{
"NDC": [
{
"NDCCode": "50222-503-92",
"PackageDescription": "2 TUBE in 1 CARTON (50222-503-92) > .47 g in 1 TUBE",
"NDC11Code": "50222-0503-92",
"ProductNDC": "50222-503",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Picato",
"NonProprietaryName": "Ingenol Mebutate",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120123",
"EndMarketingDate": "20220430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202833",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "INGENOL MEBUTATE",
"StrengthNumber": "500",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Cell Death Inducer [EPC], Increased Cellular Death [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120123",
"EndMarketingDatePackage": "20220430",
"SamplePackage": "N"
},
{
"NDCCode": "50222-503-47",
"PackageDescription": "2 TUBE in 1 CARTON (50222-503-47) > .47 g in 1 TUBE",
"NDC11Code": "50222-0503-47",
"ProductNDC": "50222-503",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Picato",
"NonProprietaryName": "Ingenol Mebutate",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120123",
"EndMarketingDate": "20220430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202833",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "INGENOL MEBUTATE",
"StrengthNumber": "500",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Cell Death Inducer [EPC], Increased Cellular Death [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120123",
"EndMarketingDatePackage": "20220430",
"SamplePackage": "N"
},
{
"NDCCode": "50222-346-92",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (50222-346-92) / 1 mL in 1 SYRINGE, GLASS (50222-346-91) ",
"NDC11Code": "50222-0346-92",
"ProductNDC": "50222-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adbry",
"NonProprietaryName": "Tralokinumab-ldrm",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20220102",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761180",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "TRALOKINUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220102",
"SamplePackage": "N",
"IndicationAndUsage": "ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids.",
"Description": "Tralokinumab-ldrm, an interleukin-13 antagonist, is a human IgG4 monoclonal antibody. Tralokinumab-ldrm is produced in mouse myeloma cells by recombinant DNA technology, consists of 1326 amino acids, and has a molecular weight of approximately 147 kilodaltons. ADBRY (tralokinumab-ldrm) injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous use supplied as either a single-dose prefilled syringe with needle guard in a siliconized Type-1 clear glass syringe or a single-dose autoinjector with a siliconized Type-1 clear glass syringe inside. None of the components of the prefilled syringe, autoinjector or the needle guard are made with natural rubber latex. Each prefilled syringe delivers 150 mg tralokinumab-ldrm in 1 mL and the inactive ingredients: acetic acid (0.3 mg), polysorbate 80 (0.1 mg), sodium acetate trihydrate (6 mg), sodium chloride (5 mg), and Water for Injection, at an approximate pH of 5.5. Each autoinjector delivers 300 mg tralokinumab-ldrm in 2 mL and the inactive ingredients: acetic acid (0.6 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (12 mg), sodium chloride (10 mg), and Water for Injection, at an approximate pH of 5.5."
},
{
"NDCCode": "10056-503-92",
"PackageDescription": "1 BOTTLE in 1 CARTON (10056-503-92) > 140 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "10056-0503-92",
"ProductNDC": "10056-503",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laxative",
"ProprietaryNameSuffix": "Fiber",
"NonProprietaryName": "Calcium Polycarbophil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000727",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Access Business Group LLC",
"SubstanceName": "CALCIUM POLYCARBOPHIL",
"StrengthNumber": "625",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "51810-503-02",
"PackageDescription": "10 VIAL in 1 CARTON (51810-503-02) / 30 mL in 1 VIAL (51810-503-01) ",
"NDC11Code": "51810-0503-02",
"ProductNDC": "51810-503",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meropenem",
"NonProprietaryName": "Meropenem",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216424",
"LabelerName": "Qilu Antibiotics Pharmaceutical Co., Ltd.",
"SubstanceName": "MEROPENEM",
"StrengthNumber": "1",
"StrengthUnit": "g/30mL",
"Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241230",
"SamplePackage": "N",
"IndicationAndUsage": "Meropenen for injection is a penem antibacterial indicated for the treatment of. Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1). Complicated intra-abdominal infections (adult and pediatric patients). (1.2). Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3). To reduce the development of drug-resistant bacteria and maintain the effectiveness of meropenen for injection and other antibacterial drugs, meropenen for injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.",
"Description": "Meropenem for Injection, USP (meropenem for injection) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6- [(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S∙3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for Injection, USP is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 1 gram Meropenem for Injection, USP vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg Meropenem for Injection, USP vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq) [see Dosage and Administration (2.4)]."
