{
"NDC": [
{
"NDCCode": "72578-087-02",
"PackageDescription": "60 g in 1 TUBE (72578-087-02) ",
"NDC11Code": "72578-0087-02",
"ProductNDC": "72578-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208989",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200430",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea.",
"Description": "Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha- difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha- isopropylidenedioxypregna-1, 4-diene-3, 20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure. Fluocinonide, USP is white or almost white microcrystalline powder. It is practically insoluble in water, very slightly soluble in ether, slightly soluble in ethanol, methanol and dioxane, sparingly soluble in acetone and chloroform. Each gram of fluocinonide cream, USP contains 1 mg micronized fluocinonide in a cream base of anhydrous citric acid, carbomer homopolymer type C, diethylene glycol monoethyl ether, diisopropanolamine, glyceryl monostearate, glyceryl stearate/PEG-100 stearate, propylene glycol and purified water."
},
{
"NDCCode": "72578-087-06",
"PackageDescription": "30 g in 1 TUBE (72578-087-06) ",
"NDC11Code": "72578-0087-06",
"ProductNDC": "72578-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208989",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200430",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea.",
"Description": "Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha- difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha- isopropylidenedioxypregna-1, 4-diene-3, 20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure. Fluocinonide, USP is white or almost white microcrystalline powder. It is practically insoluble in water, very slightly soluble in ether, slightly soluble in ethanol, methanol and dioxane, sparingly soluble in acetone and chloroform. Each gram of fluocinonide cream, USP contains 1 mg micronized fluocinonide in a cream base of anhydrous citric acid, carbomer homopolymer type C, diethylene glycol monoethyl ether, diisopropanolamine, glyceryl monostearate, glyceryl stearate/PEG-100 stearate, propylene glycol and purified water."
},
{
"NDCCode": "72578-087-07",
"PackageDescription": "120 g in 1 TUBE (72578-087-07) ",
"NDC11Code": "72578-0087-07",
"ProductNDC": "72578-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208989",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200430",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea.",
"Description": "Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha- difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha- isopropylidenedioxypregna-1, 4-diene-3, 20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure. Fluocinonide, USP is white or almost white microcrystalline powder. It is practically insoluble in water, very slightly soluble in ether, slightly soluble in ethanol, methanol and dioxane, sparingly soluble in acetone and chloroform. Each gram of fluocinonide cream, USP contains 1 mg micronized fluocinonide in a cream base of anhydrous citric acid, carbomer homopolymer type C, diethylene glycol monoethyl ether, diisopropanolamine, glyceryl monostearate, glyceryl stearate/PEG-100 stearate, propylene glycol and purified water."
},
{
"NDCCode": "72578-084-02",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (72578-084-02) / 30 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "72578-0084-02",
"ProductNDC": "72578-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate",
"NonProprietaryName": "Clindamycin Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208767",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin phosphate topical solution USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).",
"Description": "Clindamycin phosphate topical solution USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1 methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto octopyranoside 2-(dihydrogen phosphate). Clindamycin phosphate topical solution USP, 1% contains isopropyl alcohol, 50% v/v; propylene glycol and purified water. Sodium hydroxide or hydrochloric acid may be added to adjust pH between 4.0 to 7.0."
},
{
"NDCCode": "72578-085-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (72578-085-02) / 118 mL in 1 BOTTLE",
"NDC11Code": "72578-0085-02",
"ProductNDC": "72578-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205249",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200430",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).",
"Description": "Clobetasol propionate lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP is a white to cream crystalline powder. It is soluble in acetone, in dimethyl sulfoxide, in chloroform, in methanol, and in dioxane; sparingly soluble in ethanol; slightly soluble in benzene and in diethyl ether; practically insoluble in water. Each gram of clobetasol propionate lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a vehicle base contains following inactive ingredients: cetostearyl alcohol, glycerol monostearate and polyethylene glycol-75 palmitostearate, glyceryl stearate/polyethylene glycol-100 stearate, mineral oil, polyoxyethylene glycol 300 isostearate, propylene glycol and purified water."
},
{
"NDCCode": "72578-086-02",
"PackageDescription": "1 TUBE in 1 CARTON (72578-086-02) / 60 g in 1 TUBE",
"NDC11Code": "72578-0086-02",
"ProductNDC": "72578-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desonide",
"NonProprietaryName": "Desonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210198",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "DESONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200617",
"SamplePackage": "N",
"IndicationAndUsage": "Desonide cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.",
"Description": "Desonide cream USP, 0.05% contains desonide (Pregna-1, 4-diene-3, 20-dione, 11, 21-dihydroxy-16, 17-[(1- methylethylidene)bis(oxy)]-,(11β,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in desonide cream, 0.05% is C24H32O6. It has the following structural formula. The molecular weight of desonide is 416.51. It is a white to almost white crystalline powder. It is insoluble in water, soluble in methylene chloride, sparingly soluble in ethanol (96%), slightly soluble in ethyl ether. Each gram of desonide cream USP, 0.05% contains 0.5 milligram of desonide micro dispersed in a base of aluminum sulfate, calcium acetate, cetostearyl alcohol, dextrin, glycerin, light mineral oil, purified water, sodium lauryl sulfate, synthetic beeswax, and white petrolatum. Desonide cream, 0.05% is preserved with methylparaben and buffered to pH 4.2 to 5.0."
