{
"NDC": [
{
"NDCCode": "35561-344-11",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (35561-344-11) ",
"NDC11Code": "35561-0344-11",
"ProductNDC": "35561-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207803",
"LabelerName": "Bostal LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190630",
"SamplePackage": "N",
"Description": "Fenofibrate tablets USP are lipid regulating agents available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; Fenofibrate, USP is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each 54 mg and 160 mg fenofibrate tablet USP contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, lecithin (soy), microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide, and xanthan gum. Fenofibrate tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "35561-344-00",
"PackageDescription": "21631 TABLET, FILM COATED in 1 BOX (35561-344-00) ",
"NDC11Code": "35561-0344-00",
"ProductNDC": "35561-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207803",
"LabelerName": "Bostal LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190630",
"SamplePackage": "N",
"Description": "Fenofibrate tablets USP are lipid regulating agents available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; Fenofibrate, USP is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each 54 mg and 160 mg fenofibrate tablet USP contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, lecithin (soy), microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide, and xanthan gum. Fenofibrate tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "35561-344-13",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (35561-344-13) ",
"NDC11Code": "35561-0344-13",
"ProductNDC": "35561-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207803",
"LabelerName": "Bostal LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190630",
"SamplePackage": "N",
"Description": "Fenofibrate tablets USP are lipid regulating agents available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; Fenofibrate, USP is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each 54 mg and 160 mg fenofibrate tablet USP contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, lecithin (soy), microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide, and xanthan gum. Fenofibrate tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "35561-249-11",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (35561-249-11) ",
"NDC11Code": "35561-0249-11",
"ProductNDC": "35561-249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208476",
"LabelerName": "Bostal LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "48",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250815",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate tablets are peroxisome proliferator-activated receptors (PPARα) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1). , 2 For treatment of adult patients with severe hypertriglyceridemia ( 1.2). .",
"Description": "Fenofibrate tablets, USP, are a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 - 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, mannitol, microcrystalline cellulose, poloxamer, polyvinyl alcohol, sodium bicarbonate, sodium lauryl sulfate, sodium stearyl fumarate, talc, tartaric acid, titanium dioxide, xanthan gum and lecithin (soy). The 48 mg tablets also contains D&C Yellow #10 aluminum lake, FD&C Blue #2 indigo carmine aluminum lake, FD&C Red #40 allura red AC aluminum lake and FD&C Yellow #6 /sunset yellow FCF aluminum."
},
{
"NDCCode": "35561-250-11",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (35561-250-11) ",
"NDC11Code": "35561-0250-11",
"ProductNDC": "35561-250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208476",
"LabelerName": "Bostal LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "145",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250815",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate tablets are peroxisome proliferator-activated receptors (PPARα) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1). , 2 For treatment of adult patients with severe hypertriglyceridemia ( 1.2). .",
"Description": "Fenofibrate tablets, USP, are a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 - 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, mannitol, microcrystalline cellulose, poloxamer, polyvinyl alcohol, sodium bicarbonate, sodium lauryl sulfate, sodium stearyl fumarate, talc, tartaric acid, titanium dioxide, xanthan gum and lecithin (soy). The 48 mg tablets also contains D&C Yellow #10 aluminum lake, FD&C Blue #2 indigo carmine aluminum lake, FD&C Red #40 allura red AC aluminum lake and FD&C Yellow #6 /sunset yellow FCF aluminum."