},
{
"NDCCode": "50222-203-10",
"PackageDescription": "1 TUBE in 1 CARTON (50222-203-10) > 100 g in 1 TUBE",
"NDC11Code": "50222-0203-10",
"ProductNDC": "50222-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protopic",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20001208",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "LEO Pharma Inc",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160819",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "50222-203-30",
"PackageDescription": "1 TUBE in 1 CARTON (50222-203-30) > 30 g in 1 TUBE",
"NDC11Code": "50222-0203-30",
"ProductNDC": "50222-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protopic",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20001208",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "LEO Pharma Inc",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160819",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "50222-203-60",
"PackageDescription": "1 TUBE in 1 CARTON (50222-203-60) > 60 g in 1 TUBE",
"NDC11Code": "50222-0203-60",
"ProductNDC": "50222-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protopic",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20001208",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "LEO Pharma Inc",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160819",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "50222-211-10",
"PackageDescription": "1 TUBE in 1 CARTON (50222-211-10) > 100 g in 1 TUBE",
"NDC11Code": "50222-0211-10",
"ProductNDC": "50222-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protopic",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20001208",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "LEO Pharma Inc",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160819",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "50222-211-30",
"PackageDescription": "1 TUBE in 1 CARTON (50222-211-30) > 30 g in 1 TUBE",
"NDC11Code": "50222-0211-30",
"ProductNDC": "50222-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protopic",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20001208",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "LEO Pharma Inc",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160819",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "50222-211-60",
"PackageDescription": "1 TUBE in 1 CARTON (50222-211-60) > 60 g in 1 TUBE",
"NDC11Code": "50222-0211-60",
"ProductNDC": "50222-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protopic",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20001208",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "LEO Pharma Inc",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160819",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "50222-227-04",
"PackageDescription": "1 TUBE in 1 CARTON (50222-227-04) / 60 g in 1 TUBE",
"NDC11Code": "50222-0227-04",
"ProductNDC": "50222-227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Taclonex",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080601",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021852",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE",
"StrengthNumber": ".5; 50",
"StrengthUnit": "mg/g; ug/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080601",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "Taclonex® Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.",
"Description": "Taclonex® (calcipotriene and betamethasone dipropionate) Ointment, 0.005%/0.064% contains calcipotriene hydrate and betamethasone dipropionate. It is intended for topical use only. Calcipotriene hydrate is a synthetic vitamin D3 analogue. Chemically, calcipotriene hydrate is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1(alpha),3(beta),24-triol,hydrate, with the empirical formula C27H40O3,H2O, a molecular weight of 430.6, and the following structural formula. Calcipotriene hydrate is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta), 17,21-trihydroxy-16(beta)-methylpregna-1,4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to almost white odorless powder. Each gram of Taclonex® Ointment contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of butylhydroxytoluene, mineral oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, and white petrolatum."
},
{
"NDCCode": "50222-227-07",
"PackageDescription": "25 CARTON in 1 CASE (50222-227-07) > 10 TUBE in 1 CARTON > 3 g in 1 TUBE",
"NDC11Code": "50222-0227-07",
"ProductNDC": "50222-227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Taclonex",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021852",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "CALCIPOTRIENE HYDRATE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .5",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-01-29"
},
{
"NDCCode": "50222-227-81",
"PackageDescription": "1 TUBE in 1 CARTON (50222-227-81) > 100 g in 1 TUBE",
"NDC11Code": "50222-0227-81",
"ProductNDC": "50222-227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Taclonex",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021852",
"LabelerName": "LEO Pharma Inc",
"SubstanceName": "BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE",
"StrengthNumber": ".5; 50",
"StrengthUnit": "mg/g; ug/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20080601",
"EndMarketingDatePackage": "20221031",
"SamplePackage": "N"
},
{
"NDCCode": "50222-260-06",
"PackageDescription": "1 TUBE in 1 CARTON (50222-260-06) > 60 g in 1 TUBE",
"NDC11Code": "50222-0260-06",
"ProductNDC": "50222-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dovonex",
"NonProprietaryName": "Calcipotriene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19961001",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020554",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "CALCIPOTRIENE",
"StrengthNumber": "50",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19961001",
"EndMarketingDatePackage": "20230831",
