{
"NDC": [
{
"NDCCode": "78376-242-33",
"PackageDescription": "1000 mL in 1 BOTTLE (78376-242-33) ",
"NDC11Code": "78376-0242-33",
"ProductNDC": "78376-242",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Evaxo Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Evaxo International Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Use To decrease bacterial on the skin that could cause disease. Recommended for repeated use."
},
{
"NDCCode": "78376-236-33",
"PackageDescription": "1000 mL in 1 BOTTLE (78376-236-33) ",
"NDC11Code": "78376-0236-33",
"ProductNDC": "78376-236",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Evaxo Advanced Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Evaxo International Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Use Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "52686-242-60",
"PackageDescription": "1 TUBE in 1 CARTON (52686-242-60) > 33.45 g in 1 TUBE",
"NDC11Code": "52686-0242-60",
"ProductNDC": "52686-242",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Perfect Refining Foundation",
"ProprietaryNameSuffix": "O00",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICA INC.",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".63555; 1.37145",
"StrengthUnit": "g/33.45g; g/33.45g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110201",
"SamplePackage": "N"
},
{
"NDCCode": "62932-242-33",
"PackageDescription": "14 g in 1 CONTAINER (62932-242-33) ",
"NDC11Code": "62932-0242-33",
"ProductNDC": "62932-242",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen",
"NonProprietaryName": "Zinc Oxide Sunscreen",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Private Label Select Ltd CO",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "20",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N"
},
{
"NDCCode": "67877-242-33",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (67877-242-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "67877-0242-33",
"ProductNDC": "67877-242",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201504",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130301",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "83457-243-02",
"PackageDescription": "2 KIT in 1 CARTON (83457-243-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-242-01) / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01) ",
"NDC11Code": "83457-0243-02",
"ProductNDC": "83457-243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20240214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "Cordavis Limited",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240214",
"SamplePackage": "N",
"IndicationAndUsage": "HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1) , 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2) , 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3) , 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8) , 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9) .",
"Description": "Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP."
},
{
"NDCCode": "78376-234-32",
"PackageDescription": "946.6 mL in 1 BOTTLE (78376-234-32) ",
"NDC11Code": "78376-0234-32",
"ProductNDC": "78376-234",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Evaxo 3% Hydrogen Peroxide",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Evaxo International Inc",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Uses *First aid to help prevent the risk of infection in minor cuts, scrapes, and burns. *Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth."
},
{
"NDCCode": "78376-235-16",
"PackageDescription": "473 mL in 1 BOTTLE (78376-235-16) ",
"NDC11Code": "78376-0235-16",
"ProductNDC": "78376-235",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Evaxo 70% Ethyl Rubbing Alcohol",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Evaxo International Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Uses First aid to help prevent the risk of infection in minor cuts, scrapes, and burns."
},
{
"NDCCode": "78376-237-08",
"PackageDescription": "236 mL in 1 BOTTLE (78376-237-08) ",
"NDC11Code": "78376-0237-08",
"ProductNDC": "78376-237",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Evaxo Advanced Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Evaxo International Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Use Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "78376-237-67",
"PackageDescription": "2002 mL in 1 BOTTLE (78376-237-67) ",
"NDC11Code": "78376-0237-67",
"ProductNDC": "78376-237",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Evaxo Advanced Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Evaxo International Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Use Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "78376-239-08",
"PackageDescription": "236 mL in 1 BOTTLE (78376-239-08) ",
"NDC11Code": "78376-0239-08",
"ProductNDC": "78376-239",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Free Evaxo Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Evaxo International Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Use To decrease bacterial on the skin that could cause disease. Recommended for repeated use."
},
{
"NDCCode": "78376-241-32",
"PackageDescription": "946.6 mL in 1 BOTTLE (78376-241-32) ",
"NDC11Code": "78376-0241-32",
"ProductNDC": "78376-241",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Evaxo 91% Isopropyl Alcohol",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Evaxo International Inc",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "91",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Uses First aid to help prevent the risk of infection in minor cuts, scrapes, and burns."