},
{
"NDCCode": "35561-285-11",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (35561-285-11) ",
"NDC11Code": "35561-0285-11",
"ProductNDC": "35561-285",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succiate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210281",
"LabelerName": "Bostal LLC",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each Solifenacin Succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each Solifenacin Succinate tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, hypromellose 2910, magnesium stearate, triacetin, polyethylene glycol 3350 and titanium dioxide with yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "35561-286-11",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (35561-286-11) ",
"NDC11Code": "35561-0286-11",
"ProductNDC": "35561-286",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210281",
"LabelerName": "Bostal LLC",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each Solifenacin Succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each Solifenacin Succinate tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, hypromellose 2910, magnesium stearate, triacetin, polyethylene glycol 3350 and titanium dioxide with yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "35561-343-11",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (35561-343-11) ",
"NDC11Code": "35561-0343-11",
"ProductNDC": "35561-343",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207803",
"LabelerName": "Bostal LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "54",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190630",
"SamplePackage": "N",
"Description": "Fenofibrate tablets USP are lipid regulating agents available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; Fenofibrate, USP is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each 54 mg and 160 mg fenofibrate tablet USP contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, lecithin (soy), microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide, and xanthan gum. Fenofibrate tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "35561-345-11",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (35561-345-11) ",
"NDC11Code": "35561-0345-11",
"ProductNDC": "35561-345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207805",
"LabelerName": "Bostal LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "67",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171117",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).",
"Description": "Fenofibrate, USP (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride; slightly soluble in alcohol; practically insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Each 67 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 134 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 200 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "35561-346-11",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (35561-346-11) ",
"NDC11Code": "35561-0346-11",
"ProductNDC": "35561-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207805",
"LabelerName": "Bostal LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "134",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171117",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).",
"Description": "Fenofibrate, USP (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride; slightly soluble in alcohol; practically insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Each 67 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 134 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 200 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "35561-347-11",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (35561-347-11) ",
"NDC11Code": "35561-0347-11",
"ProductNDC": "35561-347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207805",
"LabelerName": "Bostal LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171117",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).",
"Description": "Fenofibrate, USP (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride; slightly soluble in alcohol; practically insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Each 67 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 134 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 200 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "41250-344-11",
"PackageDescription": "7 CONTAINER in 1 CARTON (41250-344-11) / 24 LOZENGE in 1 CONTAINER",
"NDC11Code": "41250-0344-11",
"ProductNDC": "41250-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20060301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077007",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100416",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43744-344-11",
"PackageDescription": "5 g in 1 DRUM (43744-344-11)",
"NDC11Code": "43744-0344-11",
"ProductNDC": "43744-344",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Enrofloxacin Base",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130624",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "ENROFLOXACIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "59779-344-11",
"PackageDescription": "7 CONTAINER in 1 CARTON (59779-344-11) / 24 LOZENGE in 1 CONTAINER (59779-344-03) ",
"NDC11Code": "59779-0344-11",
"ProductNDC": "59779-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20060222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077007",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100421",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "67645-344-04",
"PackageDescription": "1 BAG in 1 CARTON (67645-344-04) / 11.35 kg in 1 BAG (67645-344-03) ",
"NDC11Code": "67645-0344-04",
"ProductNDC": "67645-344",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19971103",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Nouryon Chemicals, S.A. de C.V.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "75",
"StrengthUnit": "kg/100kg",
"Status": "Unfinished",
"LastUpdate": "2026-05-18",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "01-JUL-19"
},
{
"NDCCode": "68084-344-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-344-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-344-11) ",
"NDC11Code": "68084-0344-01",
"ProductNDC": "68084-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078235",
"LabelerName": "American Health Packaging",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090421",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate capsules, USP are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white crystalline powder with bitter taste. It is freely soluble in dichloromethane. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Each topiramate tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 200 mg of topiramate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Each topiramate capsule, USP intended for oral administration contains 15 mg or 25 mg or 50 mg of topiramate. In addition, each capsule contains the following inactive ingredients: cellulose acetate, gelatin, hypromellose, povidone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and water. Each capsule is printed with black pharmaceutical ink and contains the following inactive ingredients: shellac, propylene glycol, black iron oxide and potassium hydroxide. . Topiramate Capsules, USP meet USP dissolution test 2."
