{
"NDC": [
{
"NDCCode": "0299-3822-02",
"PackageDescription": "12 TRAY in 1 BOX (0299-3822-02) / 8 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00299-3822-02",
"ProductNDC": "0299-3822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oracea",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050805",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150201",
"SamplePackage": "Y",
"Description": "ORACEA (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22H 24N 2O 8). The structural formula of doxycycline, USP is. with an empirical formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water. Inert ingredients in the formulation are: hard gelatin capsule, hypromellose, methacrylic acid copolymer, Opadry beige, sugar spheres, talc, and triethyl citrate."
},
{
"NDCCode": "0026-3822-25",
"PackageDescription": "1 KIT in 1 BOX (0026-3822-25) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-01) ",
"NDC11Code": "00026-3822-25",
"ProductNDC": "0026-3822",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kovaltry",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20160317",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125574",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160317",
"SamplePackage": "N",
"IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
"Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
},
{
"NDCCode": "0026-3822-99",
"PackageDescription": "1 KIT in 1 BOX (0026-3822-99) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-01) ",
"NDC11Code": "00026-3822-99",
"ProductNDC": "0026-3822",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kovaltry",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20160317",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125574",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160317",
"SamplePackage": "N",
"IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
"Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
},
{
"NDCCode": "37662-3822-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-3822-2) ",
"NDC11Code": "37662-3822-02",
"ProductNDC": "37662-3822",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acidum Sulphuricum",
"NonProprietaryName": "Acidum Sulphuricum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230822",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "SULFURIC ACID",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-08-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230822",
"SamplePackage": "N"
},
{
"NDCCode": "70518-3822-2",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (70518-3822-2) ",
"NDC11Code": "70518-3822-02",
"ProductNDC": "70518-3822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212517",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230823",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Tablets are indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis, 5 tendonitis, 6 bursitis, 7 acute gout.",
"Description": "Naproxen tablets, USP are nonsteroidal anti-inflammatory drugs and available as follows: Naproxen tablets, USP are available as light yellow round shaped tablets containing 250 mg naproxen, light yellow capsule shaped tablets containing 375 mg naproxen, and light yellow oblong shaped tablets containing 500 mg naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. It has the following structural formula:. Naproxen is white or almost white crystalline powder. It is insoluble in water, soluble in chloroform, dehydrated ethanol and methanol. Sparingly soluble in ether. The octanol/water partition coefficient of Naproxen at pH < 2.18 is 3.18. Each naproxen tablet, USP contains the following inactive ingredients: croscarmellose sodium, yellow iron oxide, povidone and magnesium stearate."
},
{
"NDCCode": "0299-3822-04",
"PackageDescription": "4 CAPSULE in 1 BLISTER PACK (0299-3822-04) ",
"NDC11Code": "00299-3822-04",
"ProductNDC": "0299-3822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oracea",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050805",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "Y",
"Description": "ORACEA (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22H 24N 2O 8). The structural formula of doxycycline, USP is. with an empirical formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water. Inert ingredients in the formulation are: hard gelatin capsule, hypromellose, methacrylic acid copolymer, Opadry beige, sugar spheres, talc, and triethyl citrate."
},
{
"NDCCode": "0299-3822-05",
"PackageDescription": "8 BLISTER PACK in 1 PACKAGE (0299-3822-05) / 4 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00299-3822-05",
"ProductNDC": "0299-3822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oracea",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050805",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "Y",
"Description": "ORACEA (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22H 24N 2O 8). The structural formula of doxycycline, USP is. with an empirical formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water. Inert ingredients in the formulation are: hard gelatin capsule, hypromellose, methacrylic acid copolymer, Opadry beige, sugar spheres, talc, and triethyl citrate."
},
{
"NDCCode": "0299-3822-06",
"PackageDescription": "16 KIT in 1 BOX (0299-3822-06) / 1 BLISTER PACK in 1 KIT / 4 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00299-3822-06",
"ProductNDC": "0299-3822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oracea",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050805",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "Y",
"Description": "ORACEA (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22H 24N 2O 8). The structural formula of doxycycline, USP is. with an empirical formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water. Inert ingredients in the formulation are: hard gelatin capsule, hypromellose, methacrylic acid copolymer, Opadry beige, sugar spheres, talc, and triethyl citrate."