},
{
"NDCCode": "72578-088-02",
"PackageDescription": "1 TUBE in 1 CARTON (72578-088-02) > 60 g in 1 TUBE",
"NDC11Code": "72578-0088-02",
"ProductNDC": "72578-088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin And Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200624",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207764",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2022-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200624",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and Triamcinolone Acetonide Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.",
"Description": "Nystatin and Triamcinolone Acetonide Ointment, USP for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin, USP is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow or slightly brownish powder hygroscopic with characteristics odor. It is freely soluble in dimethylformamide, slightly soluble in methanol, practically insoluble in water, alcohol and ether. Structural formula. C47H75NO17 MW 926.13. Triamcinolone acetonide, USP is designated chemically as 9-fluoro-11ß, 16α, 17, 21- tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. It is a white to cream colored, crystalline powder, having not more than slight odor. It is practically insoluble in water, sparingly soluble in dehydrated alcohol, in chloroform and in methanol. Structural formula. C24H31FO6 MW= 434.50. Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide, USP in an ointment base of mineral oil and white petrolatum."
},
{
"NDCCode": "72578-091-02",
"PackageDescription": "1 TUBE in 1 CARTON (72578-091-02) > 60 g in 1 TUBE",
"NDC11Code": "72578-0091-02",
"ProductNDC": "72578-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205620",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200831",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone cream, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone Cream USP, 0.25% contains the active synthetic corticosteroid desoximetasone, USP. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone, USP in an emollient cream consisting of cetostearyl alcohol, edetate disodium dihydrate, isopropyl myristate, lanolin alcohols, mineral oil, purified water and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "72578-094-02",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (72578-094-02) / 60 g in 1 BOTTLE, PUMP",
"NDC11Code": "72578-0094-02",
"ProductNDC": "72578-094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214019",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "DAPSONE",
"StrengthNumber": "75",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2024-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240510",
"SamplePackage": "N",
"IndicationAndUsage": "Dapsone gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "Dapsone gel, 7.5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 7.5% is an white, off white to yellow gel with suspended particles. Chemically, dapsone has an molecular formula of C12H12N2O2S. It is a white or creamy white, crystalline powder that has a molecular weight of 248.30. Dapsone's chemical name is 4-[(4-aminobenzene) sulfonyl] aniline and its structural formula is. Each gram of dapsone gel, 7.5%, contains 75 mg of dapsone, USP, in a gel of diethylene glycol monoethyl ether, methylparaben, acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, and purified water."
},
{
"NDCCode": "72578-095-02",
"PackageDescription": "1 TUBE in 1 CARTON (72578-095-02) > 60 g in 1 TUBE",
"NDC11Code": "72578-0095-02",
"ProductNDC": "72578-095",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205206",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201023",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone Ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11b,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "72578-118-02",
"PackageDescription": "1 TUBE in 1 CARTON (72578-118-02) / 60 g in 1 TUBE",
"NDC11Code": "72578-0118-02",
"ProductNDC": "72578-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate",
"NonProprietaryName": "Clindamycin Phosphate",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216587",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230920",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin phosphate gel is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).",
"Description": "Clindamycin phosphate gel, USP contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The gel contains following inactive ingredient: allantoin, carbopol, methyl paraben, polyethylene glycol, propylene glycol, purified water and sodium hydroxide. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1 methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate)."
},
{
"NDCCode": "72578-119-02",
"PackageDescription": "1 BOTTLE, PUMP in 1 BOTTLE, PUMP (72578-119-02) / 60 g in 1 BOTTLE, PUMP",
"NDC11Code": "72578-0119-02",
"ProductNDC": "72578-119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene And Benzoyl Peroxide",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214553",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "3; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220606",
"SamplePackage": "N",
"IndicationAndUsage": "Adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.",
"Description": "Adapalene and benzoyl peroxide gel 0.3%/2.5% is a white to very pale yellow opaque gel for topical use containing adapalene, USP 0.3% and benzoyl peroxide 2.5%. Adapalene USP, 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: C28H28O3. Molecular weight: 412.5. Hydrous benzoyl peroxide, USP 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: C14H10O4. Molecular weight: 242.23. Adapalene and benzoyl peroxide gel, USP contains the following inactive ingredients: acrylamide/sodium acryloyldimethyl taurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water and sorbitan monooleate."
},
{
"NDCCode": "72578-120-02",
"PackageDescription": "1 TUBE in 1 CARTON (72578-120-02) / 60 g in 1 TUBE",
"NDC11Code": "72578-0120-02",
"ProductNDC": "72578-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivermectin",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215210",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Antiparasitic [EPC], Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230610",
"SamplePackage": "N",
"IndicationAndUsage": "Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea.",
"Description": "Ivermectin cream, 1% is a white to pale yellow homogeneous cream. Each gram of ivermectin cream contains 10 mg of ivermectin, USP. It is intended for topical use. 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 A1a plus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b or H2B1a and H2B1b, respectively; and the ratio (calculated by area percentage) of component H2B1a/(H2B1a + H2B1b)) is not less than 90.0 %. The respective empirical formulas of H2B1a and H2B1b are C48H74O14 and C47H72O14 with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H2B1a: R = C2H5, Component H2B1b: R = CH3. Ivermectin cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, cocodiethanolamide, dimethicone, dimethyl isosorbide, edetate disodium, glycerin, isopropyl palmitate, methyl paraben, propyl paraben, purified water, sodium hydroxide, sodium lauryl sulfate, and stearyl alcohol."
