{
"NDC": [
{
"NDCCode": "0299-5918-25",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0299-5918-25) / 45 g in 1 BOTTLE, PUMP",
"NDC11Code": "00299-5918-25",
"ProductNDC": "0299-5918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Differin",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090915",
"EndMarketingDate": "20270201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021753",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090915",
"EndMarketingDatePackage": "20270201",
"SamplePackage": "N",
"IndicationAndUsage": "DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula."
},
{
"NDCCode": "0299-5918-02",
"PackageDescription": "2 g in 1 TUBE (0299-5918-02) ",
"NDC11Code": "00299-5918-02",
"ProductNDC": "0299-5918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Differin",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021753",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090915",
"SamplePackage": "N",
"IndicationAndUsage": "DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula."
},
{
"NDCCode": "0299-5918-15",
"PackageDescription": "1 TUBE in 1 CARTON (0299-5918-15) > 15 g in 1 TUBE",
"NDC11Code": "00299-5918-15",
"ProductNDC": "0299-5918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Differin",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021753",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090915",
"SamplePackage": "N",
"IndicationAndUsage": "DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula."
},
{
"NDCCode": "0299-5918-45",
"PackageDescription": "1 TUBE in 1 CARTON (0299-5918-45) > 45 g in 1 TUBE",
"NDC11Code": "00299-5918-45",
"ProductNDC": "0299-5918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Differin",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021753",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090915",
"SamplePackage": "N",
"IndicationAndUsage": "DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula."
},
{
"NDCCode": "0299-5908-25",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0299-5908-25) / 45 g in 1 BOTTLE, PUMP",
"NDC11Code": "00299-5908-25",
"ProductNDC": "0299-5908",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epiduo",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022320",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "1; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081208",
"SamplePackage": "N",
"IndicationAndUsage": "EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "EPIDUO (adapalene and benzoyl peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Active: Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
},
{
"NDCCode": "0517-0299-25",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0517-0299-25) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00517-0299-25",
"ProductNDC": "0517-0299",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-06-21"
},
{
"NDCCode": "38779-0299-4",
"PackageDescription": "25 g in 1 JAR (38779-0299-4) ",
"NDC11Code": "38779-0299-04",
"ProductNDC": "38779-0299",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140609",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Medisca Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-08-26",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "08-SEP-16"
},
{
"NDCCode": "52584-299-25",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (52584-299-25) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "52584-0299-25",
"ProductNDC": "52584-299",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20120125",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "General Injectables & Vaccines, Inc",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "60687-299-25",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-299-25) / 1 CAPSULE in 1 BLISTER PACK (60687-299-95) ",
"NDC11Code": "60687-0299-25",
"ProductNDC": "60687-299",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Itraconazole",
"NonProprietaryName": "Itraconazole",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205080",
"LabelerName": "American Health Packaging",
"SubstanceName": "ITRACONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170502",
"SamplePackage": "N",
"IndicationAndUsage": "Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: : 1 Blastomycosis, pulmonary and extrapulmonary, 2 Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and, 3 Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.",
"Description": "Itraconazole, USP is an azole antifungal agent. Itraconazole, USP is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. (±)-1-[( R*)- sec-butyl]-4-[ p-[4-[ p-[[(2 R*,4 S*)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy] phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one mixture with (±)-1-[( R*)- sec-butyl]-4-[ p-[4-[ p-[[(2 S*,4 R*)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one. or. (±)-1-[( RS)- sec-butyl]-4-[ p-[4-[ p-[[(2 R,4 S)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy] phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one. Itraconazole, USP has a molecular formula of C 35H 38Cl 2N 8O 4 and a molecular weight of 705.64. It is a white or almost white powder. It is insoluble in water, very slightly soluble in alcohols, and freely soluble in dichloromethane. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules, USP contain 100 mg of itraconazole, USP coated on sugar spheres. Inactive ingredients are black iron oxide, FD&C Blue No. 1, gelatin, hypromellose, liquid glucose, microcrystalline cellulose, polyethylene glycol, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate, starch (of maize), strong ammonia solution, sucrose and titanium dioxide."