},
{
"NDCCode": "0299-3822-07",
"PackageDescription": "24 TRAY in 1 BOX (0299-3822-07) / 4 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00299-3822-07",
"ProductNDC": "0299-3822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oracea",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050805",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150201",
"SamplePackage": "N",
"Description": "ORACEA (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C22H24N2O8). The structural formula of doxycycline, USP is. with an empirical formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water. Inert ingredients in the formulation are: hypromellose, iron oxide red, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate."
},
{
"NDCCode": "0299-3822-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0299-3822-30) ",
"NDC11Code": "00299-3822-30",
"ProductNDC": "0299-3822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oracea",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050805",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N",
"Description": "ORACEA (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C22H24N2O8). The structural formula of doxycycline, USP is. with an empirical formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water. Inert ingredients in the formulation are: hypromellose, iron oxide red, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate."
},
{
"NDCCode": "58036-3822-1",
"PackageDescription": "25 kg in 1 CARTON (58036-3822-1)",
"NDC11Code": "58036-3822-01",
"ProductNDC": "58036-3822",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ferrous Fumarate",
"DosageFormName": "POWDER",
"StartMarketingDate": "19900216",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "FERROPHARMA",
"SubstanceName": "FERROUS FUMARATE",
"StrengthNumber": "25",
"StrengthUnit": "kg/25kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0299-3674-02",
"PackageDescription": "1 TUBE in 1 CARTON (0299-3674-02) > 56 g in 1 TUBE",
"NDC11Code": "00299-3674-02",
"ProductNDC": "0299-3674",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benzac",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-09-26"
},
{
"NDCCode": "0299-3823-02",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (0299-3823-02) / 2 g in 1 TUBE",
"NDC11Code": "00299-3823-02",
"ProductNDC": "0299-3823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Soolantra",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206255",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Antiparasitic [EPC], Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "Y",
"IndicationAndUsage": "SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.",
"Description": "SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of SOOLANTRA cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0% and not more than 102.0% of 5-O-demethyl-22,23-dihydroavermectin A 1aplus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a, generally referred to as 22,23-dihydroavermectin B 1aand B 1bor H 2B 1aand H 2B 1b, respectively; and the ratio (calculated by area percentage) of component H 2B 1a/(H 2B 1a+ H 2B 1b) is not less than 90.0%. The respective empirical formulas of H 2B 1aand H 2B 1bare C 48H 74O 14and C 47H 72O 14with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H 2B 1a: R = C 2H 5, Component H 2B 1b: R = CH 3. SOOLANTRA cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol."
},
{
"NDCCode": "0299-3838-02",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0299-3838-02) > 59 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00299-3838-02",
"ProductNDC": "0299-3838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metrolotion",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19981124",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020901",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19981124",
"SamplePackage": "N",
"IndicationAndUsage": "MetroLotion® Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.",
"Description": "MetroLotion® (metronidazole lotion) Topical Lotion contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75% w/w) in a lotion consisting of benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, PEG-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust pH. Metronidazole is an imidazole and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1H-imidazole-1-ethanol. The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula."
},
{
"NDCCode": "0299-3848-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (0299-3848-02) / 59 mL in 1 BOTTLE",
"NDC11Code": "00299-3848-02",
"ProductNDC": "0299-3848",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20030801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021535",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030801",
"SamplePackage": "N",
"IndicationAndUsage": "CLOBEX (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": "CLOBEX (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 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water."
},
{
"NDCCode": "0299-3849-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (0299-3849-02) / 59 mL in 1 BOTTLE",
"NDC11Code": "00299-3849-02",
"ProductNDC": "0299-3849",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20051027",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021835",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20051027",
"SamplePackage": "N",
"Description": "CLOBEX ®(clobetasol propionate) Spray, 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 C 25H 32CIFO 5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX ®Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid."