},
{
"NDCCode": "0093-6303-45",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0093-6303-45) > 45 g in 1 BOTTLE, PUMP",
"NDC11Code": "00093-6303-45",
"ProductNDC": "0093-6303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene And Benzoyl Peroxide",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211201",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA207917",
"LabelerName": "TEVA PHARMACEUTICALS USA, INC",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "3; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211201",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Adapalene and Benzoyl Peroxide gel is indicated for the topical treatment of acne vulgaris.",
"Description": "Adapalene and Benzoyl Peroxide (adapalene and benzoyl peroxide) 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: C28H28O3 Molecular 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: C14H10O4 Molecular weight: 242.23. Adapalene and Benzoyl Peroxide 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": "0173-0874-10",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0874-10) / 30 POWDER in 1 INHALER",
"NDC11Code": "00173-0874-10",
"ProductNDC": "0173-0874",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arnuity Ellipta",
"NonProprietaryName": "Fluticasone Furoate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140820",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205625",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE",
"StrengthNumber": "100",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140820",
"SamplePackage": "N",
"IndicationAndUsage": "ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.",
"Description": "ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0874-14",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0874-14) / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0874-14",
"ProductNDC": "0173-0874",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arnuity Ellipta",
"NonProprietaryName": "Fluticasone Furoate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140820",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205625",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE",
"StrengthNumber": "100",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140820",
"SamplePackage": "N",
"IndicationAndUsage": "ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.",
"Description": "ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0876-10",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0876-10) / 30 POWDER in 1 INHALER",
"NDC11Code": "00173-0876-10",
"ProductNDC": "0173-0876",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arnuity Ellipta",
"NonProprietaryName": "Fluticasone Furoate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140820",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205625",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140820",
"SamplePackage": "N",
"IndicationAndUsage": "ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.",
"Description": "ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0876-14",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0876-14) / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0876-14",
"ProductNDC": "0173-0876",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arnuity Ellipta",
"NonProprietaryName": "Fluticasone Furoate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140820",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205625",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140820",
"SamplePackage": "N",
"IndicationAndUsage": "ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.",
"Description": "ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0888-10",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0888-10) / 30 POWDER in 1 INHALER",
"NDC11Code": "00173-0888-10",
"ProductNDC": "0173-0888",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arnuity Ellipta",
"NonProprietaryName": "Fluticasone Furoate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20180517",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205625",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180517",
"SamplePackage": "N",
"IndicationAndUsage": "ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.",
"Description": "ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0187-0006-10",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0187-0006-10) / 20 g in 1 BOTTLE, PUMP",
"NDC11Code": "00187-0006-10",
"ProductNDC": "0187-0006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cabtreo",
"NonProprietaryName": "Clindamycin Phosphate/benzoyl Peroxide/adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216632",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE; ADAPALENE",
"StrengthNumber": "12; 31; 1.5",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.",
"Description": "CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque gel. Each gram of CABTREO contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin and 1.5 mg (0.15%) adapalene, and 31 mg (3.1%) benzoyl peroxide. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. Benzoyl peroxide is an oxidizing agent. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C 18H 34ClN 2O 8PS Molecular Weight: 504.97. The chemical name for adapalene is 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid. The structural formula for adapalene is represented below. Adapalene. Molecular Formula: C 28H 28O 3. Molecular Weight: 412.52. The chemical name for benzoyl peroxide is dibenzoyl peroxide. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C 14H 10O 4 Molecular Weight: 242.23. CABTREO contains the following inactive ingredients: carbomer homopolymer type C (carbomer 980), potassium hydroxide, propylene glycol, and purified water."
},
{
"NDCCode": "0187-0006-25",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0187-0006-25) / 50 g in 1 BOTTLE, PUMP",
"NDC11Code": "00187-0006-25",
"ProductNDC": "0187-0006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cabtreo",
"NonProprietaryName": "Clindamycin Phosphate/benzoyl Peroxide/adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216632",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE; ADAPALENE",
"StrengthNumber": "12; 31; 1.5",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.",
"Description": "CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque gel. Each gram of CABTREO contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin and 1.5 mg (0.15%) adapalene, and 31 mg (3.1%) benzoyl peroxide. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. Benzoyl peroxide is an oxidizing agent. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C 18H 34ClN 2O 8PS Molecular Weight: 504.97. The chemical name for adapalene is 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid. The structural formula for adapalene is represented below. Adapalene. Molecular Formula: C 28H 28O 3. Molecular Weight: 412.52. The chemical name for benzoyl peroxide is dibenzoyl peroxide. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C 14H 10O 4 Molecular Weight: 242.23. CABTREO contains the following inactive ingredients: carbomer homopolymer type C (carbomer 980), potassium hydroxide, propylene glycol, and purified water."