},
{
"NDCCode": "13537-087-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-087-02) > 4 g in 1 TUBE (13537-087-01)",
"NDC11Code": "13537-0087-02",
"ProductNDC": "13537-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20",
"ProprietaryNameSuffix": "(rose Natural) - Pink",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".071; .16",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14141-087-02",
"PackageDescription": "1 TUBE in 1 BOX (14141-087-02) > 30 g in 1 TUBE (14141-087-01) ",
"NDC11Code": "14141-0087-02",
"ProductNDC": "14141-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15",
"ProprietaryNameSuffix": "Obscure 9/ Beige",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180808",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bel Star S.A. (Colombia)",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".065; .0244; .0157",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20180808",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14783-087-02",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (14783-087-02) > 27 mL in 1 BOTTLE, PLASTIC (14783-087-01) ",
"NDC11Code": "14783-0087-02",
"ProductNDC": "14783-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Concentre Total Base Serum Ultra-fluid Foundation Spf 25",
"ProprietaryNameSuffix": "Medium 5 - Beige",
"NonProprietaryName": "Octinoxate And Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170127",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": ".07; .072",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170127",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "20151-087-02",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 BOTTLE, DISPENSING (20151-087-02) > 50 mL in 1 BOTTLE, DISPENSING (20151-087-01)",
"NDC11Code": "20151-0087-02",
"ProductNDC": "20151-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitalizing Energizing Serum",
"NonProprietaryName": "Glycerin, Dimethicone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161203",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Casmara Cosmetics, SA",
"SubstanceName": "DIMETHICONE; GLYCERIN",
"StrengthNumber": ".4; 3",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "provides an intense dose of hydration and energy."
},
{
"NDCCode": "33261-087-02",
"PackageDescription": "120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33261-087-02)",
"NDC11Code": "33261-0087-02",
"ProductNDC": "33261-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075576",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Omeprazole is a proton pump inhibitor indicated for: 1 Treatment in adults of duodenal ulcer (1.1) and gastric ulcer (1.2), 2 Treatment in adults and children of gastroesophageal reflux disease (GERD) (1.3)and maintenance of healing of erosive esophagitis (1.4).",
"Description": "The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole delayed-release capsules meets USP Drug release test 2. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide."
},
{
"NDCCode": "33342-087-41",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (33342-087-41) > 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-087-02) ",
"NDC11Code": "33342-0087-41",
"ProductNDC": "33342-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan",
"NonProprietaryName": "Rizatriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203147",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180903",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.",
"Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate."
},
{
"NDCCode": "33342-087-45",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (33342-087-45) > 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-087-02) ",
"NDC11Code": "33342-0087-45",
"ProductNDC": "33342-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan",
"NonProprietaryName": "Rizatriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203147",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180903",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.",
"Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate."
},
{
"NDCCode": "37808-087-02",
"PackageDescription": "1 TUBE in 1 CARTON (37808-087-02) / 50 g in 1 TUBE",
"NDC11Code": "37808-0087-02",
"ProductNDC": "37808-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arthritis Pain Reliever",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211253",
"LabelerName": "H E B",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201112",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of arthritis pain ONLY in the following areas:. hand, wrist, elbow (upper body areas). foot, ankle, knee (lower body areas). this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use."
},
{
"NDCCode": "44717-087-02",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (44717-087-02) / 5 g in 1 BOTTLE, PLASTIC (44717-087-01) ",
"NDC11Code": "44717-0087-02",
"ProductNDC": "44717-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Illuminizing Blendrops Broad Spectrum Spf 46",
"NonProprietaryName": "Homosalate, Octisalate, Zinc Oxide",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Wasatch Product Development, LLC",
"SubstanceName": "HOMOSALATE; OCTISALATE; ZINC OXIDE",
"StrengthNumber": "6; 5; 12",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251020",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
},
{
"NDCCode": "49349-087-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-087-02)",
"NDC11Code": "49349-0087-02",
"ProductNDC": "49349-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076077",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "52125-087-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-087-02)",
"NDC11Code": "52125-0087-02",
"ProductNDC": "52125-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078525",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-10-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "52565-087-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (52565-087-02) > 59 mL in 1 BOTTLE",
"NDC11Code": "52565-0087-02",
"ProductNDC": "52565-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Butyrate",
"NonProprietaryName": "Hydrocortisone Butyrate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209556",
"LabelerName": "Teligent Pharma, Inc.",
"SubstanceName": "HYDROCORTISONE BUTYRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20171121",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone Butyrate Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.",
"Description": "Hydrocortisone Butyrate Lotion, 0.1% contains hydrocortisone butyrate, a non-fluorinated hydrocortisone ester, for topical use. The chemical name of hydrocortisone butyrate is 11ß,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate. It has the following structural formula:. Hydrocortisone butyrate is a white to off white powder with a molecular weight of 432.56, and a molecular formula of C25H36O6. It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform. Each gram of Hydrocortisone Butyrate Lotion contains 1 mg of hydrocortisone butyrate in a white to off white lotion base consisting of anhydrous citric acid, ceteth-20, cetostearyl alcohol, butylated hydroxytoluene (BHT), butylparaben, light mineral oil, propylparaben, purified water, sodium citrate, and white petrolatum."