},
{
"NDCCode": "0299-3928-02",
"PackageDescription": "4 mL in 1 POUCH (0299-3928-02)",
"NDC11Code": "00299-3928-02",
"ProductNDC": "0299-3928",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetaphil",
"NonProprietaryName": "Octocrylene, Avobenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20000401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "3; 10",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2015-02-27"
},
{
"NDCCode": "0299-3930-02",
"PackageDescription": "1 TUBE in 1 CARTON (0299-3930-02) > 50 mL in 1 TUBE",
"NDC11Code": "00299-3930-02",
"ProductNDC": "0299-3930",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetaphil Daily Facial Moisturizer Spf 50",
"NonProprietaryName": "Octinoxate, Octisalate, Octocrylene, Oxybenzone, Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE",
"StrengthNumber": "7.5; 5; 7; 6; 5.7",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0299-4930-02",
"PackageDescription": "1 TUBE in 1 CARTON (0299-4930-02) / 50 mL in 1 TUBE",
"NDC11Code": "00299-4930-02",
"ProductNDC": "0299-4930",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetaphil Daily Facial Moisturizer With Suncreen Spf 50",
"NonProprietaryName": "Octinoxate, Octisalate, Octocrylene, Oxybenzone, Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE",
"StrengthNumber": "75; 50; 70; 60; 57",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-04-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120101",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "0299-5765-02",
"PackageDescription": "59 g in 1 BOTTLE (0299-5765-02) ",
"NDC11Code": "00299-5765-02",
"ProductNDC": "0299-5765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desowen",
"NonProprietaryName": "Desonide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19880715",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072354",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "DESONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19880715",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N"
},
{
"NDCCode": "0299-5906-02",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (0299-5906-02) / 2 g in 1 TUBE",
"NDC11Code": "00299-5906-02",
"ProductNDC": "0299-5906",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epiduo Forte",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207917",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "3; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150701",
"SamplePackage": "Y",
"IndicationAndUsage": "EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.",
"Description": "EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
},
{
"NDCCode": "0299-5908-02",
"PackageDescription": "2 g in 1 TUBE (0299-5908-02) ",
"NDC11Code": "00299-5908-02",
"ProductNDC": "0299-5908",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epiduo",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022320",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "1; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081208",
"SamplePackage": "Y",
"IndicationAndUsage": "EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "EPIDUO (adapalene and benzoyl peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Active: Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
},
{
"NDCCode": "0299-5912-02",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0299-5912-02) / 59 mL in 1 BOTTLE, PUMP",
"NDC11Code": "00299-5912-02",
"ProductNDC": "0299-5912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Differin",
"NonProprietaryName": "Adapalene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100331",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022502",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100427",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "DIFFERIN Lotion is indicated for the topical treatment of acne vulgaris in patients 12 years and older.",
"Description": "DIFFERIN (adapalene) Lotion, for topical use, contains adapalene in a white to off-white oil-in-water emulsion. Adapalene is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4methoxyphenyl]- 2-naphthoic acid). Adapalene has the following structural formula. Adapalene. Molecular formula: C 28H 28O 3 Molecular weight: 412.5 Each gram of DIFFERIN Lotion contains 1 mg of adapalene. The lotion also contains the following inactive ingredients: carbomer 941, disodium edetate, medium chain triglycerides, methylparaben, phenoxyethanol, poloxamer 124, polyoxyl-6-polyoxyl-32 palmitostearate, PPG12/SMDI copolymer, propylene glycol, propylparaben, purified water, sodium hydroxide, and stearyl alcohol."
},
{
"NDCCode": "0299-5918-02",
"PackageDescription": "2 g in 1 TUBE (0299-5918-02) ",
"NDC11Code": "00299-5918-02",
"ProductNDC": "0299-5918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Differin",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021753",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090915",
"SamplePackage": "N",
"IndicationAndUsage": "DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula."
},
{
"NDCCode": "0299-5935-02",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (0299-5935-02) / 2 g in 1 TUBE",
"NDC11Code": "00299-5935-02",
"ProductNDC": "0299-5935",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aklief",
"NonProprietaryName": "Trifarotene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191004",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211527",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "TRIFAROTENE",
"StrengthNumber": "50",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191004",
"SamplePackage": "Y",
"IndicationAndUsage": "AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "AKLIEF Cream for topical administration contains 0.005% (50 mcg/g) trifarotene. Trifarotene is a terphenyl acid derivative and is a retinoid. The chemical name of trifarotene is 3”-tert-Butyl-4’-(2-hydroxy-ethoxy)-4”-pyrrolidin-1-yl-[1,1’,3’,1”]terphenyl-4- carboxylic acid. Trifarotene has the molecular formula of C 29H 33NO 4, the molecular weight of 459.58, and the following structural formula:. Trifarotene is a white to off-white to slightly yellow powder with the melting point of 245°C. It is practically insoluble in water with pKa1 of 5.69 and pKa2 of 4.55. AKLIEF (trifarotene) Cream 0.005% contains the following inactive ingredients: allantoin, copolymer of acrylamide and sodium acryloyldimethyltaurate dispersion 40% in isohexadecane, cyclomethicone, 95% (v/v) ethanol, medium-chain triglycerides, phenoxyethanol, propylene glycol, purified water."