},
{
"NDCCode": "0187-0006-35",
"PackageDescription": "3.5 g in 1 TUBE (0187-0006-35) ",
"NDC11Code": "00187-0006-35",
"ProductNDC": "0187-0006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cabtreo",
"NonProprietaryName": "Clindamycin Phosphate/benzoyl Peroxide/adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216632",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE; ADAPALENE",
"StrengthNumber": "12; 31; 1.5",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "Y",
"IndicationAndUsage": "CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.",
"Description": "CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque gel. Each gram of CABTREO contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin and 1.5 mg (0.15%) adapalene, and 31 mg (3.1%) benzoyl peroxide. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. Benzoyl peroxide is an oxidizing agent. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C 18H 34ClN 2O 8PS Molecular Weight: 504.97. The chemical name for adapalene is 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid. The structural formula for adapalene is represented below. Adapalene. Molecular Formula: C 28H 28O 3. Molecular Weight: 412.52. The chemical name for benzoyl peroxide is dibenzoyl peroxide. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C 14H 10O 4 Molecular Weight: 242.23. CABTREO contains the following inactive ingredients: carbomer homopolymer type C (carbomer 980), potassium hydroxide, propylene glycol, and purified water."
},
{
"NDCCode": "0187-3050-35",
"PackageDescription": "3.5 g in 1 TUBE (0187-3050-35) ",
"NDC11Code": "00187-3050-35",
"ProductNDC": "0187-3050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Onexton",
"NonProprietaryName": "Clindamycin Phosphate And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141124",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050819",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE",
"StrengthNumber": "10; 37.5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2025-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141124",
"SamplePackage": "N",
"IndicationAndUsage": "ONEXTON® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "ONEXTON Gel is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)‑hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6- (1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C14H10O4 Molecular Weight: 242.23. ONEXTON Gel contains the following inactive ingredients: carbomer 980, potassium hydroxide, propylene glycol, and purified water. Each gram of ONEXTON Gel contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin, and 37.5 mg (3.75%) benzoyl peroxide."
},
{
"NDCCode": "0187-3050-50",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0187-3050-50) / 50 g in 1 BOTTLE, PUMP",
"NDC11Code": "00187-3050-50",
"ProductNDC": "0187-3050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Onexton",
"NonProprietaryName": "Clindamycin Phosphate And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141124",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050819",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE",
"StrengthNumber": "10; 37.5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2025-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141124",
"SamplePackage": "N",
"IndicationAndUsage": "ONEXTON® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "ONEXTON Gel is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)‑hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6- (1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C14H10O4 Molecular Weight: 242.23. ONEXTON Gel contains the following inactive ingredients: carbomer 980, potassium hydroxide, propylene glycol, and purified water. Each gram of ONEXTON Gel contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin, and 37.5 mg (3.75%) benzoyl peroxide."
},
{
"NDCCode": "0187-5205-46",
"PackageDescription": "1 KIT in 1 BOX (0187-5205-46) * 1.6 g in 1 VIAL, PLASTIC * 40 g in 1 JAR",
"NDC11Code": "00187-5205-46",
"ProductNDC": "0187-5205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzamycin",
"NonProprietaryName": "Erythromycin And Benzoyl Peroxide",
"DosageFormName": "KIT",
"StartMarketingDate": "19841026",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050557",
"LabelerName": "Bausch Health US, LLC",
"Status": "Active",
"LastUpdate": "2021-01-08",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Benzamycin Topical Gel is indicated for the topical treatment of acne vulgaris.",
"Description": "Benzamycin® Topical Gel contains erythromycin [(3R*,4S*,5S*,6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione]. Erythromycin is a macrolide antibiotic produced from a strain of Saccharopolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. Chemically erythromycin is C37H67NO13. It has the following structural formula. Erythromycin has the molecular weight of 733.94. It is a white crystalline powder and has a solubility of approximately 1 mg/mL in water and is soluble in alcohol at 25°C. Benzamycin Topical Gel also contains benzoyl peroxide for topical use. Benzoyl peroxide is an antibacterial and keratolytic agent. Chemically benzoyl peroxide is C14H10O4. It has the following structural formula. Benzoyl peroxide has the molecular weight of 242.23. It is a white granular powder and is sparingly soluble in water and alcohol and soluble in acetone, chloroform and ether. Each gram of Benzamycin Topical Gel contains, as dispensed, 30 mg (3%) of erythromycin and 50 mg (5%) of benzoyl peroxide in a base of purified water USP, Carbomer Homopolymer Type C, alcohol 20%, sodium hydroxide NF, docusate sodium and fragrance."
