a melting point of 179 – 183°C. Its empirical formula is C17H15ClO4 and molecular weight 318.75. Fenofibric acid is insoluble in water; its solubility increases with pH in buffered media. Inactive Ingredients: Each tablet contains copovidone, crospovidone, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "13551-101-05",
"PackageDescription": "480 mL in 1 BOTTLE, PLASTIC (13551-101-05)",
"NDC11Code": "13551-0101-05",
"ProductNDC": "13551-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Karbinal",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Carbinoxamine Maleate",
"DosageFormName": "SUSPENSION, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140103",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022556",
"LabelerName": "Avadel Pharmaceuticals (USA), Inc.",
"SubstanceName": "CARBINOXAMINE MALEATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "16714-101-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (16714-101-05) ",
"NDC11Code": "16714-0101-05",
"ProductNDC": "16714-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101220",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079072",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Fibric Acids [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20101220",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil Tablets are indicated as adjunctive therapy to diet for: : 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. , 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL- CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL TABLETS ARE ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. .",
"Description": "Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil USP. Each tablet also contains colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch (botanical source: maize), sodium starch glycolate and titanium dioxide. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; practically insoluble in water, soluble in alcohol, in methanol, and in chloroform. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "21922-101-05",
"PackageDescription": "1 TUBE in 1 CARTON (21922-101-05) / 28 g in 1 TUBE",
"NDC11Code": "21922-0101-05",
"ProductNDC": "21922-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate Pramoxine Hcl",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250306",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "500; 3.5; 10000; 10",
"StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g; mg/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2025-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250306",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent infection for the temporary relief of pain in minor â– burns â– cuts â– scrapes."
},
{
"NDCCode": "23594-101-05",
"PackageDescription": "480 mL in 1 BOTTLE, PLASTIC (23594-101-05) ",
"NDC11Code": "23594-0101-05",
"ProductNDC": "23594-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Karbinal",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Carbinoxamine Maleate",
"DosageFormName": "SUSPENSION, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140103",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022556",
"LabelerName": "Aytu Therapeutics, LLC",
"SubstanceName": "CARBINOXAMINE MALEATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140103",
"SamplePackage": "N",
"IndicationAndUsage": "Karbinal ER is indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of: 1 Seasonal and perennial allergic rhinitis, 2 Vasomotor rhinitis, 3 Allergic conjunctivitis due to inhalant allergens and foods, 4 Mild, uncomplicated allergic skin manifestations of urticaria and angioedema, 5 Dermatographism, 6 As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled , 7 Amelioration of the severity of allergic reactions to blood or plasma.",
"Description": "Each 5 mL of Karbinal ER extended-release oral suspension contains 4 mg of carbinoxamine maleate (equivalent to 2.86 mg of carbinoxamine) complex with sodium polystyrene sulfonate. Karbinal ER extended-release oral suspension contains the following inactive ingredients: citric acid anhydrous, strawberry-banana flavor, glycerin, high fructose corn syrup, methylparaben, modified food starch, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, triacetin, and xanthan gum. The chemical name of carbinoxamine maleate is 2-[(4-chlorophenyl)-2-pyridinylmethoxy]- N, N-dimethylethanamine (Z)-2-butenedioate (1:1), which has the following structure:."
},
{
"NDCCode": "23667-101-05",
"PackageDescription": "150 mL in 1 BOTTLE, SPRAY (23667-101-05)",
"NDC11Code": "23667-0101-05",
"ProductNDC": "23667-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "I Protect For Her Spf 15 Clearmist",
"NonProprietaryName": "Octinoxate, Homosalate, Oxybenzone, Octisalate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110310",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Formulated Solutions, LLC",
"SubstanceName": "HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE",
"StrengthNumber": "4; 4; 2.75; 3.25",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2014-03-12"
},
{
"NDCCode": "25373-101-05",
"PackageDescription": "45 L in 1 DEWAR (25373-101-05)",
"NDC11Code": "25373-0101-05",
"ProductNDC": "25373-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19860616",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Linde Gas North America LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "30400-101-05",
"PackageDescription": "354 mL in 1 BOTTLE, PLASTIC (30400-101-05) ",
"NDC11Code": "30400-0101-05",
"ProductNDC": "30400-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl Rubbing Alcohol 50% With Wintergreen",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200618",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Jell Pharmaceuticals Pvt. Ltd.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "50",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200618",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 to decrease germs in minor cuts and scrapes, 2 helps relieve minor muscular aches due to exertion."
