{
"NDC": [
{
"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": "35561-344-11",
"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": "35561-344-13",
"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": "35561-285-00",
"PackageDescription": "256410 TABLET, FILM COATED in 1 BOX (35561-285-00) ",
"NDC11Code": "35561-0285-00",
"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": "35561-286-00",
"PackageDescription": "129032 TABLET, FILM COATED in 1 BOX (35561-286-00) ",
"NDC11Code": "35561-0286-00",
"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": "35561-343-00",
"PackageDescription": "63784 TABLET, FILM COATED in 1 BOX (35561-343-00) ",
"NDC11Code": "35561-0343-00",
"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": "42973-344-00",
"PackageDescription": "50 kg in 1 DRUM (42973-344-00) ",
"NDC11Code": "42973-0344-00",
"ProductNDC": "42973-344",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Degarelix Acetate Mannitol",
"DosageFormName": "POWDER",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Apicore Pharmaceuticals Private Limited",
"SubstanceName": "DEGARELIX ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-26",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-JAN-22"
},
{
"NDCCode": "50484-344-00",
"PackageDescription": "1 KIT in 1 CARTON (50484-344-00) * 236 mL in 1 BOTTLE, SPRAY * 78 g in 1 TUBE",
"NDC11Code": "50484-0344-00",
"ProductNDC": "50484-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Secura Two Step Kit",
"NonProprietaryName": "Benzethonium Chloride And Zinc Oxide",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20030801",
"EndMarketingDate": "20200131",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Smith & Nephew, Inc.",
"Status": "Deprecated",
"LastUpdate": "2020-02-01",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "61722-344-00",
"PackageDescription": "1 TUBE in 1 BOX (61722-344-00) > 30 mL in 1 TUBE",
"NDC11Code": "61722-0344-00",
"ProductNDC": "61722-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pretty By Flormar Weigthless Foundation 012 Amber",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170620",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Kosan Kozmetik Sanayi ve Ticaret A.S.",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170620",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "65498-344-00",
"PackageDescription": "58067 TABLET, FILM COATED in 1 DRUM (65498-344-00) ",
"NDC11Code": "65498-0344-00",
"ProductNDC": "65498-344",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20200316",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Kenvue Canada Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "500; 15; 30",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-08-08",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "16-MAR-20"
},
{
"NDCCode": "68001-344-00",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-344-00) ",
"NDC11Code": "68001-0344-00",
"ProductNDC": "68001-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ursodiol",
"NonProprietaryName": "Ursodiol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200826",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "URSODIOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bile Acid [EPC],Bile Acids and Salts [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140227",
"SamplePackage": "N"
},
{
"NDCCode": "68391-344-13",
"PackageDescription": "7 CONTAINER in 1 CARTON (68391-344-13) / 27 LOZENGE in 1 CONTAINER (68391-344-00) ",
"NDC11Code": "68391-0344-13",
"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": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160826",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "69740-344-00",
"PackageDescription": "1 KIT in 1 CARTON (69740-344-00) * 236 mL in 1 BOTTLE, SPRAY * 78 g in 1 TUBE",
"NDC11Code": "69740-0344-00",
"ProductNDC": "69740-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Secura Two Step Kit",
"NonProprietaryName": "Benzethonium Chloride And Zinc Oxide Cream",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20030801",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Smith & Nephew, Medical Ltd.",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231"
},
{
"NDCCode": "76420-344-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (76420-344-00) ",
"NDC11Code": "76420-0344-00",
"ProductNDC": "76420-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076164",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250502",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP, are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch."
},
{
"NDCCode": "82460-344-00",
"PackageDescription": "60 mL in 1 JAR (82460-344-00) ",
"NDC11Code": "82460-0344-00",
"ProductNDC": "82460-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simply Vital Antifungal Cream",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220725",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "ALPHA PLANTS INC",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2023-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220725",
"SamplePackage": "N",
"IndicationAndUsage": "proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm. for effective relief of itching, scaling, burning, soreness, irritation and discomfort."