},
{
"NDCCode": "0299-5890-00",
"PackageDescription": "3 g in 1 BOTTLE, PUMP (0299-5890-00) ",
"NDC11Code": "00299-5890-00",
"ProductNDC": "0299-5890",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epsolay",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220509",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214510",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220509",
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"SamplePackage": "Y",
"IndicationAndUsage": "EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults.",
"Description": "EPSOLAY (benzoyl peroxide) cream is for topical use. Each gram of EPSOLAY contains 50 mg of benzoyl peroxide.The chemical name for benzoyl peroxide is benzoyl benzenecarboperoxoate. It has the following structural formula. Molecular Formula: C14H10O4 Molecular Weight: 242.23. The benzoyl peroxide in EPSOLAY is in a solid form that is incorporated into a microcapsule composed of silicon dioxide, cetrimonium chloride and polyquaternium-7. EPSOLAY contains anhydrous citric acid, cetrimonium chloride, cetyl alcohol, cyclomethicone, edetate disodium, glycerin, hydrochloric acid, lactic acid, macrogol stearate Type I, mono and di-glycerides, phenoxyethanol, polyquaternium-7, purified water, silicon dioxide and sodium hydroxide as inactive ingredients."
},
{
"NDCCode": "0299-5890-30",
"PackageDescription": "1 BOTTLE, PUMP in 1 BOX (0299-5890-30) / 30 g in 1 BOTTLE, PUMP",
"NDC11Code": "00299-5890-30",
"ProductNDC": "0299-5890",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epsolay",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220509",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214510",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220527",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults.",
"Description": "EPSOLAY (benzoyl peroxide) cream is for topical use. Each gram of EPSOLAY contains 50 mg of benzoyl peroxide.The chemical name for benzoyl peroxide is benzoyl benzenecarboperoxoate. It has the following structural formula. Molecular Formula: C14H10O4 Molecular Weight: 242.23. The benzoyl peroxide in EPSOLAY is in a solid form that is incorporated into a microcapsule composed of silicon dioxide, cetrimonium chloride and polyquaternium-7. EPSOLAY contains anhydrous citric acid, cetrimonium chloride, cetyl alcohol, cyclomethicone, edetate disodium, glycerin, hydrochloric acid, lactic acid, macrogol stearate Type I, mono and di-glycerides, phenoxyethanol, polyquaternium-7, purified water, silicon dioxide and sodium hydroxide as inactive ingredients."
},
{
"NDCCode": "0299-5906-00",
"PackageDescription": "2 g in 1 TUBE (0299-5906-00) ",
"NDC11Code": "00299-5906-00",
"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",
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"StartMarketingDatePackage": "20191101",
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"IndicationAndUsage": "EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.",
"Description": "EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
},
{
"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": "0299-5906-05",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (0299-5906-05) / 5 g in 1 TUBE",
"NDC11Code": "00299-5906-05",
"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",
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"StartMarketingDatePackage": "20150701",
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"IndicationAndUsage": "EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.",
"Description": "EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
},
{
"NDCCode": "0299-5906-15",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0299-5906-15) / 15 g in 1 BOTTLE, PUMP",
"NDC11Code": "00299-5906-15",
"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",
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"IndicationAndUsage": "EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.",
"Description": "EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
}
]
}
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<NDC>
<NDCCode>78376-242-33</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (78376-242-33) </PackageDescription>
<NDC11Code>78376-0242-33</NDC11Code>
<ProductNDC>78376-242</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Evaxo Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Evaxo International Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use To decrease bacterial on the skin that could cause disease. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78376-236-33</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (78376-236-33) </PackageDescription>
<NDC11Code>78376-0236-33</NDC11Code>
<ProductNDC>78376-236</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Evaxo Advanced Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Evaxo International Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
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<NDC>
<NDCCode>52686-242-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52686-242-60) > 33.45 g in 1 TUBE</PackageDescription>
<NDC11Code>52686-0242-60</NDC11Code>
<ProductNDC>52686-242</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Perfect Refining Foundation</ProprietaryName>
<ProprietaryNameSuffix>O00</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICA INC.</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.63555; 1.37145</StrengthNumber>
<StrengthUnit>g/33.45g; g/33.45g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62932-242-33</NDCCode>
<PackageDescription>14 g in 1 CONTAINER (62932-242-33) </PackageDescription>
<NDC11Code>62932-0242-33</NDC11Code>
<ProductNDC>62932-242</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunscreen</ProprietaryName>
<NonProprietaryName>Zinc Oxide Sunscreen</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Private Label Select Ltd CO</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>67877-242-33</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (67877-242-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>67877-0242-33</NDC11Code>