},
{
"NDCCode": "42385-101-05",
"PackageDescription": ".1 kg in 1 BOTTLE (42385-101-05) ",
"NDC11Code": "42385-0101-05",
"ProductNDC": "42385-101",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Digoxin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20190405",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "LAURUS LABS LIMITED",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2022-12-20",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "05-APR-19"
},
{
"NDCCode": "42432-101-06",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 BOX (42432-101-06) > 30 mL in 1 BOTTLE, WITH APPLICATOR (42432-101-05)",
"NDC11Code": "42432-0101-06",
"ProductNDC": "42432-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kiss Fungi-gone",
"ProprietaryNameSuffix": "Anti-fungal Treatment",
"NonProprietaryName": "Tolnaftate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121023",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "Kiss Products, Inc.",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the cure of: 1 athlete's foot (tinea pedis), 2 jock itch (tinea cruris), 3 ringworm (tinea corporis)."
},
{
"NDCCode": "42571-101-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42571-101-05) ",
"NDC11Code": "42571-0101-05",
"ProductNDC": "42571-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glimepiride",
"NonProprietaryName": "Glimepiride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091220",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "GLIMEPIRIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130613",
"SamplePackage": "N",
"IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [seeClinical Studies (14.1)]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
"Description": "Glimepiride tablets, USP are an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is:. Glimepiride tablets, USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate. In addition, Glimepiride 1 mg tablets contain Ferric Oxide Red, Glimepiride 2 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Ferric Oxide Yellow, Glimepiride 3 mg tablets contain Ferric Oxide Yellow, Glimepiride 4 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Glimepiride 6 mg tablets contain Ferric Oxide Red."
},
{
"NDCCode": "42658-101-05",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (42658-101-05) ",
"NDC11Code": "42658-0101-05",
"ProductNDC": "42658-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolate Mofetil",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204076",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-03-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230901",
"SamplePackage": "N",
"IndicationAndUsage": "Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies ( 14.1)], heart [see Clinical Studies ( 14.2)] or liver transplants [see Clinical Studies ( 14.3)], in combination with other immunosuppressants.",
"Description": "Mycophenolate mofetil, USP is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine; monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of mycophenolate mofetil, USP, tablets containing 500 mg of mycophenolate mofetil, USP. Inactive ingredients in mycophenolate mofetil, USP 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C Blue #2, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The capsule is printed with edible black ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution and potassium hydroxide. Inactive ingredients in mycophenolate mofetil, USP 500 mg tablets include croscarmellose sodium, microcrystalline cellulose 102, povidone (K-90), magnesium stearate, lecithin (soy), black iron oxide, titanium dioxide, red iron oxide, yellow iron oxide, talc, polyethylene glycol, and polyvinyl alcohol."