},
{
"NDCCode": "50090-0741-0",
"PackageDescription": "1 TUBE in 1 CARTON (50090-0741-0) / 45 g in 1 TUBE",
"NDC11Code": "50090-0741-00",
"ProductNDC": "50090-0741",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"NonProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20031216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076002",
"LabelerName": "A-S Medication Solutions",
"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": "2023-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141128",
"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% (base), contains combinations of clotrimazole, USP, an azole antifungal, and betamethasone dipropionate, USP, a corticosteroid, for topical use. Chemically, clotrimazole, USP is 1-(o-Chloro-α,α-diphenylbenzyl)imidazole, with the molecular formula C22H17ClN2, a molecular weight of 344.84, and the following structural formula. Clotrimazole, USP is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate, USP has 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.59, and the following structural formula. Betamethasone dipropionate, USP is a white to creamy-white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate cream, USP contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a white to off-white hydrophilic cream. Inactive ingredients: Ceteareth-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic monohydrate, stearyl alcohol and white petrolatum; benzyl alcohol as preservative."
},
{
"NDCCode": "50090-1558-0",
"PackageDescription": "1 TUBE in 1 CARTON (50090-1558-0) > 15 g in 1 TUBE",
"NDC11Code": "50090-1558-00",
"ProductNDC": "50090-1558",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"NonProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20031216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076002",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "10; .5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Azole Antifungal [EPC],Azoles [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
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"StartMarketingDatePackage": "20141218",
"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% (base), contains combinations of clotrimazole USP, an azole antifungal, and betamethasone dipropionate USP, a corticosteroid, for topical use. Chemically, clotrimazole, USP is 1-(o-Chloro-α,α-diphenylbenzyl)imidazole, with the molecular formula C22H17ClN2, a molecular weight of 344.84, and the following structural formula. Clotrimazole, USP is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate, USP has 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.59, and the following structural formula. Betamethasone dipropionate, USP is a white to creamy-white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate cream, USP contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a white to off-white hydrophilic cream. Inactive ingredients: Ceteareth-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic monohydrate, stearyl alcohol and white petrolatum; benzyl alcohol as preservative."
},
{
"NDCCode": "50090-2357-0",
"PackageDescription": "45 g in 1 TUBE (50090-2357-0) ",
"NDC11Code": "50090-2357-00",
"ProductNDC": "50090-2357",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"NonProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202894",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "10; .5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Azole Antifungal [EPC],Azoles [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160421",
"SamplePackage": "N",
"IndicationAndUsage": "Clotrimazole and betamethasone dipropionate cream USP 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% (base), contains combinations of clotrimazole USP, an azole antifungal, and betamethasone dipropionate USP, a corticosteroid, for topical use. Chemically, clotrimazole USP is 1-[(2-Chlorophenyl)diphenylmethyl]-1H-imidazole, with the empirical formula C22H17ClN2, a molecular weight of 344.84, and the following structural formula. Clotrimazole USP is a white to pale yellow, crystalline powder, odorless, practically insoluble in water, freely soluble in methanol, in acetone, in chloroform, and in alcohol. Betamethasone dipropionate USP has the chemical name 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 USP is a white to almost white crystalline powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, sparingly soluble in alcohol. Each gram of clotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base) contains 10 mg of clotrimazole USP and 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg of betamethasone), in a white to off-white, hydrophilic cream consisting of benzyl alcohol, cetyl alcohol plus stearyl alcohol, ceteareth-30, mineral oil, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, sodium hydroxide, white petrolatum and purified water."