},
{
"NDCCode": "75839-299-25",
"PackageDescription": "25 g in 1 BOTTLE (75839-299-25)",
"NDC11Code": "75839-0299-25",
"ProductNDC": "75839-299",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Indocyanine Green",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Attix Pharmaceuticals",
"SubstanceName": "INDOCYANINE GREEN",
"StrengthNumber": "25",
"StrengthUnit": "g/25g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "54868-5918-0",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (54868-5918-0)",
"NDC11Code": "54868-5918-00",
"ProductNDC": "54868-5918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079088",
"LabelerName": "Physicians Total Care, Inc",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Enter section text here.",
"Description": "Risperidone tablets, USP, contain risperidone, USP, a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido [1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&C yellow # 6 Orange yellow S (E 110). 4 mg tablets: FD&C Blue # 2 Lake of indigo carmine."
},
{
"NDCCode": "54868-5918-1",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (54868-5918-1)",
"NDC11Code": "54868-5918-01",
"ProductNDC": "54868-5918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079088",
"LabelerName": "Physicians Total Care, Inc",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Enter section text here.",
"Description": "Risperidone tablets, USP, contain risperidone, USP, a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido [1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&C yellow # 6 Orange yellow S (E 110). 4 mg tablets: FD&C Blue # 2 Lake of indigo carmine."
},
{
"NDCCode": "0299-2012-05",
"PackageDescription": "5 g in 1 TUBE (0299-2012-05) ",
"NDC11Code": "00299-2012-05",
"ProductNDC": "0299-2012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vectical",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022087",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": "3",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090201",
"SamplePackage": "Y",
"IndicationAndUsage": "VECTICAL Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adult and pediatric patients 2 years and older. ( 1.1) Limitations of Use The safety and effectiveness of VECTICAL Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. ( 1.2).",
"Description": "VECTICAL (calcitriol) Ointment 3 mcg/g is a vitamin D analog intended for topical application to the skin. The chemical name of the active ingredient is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol. The structural formula is. Calcitriol is a white or almost white crystalline solid. It is practically insoluble in water, soluble in alcohol and in fatty oils. The molecular formula is C 27H 44O 3, and the molecular weight is 416.64. VECTICAL Ointment is a translucent ointment containing 3 mcg/g (0.0003% w/w) of calcitriol, packaged in aluminum tubes with screw caps. Other components of the ointment are mineral oil, dl-α-tocopherol, and white petrolatum."
},
{
"NDCCode": "0299-2012-10",
"PackageDescription": "1 TUBE in 1 CARTON (0299-2012-10) / 100 g in 1 TUBE",
"NDC11Code": "00299-2012-10",
"ProductNDC": "0299-2012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vectical",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022087",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": "3",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090201",
"SamplePackage": "N",
"IndicationAndUsage": "VECTICAL Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adult and pediatric patients 2 years and older. ( 1.1) Limitations of Use The safety and effectiveness of VECTICAL Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. ( 1.2).",
"Description": "VECTICAL (calcitriol) Ointment 3 mcg/g is a vitamin D analog intended for topical application to the skin. The chemical name of the active ingredient is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol. The structural formula is. Calcitriol is a white or almost white crystalline solid. It is practically insoluble in water, soluble in alcohol and in fatty oils. The molecular formula is C 27H 44O 3, and the molecular weight is 416.64. VECTICAL Ointment is a translucent ointment containing 3 mcg/g (0.0003% w/w) of calcitriol, packaged in aluminum tubes with screw caps. Other components of the ointment are mineral oil, dl-α-tocopherol, and white petrolatum."
},
{
"NDCCode": "0299-3823-00",
"PackageDescription": "2 g in 1 TUBE (0299-3823-00) ",
"NDC11Code": "00299-3823-00",
"ProductNDC": "0299-3823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Soolantra",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206255",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Antiparasitic [EPC], Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191101",
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"IndicationAndUsage": "SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.",
"Description": "SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of SOOLANTRA cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0% and not more than 102.0% of 5-O-demethyl-22,23-dihydroavermectin A 1aplus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a, generally referred to as 22,23-dihydroavermectin B 1aand B 1bor H 2B 1aand H 2B 1b, respectively; and the ratio (calculated by area percentage) of component H 2B 1a/(H 2B 1a+ H 2B 1b) is not less than 90.0%. The respective empirical formulas of H 2B 1aand H 2B 1bare C 48H 74O 14and C 47H 72O 14with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H 2B 1a: R = C 2H 5, Component H 2B 1b: R = CH 3. SOOLANTRA cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol."