},
{
"NDCCode": "42737-101-05",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (42737-101-05) > 5 CAPSULE in 1 BOTTLE, GLASS",
"NDC11Code": "42737-0101-05",
"ProductNDC": "42737-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204639",
"LabelerName": "Chemi Pharma LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181231",
"SamplePackage": "N"
},
{
"NDCCode": "43128-101-05",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (43128-101-05) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "43128-0101-05",
"ProductNDC": "43128-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Articaine",
"NonProprietaryName": "Articaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20150622",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020971",
"LabelerName": "NDC, Inc.",
"SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; .01",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150622",
"SamplePackage": "N",
"IndicationAndUsage": "Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
"Description": "Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
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<Description>Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in five strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, or 60 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.</Description>
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<Description>Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>72237-101-01</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (72237-101-01) / 3 TABLET, FILM COATED in 1 BLISTER PACK (72237-101-11) </PackageDescription>
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<LastUpdate>2025-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<Description>Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in five strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, or 60 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.</Description>
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<PackageDescription>4 BLISTER PACK in 1 CARTON (72237-101-02) / 4 TABLET, FILM COATED in 1 BLISTER PACK (72237-101-12) </PackageDescription>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). , 3 For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s) (1.2). .</IndicationAndUsage>
<Description>Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in five strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, or 60 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.</Description>
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<PackageDescription>4 BLISTER PACK in 1 CARTON (72237-101-03) / 6 TABLET, FILM COATED in 1 BLISTER PACK (72237-101-13) </PackageDescription>
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<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200622</StartMarketingDatePackage>
<EndMarketingDatePackage>20270531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .</IndicationAndUsage>
<Description>Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.</Description>
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<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .</IndicationAndUsage>
<Description>Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.</Description>
</NDC>
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<NDCCode>72237-101-06</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (72237-101-06) / 4 TABLET, FILM COATED in 1 BLISTER PACK (72237-101-16) </PackageDescription>
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<LastUpdate>2025-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). , 3 For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s) (1.2). .</IndicationAndUsage>
<Description>Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in five strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, or 60 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.</Description>
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<IndicationAndUsage>XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). , 3 For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s) (1.2). .</IndicationAndUsage>
<Description>Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in five strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, or 60 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.</Description>
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<LastUpdate>2026-05-14</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .</IndicationAndUsage>
<Description>Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.</Description>
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<NDC>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<EndMarketingDatePackage>20270228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .</IndicationAndUsage>
<Description>Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.</Description>
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<StartMarketingDate>20210519</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212306</ApplicationNumber>
<LabelerName>Karyopharm Therapeutics Inc.</LabelerName>
<SubstanceName>SELINEXOR</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nuclear Export Inhibitor [EPC], Nuclear Export Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .</IndicationAndUsage>
<Description>Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.</Description>
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<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .</IndicationAndUsage>
<Description>Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
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<ApplicationNumber>NDA212306</ApplicationNumber>
<LabelerName>Karyopharm Therapeutics Inc.</LabelerName>
<SubstanceName>SELINEXOR</SubstanceName>
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<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .</IndicationAndUsage>
<Description>Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.</Description>
</NDC>
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<NDC11Code>72237-0106-01</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xpovio</ProprietaryName>
<NonProprietaryName>Selinexor</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212306</ApplicationNumber>
<LabelerName>Karyopharm Therapeutics Inc.</LabelerName>
<SubstanceName>SELINEXOR</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nuclear Export Inhibitor [EPC], Nuclear Export Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XPOVIO is a nuclear export inhibitor indicated: : 1 In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1). , 2 In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1). .</IndicationAndUsage>