},
{
"NDCCode": "68391-344-11",
"PackageDescription": "7 CONTAINER in 1 CARTON (68391-344-11) > 24 LOZENGE in 1 CONTAINER",
"NDC11Code": "68391-0344-11",
"ProductNDC": "68391-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Berkley And Jensen Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077007",
"LabelerName": "BJWC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Deprecated",
"LastUpdate": "2018-07-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "68428-344-11",
"PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-344-11) ",
"NDC11Code": "68428-0344-11",
"ProductNDC": "68428-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crocus Sativus",
"NonProprietaryName": "Saffron",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100803",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SAFFRON",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100803",
"SamplePackage": "N"
},
{
"NDCCode": "84448-344-11",
"PackageDescription": "1 TUBE in 1 CARTON (84448-344-11) / 100 mL in 1 TUBE",
"NDC11Code": "84448-0344-11",
"ProductNDC": "84448-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Biossance Squalane And Zinc Sheer Mineral Sunscreen Broad Spectrum Spf 30",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240708",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "THG Beauty USA LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "17.68",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240708",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "10812-344-01",
"PackageDescription": "3.4 g in 1 TUBE (10812-344-01) ",
"NDC11Code": "10812-0344-01",
"ProductNDC": "10812-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Moistureshine Spf20",
"ProprietaryNameSuffix": "Berry Burst 400",
"NonProprietaryName": "Octinoxate, Octisalate, And Titanium Dioxide",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100215",
"EndMarketingDate": "20231201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "50; 25; 11",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100215",
"EndMarketingDatePackage": "20231201",
"SamplePackage": "N"
},
{
"NDCCode": "16714-496-01",
"PackageDescription": "1 TUBE in 1 CARTON (16714-496-01) / 15 g in 1 TUBE",
"NDC11Code": "16714-0496-01",
"ProductNDC": "16714-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"NonProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20010529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075673",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "10; .5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160815",
"SamplePackage": "N",
"IndicationAndUsage": "Clotrimazole and Betamethasone Dipropionate Cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.",
"Description": "Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, contains combinations of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, for topical use. Chemically, clotrimazole is 1–(o-chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula C22H17CLN2, a molecular weight of 344.84, and the following structural formula. Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate has 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.59, and the following structural formula. Betamethasone dipropionate is a white to creamy-white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate cream contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of ceteareth-30, cetostearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic monohydrate, white petrolatum; benzyl alcohol as preservative."
},
{
"NDCCode": "16714-496-02",
"PackageDescription": "1 TUBE in 1 CARTON (16714-496-02) / 45 g in 1 TUBE",
"NDC11Code": "16714-0496-02",
"ProductNDC": "16714-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"NonProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20010529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075673",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "10; .5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160815",
"SamplePackage": "N",
"IndicationAndUsage": "Clotrimazole and Betamethasone Dipropionate Cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.",
"Description": "Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, contains combinations of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, for topical use. Chemically, clotrimazole is 1–(o-chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula C22H17CLN2, a molecular weight of 344.84, and the following structural formula. Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate has 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.59, and the following structural formula. Betamethasone dipropionate is a white to creamy-white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate cream contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of ceteareth-30, cetostearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic monohydrate, white petrolatum; benzyl alcohol as preservative."
},
{
"NDCCode": "37000-344-38",
"PackageDescription": "380 mL in 1 BOTTLE, PLASTIC (37000-344-38) ",
"NDC11Code": "37000-0344-38",
"ProductNDC": "37000-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Head And Shoulders",
"ProprietaryNameSuffix": "Instant Oil Control",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "LOTION/SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140901",
"EndMarketingDate": "20221122",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140901",
"EndMarketingDatePackage": "20221122",
"SamplePackage": "N"
},
{
"NDCCode": "41250-344-03",
"PackageDescription": "1 CONTAINER in 1 CARTON (41250-344-03) / 24 LOZENGE in 1 CONTAINER",
"NDC11Code": "41250-0344-03",
"ProductNDC": "41250-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20060301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077007",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "41250-344-06",
"PackageDescription": "4 CONTAINER in 1 CARTON (41250-344-06) > 24 LOZENGE in 1 CONTAINER",
"NDC11Code": "41250-0344-06",
"ProductNDC": "41250-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20060301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077007",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-08"
},
{
"NDCCode": "41250-344-10",
"PackageDescription": "4 CONTAINER in 1 CARTON (41250-344-10) / 27 LOZENGE in 1 CONTAINER",
"NDC11Code": "41250-0344-10",