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"IndicationAndUsage": "SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.",
"Description": "SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of SOOLANTRA cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0% and not more than 102.0% of 5-O-demethyl-22,23-dihydroavermectin A 1aplus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a, generally referred to as 22,23-dihydroavermectin B 1aand B 1bor H 2B 1aand H 2B 1b, respectively; and the ratio (calculated by area percentage) of component H 2B 1a/(H 2B 1a+ H 2B 1b) is not less than 90.0%. The respective empirical formulas of H 2B 1aand H 2B 1bare C 48H 74O 14and C 47H 72O 14with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H 2B 1a: R = C 2H 5, Component H 2B 1b: R = CH 3. SOOLANTRA cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.",
"Description": "SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of SOOLANTRA cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0% and not more than 102.0% of 5-O-demethyl-22,23-dihydroavermectin A 1aplus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a, generally referred to as 22,23-dihydroavermectin B 1aand B 1bor H 2B 1aand H 2B 1b, respectively; and the ratio (calculated by area percentage) of component H 2B 1a/(H 2B 1a+ H 2B 1b) is not less than 90.0%. The respective empirical formulas of H 2B 1aand H 2B 1bare C 48H 74O 14and C 47H 72O 14with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H 2B 1a: R = C 2H 5, Component H 2B 1b: R = CH 3. SOOLANTRA cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.",
"Description": "SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of SOOLANTRA cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0% and not more than 102.0% of 5-O-demethyl-22,23-dihydroavermectin A 1aplus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a, generally referred to as 22,23-dihydroavermectin B 1aand B 1bor H 2B 1aand H 2B 1b, respectively; and the ratio (calculated by area percentage) of component H 2B 1a/(H 2B 1a+ H 2B 1b) is not less than 90.0%. The respective empirical formulas of H 2B 1aand H 2B 1bare C 48H 74O 14and C 47H 72O 14with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H 2B 1a: R = C 2H 5, Component H 2B 1b: R = CH 3. SOOLANTRA cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.",
"Description": "SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of SOOLANTRA cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0% and not more than 102.0% of 5-O-demethyl-22,23-dihydroavermectin A 1aplus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a, generally referred to as 22,23-dihydroavermectin B 1aand B 1bor H 2B 1aand H 2B 1b, respectively; and the ratio (calculated by area percentage) of component H 2B 1a/(H 2B 1a+ H 2B 1b) is not less than 90.0%. The respective empirical formulas of H 2B 1aand H 2B 1bare C 48H 74O 14and C 47H 72O 14with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H 2B 1a: R = C 2H 5, Component H 2B 1b: R = CH 3. SOOLANTRA cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol."
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"ProductTypeName": "HUMAN OTC DRUG",
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"ProductNDC": "0299-4908",
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"ProductNDC": "0299-4908",
"ProductTypeName": "HUMAN OTC DRUG",
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{
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"Description": "EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
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"Description": "EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
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"Description": "EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
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"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150701",
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"IndicationAndUsage": "EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.",
"Description": "EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epiduo Forte",
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"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
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"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150701",
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<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: : 1 Blastomycosis, pulmonary and extrapulmonary, 2 Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and, 3 Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.</IndicationAndUsage>
<Description>Itraconazole, USP is an azole antifungal agent. Itraconazole, USP is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. (±)-1-[( R*)- sec-butyl]-4-[ p-[4-[ p-[[(2 R*,4 S*)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy] phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one mixture with (±)-1-[( R*)- sec-butyl]-4-[ p-[4-[ p-[[(2 S*,4 R*)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one. or. (±)-1-[( RS)- sec-butyl]-4-[ p-[4-[ p-[[(2 R,4 S)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy] phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one. Itraconazole, USP has a molecular formula of C 35H 38Cl 2N 8O 4 and a molecular weight of 705.64. It is a white or almost white powder. It is insoluble in water, very slightly soluble in alcohols, and freely soluble in dichloromethane. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules, USP contain 100 mg of itraconazole, USP coated on sugar spheres. Inactive ingredients are black iron oxide, FD&C Blue No. 1, gelatin, hypromellose, liquid glucose, microcrystalline cellulose, polyethylene glycol, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate, starch (of maize), strong ammonia solution, sucrose and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>75839-299-25</NDCCode>
<PackageDescription>25 g in 1 BOTTLE (75839-299-25)</PackageDescription>
<NDC11Code>75839-0299-25</NDC11Code>
<ProductNDC>75839-299</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Indocyanine Green</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Attix Pharmaceuticals</LabelerName>