<Description>Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:. XPOVIO tablets for oral dosing are supplied in six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.</Description>
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<NDC>
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<NDC11Code>10842-0101-05</NDC11Code>
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<LabelerName>DOCTOR HOY'S, LLC</LabelerName>
<SubstanceName>CAMPHOR (NATURAL)</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10927-101-05</NDCCode>
<PackageDescription>1300 L in 1 CYLINDER (10927-101-05)</PackageDescription>
<NDC11Code>10927-0101-05</NDC11Code>
<ProductNDC>10927-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19381020</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>PURITY CYLINDER GASES INC</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13310-101-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (13310-101-05)</PackageDescription>
<NDC11Code>13310-0101-05</NDC11Code>
<ProductNDC>13310-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fibricor</ProprietaryName>
<NonProprietaryName>Fenofibric Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090814</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022418</ApplicationNumber>
<LabelerName>AR Scientific, Inc.</LabelerName>
<SubstanceName>FENOFIBRIC ACID</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FIBRICOR is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: 1 to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (≥ 500 mg/dL) (1.1)., 2 to reduce elevated total cholesterol (TC), low-density-lipoprotein cholesterol (LDL-C), TG and apolipoprotein (Apo) B and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.2).</IndicationAndUsage>
<Description>FIBRICOR is a lipid regulating agent available as tablets for oral administration. Each tablet contains 35 mg or 105 mg of fenofibric acid. The chemical name for fenofibric acid is 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid with the following structural formula. Fenofibric acid is a white to almost white crystalline powder that is stable under ordinary conditions, and has a melting point of 179 – 183°C. Its empirical formula is C17H15ClO4 and molecular weight 318.75. Fenofibric acid is insoluble in water; its solubility increases with pH in buffered media. Inactive Ingredients: Each tablet contains copovidone, crospovidone, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>13551-101-05</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE, PLASTIC (13551-101-05)</PackageDescription>
<NDC11Code>13551-0101-05</NDC11Code>
<ProductNDC>13551-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Karbinal</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Carbinoxamine Maleate</NonProprietaryName>
<DosageFormName>SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140103</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022556</ApplicationNumber>
<LabelerName>Avadel Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>CARBINOXAMINE MALEATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16714-101-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (16714-101-05) </PackageDescription>
<NDC11Code>16714-0101-05</NDC11Code>
<ProductNDC>16714-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101220</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079072</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Fibric Acids [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20101220</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil Tablets are indicated as adjunctive therapy to diet for: : 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. , 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL- CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL TABLETS ARE ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. .</IndicationAndUsage>
<Description>Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil USP. Each tablet also contains colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch (botanical source: maize), sodium starch glycolate and titanium dioxide. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; practically insoluble in water, soluble in alcohol, in methanol, and in chloroform. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
</NDC>
<NDC>
<NDCCode>21922-101-05</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-101-05) / 28 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0101-05</NDC11Code>
<ProductNDC>21922-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate Pramoxine Hcl</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250306</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M004</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 3.5; 10000; 10</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent infection for the temporary relief of pain in minor â– burns â– cuts â– scrapes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23594-101-05</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE, PLASTIC (23594-101-05) </PackageDescription>
<NDC11Code>23594-0101-05</NDC11Code>
<ProductNDC>23594-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Karbinal</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Carbinoxamine Maleate</NonProprietaryName>
<DosageFormName>SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140103</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022556</ApplicationNumber>
<LabelerName>Aytu Therapeutics, LLC</LabelerName>
<SubstanceName>CARBINOXAMINE MALEATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Karbinal ER is indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of: 1 Seasonal and perennial allergic rhinitis, 2 Vasomotor rhinitis, 3 Allergic conjunctivitis due to inhalant allergens and foods, 4 Mild, uncomplicated allergic skin manifestations of urticaria and angioedema, 5 Dermatographism, 6 As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled , 7 Amelioration of the severity of allergic reactions to blood or plasma.</IndicationAndUsage>
<Description>Each 5 mL of Karbinal ER extended-release oral suspension contains 4 mg of carbinoxamine maleate (equivalent to 2.86 mg of carbinoxamine) complex with sodium polystyrene sulfonate. Karbinal ER extended-release oral suspension contains the following inactive ingredients: citric acid anhydrous, strawberry-banana flavor, glycerin, high fructose corn syrup, methylparaben, modified food starch, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, triacetin, and xanthan gum. The chemical name of carbinoxamine maleate is 2-[(4-chlorophenyl)-2-pyridinylmethoxy]- N, N-dimethylethanamine (Z)-2-butenedioate (1:1), which has the following structure:.</Description>