},
{
"NDCCode": "54575-087-02",
"PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-087-02)",
"NDC11Code": "54575-0087-02",
"ProductNDC": "54575-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Kentucky Bluegrass Pollen",
"NonProprietaryName": "Poa Pratensis Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19970529",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101380",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "POA PRATENSIS POLLEN",
"StrengthNumber": "100000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Standardized grass pollen extracts are used for the diagnosis and treatment of allergic disease to grass pollen. The standardized (Bioequivalent Allergy Unit) extract in these vials is designed primarily for the physician equipped to prepare dilutions and mixtures as required. STANDARDIZED GRASS POLLEN EXTRACTS LABELED IN BAU/ml ARE NOT INTERCHANGEABLE WITH GRASS POLLEN EXTRACTS LABELED IN AU/ml OR WITH NON-STANDARDIZED (WEIGHT/VOLUME) GRASS POLLEN EXTRACTS. Patients being switched from other types of extracts to Allergy Laboratories should have their dose adjusted. Diagnosis of allergic disease to these grasses is made through a combined medical history sufficiently complete to identify allergic symptoms to grass pollen and identification of grass allergy by diagnostic skin testing. It is recommended that diagnostic skin testing (scratch or puncture) be performed with 10,000 BAU/ml grass pollen extracts before testing with 100,000 BAU/ml grass pollen extracts. 10,000 BAU/mL and 100,000 BAU/ml grass pollen extracts for immunotherapy are available for previously treated patients to facilitate dose selection for safe switching from non-standardized to standardized extracts. Patients being treated with grass pollen extracts for the first time can be initially immunized with dilutions prepared from the 10,000 BAU/ml extract (see Dosage and Administration). 100,000 BAU/ml grass pollen extract can be administered if the patient tolerates the 10,000 BAU/ml extract. Grass pollen immunotherapy is intended for patients whose grass allergic symptoms cannot be satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. (5).",
"Description": "Standardized grass pollen extracts labeled in BAU/ml are not interchangeable with grass pollen extracts labeled in AU/ml or with non-standardized grass pollen extracts. The recommended route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Do not inject intravenously. The extract is sterile and contains 50% (v/v) glycerin as a preservative. Standardized grass pollen extracts are available in both 10,000 BAU/ml and 100,000 BAU/ml potencies, except for Bermuda which is only available in 10,000 BAU/ml. The source material of the standardized grass extracts are the grass pollens. The 100,000 BAU/ml grass pollen extracts are prepared by extracting pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 100,000 BAU/ml. The 10,000 BAU/ml grass pollen extracts are prepared by dilution of the 100,000 BAU/ml grass pollen extracts. The 10,000 BAU/ml Bermuda grass pollen extract is prepared by extracting Bermuda grass pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 10,000 BAU/ml. The potency (in Bioequivalent Allergy Units per ml or BAU/ml) of standardized grass pollen extracts is determined by an in-vitro ELISA Competition assay (1) against CBER reference extracts and CBER reference serum pools distributed by the Center for Biologics Evaluation and Research, U S Food and Drug Administration. Potency based on Bioequivalent Allergy Units (BAU/ml) is printed on the label. FDA reference grass pollen extracts were assigned potency designations based on quantitative skin testing (2). The FDA reference extracts which can be diluted 1:500,000 fold intradermally to produce a sum of erythema diameter response of 50mm in highly puncture reactive subjects have been assigned 10,000 BAU/ml. References which can be diluted 1:5,000,000 fold intraderrnally to produce a sum of erythema diameter response of 50mm have been assigned 100,000 BAU/ml."
},
{
"NDCCode": "58159-087-02",
"PackageDescription": "20 kg in 1 DRUM (58159-087-02) ",
"NDC11Code": "58159-0087-02",
"ProductNDC": "58159-087",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Cevimeline Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210706",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
"SubstanceName": "CEVIMELINE HYDROCHLORIDE",
"StrengthNumber": "35",
"StrengthUnit": "kg/35kg",
"Status": "Unfinished",
"LastUpdate": "2021-07-15",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "06-JUL-21"
},
{
"NDCCode": "60290-087-02",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (60290-087-02) ",
"NDC11Code": "60290-0087-02",
"ProductNDC": "60290-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219946",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "97; 103",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260810",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. ( 1.1) , 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2) .",
"Description": "Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1 S,3 R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis( N-pentanoyl- N-{[2´-(1 H-tetrazol-1-id-5- yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate). Its empirical formula is C 48H 57N 6O 8Na 3. Its molecular mass is 914.97 g/mol and its schematic structural formula is:. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are hypromellose, iron oxide red, macrogol, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
},
{
"NDCCode": "60764-087-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (60764-087-02) > 1 g in 1 BOTTLE (60764-087-01)",
"NDC11Code": "60764-0087-02",
"ProductNDC": "60764-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "3ce Matte Lip Crayon Speak Low",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160810",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Nanda Co., Ltd",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".11",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"Description": "INSTRUCTIONS: Powdery finish matte lip crayon adheres smoothly onto your lips and imparts a non-oily finish for a chic look. Directions: Glide across the entire lip with powdery finish matte lip crayon and apply it again to the center of your lips to get voluminous and fuller lips."