<SubstanceName>INDOCYANINE GREEN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/25g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-5918-0</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (54868-5918-0)</PackageDescription>
<NDC11Code>54868-5918-00</NDC11Code>
<ProductNDC>54868-5918</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079088</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Enter section text here.</IndicationAndUsage>
<Description>Risperidone tablets, USP, contain risperidone, USP, a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido [1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&C yellow # 6 Orange yellow S (E 110). 4 mg tablets: FD&C Blue # 2 Lake of indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>54868-5918-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (54868-5918-1)</PackageDescription>
<NDC11Code>54868-5918-01</NDC11Code>
<ProductNDC>54868-5918</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079088</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Enter section text here.</IndicationAndUsage>
<Description>Risperidone tablets, USP, contain risperidone, USP, a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido [1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&C yellow # 6 Orange yellow S (E 110). 4 mg tablets: FD&C Blue # 2 Lake of indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>0299-2012-05</NDCCode>
<PackageDescription>5 g in 1 TUBE (0299-2012-05) </PackageDescription>
<NDC11Code>00299-2012-05</NDC11Code>
<ProductNDC>0299-2012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vectical</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022087</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090201</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>VECTICAL Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adult and pediatric patients 2 years and older. ( 1.1) Limitations of Use The safety and effectiveness of VECTICAL Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. ( 1.2).</IndicationAndUsage>
<Description>VECTICAL (calcitriol) Ointment 3 mcg/g is a vitamin D analog intended for topical application to the skin. The chemical name of the active ingredient is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol. The structural formula is. Calcitriol is a white or almost white crystalline solid. It is practically insoluble in water, soluble in alcohol and in fatty oils. The molecular formula is C 27H 44O 3, and the molecular weight is 416.64. VECTICAL Ointment is a translucent ointment containing 3 mcg/g (0.0003% w/w) of calcitriol, packaged in aluminum tubes with screw caps. Other components of the ointment are mineral oil, dl-α-tocopherol, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>0299-2012-10</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0299-2012-10) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-2012-10</NDC11Code>
<ProductNDC>0299-2012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vectical</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022087</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VECTICAL Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adult and pediatric patients 2 years and older. ( 1.1) Limitations of Use The safety and effectiveness of VECTICAL Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. ( 1.2).</IndicationAndUsage>
<Description>VECTICAL (calcitriol) Ointment 3 mcg/g is a vitamin D analog intended for topical application to the skin. The chemical name of the active ingredient is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol. The structural formula is. Calcitriol is a white or almost white crystalline solid. It is practically insoluble in water, soluble in alcohol and in fatty oils. The molecular formula is C 27H 44O 3, and the molecular weight is 416.64. VECTICAL Ointment is a translucent ointment containing 3 mcg/g (0.0003% w/w) of calcitriol, packaged in aluminum tubes with screw caps. Other components of the ointment are mineral oil, dl-α-tocopherol, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>0299-3823-00</NDCCode>
<PackageDescription>2 g in 1 TUBE (0299-3823-00) </PackageDescription>
<NDC11Code>00299-3823-00</NDC11Code>
<ProductNDC>0299-3823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Soolantra</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206255</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.</IndicationAndUsage>
<Description>SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of SOOLANTRA cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0% and not more than 102.0% of 5-O-demethyl-22,23-dihydroavermectin A 1aplus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a, generally referred to as 22,23-dihydroavermectin B 1aand B 1bor H 2B 1aand H 2B 1b, respectively; and the ratio (calculated by area percentage) of component H 2B 1a/(H 2B 1a+ H 2B 1b) is not less than 90.0%. The respective empirical formulas of H 2B 1aand H 2B 1bare C 48H 74O 14and C 47H 72O 14with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H 2B 1a: R = C 2H 5, Component H 2B 1b: R = CH 3. SOOLANTRA cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol.</Description>
</NDC>
<NDC>
<NDCCode>0299-3823-02</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (0299-3823-02) / 2 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-3823-02</NDC11Code>
<ProductNDC>0299-3823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Soolantra</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206255</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.</IndicationAndUsage>
<Description>SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of SOOLANTRA cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0% and not more than 102.0% of 5-O-demethyl-22,23-dihydroavermectin A 1aplus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a, generally referred to as 22,23-dihydroavermectin B 1aand B 1bor H 2B 1aand H 2B 1b, respectively; and the ratio (calculated by area percentage) of component H 2B 1a/(H 2B 1a+ H 2B 1b) is not less than 90.0%. The respective empirical formulas of H 2B 1aand H 2B 1bare C 48H 74O 14and C 47H 72O 14with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H 2B 1a: R = C 2H 5, Component H 2B 1b: R = CH 3. SOOLANTRA cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol.</Description>