"SamplePackage": "N"
},
{
"NDCCode": "50222-260-12",
"PackageDescription": "1 TUBE in 1 CARTON (50222-260-12) > 120 g in 1 TUBE",
"NDC11Code": "50222-0260-12",
"ProductNDC": "50222-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dovonex",
"NonProprietaryName": "Calcipotriene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19961001",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020554",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "CALCIPOTRIENE",
"StrengthNumber": "50",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19961001",
"EndMarketingDatePackage": "20221031",
"SamplePackage": "N"
},
{
"NDCCode": "50222-260-99",
"PackageDescription": "25 CARTON in 1 CASE (50222-260-99) > 10 TUBE in 1 CARTON > 3 g in 1 TUBE",
"NDC11Code": "50222-0260-99",
"ProductNDC": "50222-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dovonex",
"NonProprietaryName": "Calcipotriene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19961001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020554",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "CALCIPOTRIENE",
"StrengthNumber": "50",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-09-19"
},
{
"NDCCode": "50222-280-30",
"PackageDescription": "1 TUBE in 1 CARTON (50222-280-30) / 30 g in 1 TUBE",
"NDC11Code": "50222-0280-30",
"ProductNDC": "50222-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anzupgo",
"NonProprietaryName": "Delgocitinib",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250724",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219155",
"LabelerName": "LEO Pharma, Inc",
"SubstanceName": "DELGOCITINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250724",
"SamplePackage": "N",
"IndicationAndUsage": "ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.",
"Description": "ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C16H18N6O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula. Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water."
},
{
"NDCCode": "50222-280-91",
"PackageDescription": "1 TUBE in 1 CARTON (50222-280-91) / 15 g in 1 TUBE",
"NDC11Code": "50222-0280-91",
"ProductNDC": "50222-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anzupgo",
"NonProprietaryName": "Delgocitinib",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250724",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219155",
"LabelerName": "LEO Pharma, Inc",
"SubstanceName": "DELGOCITINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250724",
"SamplePackage": "Y",
"IndicationAndUsage": "ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.",
"Description": "ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C16H18N6O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula. Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water."
},
{
"NDCCode": "50222-280-99",
"PackageDescription": "1 TUBE in 1 CARTON (50222-280-99) / 5 g in 1 TUBE",
"NDC11Code": "50222-0280-99",
"ProductNDC": "50222-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anzupgo",
"NonProprietaryName": "Delgocitinib",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250724",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219155",
"LabelerName": "LEO Pharma, Inc",
"SubstanceName": "DELGOCITINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250830",
"SamplePackage": "Y",
"IndicationAndUsage": "ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.",
"Description": "ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C16H18N6O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula. Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water."
},
{
"NDCCode": "50222-302-60",
"PackageDescription": "1 CAN in 1 CARTON (50222-302-60) > 60 g in 1 CAN",
"NDC11Code": "50222-0302-60",
"ProductNDC": "50222-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enstilar",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151016",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207589",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "CALCIPOTRIENE MONOHYDRATE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .5",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2022-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151016",
"SamplePackage": "N",
"IndicationAndUsage": "Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.",
"Description": "Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only."
},
{
"NDCCode": "50222-302-66",
"PackageDescription": "2 CAN in 1 CARTON (50222-302-66) > 60 g in 1 CAN",
"NDC11Code": "50222-0302-66",
"ProductNDC": "50222-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enstilar",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151016",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207589",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "CALCIPOTRIENE MONOHYDRATE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .5",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2022-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151016",
"SamplePackage": "N",
"IndicationAndUsage": "Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.",
"Description": "Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only."
},
{
"NDCCode": "50222-302-91",
"PackageDescription": "1 CAN in 1 CARTON (50222-302-91) > 60 g in 1 CAN",
"NDC11Code": "50222-0302-91",
"ProductNDC": "50222-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enstilar",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151016",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207589",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "CALCIPOTRIENE MONOHYDRATE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .5",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2022-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151016",
"SamplePackage": "Y",
"IndicationAndUsage": "Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.",
"Description": "Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only."