},
{
"NDCCode": "63545-087-02",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (63545-087-02) ",
"NDC11Code": "63545-0087-02",
"ProductNDC": "63545-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Araneus Diadematus",
"NonProprietaryName": "Araneus Diadematus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210225",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "ARANEUS DIADEMATUS",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2021-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210225",
"SamplePackage": "N"
}
]
}
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<PackageDescription>60 g in 1 TUBE (72578-087-02) </PackageDescription>
<NDC11Code>72578-0087-02</NDC11Code>
<ProductNDC>72578-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
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<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208989</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
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<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-23</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea.</IndicationAndUsage>
<Description>Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha- difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha- isopropylidenedioxypregna-1, 4-diene-3, 20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure. Fluocinonide, USP is white or almost white microcrystalline powder. It is practically insoluble in water, very slightly soluble in ether, slightly soluble in ethanol, methanol and dioxane, sparingly soluble in acetone and chloroform. Each gram of fluocinonide cream, USP contains 1 mg micronized fluocinonide in a cream base of anhydrous citric acid, carbomer homopolymer type C, diethylene glycol monoethyl ether, diisopropanolamine, glyceryl monostearate, glyceryl stearate/PEG-100 stearate, propylene glycol and purified water.</Description>
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<NDC>
<NDCCode>72578-087-06</NDCCode>
<PackageDescription>30 g in 1 TUBE (72578-087-06) </PackageDescription>
<NDC11Code>72578-0087-06</NDC11Code>
<ProductNDC>72578-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208989</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea.</IndicationAndUsage>
<Description>Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha- difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha- isopropylidenedioxypregna-1, 4-diene-3, 20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure. Fluocinonide, USP is white or almost white microcrystalline powder. It is practically insoluble in water, very slightly soluble in ether, slightly soluble in ethanol, methanol and dioxane, sparingly soluble in acetone and chloroform. Each gram of fluocinonide cream, USP contains 1 mg micronized fluocinonide in a cream base of anhydrous citric acid, carbomer homopolymer type C, diethylene glycol monoethyl ether, diisopropanolamine, glyceryl monostearate, glyceryl stearate/PEG-100 stearate, propylene glycol and purified water.</Description>
</NDC>
<NDC>
<NDCCode>72578-087-07</NDCCode>
<PackageDescription>120 g in 1 TUBE (72578-087-07) </PackageDescription>
<NDC11Code>72578-0087-07</NDC11Code>
<ProductNDC>72578-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208989</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea.</IndicationAndUsage>
<Description>Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha- difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha- isopropylidenedioxypregna-1, 4-diene-3, 20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure. Fluocinonide, USP is white or almost white microcrystalline powder. It is practically insoluble in water, very slightly soluble in ether, slightly soluble in ethanol, methanol and dioxane, sparingly soluble in acetone and chloroform. Each gram of fluocinonide cream, USP contains 1 mg micronized fluocinonide in a cream base of anhydrous citric acid, carbomer homopolymer type C, diethylene glycol monoethyl ether, diisopropanolamine, glyceryl monostearate, glyceryl stearate/PEG-100 stearate, propylene glycol and purified water.</Description>
</NDC>
<NDC>
<NDCCode>72578-084-02</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (72578-084-02) / 30 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>72578-0084-02</NDC11Code>
<ProductNDC>72578-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208767</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin phosphate topical solution USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).</IndicationAndUsage>
<Description>Clindamycin phosphate topical solution USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1 methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto octopyranoside 2-(dihydrogen phosphate). Clindamycin phosphate topical solution USP, 1% contains isopropyl alcohol, 50% v/v; propylene glycol and purified water. Sodium hydroxide or hydrochloric acid may be added to adjust pH between 4.0 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>72578-085-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (72578-085-02) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72578-0085-02</NDC11Code>
<ProductNDC>72578-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205249</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).</IndicationAndUsage>
<Description>Clobetasol propionate lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP is a white to cream crystalline powder. It is soluble in acetone, in dimethyl sulfoxide, in chloroform, in methanol, and in dioxane; sparingly soluble in ethanol; slightly soluble in benzene and in diethyl ether; practically insoluble in water. Each gram of clobetasol propionate lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a vehicle base contains following inactive ingredients: cetostearyl alcohol, glycerol monostearate and polyethylene glycol-75 palmitostearate, glyceryl stearate/polyethylene glycol-100 stearate, mineral oil, polyoxyethylene glycol 300 isostearate, propylene glycol and purified water.</Description>
</NDC>
<NDC>
<NDCCode>72578-086-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72578-086-02) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>72578-0086-02</NDC11Code>
<ProductNDC>72578-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desonide</ProprietaryName>
<NonProprietaryName>Desonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210198</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>DESONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desonide cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.</IndicationAndUsage>
<Description>Desonide cream USP, 0.05% contains desonide (Pregna-1, 4-diene-3, 20-dione, 11, 21-dihydroxy-16, 17-[(1- methylethylidene)bis(oxy)]-,(11β,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in desonide cream, 0.05% is C24H32O6. It has the following structural formula. The molecular weight of desonide is 416.51. It is a white to almost white crystalline powder. It is insoluble in water, soluble in methylene chloride, sparingly soluble in ethanol (96%), slightly soluble in ethyl ether. Each gram of desonide cream USP, 0.05% contains 0.5 milligram of desonide micro dispersed in a base of aluminum sulfate, calcium acetate, cetostearyl alcohol, dextrin, glycerin, light mineral oil, purified water, sodium lauryl sulfate, synthetic beeswax, and white petrolatum. Desonide cream, 0.05% is preserved with methylparaben and buffered to pH 4.2 to 5.0.</Description>