"ProductNDC": "41250-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20060301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077007",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100331",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "42291-344-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-344-90)",
"NDC11Code": "42291-0344-90",
"ProductNDC": "42291-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isometheptene-dichloral-apap",
"ProprietaryNameSuffix": "Oral",
"NonProprietaryName": "Isometheptene Mucate, Dichloralphenazone, And Acetaminophen",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150520",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ISOMETHEPTENE MUCATE; DICHLORALPHENAZONE; ACETAMINOPHEN",
"StrengthNumber": "65; 100; 325",
"StrengthUnit": "mg/1; mg/1; mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2017-11-08"
},
{
"NDCCode": "42571-344-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (42571-344-01) ",
"NDC11Code": "42571-0344-01",
"ProductNDC": "42571-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213219",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules, USP for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules, USP for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient ( seeDOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride capsules, USP are available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5 H-dibenz[b,f ]azepine monohydrochloride, and its structural formula is:. Clomipramine hydrochloride USP is a white to faintly yellow crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients:magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: D&C Yellow No. 10, gelatin, iron oxide yellow and titanium dioxide. The 50 mg capsule shell contains: D&C Yellow No. 10, FD&C Blue No. 1, gelatin and titanium dioxide. The 75 mg capsule shell contains: D&C Yellow No. 10, gelatin and titanium dioxide. The black imprinting ink contains: black iron oxide and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42571-344-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42571-344-30) ",
"NDC11Code": "42571-0344-30",
"ProductNDC": "42571-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
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"IndicationAndUsage": "Clomipramine hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules, USP for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules, USP for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient ( seeDOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride capsules, USP are available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5 H-dibenz[b,f ]azepine monohydrochloride, and its structural formula is:. Clomipramine hydrochloride USP is a white to faintly yellow crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients:magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: D&C Yellow No. 10, gelatin, iron oxide yellow and titanium dioxide. The 50 mg capsule shell contains: D&C Yellow No. 10, FD&C Blue No. 1, gelatin and titanium dioxide. The 75 mg capsule shell contains: D&C Yellow No. 10, gelatin and titanium dioxide. The black imprinting ink contains: black iron oxide and shellac. FDA approved dissolution test specifications differ from USP."
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"IndicationAndUsage": "Clomipramine hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules, USP for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules, USP for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient ( seeDOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride capsules, USP are available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5 H-dibenz[b,f ]azepine monohydrochloride, and its structural formula is:. Clomipramine hydrochloride USP is a white to faintly yellow crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients:magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: D&C Yellow No. 10, gelatin, iron oxide yellow and titanium dioxide. The 50 mg capsule shell contains: D&C Yellow No. 10, FD&C Blue No. 1, gelatin and titanium dioxide. The 75 mg capsule shell contains: D&C Yellow No. 10, gelatin and titanium dioxide. The black imprinting ink contains: black iron oxide and shellac. FDA approved dissolution test specifications differ from USP."
}
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<Description>Fenofibrate tablets, USP, are a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 - 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, mannitol, microcrystalline cellulose, poloxamer, polyvinyl alcohol, sodium bicarbonate, sodium lauryl sulfate, sodium stearyl fumarate, talc, tartaric acid, titanium dioxide, xanthan gum and lecithin (soy). The 48 mg tablets also contains D&C Yellow #10 aluminum lake, FD&C Blue #2 indigo carmine aluminum lake, FD&C Red #40 allura red AC aluminum lake and FD&C Yellow #6 /sunset yellow FCF aluminum.</Description>
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<Description>Fenofibrate tablets, USP, are a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 - 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, mannitol, microcrystalline cellulose, poloxamer, polyvinyl alcohol, sodium bicarbonate, sodium lauryl sulfate, sodium stearyl fumarate, talc, tartaric acid, titanium dioxide, xanthan gum and lecithin (soy). The 48 mg tablets also contains D&C Yellow #10 aluminum lake, FD&C Blue #2 indigo carmine aluminum lake, FD&C Red #40 allura red AC aluminum lake and FD&C Yellow #6 /sunset yellow FCF aluminum.</Description>
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<IndicationAndUsage>Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each Solifenacin Succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each Solifenacin Succinate tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, hypromellose 2910, magnesium stearate, triacetin, polyethylene glycol 3350 and titanium dioxide with yellow ferric oxide and red ferric oxide.</Description>
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<Description>Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each Solifenacin Succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each Solifenacin Succinate tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, hypromellose 2910, magnesium stearate, triacetin, polyethylene glycol 3350 and titanium dioxide with yellow ferric oxide and red ferric oxide.</Description>