},
{
"NDCCode": "50090-3121-0",
"PackageDescription": "1 TUBE in 1 CARTON (50090-3121-0) / 45 g in 1 TUBE",
"NDC11Code": "50090-3121-00",
"ProductNDC": "50090-3121",
"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": "A-S Medication Solutions",
"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": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170815",
"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": "50090-4876-0",
"PackageDescription": "1 TUBE in 1 CARTON (50090-4876-0) / 15 g in 1 TUBE",
"NDC11Code": "50090-4876-00",
"ProductNDC": "50090-4876",
"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": "A-S Medication Solutions",
"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": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200205",
"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": "50090-5931-0",
"PackageDescription": "1 TUBE in 1 CARTON (50090-5931-0) / 15 g in 1 TUBE",
"NDC11Code": "50090-5931-00",
"ProductNDC": "50090-5931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19930831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072640",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220304",
"SamplePackage": "N",
"IndicationAndUsage": "Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.",
"Description": "Clotrimazole Cream USP, 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C22H17ClN2; a molecular weight of 344.84; and the structural formula. Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole, dispersed in a vanishing cream base of cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and benzyl alcohol (1%) as preservative."
},
{
"NDCCode": "50090-6474-0",
"PackageDescription": "1 TUBE in 1 CARTON (50090-6474-0) / 45 g in 1 TUBE",
"NDC11Code": "50090-6474-00",
"ProductNDC": "50090-6474",
"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": "A-S Medication Solutions",
"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": "2023-06-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230512",
"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": "50090-7343-0",
"PackageDescription": "30 g in 1 TUBE (50090-7343-0) ",
"NDC11Code": "50090-7343-00",
"ProductNDC": "50090-7343",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090219",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241016",
"SamplePackage": "N",
"IndicationAndUsage": "Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum,Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.",
"Description": "Clotrimazole cream USP, 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C22H17ClN2; a molecular weight of 344.84; and the structural formula:. Clotrimazole USP is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole USP, dispersed in a vanishing cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, octyldodecanol, purified water, and benzyl alcohol (1%) as preservative."
},
{
"NDCCode": "54868-4546-0",
"PackageDescription": "1 TUBE in 1 CARTON (54868-4546-0) > 45 g in 1 TUBE",
"NDC11Code": "54868-4546-00",
"ProductNDC": "54868-4546",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"NonProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20010831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075673",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "10; .64",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Clotrimazole and Betamethasone Dipropionate Cream and Lotion are indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of Clotrimazole and Betamethasone Dipropionate Cream or Lotion for the treatment of infections caused by zoophilic dermatophytes (e.g. Microsporum canis) has not been established. Several cases of treatment failure of Clotrimazole and Betamethasone Dipropionate Cream, USP in the treatment of infections caused by Microsporum canis have been reported.",
"Description": "Clotrimazole and Betamethasone Dipropionate Cream and Lotion contain combinations of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic 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 the chemical name 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, USP contains 10.0 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, white petrolatum; benzyl alcohol as preservative. Clotrimazole and betamethasone dipropionate cream is smooth, uniform and white to off-white in color. Each gram of Clotrimazole and Betamethasone Dipropionate Lotion contains 10.0 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic base of ceteareth-30, cetyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic, stearyl alcohol, white petrolatum; benzyl alcohol as preservative. Clotrimazole and Betamethasone Dipropionate Lotion is opaque and white in color."
},
{
"NDCCode": "54868-5232-0",
"PackageDescription": "1 BOTTLE in 1 CARTON (54868-5232-0) > 30 mL in 1 BOTTLE",
"NDC11Code": "54868-5232-00",
"ProductNDC": "54868-5232",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"NonProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20071231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076493",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "10; .64",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Clotrimazole and Betamethasone Dipropionate Cream and Lotion are indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of Clotrimazole and Betamethasone Dipropionate Cream or Lotion for the treatment of infections caused by zoophilic dermatophytes (e.g. Microsporum canis) has not been established. Several cases of treatment failure of Clotrimazole and Betamethasone Dipropionate Cream, USP in the treatment of infections caused by Microsporum canis have been reported.",
"Description": "Clotrimazole and Betamethasone Dipropionate Cream and Lotion contain combinations of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic 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 the chemical name 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, USP contains 10.0 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, white petrolatum; benzyl alcohol as preservative. Clotrimazole and betamethasone dipropionate cream is smooth, uniform and white to off-white in color. Each gram of Clotrimazole and Betamethasone Dipropionate Lotion contains 10.0 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic base of ceteareth-30, cetyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic, stearyl alcohol, white petrolatum; benzyl alcohol as preservative. Clotrimazole and Betamethasone Dipropionate Lotion is opaque and white in color."