</NDC>
<NDC>
<NDCCode>72578-088-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72578-088-02) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>72578-0088-02</NDC11Code>
<ProductNDC>72578-088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200624</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207764</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>NYSTATIN; TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>100000; 1</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and Triamcinolone Acetonide Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.</IndicationAndUsage>
<Description>Nystatin and Triamcinolone Acetonide Ointment, USP for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin, USP is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow or slightly brownish powder hygroscopic with characteristics odor. It is freely soluble in dimethylformamide, slightly soluble in methanol, practically insoluble in water, alcohol and ether. Structural formula. C47H75NO17 MW 926.13. Triamcinolone acetonide, USP is designated chemically as 9-fluoro-11ß, 16α, 17, 21- tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. It is a white to cream colored, crystalline powder, having not more than slight odor. It is practically insoluble in water, sparingly soluble in dehydrated alcohol, in chloroform and in methanol. Structural formula. C24H31FO6 MW= 434.50. Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide, USP in an ointment base of mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>72578-091-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72578-091-02) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>72578-0091-02</NDC11Code>
<ProductNDC>72578-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205620</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone cream, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone Cream USP, 0.25% contains the active synthetic corticosteroid desoximetasone, USP. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone, USP in an emollient cream consisting of cetostearyl alcohol, edetate disodium dihydrate, isopropyl myristate, lanolin alcohols, mineral oil, purified water and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>72578-094-02</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (72578-094-02) / 60 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>72578-0094-02</NDC11Code>
<ProductNDC>72578-094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214019</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapsone gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>Dapsone gel, 7.5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 7.5% is an white, off white to yellow gel with suspended particles. Chemically, dapsone has an molecular formula of C12H12N2O2S. It is a white or creamy white, crystalline powder that has a molecular weight of 248.30. Dapsone's chemical name is 4-[(4-aminobenzene) sulfonyl] aniline and its structural formula is. Each gram of dapsone gel, 7.5%, contains 75 mg of dapsone, USP, in a gel of diethylene glycol monoethyl ether, methylparaben, acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>72578-095-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72578-095-02) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>72578-0095-02</NDC11Code>
<ProductNDC>72578-095</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205206</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone Ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11b,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>72578-118-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72578-118-02) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>72578-0118-02</NDC11Code>
<ProductNDC>72578-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230920</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216587</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin phosphate gel is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).</IndicationAndUsage>
<Description>Clindamycin phosphate gel, USP contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The gel contains following inactive ingredient: allantoin, carbopol, methyl paraben, polyethylene glycol, propylene glycol, purified water and sodium hydroxide. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1 methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate).</Description>
</NDC>
<NDC>
<NDCCode>72578-119-02</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 BOTTLE, PUMP (72578-119-02) / 60 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>72578-0119-02</NDC11Code>
<ProductNDC>72578-119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214553</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</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>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>Adapalene and benzoyl peroxide gel 0.3%/2.5% is a white to very pale yellow opaque gel for topical use containing adapalene, USP 0.3% and benzoyl peroxide 2.5%. Adapalene USP, 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: C28H28O3. Molecular weight: 412.5. Hydrous benzoyl peroxide, USP 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: C14H10O4. Molecular weight: 242.23. Adapalene and benzoyl peroxide gel, USP contains the following inactive ingredients: acrylamide/sodium acryloyldimethyl taurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water and sorbitan monooleate.</Description>
</NDC>
<NDC>
<NDCCode>72578-120-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72578-120-02) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>72578-0120-02</NDC11Code>
<ProductNDC>72578-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivermectin</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215210</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea.</IndicationAndUsage>
<Description>Ivermectin cream, 1% is a white to pale yellow homogeneous cream. Each gram of ivermectin cream contains 10 mg of ivermectin, USP. It is intended for topical use. 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 A1a plus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b or H2B1a and H2B1b, respectively; and the ratio (calculated by area percentage) of component H2B1a/(H2B1a + H2B1b)) is not less than 90.0 %. The respective empirical formulas of H2B1a and H2B1b are C48H74O14 and C47H72O14 with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H2B1a: R = C2H5, Component H2B1b: R = CH3. Ivermectin cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, cocodiethanolamide, dimethicone, dimethyl isosorbide, edetate disodium, glycerin, isopropyl palmitate, methyl paraben, propyl paraben, purified water, sodium hydroxide, sodium lauryl sulfate, and stearyl alcohol.</Description>