},
{
"NDCCode": "50222-303-50",
"PackageDescription": "1 CAN in 1 CARTON (50222-303-50) > 50 g in 1 CAN",
"NDC11Code": "50222-0303-50",
"ProductNDC": "50222-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finacea Foam",
"NonProprietaryName": "Azelaic Acid",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207071",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "AZELAIC ACID",
"StrengthNumber": ".15",
"StrengthUnit": "g/g",
"Pharm_Classes": "Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]",
"Status": "Active",
"LastUpdate": "2020-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "FINACEA Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.",
"Description": "FINACEA (azelaic acid) Foam contains 15% (w/w) azelaic acid, a naturally-occurring saturated dicarboxylic acid and is suspended in an oil-in-water emulsion vehicle. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The structural formula of azelaic acid is. Azelaic acid has a molecular formula of C9 H16 O4 and a molecular weight of 188.22. The aluminum containers are filled with hydrophilic emulsion, crimped with a continuous spray valve, and pressurized with propellants consisting of propane, butane, and isobutane. Each gram of FINACEA Foam, 15% contains 0.15 g of azelaic acid. FINACEA Foam also contains benzoic acid (as a preservative), cetostearyl alcohol, dimethyl isosorbide, medium-chain triglycerides, methylcellulose, mono- and di-glycerides, polyoxyl 40 stearate, polysorbate 80, propylene glycol, purified water, sodium hydroxide (to adjust pH), and xanthan gum as inactive ingredients."
},
{
"NDCCode": "50222-303-91",
"PackageDescription": "1 CAN in 1 CARTON (50222-303-91) > 15 g in 1 CAN",
"NDC11Code": "50222-0303-91",
"ProductNDC": "50222-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finacea Foam",
"NonProprietaryName": "Azelaic Acid",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207071",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "AZELAIC ACID",
"StrengthNumber": ".15",
"StrengthUnit": "g/g",
"Pharm_Classes": "Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]",
"Status": "Active",
"LastUpdate": "2020-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "Y",
"IndicationAndUsage": "FINACEA Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.",
"Description": "FINACEA (azelaic acid) Foam contains 15% (w/w) azelaic acid, a naturally-occurring saturated dicarboxylic acid and is suspended in an oil-in-water emulsion vehicle. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The structural formula of azelaic acid is. Azelaic acid has a molecular formula of C9 H16 O4 and a molecular weight of 188.22. The aluminum containers are filled with hydrophilic emulsion, crimped with a continuous spray valve, and pressurized with propellants consisting of propane, butane, and isobutane. Each gram of FINACEA Foam, 15% contains 0.15 g of azelaic acid. FINACEA Foam also contains benzoic acid (as a preservative), cetostearyl alcohol, dimethyl isosorbide, medium-chain triglycerides, methylcellulose, mono- and di-glycerides, polyoxyl 40 stearate, polysorbate 80, propylene glycol, purified water, sodium hydroxide (to adjust pH), and xanthan gum as inactive ingredients."
},
{
"NDCCode": "50222-342-08",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (50222-342-08) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "50222-0342-08",
"ProductNDC": "50222-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Innohep",
"NonProprietaryName": "Tinzaparin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020484",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "TINZAPARIN SODIUM",
"StrengthNumber": "20000",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-08-02"
},
{
"NDCCode": "50222-342-53",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (50222-342-53) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "50222-0342-53",
"ProductNDC": "50222-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Innohep",
"NonProprietaryName": "Tinzaparin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020484",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "TINZAPARIN SODIUM",
"StrengthNumber": "20000",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-08-02"
},
{
"NDCCode": "50222-346-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (50222-346-02) / 1 mL in 1 SYRINGE, GLASS (50222-346-01) ",
"NDC11Code": "50222-0346-02",
"ProductNDC": "50222-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adbry",
"NonProprietaryName": "Tralokinumab-ldrm",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20220102",
"MarketingCategoryName": "BLA",
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}
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<LastUpdate>2024-09-03</LastUpdate>
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<Description>Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>50222-211-10</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-211-10) > 100 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0211-10</NDC11Code>
<ProductNDC>50222-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Protopic</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20001208</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050777</ApplicationNumber>
<LabelerName>LEO Pharma Inc</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160819</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>50222-211-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-211-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0211-30</NDC11Code>
<ProductNDC>50222-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Protopic</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20001208</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050777</ApplicationNumber>
<LabelerName>LEO Pharma Inc</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160819</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>50222-211-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-211-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0211-60</NDC11Code>
<ProductNDC>50222-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Protopic</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20001208</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050777</ApplicationNumber>