</NDC>
<NDC>
<NDCCode>0299-3823-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0299-3823-30) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-3823-30</NDC11Code>
<ProductNDC>0299-3823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Soolantra</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206255</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.</IndicationAndUsage>
<Description>SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of SOOLANTRA cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0% and not more than 102.0% of 5-O-demethyl-22,23-dihydroavermectin A 1aplus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a, generally referred to as 22,23-dihydroavermectin B 1aand B 1bor H 2B 1aand H 2B 1b, respectively; and the ratio (calculated by area percentage) of component H 2B 1a/(H 2B 1a+ H 2B 1b) is not less than 90.0%. The respective empirical formulas of H 2B 1aand H 2B 1bare C 48H 74O 14and C 47H 72O 14with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H 2B 1a: R = C 2H 5, Component H 2B 1b: R = CH 3. SOOLANTRA cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol.</Description>
</NDC>
<NDC>
<NDCCode>0299-3823-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0299-3823-45) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-3823-45</NDC11Code>
<ProductNDC>0299-3823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Soolantra</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206255</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.</IndicationAndUsage>
<Description>SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of SOOLANTRA cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0% and not more than 102.0% of 5-O-demethyl-22,23-dihydroavermectin A 1aplus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a, generally referred to as 22,23-dihydroavermectin B 1aand B 1bor H 2B 1aand H 2B 1b, respectively; and the ratio (calculated by area percentage) of component H 2B 1a/(H 2B 1a+ H 2B 1b) is not less than 90.0%. The respective empirical formulas of H 2B 1aand H 2B 1bare C 48H 74O 14and C 47H 72O 14with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H 2B 1a: R = C 2H 5, Component H 2B 1b: R = CH 3. SOOLANTRA cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol.</Description>
</NDC>
<NDC>
<NDCCode>0299-3823-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0299-3823-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-3823-60</NDC11Code>
<ProductNDC>0299-3823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Soolantra</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206255</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.</IndicationAndUsage>
<Description>SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of SOOLANTRA cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0% and not more than 102.0% of 5-O-demethyl-22,23-dihydroavermectin A 1aplus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a, generally referred to as 22,23-dihydroavermectin B 1aand B 1bor H 2B 1aand H 2B 1b, respectively; and the ratio (calculated by area percentage) of component H 2B 1a/(H 2B 1a+ H 2B 1b) is not less than 90.0%. The respective empirical formulas of H 2B 1aand H 2B 1bare C 48H 74O 14and C 47H 72O 14with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H 2B 1a: R = C 2H 5, Component H 2B 1b: R = CH 3. SOOLANTRA cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol.</Description>
</NDC>
<NDC>
<NDCCode>0299-4908-00</NDCCode>
<PackageDescription>2 g in 1 TUBE (0299-4908-00) </PackageDescription>
<NDC11Code>00299-4908-00</NDC11Code>
<ProductNDC>0299-4908</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Differin Epiduo</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220736</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260522</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>For the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0299-4908-10</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-4908-10) / 15 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-4908-10</NDC11Code>
<ProductNDC>0299-4908</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Differin Epiduo</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220736</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0299-4908-40</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-4908-40) / 45 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-4908-40</NDC11Code>
<ProductNDC>0299-4908</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Differin Epiduo</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220736</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0299-5906-00</NDCCode>
<PackageDescription>2 g in 1 TUBE (0299-5906-00) </PackageDescription>
<NDC11Code>00299-5906-00</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-02</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (0299-5906-02) / 2 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-5906-02</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-05</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (0299-5906-05) / 5 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-5906-05</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-15</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-5906-15) / 15 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5906-15</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-30</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-5906-30) / 30 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5906-30</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-45</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-5906-45) / 45 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5906-45</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-60</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-5906-60) / 60 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5906-60</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-70</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-5906-70) / 70 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5906-70</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
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