</NDC>
<NDC>
<NDCCode>13537-087-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-087-02) > 4 g in 1 TUBE (13537-087-01)</PackageDescription>
<NDC11Code>13537-0087-02</NDC11Code>
<ProductNDC>13537-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20</ProprietaryName>
<ProprietaryNameSuffix>(rose Natural) - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.071; .16</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14141-087-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14141-087-02) > 30 g in 1 TUBE (14141-087-01) </PackageDescription>
<NDC11Code>14141-0087-02</NDC11Code>
<ProductNDC>14141-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15</ProprietaryName>
<ProprietaryNameSuffix>Obscure 9/ Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180808</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bel Star S.A. (Colombia)</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.065; .0244; .0157</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14783-087-02</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (14783-087-02) > 27 mL in 1 BOTTLE, PLASTIC (14783-087-01) </PackageDescription>
<NDC11Code>14783-0087-02</NDC11Code>
<ProductNDC>14783-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Concentre Total Base Serum Ultra-fluid Foundation Spf 25</ProprietaryName>
<ProprietaryNameSuffix>Medium 5 - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170127</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.07; .072</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>20151-087-02</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 BOTTLE, DISPENSING (20151-087-02) > 50 mL in 1 BOTTLE, DISPENSING (20151-087-01)</PackageDescription>
<NDC11Code>20151-0087-02</NDC11Code>
<ProductNDC>20151-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitalizing Energizing Serum</ProprietaryName>
<NonProprietaryName>Glycerin, Dimethicone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161203</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Casmara Cosmetics, SA</LabelerName>
<SubstanceName>DIMETHICONE; GLYCERIN</SubstanceName>
<StrengthNumber>.4; 3</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>provides an intense dose of hydration and energy.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33261-087-02</NDCCode>
<PackageDescription>120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33261-087-02)</PackageDescription>
<NDC11Code>33261-0087-02</NDC11Code>
<ProductNDC>33261-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075576</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Omeprazole is a proton pump inhibitor indicated for: 1 Treatment in adults of duodenal ulcer (1.1) and gastric ulcer (1.2), 2 Treatment in adults and children of gastroesophageal reflux disease (GERD) (1.3)and maintenance of healing of erosive esophagitis (1.4).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole delayed-release capsules meets USP Drug release test 2. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>33342-087-41</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (33342-087-41) > 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-087-02) </PackageDescription>
<NDC11Code>33342-0087-41</NDC11Code>
<ProductNDC>33342-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan</ProprietaryName>
<NonProprietaryName>Rizatriptan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203147</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>33342-087-45</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (33342-087-45) > 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-087-02) </PackageDescription>
<NDC11Code>33342-0087-45</NDC11Code>
<ProductNDC>33342-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan</ProprietaryName>
<NonProprietaryName>Rizatriptan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203147</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients:. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>37808-087-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (37808-087-02) / 50 g in 1 TUBE</PackageDescription>
<NDC11Code>37808-0087-02</NDC11Code>
<ProductNDC>37808-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arthritis Pain Reliever</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211253</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of arthritis pain ONLY in the following areas:. hand, wrist, elbow (upper body areas). foot, ankle, knee (lower body areas). this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>44717-087-02</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (44717-087-02) / 5 g in 1 BOTTLE, PLASTIC (44717-087-01) </PackageDescription>
<NDC11Code>44717-0087-02</NDC11Code>
<ProductNDC>44717-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Illuminizing Blendrops Broad Spectrum Spf 46</ProprietaryName>
<NonProprietaryName>Homosalate, Octisalate, Zinc Oxide</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Wasatch Product Development, LLC</LabelerName>
<SubstanceName>HOMOSALATE; OCTISALATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>6; 5; 12</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49349-087-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (49349-087-02)</PackageDescription>
<NDC11Code>49349-0087-02</NDC11Code>
<ProductNDC>49349-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076077</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-087-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (52125-087-02)</PackageDescription>
<NDC11Code>52125-0087-02</NDC11Code>
<ProductNDC>52125-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120720</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078525</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52565-087-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52565-087-02) > 59 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>52565-0087-02</NDC11Code>
<ProductNDC>52565-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Butyrate</ProprietaryName>
<NonProprietaryName>Hydrocortisone Butyrate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209556</ApplicationNumber>
<LabelerName>Teligent Pharma, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE BUTYRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone Butyrate Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.</IndicationAndUsage>
<Description>Hydrocortisone Butyrate Lotion, 0.1% contains hydrocortisone butyrate, a non-fluorinated hydrocortisone ester, for topical use. The chemical name of hydrocortisone butyrate is 11ß,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate. It has the following structural formula:. Hydrocortisone butyrate is a white to off white powder with a molecular weight of 432.56, and a molecular formula of C25H36O6. It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform. Each gram of Hydrocortisone Butyrate Lotion contains 1 mg of hydrocortisone butyrate in a white to off white lotion base consisting of anhydrous citric acid, ceteth-20, cetostearyl alcohol, butylated hydroxytoluene (BHT), butylparaben, light mineral oil, propylparaben, purified water, sodium citrate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>54575-087-02</NDCCode>
<PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (54575-087-02)</PackageDescription>
<NDC11Code>54575-0087-02</NDC11Code>
<ProductNDC>54575-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Kentucky Bluegrass Pollen</ProprietaryName>
<NonProprietaryName>Poa Pratensis Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19970529</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101380</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>POA PRATENSIS POLLEN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Standardized grass pollen extracts are used for the diagnosis and treatment of allergic disease to grass pollen. The standardized (Bioequivalent Allergy Unit) extract in these vials is designed primarily for the physician equipped to prepare dilutions and mixtures as required. STANDARDIZED GRASS POLLEN EXTRACTS LABELED IN BAU/ml ARE NOT INTERCHANGEABLE WITH GRASS POLLEN EXTRACTS LABELED IN AU/ml OR WITH NON-STANDARDIZED (WEIGHT/VOLUME) GRASS POLLEN EXTRACTS. Patients being switched from other types of extracts to Allergy Laboratories should have their dose adjusted. Diagnosis of allergic disease to these grasses is made through a combined medical history sufficiently complete to identify allergic symptoms to grass pollen and identification of grass allergy by diagnostic skin testing. It is recommended that diagnostic skin testing (scratch or puncture) be performed with 10,000 BAU/ml grass pollen extracts before testing with 100,000 BAU/ml grass pollen extracts. 10,000 BAU/mL and 100,000 BAU/ml grass pollen extracts for immunotherapy are available for previously treated patients to facilitate dose selection for safe switching from non-standardized to standardized extracts. Patients being treated with grass pollen extracts for the first time can be initially immunized with dilutions prepared from the 10,000 BAU/ml extract (see Dosage and Administration). 100,000 BAU/ml grass pollen extract can be administered if the patient tolerates the 10,000 BAU/ml extract. Grass pollen immunotherapy is intended for patients whose grass allergic symptoms cannot be satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. (5).</IndicationAndUsage>
<Description>Standardized grass pollen extracts labeled in BAU/ml are not interchangeable with grass pollen extracts labeled in AU/ml or with non-standardized grass pollen extracts. The recommended route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Do not inject intravenously. The extract is sterile and contains 50% (v/v) glycerin as a preservative. Standardized grass pollen extracts are available in both 10,000 BAU/ml and 100,000 BAU/ml potencies, except for Bermuda which is only available in 10,000 BAU/ml. The source material of the standardized grass extracts are the grass pollens. The 100,000 BAU/ml grass pollen extracts are prepared by extracting pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 100,000 BAU/ml. The 10,000 BAU/ml grass pollen extracts are prepared by dilution of the 100,000 BAU/ml grass pollen extracts. The 10,000 BAU/ml Bermuda grass pollen extract is prepared by extracting Bermuda grass pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 10,000 BAU/ml. The potency (in Bioequivalent Allergy Units per ml or BAU/ml) of standardized grass pollen extracts is determined by an in-vitro ELISA Competition assay (1) against CBER reference extracts and CBER reference serum pools distributed by the Center for Biologics Evaluation and Research, U S Food and Drug Administration. Potency based on Bioequivalent Allergy Units (BAU/ml) is printed on the label. FDA reference grass pollen extracts were assigned potency designations based on quantitative skin testing (2). The FDA reference extracts which can be diluted 1:500,000 fold intradermally to produce a sum of erythema diameter response of 50mm in highly puncture reactive subjects have been assigned 10,000 BAU/ml. References which can be diluted 1:5,000,000 fold intraderrnally to produce a sum of erythema diameter response of 50mm have been assigned 100,000 BAU/ml.</Description>
</NDC>
<NDC>
<NDCCode>58159-087-02</NDCCode>
<PackageDescription>20 kg in 1 DRUM (58159-087-02) </PackageDescription>
<NDC11Code>58159-0087-02</NDC11Code>
<ProductNDC>58159-087</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Cevimeline Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20210706</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
<SubstanceName>CEVIMELINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>kg/35kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2021-07-15</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>06-JUL-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>60290-087-02</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (60290-087-02) </PackageDescription>
<NDC11Code>60290-0087-02</NDC11Code>
<ProductNDC>60290-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219946</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>97; 103</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. ( 1.1) , 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2) .</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1 S,3 R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis( N-pentanoyl- N-{[2´-(1 H-tetrazol-1-id-5- yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate). Its empirical formula is C 48H 57N 6O 8Na 3. Its molecular mass is 914.97 g/mol and its schematic structural formula is:. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are hypromellose, iron oxide red, macrogol, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>60764-087-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (60764-087-02) > 1 g in 1 BOTTLE (60764-087-01)</PackageDescription>
<NDC11Code>60764-0087-02</NDC11Code>
<ProductNDC>60764-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>3ce Matte Lip Crayon Speak Low</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160810</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Nanda Co., Ltd</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.11</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<Description>INSTRUCTIONS: Powdery finish matte lip crayon adheres smoothly onto your lips and imparts a non-oily finish for a chic look. Directions: Glide across the entire lip with powdery finish matte lip crayon and apply it again to the center of your lips to get voluminous and fuller lips.</Description>
</NDC>
<NDC>
<NDCCode>63545-087-02</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (63545-087-02) </PackageDescription>
<NDC11Code>63545-0087-02</NDC11Code>
<ProductNDC>63545-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Araneus Diadematus</ProprietaryName>
<NonProprietaryName>Araneus Diadematus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210225</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>ARANEUS DIADEMATUS</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>