<LabelerName>LEO Pharma Inc</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160819</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>50222-227-04</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-227-04) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0227-04</NDC11Code>
<ProductNDC>50222-227</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Taclonex</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080601</StartMarketingDate>
<EndMarketingDate>20241031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021852</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE</SubstanceName>
<StrengthNumber>.5; 50</StrengthNumber>
<StrengthUnit>mg/g; ug/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20080601</StartMarketingDatePackage>
<EndMarketingDatePackage>20241031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Taclonex® Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.</IndicationAndUsage>
<Description>Taclonex® (calcipotriene and betamethasone dipropionate) Ointment, 0.005%/0.064% contains calcipotriene hydrate and betamethasone dipropionate. It is intended for topical use only. Calcipotriene hydrate is a synthetic vitamin D3 analogue. Chemically, calcipotriene hydrate is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1(alpha),3(beta),24-triol,hydrate, with the empirical formula C27H40O3,H2O, a molecular weight of 430.6, and the following structural formula. Calcipotriene hydrate is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta), 17,21-trihydroxy-16(beta)-methylpregna-1,4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to almost white odorless powder. Each gram of Taclonex® Ointment contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of butylhydroxytoluene, mineral oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>50222-227-07</NDCCode>
<PackageDescription>25 CARTON in 1 CASE (50222-227-07) > 10 TUBE in 1 CARTON > 3 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0227-07</NDC11Code>
<ProductNDC>50222-227</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Taclonex</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021852</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE HYDRATE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .5</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>50222-227-81</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-227-81) > 100 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0227-81</NDC11Code>
<ProductNDC>50222-227</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Taclonex</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021852</ApplicationNumber>
<LabelerName>LEO Pharma Inc</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE</SubstanceName>
<StrengthNumber>.5; 50</StrengthNumber>
<StrengthUnit>mg/g; ug/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080601</StartMarketingDatePackage>
<EndMarketingDatePackage>20221031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50222-260-06</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-260-06) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0260-06</NDC11Code>
<ProductNDC>50222-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dovonex</ProprietaryName>
<NonProprietaryName>Calcipotriene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19961001</StartMarketingDate>
<EndMarketingDate>20230831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020554</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19961001</StartMarketingDatePackage>
<EndMarketingDatePackage>20230831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50222-260-12</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-260-12) > 120 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0260-12</NDC11Code>
<ProductNDC>50222-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dovonex</ProprietaryName>
<NonProprietaryName>Calcipotriene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19961001</StartMarketingDate>
<EndMarketingDate>20230831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020554</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19961001</StartMarketingDatePackage>
<EndMarketingDatePackage>20221031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50222-260-99</NDCCode>
<PackageDescription>25 CARTON in 1 CASE (50222-260-99) > 10 TUBE in 1 CARTON > 3 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0260-99</NDC11Code>
<ProductNDC>50222-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dovonex</ProprietaryName>
<NonProprietaryName>Calcipotriene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19961001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020554</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>50222-280-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-280-30) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0280-30</NDC11Code>
<ProductNDC>50222-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anzupgo</ProprietaryName>
<NonProprietaryName>Delgocitinib</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250724</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219155</ApplicationNumber>
<LabelerName>LEO Pharma, Inc</LabelerName>
<SubstanceName>DELGOCITINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.</IndicationAndUsage>
<Description>ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C16H18N6O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula. Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>50222-280-91</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-280-91) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0280-91</NDC11Code>
<ProductNDC>50222-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anzupgo</ProprietaryName>
<NonProprietaryName>Delgocitinib</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250724</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219155</ApplicationNumber>
<LabelerName>LEO Pharma, Inc</LabelerName>
<SubstanceName>DELGOCITINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250724</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.</IndicationAndUsage>