},
{
"NDCCode": "0299-5950-02",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (0299-5950-02) / 3 g in 1 TUBE",
"NDC11Code": "00299-5950-02",
"ProductNDC": "0299-5950",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-luma",
"NonProprietaryName": "Fluocinolone Acetonide, Hydroquinone, And Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20020118",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021112",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN",
"StrengthNumber": ".1; 40; .5",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120401",
"SamplePackage": "Y",
"Description": "TRI-LUMA (fluocinolone acetonide, hydroquinone, and tretinoin) Cream, 0.01%/4%/0.05% contains fluocinolone acetonide, USP, hydroquinone, USP, and tretinoin, USP, in a light yellow, hydrophilic cream base for topical application. Fluocinolone acetonide is a synthetic fluorinated corticosteroid. It is a white crystalline powder that is odorless and stable in light. The chemical name for fluocinolone acetonide is: (6α,11β,16α)-6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-pregna-1,-4-diene-3,20-dione. The molecular formula is C 24H 30F 2O 6and molecular weight is 452.50. Fluocinolone acetonide has the following structural formula. Hydroquinone is a melanin synthesis inhibitor. It is prepared from the reduction of p-benzoquinone with sodium bisulfite. It occurs as fine white needles that darken on exposure to air. The chemical name for hydroquinone is: 1,4-benzenediol. The molecular formula is C 6H 6O 2and molecular weight is 110.11. Hydroquinone has the following structural formula. Tretinoin, a retinoid, is all- trans-retinoic acid formed from the oxidation of the aldehyde group of retinene to a carboxyl group. It occurs as yellow to light-orange crystals or crystalline powder with a characteristic odor of ensilage. It is highly reactive to light and moisture. The chemical name for tretinoin is: ( all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. The molecular formula is C 20H 28O 2and molecular weight is 300.44. Tretinoin has the following structural formula. Each gram of TRI-LUMA Cream contains Active:fluocinolone acetonide 0.01% (0.1 mg), hydroquinone 4% (40 mg), and tretinoin 0.05% (0.5 mg). Inactive:butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl alcohol."
},
{
"NDCCode": "0299-5980-02",
"PackageDescription": "2 g in 1 TUBE (0299-5980-02) ",
"NDC11Code": "00299-5980-02",
"ProductNDC": "0299-5980",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirvaso",
"NonProprietaryName": "Brimonidine Tartrate",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130823",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204708",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "BRIMONIDINE TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130823",
"SamplePackage": "Y",
"IndicationAndUsage": "MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older.",
"Description": "MIRVASO (brimonidine) topical gel, 0.33% contains brimonidine tartrate, an alpha adrenergic agonist. The molecular formula of brimonidine tartrate is C 11H 10BrN 5 C 4H 6O 6. It has the following structural formula:. Chemically, brimonidine tartrate is 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Brimonidine tartrate has a molecular weight of 442.24 and appears as white to slightly yellowish powder. Each gram of MIRVASO (brimonidine) topical gel, 0.33% contains 5 mg of the active ingredient brimonidine tartrate (equivalent to 3.3 mg of brimonidine free base), in a white to light yellow opaque gel composed of the inactive ingredients carbomer homopolymer type B, glycerin, methylparaben, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, and titanium dioxide."
},
{
"NDCCode": "10096-0299-2",
"PackageDescription": "1 JAR in 1 CARTON (10096-0299-2) > 50 mL in 1 JAR (10096-0299-1)",
"NDC11Code": "10096-0299-02",
"ProductNDC": "10096-0299",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Avon Elements",
"ProprietaryNameSuffix": "Youth-restoring Anti-wrinkle Moisture",
"NonProprietaryName": "Octinoxate, Octisalate, Oxybenzone, Avobenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "New Avon LLC",
"SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE",
"StrengthNumber": "71.2; 47.5; 20; 20",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses: 1 helps prevent sunburn."