},
{
"NDCCode": "59088-893-00",
"PackageDescription": "1 KIT in 1 CARTON (59088-893-00) * 1 TUBE in 1 CARTON (0472-0379-15) / 15 g in 1 TUBE * 4 g in 1 PACKET (59088-563-01) ",
"NDC11Code": "59088-0893-00",
"ProductNDC": "59088-893",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dermacinrx Therazole Pak",
"NonProprietaryName": "Clotrimazole And Betamethasone Dipropionate, Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20160809",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
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"Description": "Clotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base), contains combinations of clotrimazole USP, an azole antifungal, and betamethasone dipropionate USP, a corticosteroid, for topical use. Chemically, clotrimazole, USP is 1-( o-Chloro-α,α-diphenylbenzyl)imidazole, with the molecular formula C 22H 17ClN 2, a molecular weight of 344.84, and the following structural formula:. Clotrimazole, USP is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate, USP has 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C 28H 37FO 7, a molecular weight of 504.59, and the following structural formula:. Betamethasone dipropionate, USP is a white to creamy-white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate cream, USP contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a white to off-white hydrophilic cream. Inactive ingredients: Ceteareth-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic monohydrate, stearyl alcohol and white petrolatum; benzyl alcohol as preservative."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075502",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE",
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"Description": "Clotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base) 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 molecular formula C 22H 17CLN 2, 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 molecular formula C 28H 37FO 7, 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 USP, 1%/0.05% (base) contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of purified water, mineral oil, white petrolatum, cetostearyl alcohol, ceteareth-30, propylene glycol, monobasic sodium phosphate monohydrate, and benzyl alcohol as a preservative."
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"PackageDescription": "45 g in 1 TUBE (70518-2326-0) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE",
"StrengthNumber": ".5; 10",
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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.",
"Description": "Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base), contains combinations of clotrimazole, USP, an azole antifungal, and betamethasone dipropionate, USP, a corticosteroid, for topical use. Chemically, clotrimazole, USP is 1-[(2-Chlorophenyl)diphenylmethyl]-1H-imidazole, with the empirical formula C 22H 17ClN 2, a molecular weight of 344.84 g/mol, and the following structural formula:. Clotrimazole, USP is a white to pale yellow, crystalline powder, odorless, practically insoluble in water, freely soluble in methanol, in acetone, in chloroform and in alcohol. Betamethasone dipropionate, USP has the chemical name 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28H 37FO 7, a molecular weight of 504.60 g/mol, and the following structural formula:. Betamethasone dipropionate, USP is a white to almost white crystalline powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, sparingly soluble in alcohol. Each gram of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) contains 10 mg clotrimazole, USP and 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a white to off-white, uniform and smooth cream consisting of benzyl alcohol, ceteareth-30, cetyl alcohol, mineral oil, monobasic sodium phosphate, phosphoric acid, propylene glycol, purified water, sodium hydroxide, stearyl alcohol, and white petrolatum."
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"PackageDescription": "1 TUBE in 1 CARTON (70518-2352-0) / 45 g in 1 TUBE",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
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"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE",
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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 rubrumin 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 C 22H 17CLN 2, 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 C 28H 37FO 7, 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."