</NDC>
<NDC>
<NDCCode>23667-101-05</NDCCode>
<PackageDescription>150 mL in 1 BOTTLE, SPRAY (23667-101-05)</PackageDescription>
<NDC11Code>23667-0101-05</NDC11Code>
<ProductNDC>23667-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>I Protect For Her Spf 15 Clearmist</ProprietaryName>
<NonProprietaryName>Octinoxate, Homosalate, Oxybenzone, Octisalate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110310</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Formulated Solutions, LLC</LabelerName>
<SubstanceName>HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
<StrengthNumber>4; 4; 2.75; 3.25</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>25373-101-05</NDCCode>
<PackageDescription>45 L in 1 DEWAR (25373-101-05)</PackageDescription>
<NDC11Code>25373-0101-05</NDC11Code>
<ProductNDC>25373-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19860616</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Linde Gas North America LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>30400-101-05</NDCCode>
<PackageDescription>354 mL in 1 BOTTLE, PLASTIC (30400-101-05) </PackageDescription>
<NDC11Code>30400-0101-05</NDC11Code>
<ProductNDC>30400-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopropyl Rubbing Alcohol 50% With Wintergreen</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200618</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Jell Pharmaceuticals Pvt. Ltd.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 to decrease germs in minor cuts and scrapes, 2 helps relieve minor muscular aches due to exertion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42385-101-05</NDCCode>
<PackageDescription>.1 kg in 1 BOTTLE (42385-101-05) </PackageDescription>
<NDC11Code>42385-0101-05</NDC11Code>
<ProductNDC>42385-101</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20190405</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>LAURUS LABS LIMITED</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-12-20</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-APR-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>42432-101-06</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 BOX (42432-101-06) > 30 mL in 1 BOTTLE, WITH APPLICATOR (42432-101-05)</PackageDescription>
<NDC11Code>42432-0101-06</NDC11Code>
<ProductNDC>42432-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kiss Fungi-gone</ProprietaryName>
<ProprietaryNameSuffix>Anti-fungal Treatment</ProprietaryNameSuffix>
<NonProprietaryName>Tolnaftate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121023</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>Kiss Products, Inc.</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the cure of: 1 athlete's foot (tinea pedis), 2 jock itch (tinea cruris), 3 ringworm (tinea corporis).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42571-101-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42571-101-05) </PackageDescription>
<NDC11Code>42571-0101-05</NDC11Code>
<ProductNDC>42571-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glimepiride</ProprietaryName>
<NonProprietaryName>Glimepiride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091220</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>GLIMEPIRIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [seeClinical Studies (14.1)]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.</IndicationAndUsage>
<Description>Glimepiride tablets, USP are an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is:. Glimepiride tablets, USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate. In addition, Glimepiride 1 mg tablets contain Ferric Oxide Red, Glimepiride 2 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Ferric Oxide Yellow, Glimepiride 3 mg tablets contain Ferric Oxide Yellow, Glimepiride 4 mg tablets contain FD&C Blue #2 Indigo carmine Lake and Glimepiride 6 mg tablets contain Ferric Oxide Red.</Description>
</NDC>
<NDC>
<NDCCode>42658-101-05</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (42658-101-05) </PackageDescription>
<NDC11Code>42658-0101-05</NDC11Code>
<ProductNDC>42658-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
<NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204076</ApplicationNumber>
<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies ( 14.1)], heart [see Clinical Studies ( 14.2)] or liver transplants [see Clinical Studies ( 14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>Mycophenolate mofetil, USP is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine; monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of mycophenolate mofetil, USP, tablets containing 500 mg of mycophenolate mofetil, USP. Inactive ingredients in mycophenolate mofetil, USP 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C Blue #2, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The capsule is printed with edible black ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution and potassium hydroxide. Inactive ingredients in mycophenolate mofetil, USP 500 mg tablets include croscarmellose sodium, microcrystalline cellulose 102, povidone (K-90), magnesium stearate, lecithin (soy), black iron oxide, titanium dioxide, red iron oxide, yellow iron oxide, talc, polyethylene glycol, and polyvinyl alcohol.</Description>
</NDC>
<NDC>
<NDCCode>42737-101-05</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (42737-101-05) > 5 CAPSULE in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>42737-0101-05</NDC11Code>
<ProductNDC>42737-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204639</ApplicationNumber>
<LabelerName>Chemi Pharma LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43128-101-05</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (43128-101-05) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>43128-0101-05</NDC11Code>
<ProductNDC>43128-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Articaine</ProprietaryName>
<NonProprietaryName>Articaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20150622</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020971</ApplicationNumber>
<LabelerName>NDC, Inc.</LabelerName>
<SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; .01</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
<Description>Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
</NDC>
</NDCList>