},
{
"NDCCode": "13537-299-02",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (13537-299-02) > 30 mL in 1 BOTTLE, PLASTIC (13537-299-01)",
"NDC11Code": "13537-0299-02",
"ProductNDC": "13537-299",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Natural Finish Moisturizing Foundation Spf 25",
"ProprietaryNameSuffix": "(medium 6a) - Brown",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".065; .016",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "15631-0299-2",
"PackageDescription": "400 PELLET in 1 PACKAGE (15631-0299-2) ",
"NDC11Code": "15631-0299-02",
"ProductNDC": "15631-0299",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Murex Purpurea",
"NonProprietaryName": "Murex Purpurea",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150910",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE",
"StrengthNumber": "2",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0299-3822-02</NDCCode>
<PackageDescription>12 TRAY in 1 BOX (0299-3822-02) / 8 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00299-3822-02</NDC11Code>
<ProductNDC>0299-3822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oracea</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100514</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050805</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150201</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<Description>ORACEA (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22H 24N 2O 8). The structural formula of doxycycline, USP is. with an empirical formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water. Inert ingredients in the formulation are: hard gelatin capsule, hypromellose, methacrylic acid copolymer, Opadry beige, sugar spheres, talc, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>0026-3822-25</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0026-3822-25) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-01) </PackageDescription>
<NDC11Code>00026-3822-25</NDC11Code>
<ProductNDC>0026-3822</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Kovaltry</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160317</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125574</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.</IndicationAndUsage>
<Description>KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates.</Description>
</NDC>
<NDC>
<NDCCode>0026-3822-99</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0026-3822-99) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-01) </PackageDescription>
<NDC11Code>00026-3822-99</NDC11Code>
<ProductNDC>0026-3822</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Kovaltry</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160317</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125574</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.</IndicationAndUsage>
<Description>KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates.</Description>
</NDC>
<NDC>
<NDCCode>37662-3822-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-3822-2) </PackageDescription>
<NDC11Code>37662-3822-02</NDC11Code>
<ProductNDC>37662-3822</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acidum Sulphuricum</ProprietaryName>
<NonProprietaryName>Acidum Sulphuricum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230822</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>SULFURIC ACID</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-08-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70518-3822-2</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (70518-3822-2) </PackageDescription>
<NDC11Code>70518-3822-02</NDC11Code>
<ProductNDC>70518-3822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212517</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Tablets are indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis, 5 tendonitis, 6 bursitis, 7 acute gout.</IndicationAndUsage>
<Description>Naproxen tablets, USP are nonsteroidal anti-inflammatory drugs and available as follows: Naproxen tablets, USP are available as light yellow round shaped tablets containing 250 mg naproxen, light yellow capsule shaped tablets containing 375 mg naproxen, and light yellow oblong shaped tablets containing 500 mg naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. It has the following structural formula:. Naproxen is white or almost white crystalline powder. It is insoluble in water, soluble in chloroform, dehydrated ethanol and methanol. Sparingly soluble in ether. The octanol/water partition coefficient of Naproxen at pH < 2.18 is 3.18. Each naproxen tablet, USP contains the following inactive ingredients: croscarmellose sodium, yellow iron oxide, povidone and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0299-3822-04</NDCCode>
<PackageDescription>4 CAPSULE in 1 BLISTER PACK (0299-3822-04) </PackageDescription>
<NDC11Code>00299-3822-04</NDC11Code>
<ProductNDC>0299-3822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oracea</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100514</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050805</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100514</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<Description>ORACEA (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22H 24N 2O 8). The structural formula of doxycycline, USP is. with an empirical formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water. Inert ingredients in the formulation are: hard gelatin capsule, hypromellose, methacrylic acid copolymer, Opadry beige, sugar spheres, talc, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>0299-3822-05</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 PACKAGE (0299-3822-05) / 4 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00299-3822-05</NDC11Code>
<ProductNDC>0299-3822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oracea</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100514</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050805</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100514</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<Description>ORACEA (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22H 24N 2O 8). The structural formula of doxycycline, USP is. with an empirical formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water. Inert ingredients in the formulation are: hard gelatin capsule, hypromellose, methacrylic acid copolymer, Opadry beige, sugar spheres, talc, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>0299-3822-06</NDCCode>