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{
"NDCCode": "70518-4037-0",
"PackageDescription": "1 TUBE in 1 CARTON (70518-4037-0) / 15 g in 1 TUBE",
"NDC11Code": "70518-4037-00",
"ProductNDC": "70518-4037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072640",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-08-11",
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"StartMarketingDatePackage": "20240315",
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"IndicationAndUsage": "Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicansand tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum,and Microsporum canis.",
"Description": "Clotrimazole Cream USP, 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C 22H 17ClN 2; a molecular weight of 344.84; and the structural formula:. Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole, dispersed in a vanishing cream base of cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and benzyl alcohol (1%) as preservative."
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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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<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (35561-344-11) </PackageDescription>
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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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<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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<PackageDescription>256410 TABLET, FILM COATED in 1 BOX (35561-285-00) </PackageDescription>
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<ProductNDC>35561-285</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succiate</NonProprietaryName>
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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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<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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<StrengthUnit>mg/1</StrengthUnit>
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<SamplePackage>N</SamplePackage>
<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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<LabelerName>Apicore Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>DEGARELIX ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-26</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>50484-344-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (50484-344-00) * 236 mL in 1 BOTTLE, SPRAY * 78 g in 1 TUBE</PackageDescription>
<NDC11Code>50484-0344-00</NDC11Code>
<ProductNDC>50484-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Secura Two Step Kit</ProprietaryName>
<NonProprietaryName>Benzethonium Chloride And Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20030801</StartMarketingDate>
<EndMarketingDate>20200131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Smith & Nephew, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-02-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>61722-344-00</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (61722-344-00) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>61722-0344-00</NDC11Code>
<ProductNDC>61722-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pretty By Flormar Weigthless Foundation 012 Amber</ProprietaryName>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170620</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Kosan Kozmetik Sanayi ve Ticaret A.S.</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65498-344-00</NDCCode>
<PackageDescription>58067 TABLET, FILM COATED in 1 DRUM (65498-344-00) </PackageDescription>
<NDC11Code>65498-0344-00</NDC11Code>
<ProductNDC>65498-344</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Acetaminophen, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20200316</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Kenvue Canada Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 15; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-08-08</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-MAR-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68001-344-00</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-344-00) </PackageDescription>
<NDC11Code>68001-0344-00</NDC11Code>
<ProductNDC>68001-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ursodiol</ProprietaryName>
<NonProprietaryName>Ursodiol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200826</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>URSODIOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bile Acid [EPC],Bile Acids and Salts [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68391-344-13</NDCCode>
<PackageDescription>7 CONTAINER in 1 CARTON (68391-344-13) / 27 LOZENGE in 1 CONTAINER (68391-344-00) </PackageDescription>
<NDC11Code>68391-0344-13</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>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69740-344-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (69740-344-00) * 236 mL in 1 BOTTLE, SPRAY * 78 g in 1 TUBE</PackageDescription>
<NDC11Code>69740-0344-00</NDC11Code>
<ProductNDC>69740-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Secura Two Step Kit</ProprietaryName>
<NonProprietaryName>Benzethonium Chloride And Zinc Oxide Cream</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20030801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Smith & Nephew, Medical Ltd.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>76420-344-00</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (76420-344-00) </PackageDescription>
<NDC11Code>76420-0344-00</NDC11Code>
<ProductNDC>76420-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076164</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP, are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch.</Description>
</NDC>
<NDC>
<NDCCode>82460-344-00</NDCCode>
<PackageDescription>60 mL in 1 JAR (82460-344-00) </PackageDescription>
<NDC11Code>82460-0344-00</NDC11Code>