<Description>ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C16H18N6O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula. Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>50222-280-99</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-280-99) / 5 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0280-99</NDC11Code>
<ProductNDC>50222-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anzupgo</ProprietaryName>
<NonProprietaryName>Delgocitinib</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250724</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219155</ApplicationNumber>
<LabelerName>LEO Pharma, Inc</LabelerName>
<SubstanceName>DELGOCITINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250830</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.</IndicationAndUsage>
<Description>ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C16H18N6O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula. Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>50222-302-60</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (50222-302-60) > 60 g in 1 CAN</PackageDescription>
<NDC11Code>50222-0302-60</NDC11Code>
<ProductNDC>50222-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enstilar</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151016</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207589</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE MONOHYDRATE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .5</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.</IndicationAndUsage>
<Description>Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only.</Description>
</NDC>
<NDC>
<NDCCode>50222-302-66</NDCCode>
<PackageDescription>2 CAN in 1 CARTON (50222-302-66) > 60 g in 1 CAN</PackageDescription>
<NDC11Code>50222-0302-66</NDC11Code>
<ProductNDC>50222-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enstilar</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151016</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207589</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE MONOHYDRATE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .5</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.</IndicationAndUsage>
<Description>Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only.</Description>
</NDC>
<NDC>
<NDCCode>50222-302-91</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (50222-302-91) > 60 g in 1 CAN</PackageDescription>
<NDC11Code>50222-0302-91</NDC11Code>
<ProductNDC>50222-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enstilar</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151016</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207589</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE MONOHYDRATE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .5</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151016</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.</IndicationAndUsage>
<Description>Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only.</Description>
</NDC>
<NDC>
<NDCCode>50222-303-50</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (50222-303-50) > 50 g in 1 CAN</PackageDescription>
<NDC11Code>50222-0303-50</NDC11Code>
<ProductNDC>50222-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finacea Foam</ProprietaryName>
<NonProprietaryName>Azelaic Acid</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207071</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>AZELAIC ACID</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FINACEA Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.</IndicationAndUsage>
<Description>FINACEA (azelaic acid) Foam contains 15% (w/w) azelaic acid, a naturally-occurring saturated dicarboxylic acid and is suspended in an oil-in-water emulsion vehicle. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The structural formula of azelaic acid is. Azelaic acid has a molecular formula of C9 H16 O4 and a molecular weight of 188.22. The aluminum containers are filled with hydrophilic emulsion, crimped with a continuous spray valve, and pressurized with propellants consisting of propane, butane, and isobutane. Each gram of FINACEA Foam, 15% contains 0.15 g of azelaic acid. FINACEA Foam also contains benzoic acid (as a preservative), cetostearyl alcohol, dimethyl isosorbide, medium-chain triglycerides, methylcellulose, mono- and di-glycerides, polyoxyl 40 stearate, polysorbate 80, propylene glycol, purified water, sodium hydroxide (to adjust pH), and xanthan gum as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>50222-303-91</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (50222-303-91) > 15 g in 1 CAN</PackageDescription>
<NDC11Code>50222-0303-91</NDC11Code>
<ProductNDC>50222-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finacea Foam</ProprietaryName>
<NonProprietaryName>Azelaic Acid</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207071</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>AZELAIC ACID</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>FINACEA Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.</IndicationAndUsage>
<Description>FINACEA (azelaic acid) Foam contains 15% (w/w) azelaic acid, a naturally-occurring saturated dicarboxylic acid and is suspended in an oil-in-water emulsion vehicle. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The structural formula of azelaic acid is. Azelaic acid has a molecular formula of C9 H16 O4 and a molecular weight of 188.22. The aluminum containers are filled with hydrophilic emulsion, crimped with a continuous spray valve, and pressurized with propellants consisting of propane, butane, and isobutane. Each gram of FINACEA Foam, 15% contains 0.15 g of azelaic acid. FINACEA Foam also contains benzoic acid (as a preservative), cetostearyl alcohol, dimethyl isosorbide, medium-chain triglycerides, methylcellulose, mono- and di-glycerides, polyoxyl 40 stearate, polysorbate 80, propylene glycol, purified water, sodium hydroxide (to adjust pH), and xanthan gum as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>50222-342-08</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (50222-342-08) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>50222-0342-08</NDC11Code>