<PackageDescription>16 KIT in 1 BOX (0299-3822-06) / 1 BLISTER PACK in 1 KIT / 4 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00299-3822-06</NDC11Code>
<ProductNDC>0299-3822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oracea</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100514</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050805</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100514</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<Description>ORACEA (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22H 24N 2O 8). The structural formula of doxycycline, USP is. with an empirical formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water. Inert ingredients in the formulation are: hard gelatin capsule, hypromellose, methacrylic acid copolymer, Opadry beige, sugar spheres, talc, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>0299-3822-07</NDCCode>
<PackageDescription>24 TRAY in 1 BOX (0299-3822-07) / 4 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00299-3822-07</NDC11Code>
<ProductNDC>0299-3822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oracea</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100514</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050805</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>ORACEA (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C22H24N2O8). The structural formula of doxycycline, USP is. with an empirical formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water. Inert ingredients in the formulation are: hypromellose, iron oxide red, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>0299-3822-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0299-3822-30) </PackageDescription>
<NDC11Code>00299-3822-30</NDC11Code>
<ProductNDC>0299-3822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oracea</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100514</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050805</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>ORACEA (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C22H24N2O8). The structural formula of doxycycline, USP is. with an empirical formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water. Inert ingredients in the formulation are: hypromellose, iron oxide red, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>58036-3822-1</NDCCode>
<PackageDescription>25 kg in 1 CARTON (58036-3822-1)</PackageDescription>
<NDC11Code>58036-3822-01</NDC11Code>
<ProductNDC>58036-3822</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ferrous Fumarate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19900216</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>FERROPHARMA</LabelerName>
<SubstanceName>FERROUS FUMARATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0299-3674-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0299-3674-02) > 56 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-3674-02</NDC11Code>
<ProductNDC>0299-3674</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benzac</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-09-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>0299-3823-02</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (0299-3823-02) / 2 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-3823-02</NDC11Code>
<ProductNDC>0299-3823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Soolantra</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206255</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.</IndicationAndUsage>
<Description>SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of SOOLANTRA cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0% and not more than 102.0% of 5-O-demethyl-22,23-dihydroavermectin A 1aplus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a, generally referred to as 22,23-dihydroavermectin B 1aand B 1bor H 2B 1aand H 2B 1b, respectively; and the ratio (calculated by area percentage) of component H 2B 1a/(H 2B 1a+ H 2B 1b) is not less than 90.0%. The respective empirical formulas of H 2B 1aand H 2B 1bare C 48H 74O 14and C 47H 72O 14with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H 2B 1a: R = C 2H 5, Component H 2B 1b: R = CH 3. SOOLANTRA cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol.</Description>
</NDC>
<NDC>
<NDCCode>0299-3838-02</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0299-3838-02) > 59 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00299-3838-02</NDC11Code>
<ProductNDC>0299-3838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metrolotion</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19981124</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020901</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19981124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MetroLotion® Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.</IndicationAndUsage>
<Description>MetroLotion® (metronidazole lotion) Topical Lotion contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75% w/w) in a lotion consisting of benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, PEG-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust pH. Metronidazole is an imidazole and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1H-imidazole-1-ethanol. The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0299-3848-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0299-3848-02) / 59 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00299-3848-02</NDC11Code>
<ProductNDC>0299-3848</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobex</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20030801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021535</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLOBEX (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>CLOBEX (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 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0299-3849-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0299-3849-02) / 59 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00299-3849-02</NDC11Code>