<ProductNDC>82460-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simply Vital Antifungal Cream</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220725</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>ALPHA PLANTS INC</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm. for effective relief of itching, scaling, burning, soreness, irritation and discomfort.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-0741-0</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50090-0741-0) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>50090-0741-00</NDC11Code>
<ProductNDC>50090-0741</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Clotrimazole And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20031216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076002</ApplicationNumber>
<LabelerName>A-S Medication Solutions</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>2023-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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% (base), contains combinations of clotrimazole, USP, an azole antifungal, and betamethasone dipropionate, USP, a corticosteroid, for topical use. Chemically, clotrimazole, USP is 1-(o-Chloro-α,α-diphenylbenzyl)imidazole, with the molecular formula C22H17ClN2, a molecular weight of 344.84, and the following structural formula. Clotrimazole, USP is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate, USP has 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.59, and the following structural formula. Betamethasone dipropionate, USP is a white to creamy-white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate cream, USP contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a white to off-white hydrophilic cream. Inactive ingredients: Ceteareth-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic monohydrate, stearyl alcohol and white petrolatum; benzyl alcohol as preservative.</Description>
</NDC>
<NDC>
<NDCCode>50090-1558-0</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50090-1558-0) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>50090-1558-00</NDC11Code>
<ProductNDC>50090-1558</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Clotrimazole And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20031216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076002</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>10; .5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC],Azoles [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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% (base), contains combinations of clotrimazole USP, an azole antifungal, and betamethasone dipropionate USP, a corticosteroid, for topical use. Chemically, clotrimazole, USP is 1-(o-Chloro-α,α-diphenylbenzyl)imidazole, with the molecular formula C22H17ClN2, a molecular weight of 344.84, and the following structural formula. Clotrimazole, USP is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate, USP has 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.59, and the following structural formula. Betamethasone dipropionate, USP is a white to creamy-white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate cream, USP contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a white to off-white hydrophilic cream. Inactive ingredients: Ceteareth-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic monohydrate, stearyl alcohol and white petrolatum; benzyl alcohol as preservative.</Description>
</NDC>
<NDC>
<NDCCode>50090-2357-0</NDCCode>
<PackageDescription>45 g in 1 TUBE (50090-2357-0) </PackageDescription>
<NDC11Code>50090-2357-00</NDC11Code>
<ProductNDC>50090-2357</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Clotrimazole And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202894</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>10; .5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC],Azoles [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clotrimazole and betamethasone dipropionate cream USP 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% (base), contains combinations of clotrimazole USP, an azole antifungal, and betamethasone dipropionate USP, a corticosteroid, for topical use. Chemically, clotrimazole USP is 1-[(2-Chlorophenyl)diphenylmethyl]-1H-imidazole, with the empirical formula C22H17ClN2, a molecular weight of 344.84, and the following structural formula. Clotrimazole USP is a white to pale yellow, crystalline powder, odorless, practically insoluble in water, freely soluble in methanol, in acetone, in chloroform, and in alcohol. Betamethasone dipropionate USP has the chemical name 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 USP is a white to almost white crystalline powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, sparingly soluble in alcohol. Each gram of clotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base) contains 10 mg of clotrimazole USP and 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg of betamethasone), in a white to off-white, hydrophilic cream consisting of benzyl alcohol, cetyl alcohol plus stearyl alcohol, ceteareth-30, mineral oil, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, sodium hydroxide, white petrolatum and purified water.</Description>
</NDC>
<NDC>
<NDCCode>50090-3121-0</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50090-3121-0) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>50090-3121-00</NDC11Code>
<ProductNDC>50090-3121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Clotrimazole And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20010529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075673</ApplicationNumber>
<LabelerName>A-S Medication Solutions</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>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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>
</NDC>
<NDC>
<NDCCode>50090-4876-0</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50090-4876-0) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>50090-4876-00</NDC11Code>
<ProductNDC>50090-4876</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Clotrimazole And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20010529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075673</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE</SubstanceName>