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<Description>Fenofibrate tablets USP are lipid regulating agents available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; Fenofibrate, USP is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each 54 mg and 160 mg fenofibrate tablet USP contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, lecithin (soy), microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide, and xanthan gum. Fenofibrate tablets meet USP Dissolution Test 2.</Description>
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<NDC>
<NDCCode>35561-345-11</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (35561-345-11) </PackageDescription>
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<ProductNDC>35561-345</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207805</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>67</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).</IndicationAndUsage>
<Description>Fenofibrate, USP (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride; slightly soluble in alcohol; practically insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Each 67 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 134 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 200 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide.</Description>
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<NDCCode>35561-346-11</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (35561-346-11) </PackageDescription>
<NDC11Code>35561-0346-11</NDC11Code>
<ProductNDC>35561-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207805</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>134</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).</IndicationAndUsage>
<Description>Fenofibrate, USP (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride; slightly soluble in alcohol; practically insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Each 67 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 134 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 200 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>35561-347-11</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (35561-347-11) </PackageDescription>
<NDC11Code>35561-0347-11</NDC11Code>
<ProductNDC>35561-347</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207805</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).</IndicationAndUsage>
<Description>Fenofibrate, USP (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride; slightly soluble in alcohol; practically insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Each 67 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 134 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 200 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>41250-344-11</NDCCode>
<PackageDescription>7 CONTAINER in 1 CARTON (41250-344-11) / 24 LOZENGE in 1 CONTAINER</PackageDescription>
<NDC11Code>41250-0344-11</NDC11Code>
<ProductNDC>41250-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077007</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43744-344-11</NDCCode>
<PackageDescription>5 g in 1 DRUM (43744-344-11)</PackageDescription>
<NDC11Code>43744-0344-11</NDC11Code>
<ProductNDC>43744-344</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Enrofloxacin Base</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130624</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>ENROFLOXACIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
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<NDC>
<NDCCode>59779-344-11</NDCCode>
<PackageDescription>7 CONTAINER in 1 CARTON (59779-344-11) / 24 LOZENGE in 1 CONTAINER (59779-344-03) </PackageDescription>
<NDC11Code>59779-0344-11</NDC11Code>
<ProductNDC>59779-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077007</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67645-344-04</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (67645-344-04) / 11.35 kg in 1 BAG (67645-344-03) </PackageDescription>
<NDC11Code>67645-0344-04</NDC11Code>
<ProductNDC>67645-344</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19971103</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Nouryon Chemicals, S.A. de C.V.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-05-18</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JUL-19</StartMarketingDatePackage>
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<NDC>
<NDCCode>68084-344-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-344-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-344-11) </PackageDescription>
<NDC11Code>68084-0344-01</NDC11Code>
<ProductNDC>68084-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078235</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate capsules, USP are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white crystalline powder with bitter taste. It is freely soluble in dichloromethane. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Each topiramate tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 200 mg of topiramate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Each topiramate capsule, USP intended for oral administration contains 15 mg or 25 mg or 50 mg of topiramate. In addition, each capsule contains the following inactive ingredients: cellulose acetate, gelatin, hypromellose, povidone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and water. Each capsule is printed with black pharmaceutical ink and contains the following inactive ingredients: shellac, propylene glycol, black iron oxide and potassium hydroxide. . Topiramate Capsules, USP meet USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>68391-344-11</NDCCode>
<PackageDescription>7 CONTAINER in 1 CARTON (68391-344-11) > 24 LOZENGE in 1 CONTAINER</PackageDescription>
<NDC11Code>68391-0344-11</NDC11Code>
<ProductNDC>68391-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Berkley And Jensen Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077007</ApplicationNumber>
<LabelerName>BJWC</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
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<NDCCode>68428-344-11</NDCCode>
<PackageDescription>300 PELLET in 1 BOTTLE, GLASS (68428-344-11) </PackageDescription>
<NDC11Code>68428-0344-11</NDC11Code>
<ProductNDC>68428-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crocus Sativus</ProprietaryName>
<NonProprietaryName>Saffron</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100803</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SAFFRON</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>84448-344-11</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (84448-344-11) / 100 mL in 1 TUBE</PackageDescription>