<ProductNDC>0299-3849</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobex</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20051027</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021835</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>CLOBEX ®(clobetasol propionate) Spray, 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 C 25H 32CIFO 5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX ®Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.</Description>
</NDC>
<NDC>
<NDCCode>0299-3928-02</NDCCode>
<PackageDescription>4 mL in 1 POUCH (0299-3928-02)</PackageDescription>
<NDC11Code>00299-3928-02</NDC11Code>
<ProductNDC>0299-3928</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetaphil</ProprietaryName>
<NonProprietaryName>Octocrylene, Avobenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20000401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 10</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-02-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>0299-3930-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0299-3930-02) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>00299-3930-02</NDC11Code>
<ProductNDC>0299-3930</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetaphil Daily Facial Moisturizer Spf 50</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate, Octocrylene, Oxybenzone, Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>7.5; 5; 7; 6; 5.7</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0299-4930-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0299-4930-02) / 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>00299-4930-02</NDC11Code>
<ProductNDC>0299-4930</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetaphil Daily Facial Moisturizer With Suncreen Spf 50</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate, Octocrylene, Oxybenzone, Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>75; 50; 70; 60; 57</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-04-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0299-5765-02</NDCCode>
<PackageDescription>59 g in 1 BOTTLE (0299-5765-02) </PackageDescription>
<NDC11Code>00299-5765-02</NDC11Code>
<ProductNDC>0299-5765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desowen</ProprietaryName>
<NonProprietaryName>Desonide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19880715</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072354</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>DESONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19880715</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0299-5906-02</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (0299-5906-02) / 2 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-5906-02</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5908-02</NDCCode>
<PackageDescription>2 g in 1 TUBE (0299-5908-02) </PackageDescription>
<NDC11Code>00299-5908-02</NDC11Code>
<ProductNDC>0299-5908</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081208</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022320</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081208</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>EPIDUO (adapalene and benzoyl peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Active: Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5912-02</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-5912-02) / 59 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5912-02</NDC11Code>
<ProductNDC>0299-5912</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Differin</ProprietaryName>
<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100331</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022502</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100427</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DIFFERIN Lotion is indicated for the topical treatment of acne vulgaris in patients 12 years and older.</IndicationAndUsage>
<Description>DIFFERIN (adapalene) Lotion, for topical use, contains adapalene in a white to off-white oil-in-water emulsion. Adapalene is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4methoxyphenyl]- 2-naphthoic acid). Adapalene has the following structural formula. Adapalene. Molecular formula: C 28H 28O 3 Molecular weight: 412.5 Each gram of DIFFERIN Lotion contains 1 mg of adapalene. The lotion also contains the following inactive ingredients: carbomer 941, disodium edetate, medium chain triglycerides, methylparaben, phenoxyethanol, poloxamer 124, polyoxyl-6-polyoxyl-32 palmitostearate, PPG12/SMDI copolymer, propylene glycol, propylparaben, purified water, sodium hydroxide, and stearyl alcohol.</Description>
</NDC>
<NDC>
<NDCCode>0299-5918-02</NDCCode>
<PackageDescription>2 g in 1 TUBE (0299-5918-02) </PackageDescription>
<NDC11Code>00299-5918-02</NDC11Code>
<ProductNDC>0299-5918</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Differin</ProprietaryName>
<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021753</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.</IndicationAndUsage>
<Description>DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0299-5935-02</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (0299-5935-02) / 2 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-5935-02</NDC11Code>
<ProductNDC>0299-5935</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aklief</ProprietaryName>