<ProductNDC>67877-242</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine</ProprietaryName>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201504</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>83457-243-02</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (83457-243-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-242-01) / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01) </PackageDescription>
<NDC11Code>83457-0243-02</NDC11Code>
<ProductNDC>83457-243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humira</ProprietaryName>
<NonProprietaryName>Adalimumab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125057</ApplicationNumber>
<LabelerName>Cordavis Limited</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1) , 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2) , 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3) , 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8) , 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9) .</IndicationAndUsage>
<Description>Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>78376-234-32</NDCCode>
<PackageDescription>946.6 mL in 1 BOTTLE (78376-234-32) </PackageDescription>
<NDC11Code>78376-0234-32</NDC11Code>
<ProductNDC>78376-234</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Evaxo 3% Hydrogen Peroxide</ProprietaryName>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Evaxo International Inc</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses *First aid to help prevent the risk of infection in minor cuts, scrapes, and burns. *Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78376-235-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (78376-235-16) </PackageDescription>
<NDC11Code>78376-0235-16</NDC11Code>
<ProductNDC>78376-235</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Evaxo 70% Ethyl Rubbing Alcohol</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Evaxo International Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses First aid to help prevent the risk of infection in minor cuts, scrapes, and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78376-237-08</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE (78376-237-08) </PackageDescription>
<NDC11Code>78376-0237-08</NDC11Code>
<ProductNDC>78376-237</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Evaxo Advanced Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Evaxo International Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78376-237-67</NDCCode>
<PackageDescription>2002 mL in 1 BOTTLE (78376-237-67) </PackageDescription>
<NDC11Code>78376-0237-67</NDC11Code>
<ProductNDC>78376-237</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Evaxo Advanced Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Evaxo International Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78376-239-08</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE (78376-239-08) </PackageDescription>
<NDC11Code>78376-0239-08</NDC11Code>
<ProductNDC>78376-239</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Free Evaxo Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Evaxo International Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use To decrease bacterial on the skin that could cause disease. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78376-241-32</NDCCode>
<PackageDescription>946.6 mL in 1 BOTTLE (78376-241-32) </PackageDescription>
<NDC11Code>78376-0241-32</NDC11Code>
<ProductNDC>78376-241</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Evaxo 91% Isopropyl Alcohol</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Evaxo International Inc</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>91</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses First aid to help prevent the risk of infection in minor cuts, scrapes, and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0093-6303-45</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0093-6303-45) > 45 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00093-6303-45</NDC11Code>
<ProductNDC>0093-6303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211201</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>TEVA PHARMACEUTICALS USA, INC</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211201</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adapalene and Benzoyl Peroxide gel is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Adapalene and Benzoyl Peroxide (adapalene and benzoyl peroxide) 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: C28H28O3 Molecular 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: C14H10O4 Molecular weight: 242.23. Adapalene and Benzoyl Peroxide 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>0173-0874-10</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0874-10) / 30 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0874-10</NDC11Code>
<ProductNDC>0173-0874</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arnuity Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140820</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205625</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0874-14</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0874-14) / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0874-14</NDC11Code>
<ProductNDC>0173-0874</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arnuity Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140820</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205625</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0876-10</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0876-10) / 30 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0876-10</NDC11Code>
<ProductNDC>0173-0876</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arnuity Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140820</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205625</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0876-14</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0876-14) / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0876-14</NDC11Code>