<NDC11Code>84448-0344-11</NDC11Code>
<ProductNDC>84448-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Biossance Squalane And Zinc Sheer Mineral Sunscreen Broad Spectrum Spf 30</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240708</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>THG Beauty USA LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>17.68</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
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<NDC>
<NDCCode>10812-344-01</NDCCode>
<PackageDescription>3.4 g in 1 TUBE (10812-344-01) </PackageDescription>
<NDC11Code>10812-0344-01</NDC11Code>
<ProductNDC>10812-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Moistureshine Spf20</ProprietaryName>
<ProprietaryNameSuffix>Berry Burst 400</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<EndMarketingDate>20231201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>50; 25; 11</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<NDC11Code>16714-0496-01</NDC11Code>
<ProductNDC>16714-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Clotrimazole And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075673</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>10; .5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-11</LastUpdate>
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<IndicationAndUsage>Clotrimazole and Betamethasone Dipropionate Cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.</IndicationAndUsage>
<Description>Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, contains combinations of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, for topical use. Chemically, clotrimazole is 1–(o-chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula C22H17CLN2, a molecular weight of 344.84, and the following structural formula. Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate has 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.59, and the following structural formula. Betamethasone dipropionate is a white to creamy-white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate cream contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of ceteareth-30, cetostearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic monohydrate, white petrolatum; benzyl alcohol as preservative.</Description>
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<IndicationAndUsage>Clotrimazole and Betamethasone Dipropionate Cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.</IndicationAndUsage>
<Description>Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, contains combinations of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, for topical use. Chemically, clotrimazole is 1–(o-chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula C22H17CLN2, a molecular weight of 344.84, and the following structural formula. Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate has 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.59, and the following structural formula. Betamethasone dipropionate is a white to creamy-white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate cream contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of ceteareth-30, cetostearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic monohydrate, white petrolatum; benzyl alcohol as preservative.</Description>
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<IndicationAndUsage>Clomipramine hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules, USP for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules, USP for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient ( seeDOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride capsules, USP are available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5 H-dibenz[b,f ]azepine monohydrochloride, and its structural formula is:. Clomipramine hydrochloride USP is a white to faintly yellow crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients:magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: D&C Yellow No. 10, gelatin, iron oxide yellow and titanium dioxide. The 50 mg capsule shell contains: D&C Yellow No. 10, FD&C Blue No. 1, gelatin and titanium dioxide. The 75 mg capsule shell contains: D&C Yellow No. 10, gelatin and titanium dioxide. The black imprinting ink contains: black iron oxide and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Clomipramine hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules, USP for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules, USP for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient ( seeDOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride capsules, USP are available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5 H-dibenz[b,f ]azepine monohydrochloride, and its structural formula is:. Clomipramine hydrochloride USP is a white to faintly yellow crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients:magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: D&C Yellow No. 10, gelatin, iron oxide yellow and titanium dioxide. The 50 mg capsule shell contains: D&C Yellow No. 10, FD&C Blue No. 1, gelatin and titanium dioxide. The 75 mg capsule shell contains: D&C Yellow No. 10, gelatin and titanium dioxide. The black imprinting ink contains: black iron oxide and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Clomipramine hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules, USP for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules, USP for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient ( seeDOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride capsules, USP are available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5 H-dibenz[b,f ]azepine monohydrochloride, and its structural formula is:. Clomipramine hydrochloride USP is a white to faintly yellow crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients:magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: D&C Yellow No. 10, gelatin, iron oxide yellow and titanium dioxide. The 50 mg capsule shell contains: D&C Yellow No. 10, FD&C Blue No. 1, gelatin and titanium dioxide. The 75 mg capsule shell contains: D&C Yellow No. 10, gelatin and titanium dioxide. The black imprinting ink contains: black iron oxide and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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