<NonProprietaryName>Trifarotene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191004</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211527</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>TRIFAROTENE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191004</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>AKLIEF Cream for topical administration contains 0.005% (50 mcg/g) trifarotene. Trifarotene is a terphenyl acid derivative and is a retinoid. The chemical name of trifarotene is 3”-tert-Butyl-4’-(2-hydroxy-ethoxy)-4”-pyrrolidin-1-yl-[1,1’,3’,1”]terphenyl-4- carboxylic acid. Trifarotene has the molecular formula of C 29H 33NO 4, the molecular weight of 459.58, and the following structural formula:. Trifarotene is a white to off-white to slightly yellow powder with the melting point of 245°C. It is practically insoluble in water with pKa1 of 5.69 and pKa2 of 4.55. AKLIEF (trifarotene) Cream 0.005% contains the following inactive ingredients: allantoin, copolymer of acrylamide and sodium acryloyldimethyltaurate dispersion 40% in isohexadecane, cyclomethicone, 95% (v/v) ethanol, medium-chain triglycerides, phenoxyethanol, propylene glycol, purified water.</Description>
</NDC>
<NDC>
<NDCCode>0299-5950-02</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (0299-5950-02) / 3 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-5950-02</NDC11Code>
<ProductNDC>0299-5950</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-luma</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide, Hydroquinone, And Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20020118</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021112</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN</SubstanceName>
<StrengthNumber>.1; 40; .5</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120401</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<Description>TRI-LUMA (fluocinolone acetonide, hydroquinone, and tretinoin) Cream, 0.01%/4%/0.05% contains fluocinolone acetonide, USP, hydroquinone, USP, and tretinoin, USP, in a light yellow, hydrophilic cream base for topical application. Fluocinolone acetonide is a synthetic fluorinated corticosteroid. It is a white crystalline powder that is odorless and stable in light. The chemical name for fluocinolone acetonide is: (6α,11β,16α)-6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-pregna-1,-4-diene-3,20-dione. The molecular formula is C 24H 30F 2O 6and molecular weight is 452.50. Fluocinolone acetonide has the following structural formula. Hydroquinone is a melanin synthesis inhibitor. It is prepared from the reduction of p-benzoquinone with sodium bisulfite. It occurs as fine white needles that darken on exposure to air. The chemical name for hydroquinone is: 1,4-benzenediol. The molecular formula is C 6H 6O 2and molecular weight is 110.11. Hydroquinone has the following structural formula. Tretinoin, a retinoid, is all- trans-retinoic acid formed from the oxidation of the aldehyde group of retinene to a carboxyl group. It occurs as yellow to light-orange crystals or crystalline powder with a characteristic odor of ensilage. It is highly reactive to light and moisture. The chemical name for tretinoin is: ( all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. The molecular formula is C 20H 28O 2and molecular weight is 300.44. Tretinoin has the following structural formula. Each gram of TRI-LUMA Cream contains Active:fluocinolone acetonide 0.01% (0.1 mg), hydroquinone 4% (40 mg), and tretinoin 0.05% (0.5 mg). Inactive:butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl alcohol.</Description>
</NDC>
<NDC>
<NDCCode>0299-5980-02</NDCCode>
<PackageDescription>2 g in 1 TUBE (0299-5980-02) </PackageDescription>
<NDC11Code>00299-5980-02</NDC11Code>
<ProductNDC>0299-5980</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirvaso</ProprietaryName>
<NonProprietaryName>Brimonidine Tartrate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130823</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204708</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>BRIMONIDINE TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130823</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older.</IndicationAndUsage>
<Description>MIRVASO (brimonidine) topical gel, 0.33% contains brimonidine tartrate, an alpha adrenergic agonist. The molecular formula of brimonidine tartrate is C 11H 10BrN 5 C 4H 6O 6. It has the following structural formula:. Chemically, brimonidine tartrate is 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Brimonidine tartrate has a molecular weight of 442.24 and appears as white to slightly yellowish powder. Each gram of MIRVASO (brimonidine) topical gel, 0.33% contains 5 mg of the active ingredient brimonidine tartrate (equivalent to 3.3 mg of brimonidine free base), in a white to light yellow opaque gel composed of the inactive ingredients carbomer homopolymer type B, glycerin, methylparaben, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>10096-0299-2</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (10096-0299-2) > 50 mL in 1 JAR (10096-0299-1)</PackageDescription>
<NDC11Code>10096-0299-02</NDC11Code>
<ProductNDC>10096-0299</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Avon Elements</ProprietaryName>
<ProprietaryNameSuffix>Youth-restoring Anti-wrinkle Moisture</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate, Oxybenzone, Avobenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>New Avon LLC</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE</SubstanceName>
<StrengthNumber>71.2; 47.5; 20; 20</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: 1 helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-299-02</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (13537-299-02) > 30 mL in 1 BOTTLE, PLASTIC (13537-299-01)</PackageDescription>
<NDC11Code>13537-0299-02</NDC11Code>
<ProductNDC>13537-299</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Natural Finish Moisturizing Foundation Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(medium 6a) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131216</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.065; .016</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0299-2</NDCCode>
<PackageDescription>400 PELLET in 1 PACKAGE (15631-0299-2) </PackageDescription>
<NDC11Code>15631-0299-02</NDC11Code>
<ProductNDC>15631-0299</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Murex Purpurea</ProprietaryName>
<NonProprietaryName>Murex Purpurea</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150910</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
</NDCList>