<ProductNDC>0173-0876</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arnuity Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140820</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205625</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0888-10</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0888-10) / 30 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0888-10</NDC11Code>
<ProductNDC>0173-0888</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arnuity Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20180517</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205625</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0187-0006-10</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0187-0006-10) / 20 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00187-0006-10</NDC11Code>
<ProductNDC>0187-0006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cabtreo</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate/benzoyl Peroxide/adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216632</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE; ADAPALENE</SubstanceName>
<StrengthNumber>12; 31; 1.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque gel. Each gram of CABTREO contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin and 1.5 mg (0.15%) adapalene, and 31 mg (3.1%) benzoyl peroxide. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. Benzoyl peroxide is an oxidizing agent. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C 18H 34ClN 2O 8PS Molecular Weight: 504.97. The chemical name for adapalene is 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid. The structural formula for adapalene is represented below. Adapalene. Molecular Formula: C 28H 28O 3. Molecular Weight: 412.52. The chemical name for benzoyl peroxide is dibenzoyl peroxide. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C 14H 10O 4 Molecular Weight: 242.23. CABTREO contains the following inactive ingredients: carbomer homopolymer type C (carbomer 980), potassium hydroxide, propylene glycol, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0187-0006-25</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0187-0006-25) / 50 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00187-0006-25</NDC11Code>
<ProductNDC>0187-0006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cabtreo</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate/benzoyl Peroxide/adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216632</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE; ADAPALENE</SubstanceName>
<StrengthNumber>12; 31; 1.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque gel. Each gram of CABTREO contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin and 1.5 mg (0.15%) adapalene, and 31 mg (3.1%) benzoyl peroxide. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. Benzoyl peroxide is an oxidizing agent. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C 18H 34ClN 2O 8PS Molecular Weight: 504.97. The chemical name for adapalene is 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid. The structural formula for adapalene is represented below. Adapalene. Molecular Formula: C 28H 28O 3. Molecular Weight: 412.52. The chemical name for benzoyl peroxide is dibenzoyl peroxide. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C 14H 10O 4 Molecular Weight: 242.23. CABTREO contains the following inactive ingredients: carbomer homopolymer type C (carbomer 980), potassium hydroxide, propylene glycol, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0187-0006-35</NDCCode>
<PackageDescription>3.5 g in 1 TUBE (0187-0006-35) </PackageDescription>
<NDC11Code>00187-0006-35</NDC11Code>
<ProductNDC>0187-0006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cabtreo</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate/benzoyl Peroxide/adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216632</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE; ADAPALENE</SubstanceName>
<StrengthNumber>12; 31; 1.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque gel. Each gram of CABTREO contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin and 1.5 mg (0.15%) adapalene, and 31 mg (3.1%) benzoyl peroxide. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. Benzoyl peroxide is an oxidizing agent. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C 18H 34ClN 2O 8PS Molecular Weight: 504.97. The chemical name for adapalene is 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid. The structural formula for adapalene is represented below. Adapalene. Molecular Formula: C 28H 28O 3. Molecular Weight: 412.52. The chemical name for benzoyl peroxide is dibenzoyl peroxide. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C 14H 10O 4 Molecular Weight: 242.23. CABTREO contains the following inactive ingredients: carbomer homopolymer type C (carbomer 980), potassium hydroxide, propylene glycol, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0187-3050-35</NDCCode>
<PackageDescription>3.5 g in 1 TUBE (0187-3050-35) </PackageDescription>
<NDC11Code>00187-3050-35</NDC11Code>
<ProductNDC>0187-3050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Onexton</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141124</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050819</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>10; 37.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ONEXTON® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.</IndicationAndUsage>
<Description>ONEXTON Gel is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)‑hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6- (1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C14H10O4 Molecular Weight: 242.23. ONEXTON Gel contains the following inactive ingredients: carbomer 980, potassium hydroxide, propylene glycol, and purified water. Each gram of ONEXTON Gel contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin, and 37.5 mg (3.75%) benzoyl peroxide.</Description>
</NDC>
<NDC>
<NDCCode>0187-3050-50</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0187-3050-50) / 50 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00187-3050-50</NDC11Code>