<ProductNDC>50222-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Innohep</ProprietaryName>
<NonProprietaryName>Tinzaparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020484</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>TINZAPARIN SODIUM</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>50222-342-53</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (50222-342-53) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>50222-0342-53</NDC11Code>
<ProductNDC>50222-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Innohep</ProprietaryName>
<NonProprietaryName>Tinzaparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020484</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>TINZAPARIN SODIUM</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>50222-346-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (50222-346-02) / 1 mL in 1 SYRINGE, GLASS (50222-346-01) </PackageDescription>
<NDC11Code>50222-0346-02</NDC11Code>
<ProductNDC>50222-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adbry</ProprietaryName>
<NonProprietaryName>Tralokinumab-ldrm</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220102</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761180</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>TRALOKINUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids.</IndicationAndUsage>
<Description>Tralokinumab-ldrm, an interleukin-13 antagonist, is a human IgG4 monoclonal antibody. Tralokinumab-ldrm is produced in mouse myeloma cells by recombinant DNA technology, consists of 1326 amino acids, and has a molecular weight of approximately 147 kilodaltons. ADBRY (tralokinumab-ldrm) injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous use supplied as either a single-dose prefilled syringe with needle guard in a siliconized Type-1 clear glass syringe or a single-dose autoinjector with a siliconized Type-1 clear glass syringe inside. None of the components of the prefilled syringe, autoinjector or the needle guard are made with natural rubber latex. Each prefilled syringe delivers 150 mg tralokinumab-ldrm in 1 mL and the inactive ingredients: acetic acid (0.3 mg), polysorbate 80 (0.1 mg), sodium acetate trihydrate (6 mg), sodium chloride (5 mg), and Water for Injection, at an approximate pH of 5.5. Each autoinjector delivers 300 mg tralokinumab-ldrm in 2 mL and the inactive ingredients: acetic acid (0.6 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (12 mg), sodium chloride (10 mg), and Water for Injection, at an approximate pH of 5.5.</Description>
</NDC>
<NDC>
<NDCCode>50222-346-04</NDCCode>
<PackageDescription>2 CARTON in 1 CARTON (50222-346-04) / 2 SYRINGE, GLASS in 1 CARTON (50222-346-22) / 1 mL in 1 SYRINGE, GLASS (50222-346-01) </PackageDescription>
<NDC11Code>50222-0346-04</NDC11Code>
<ProductNDC>50222-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adbry</ProprietaryName>
<NonProprietaryName>Tralokinumab-ldrm</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220102</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761180</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>TRALOKINUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids.</IndicationAndUsage>
<Description>Tralokinumab-ldrm, an interleukin-13 antagonist, is a human IgG4 monoclonal antibody. Tralokinumab-ldrm is produced in mouse myeloma cells by recombinant DNA technology, consists of 1326 amino acids, and has a molecular weight of approximately 147 kilodaltons. ADBRY (tralokinumab-ldrm) injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous use supplied as either a single-dose prefilled syringe with needle guard in a siliconized Type-1 clear glass syringe or a single-dose autoinjector with a siliconized Type-1 clear glass syringe inside. None of the components of the prefilled syringe, autoinjector or the needle guard are made with natural rubber latex. Each prefilled syringe delivers 150 mg tralokinumab-ldrm in 1 mL and the inactive ingredients: acetic acid (0.3 mg), polysorbate 80 (0.1 mg), sodium acetate trihydrate (6 mg), sodium chloride (5 mg), and Water for Injection, at an approximate pH of 5.5. Each autoinjector delivers 300 mg tralokinumab-ldrm in 2 mL and the inactive ingredients: acetic acid (0.6 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (12 mg), sodium chloride (10 mg), and Water for Injection, at an approximate pH of 5.5.</Description>
</NDC>
<NDC>
<NDCCode>50222-350-01</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (50222-350-01) / 2 mL in 1 SYRINGE, GLASS (50222-350-00) </PackageDescription>
<NDC11Code>50222-0350-01</NDC11Code>
<ProductNDC>50222-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adbry</ProprietaryName>
<NonProprietaryName>Tralokinumab-ldrm</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761180</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>TRALOKINUMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids.</IndicationAndUsage>
<Description>Tralokinumab-ldrm, an interleukin-13 antagonist, is a human IgG4 monoclonal antibody. Tralokinumab-ldrm is produced in mouse myeloma cells by recombinant DNA technology, consists of 1326 amino acids, and has a molecular weight of approximately 147 kilodaltons. ADBRY (tralokinumab-ldrm) injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous use supplied as either a single-dose prefilled syringe with needle guard in a siliconized Type-1 clear glass syringe or a single-dose autoinjector with a siliconized Type-1 clear glass syringe inside. None of the components of the prefilled syringe, autoinjector or the needle guard are made with natural rubber latex. Each prefilled syringe delivers 150 mg tralokinumab-ldrm in 1 mL and the inactive ingredients: acetic acid (0.3 mg), polysorbate 80 (0.1 mg), sodium acetate trihydrate (6 mg), sodium chloride (5 mg), and Water for Injection, at an approximate pH of 5.5. Each autoinjector delivers 300 mg tralokinumab-ldrm in 2 mL and the inactive ingredients: acetic acid (0.6 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (12 mg), sodium chloride (10 mg), and Water for Injection, at an approximate pH of 5.5.</Description>
</NDC>
</NDCList>