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<StrengthUnit>mg/g; mg/g</StrengthUnit>
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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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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole</ProprietaryName>
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<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19930831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072640</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2024-09-07</LastUpdate>
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<IndicationAndUsage>Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.</IndicationAndUsage>
<Description>Clotrimazole Cream USP, 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C22H17ClN2; a molecular weight of 344.84; and the structural formula. Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole, dispersed in a vanishing cream base of cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and benzyl alcohol (1%) as preservative.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075673</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>10; .5</StrengthNumber>
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<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
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<LastUpdate>2023-06-09</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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<NDC>
<NDCCode>50090-7343-0</NDCCode>
<PackageDescription>30 g in 1 TUBE (50090-7343-0) </PackageDescription>
<NDC11Code>50090-7343-00</NDC11Code>
<ProductNDC>50090-7343</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090219</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum,Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.</IndicationAndUsage>
<Description>Clotrimazole cream USP, 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C22H17ClN2; a molecular weight of 344.84; and the structural formula:. Clotrimazole USP is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole USP, dispersed in a vanishing cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, octyldodecanol, purified water, and benzyl alcohol (1%) as preservative.</Description>
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<NDC>
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<PackageDescription>1 TUBE in 1 CARTON (54868-4546-0) > 45 g in 1 TUBE</PackageDescription>
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<ProductNDC>54868-4546</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Clotrimazole And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20010831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075673</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>10; .64</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clotrimazole and Betamethasone Dipropionate Cream and Lotion are indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of Clotrimazole and Betamethasone Dipropionate Cream or Lotion for the treatment of infections caused by zoophilic dermatophytes (e.g. Microsporum canis) has not been established. Several cases of treatment failure of Clotrimazole and Betamethasone Dipropionate Cream, USP in the treatment of infections caused by Microsporum canis have been reported.</IndicationAndUsage>
<Description>Clotrimazole and Betamethasone Dipropionate Cream and Lotion contain combinations of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic 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 the chemical name 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, USP contains 10.0 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, white petrolatum; benzyl alcohol as preservative. Clotrimazole and betamethasone dipropionate cream is smooth, uniform and white to off-white in color. Each gram of Clotrimazole and Betamethasone Dipropionate Lotion contains 10.0 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic base of ceteareth-30, cetyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic, stearyl alcohol, white petrolatum; benzyl alcohol as preservative. Clotrimazole and Betamethasone Dipropionate Lotion is opaque and white in color.</Description>
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<NDC>
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<PackageDescription>1 BOTTLE in 1 CARTON (54868-5232-0) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>54868-5232-00</NDC11Code>
<ProductNDC>54868-5232</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Clotrimazole And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20071231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076493</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>10; .64</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clotrimazole and Betamethasone Dipropionate Cream and Lotion are indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of Clotrimazole and Betamethasone Dipropionate Cream or Lotion for the treatment of infections caused by zoophilic dermatophytes (e.g. Microsporum canis) has not been established. Several cases of treatment failure of Clotrimazole and Betamethasone Dipropionate Cream, USP in the treatment of infections caused by Microsporum canis have been reported.</IndicationAndUsage>
<Description>Clotrimazole and Betamethasone Dipropionate Cream and Lotion contain combinations of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic 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 the chemical name 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, USP contains 10.0 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, white petrolatum; benzyl alcohol as preservative. Clotrimazole and betamethasone dipropionate cream is smooth, uniform and white to off-white in color. Each gram of Clotrimazole and Betamethasone Dipropionate Lotion contains 10.0 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic base of ceteareth-30, cetyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic, stearyl alcohol, white petrolatum; benzyl alcohol as preservative. Clotrimazole and Betamethasone Dipropionate Lotion is opaque and white in color.</Description>