<ProductNDC>0187-3050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Onexton</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141124</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050819</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>10; 37.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ONEXTON® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.</IndicationAndUsage>
<Description>ONEXTON Gel is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)‑hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6- (1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C14H10O4 Molecular Weight: 242.23. ONEXTON Gel contains the following inactive ingredients: carbomer 980, potassium hydroxide, propylene glycol, and purified water. Each gram of ONEXTON Gel contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin, and 37.5 mg (3.75%) benzoyl peroxide.</Description>
</NDC>
<NDC>
<NDCCode>0187-5205-46</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0187-5205-46) * 1.6 g in 1 VIAL, PLASTIC * 40 g in 1 JAR</PackageDescription>
<NDC11Code>00187-5205-46</NDC11Code>
<ProductNDC>0187-5205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzamycin</ProprietaryName>
<NonProprietaryName>Erythromycin And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19841026</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050557</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2021-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19841026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzamycin Topical Gel is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Benzamycin® Topical Gel contains erythromycin [(3R*,4S*,5S*,6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione]. Erythromycin is a macrolide antibiotic produced from a strain of Saccharopolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. Chemically erythromycin is C37H67NO13. It has the following structural formula. Erythromycin has the molecular weight of 733.94. It is a white crystalline powder and has a solubility of approximately 1 mg/mL in water and is soluble in alcohol at 25°C. Benzamycin Topical Gel also contains benzoyl peroxide for topical use. Benzoyl peroxide is an antibacterial and keratolytic agent. Chemically benzoyl peroxide is C14H10O4. It has the following structural formula. Benzoyl peroxide has the molecular weight of 242.23. It is a white granular powder and is sparingly soluble in water and alcohol and soluble in acetone, chloroform and ether. Each gram of Benzamycin Topical Gel contains, as dispensed, 30 mg (3%) of erythromycin and 50 mg (5%) of benzoyl peroxide in a base of purified water USP, Carbomer Homopolymer Type C, alcohol 20%, sodium hydroxide NF, docusate sodium and fragrance.</Description>
</NDC>
<NDC>
<NDCCode>0299-5890-00</NDCCode>
<PackageDescription>3 g in 1 BOTTLE, PUMP (0299-5890-00) </PackageDescription>
<NDC11Code>00299-5890-00</NDC11Code>
<ProductNDC>0299-5890</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epsolay</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220509</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214510</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220509</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults.</IndicationAndUsage>
<Description>EPSOLAY (benzoyl peroxide) cream is for topical use. Each gram of EPSOLAY contains 50 mg of benzoyl peroxide.The chemical name for benzoyl peroxide is benzoyl benzenecarboperoxoate. It has the following structural formula. Molecular Formula: C14H10O4 Molecular Weight: 242.23. The benzoyl peroxide in EPSOLAY is in a solid form that is incorporated into a microcapsule composed of silicon dioxide, cetrimonium chloride and polyquaternium-7. EPSOLAY contains anhydrous citric acid, cetrimonium chloride, cetyl alcohol, cyclomethicone, edetate disodium, glycerin, hydrochloric acid, lactic acid, macrogol stearate Type I, mono and di-glycerides, phenoxyethanol, polyquaternium-7, purified water, silicon dioxide and sodium hydroxide as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0299-5890-30</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 BOX (0299-5890-30) / 30 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5890-30</NDC11Code>
<ProductNDC>0299-5890</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epsolay</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220509</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214510</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220527</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults.</IndicationAndUsage>
<Description>EPSOLAY (benzoyl peroxide) cream is for topical use. Each gram of EPSOLAY contains 50 mg of benzoyl peroxide.The chemical name for benzoyl peroxide is benzoyl benzenecarboperoxoate. It has the following structural formula. Molecular Formula: C14H10O4 Molecular Weight: 242.23. The benzoyl peroxide in EPSOLAY is in a solid form that is incorporated into a microcapsule composed of silicon dioxide, cetrimonium chloride and polyquaternium-7. EPSOLAY contains anhydrous citric acid, cetrimonium chloride, cetyl alcohol, cyclomethicone, edetate disodium, glycerin, hydrochloric acid, lactic acid, macrogol stearate Type I, mono and di-glycerides, phenoxyethanol, polyquaternium-7, purified water, silicon dioxide and sodium hydroxide as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-00</NDCCode>
<PackageDescription>2 g in 1 TUBE (0299-5906-00) </PackageDescription>
<NDC11Code>00299-5906-00</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-02</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (0299-5906-02) / 2 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-5906-02</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-05</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (0299-5906-05) / 5 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-5906-05</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-15</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-5906-15) / 15 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5906-15</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
</NDCList>