</NDC>
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<NDCCode>59088-893-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59088-893-00) * 1 TUBE in 1 CARTON (0472-0379-15) / 15 g in 1 TUBE * 4 g in 1 PACKET (59088-563-01) </PackageDescription>
<NDC11Code>59088-0893-00</NDC11Code>
<ProductNDC>59088-893</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dermacinrx Therazole Pak</ProprietaryName>
<NonProprietaryName>Clotrimazole And Betamethasone Dipropionate, Zinc Oxide</NonProprietaryName>
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<StartMarketingDate>20160809</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Clotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base), contains combinations of clotrimazole USP, an azole antifungal, and betamethasone dipropionate USP, a corticosteroid, for topical use. Chemically, clotrimazole, USP is 1-( o-Chloro-α,α-diphenylbenzyl)imidazole, with the molecular formula C 22H 17ClN 2, a molecular weight of 344.84, and the following structural formula:. Clotrimazole, USP is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate, USP has 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C 28H 37FO 7, a molecular weight of 504.59, and the following structural formula:. Betamethasone dipropionate, USP is a white to creamy-white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate cream, USP contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a white to off-white hydrophilic cream. Inactive ingredients: Ceteareth-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic monohydrate, stearyl alcohol and white petrolatum; benzyl alcohol as preservative.</Description>
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<PackageDescription>45 g in 1 TUBE (70518-0339-0) </PackageDescription>
<NDC11Code>70518-0339-00</NDC11Code>
<ProductNDC>70518-0339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole And Betamethasone Dipropionate</ProprietaryName>
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<DosageFormName>CREAM</DosageFormName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075502</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>.5; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) 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% (base) 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 molecular formula C 22H 17CLN 2, 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 molecular formula C 28H 37FO 7, 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 USP, 1%/0.05% (base) contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of purified water, mineral oil, white petrolatum, cetostearyl alcohol, ceteareth-30, propylene glycol, monobasic sodium phosphate monohydrate, and benzyl alcohol as a preservative.</Description>
</NDC>
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<PackageDescription>45 g in 1 TUBE (70518-2326-0) </PackageDescription>
<NDC11Code>70518-2326-00</NDC11Code>
<ProductNDC>70518-2326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Clotrimazole And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202894</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>.5; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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% (base), contains combinations of clotrimazole, USP, an azole antifungal, and betamethasone dipropionate, USP, a corticosteroid, for topical use. Chemically, clotrimazole, USP is 1-[(2-Chlorophenyl)diphenylmethyl]-1H-imidazole, with the empirical formula C 22H 17ClN 2, a molecular weight of 344.84 g/mol, and the following structural formula:. Clotrimazole, USP is a white to pale yellow, crystalline powder, odorless, practically insoluble in water, freely soluble in methanol, in acetone, in chloroform and in alcohol. Betamethasone dipropionate, USP has the chemical name 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28H 37FO 7, a molecular weight of 504.60 g/mol, and the following structural formula:. Betamethasone dipropionate, USP is a white to almost white crystalline powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, sparingly soluble in alcohol. Each gram of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) contains 10 mg clotrimazole, USP and 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a white to off-white, uniform and smooth cream consisting of benzyl alcohol, ceteareth-30, cetyl alcohol, mineral oil, monobasic sodium phosphate, phosphoric acid, propylene glycol, purified water, sodium hydroxide, stearyl alcohol, and white petrolatum.</Description>
</NDC>
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<PackageDescription>1 TUBE in 1 CARTON (70518-2352-0) / 45 g in 1 TUBE</PackageDescription>
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<ProductNDC>70518-2352</ProductNDC>
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<NonProprietaryName>Clotrimazole And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075673</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</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>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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 rubrumin 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 C 22H 17CLN 2, 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 C 28H 37FO 7, 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>
</NDC>
<NDC>
<NDCCode>70518-4037-0</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (70518-4037-0) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>70518-4037-00</NDC11Code>
<ProductNDC>70518-4037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072640</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicansand tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum,and Microsporum canis.</IndicationAndUsage>
<Description>Clotrimazole Cream USP, 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C 22H 17ClN 2; a molecular weight of 344.84; and the structural formula:. Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole, dispersed in a vanishing cream base of cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and benzyl alcohol (1%) as preservative.</Description>
</NDC>
</NDCList>