{
"NDC": [
{
"NDCCode": "70445-412-23",
"PackageDescription": "10 mL in 1 BOTTLE, SPRAY (70445-412-23) ",
"NDC11Code": "70445-0412-23",
"ProductNDC": "70445-412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200508",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Webb Business Promotion",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200625",
"SamplePackage": "N",
"IndicationAndUsage": "Antibacterial hand sanitizer spray."
},
{
"NDCCode": "52125-412-23",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (52125-412-23)",
"NDC11Code": "52125-0412-23",
"ProductNDC": "52125-412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150317",
"EndMarketingDate": "20171212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078332",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "70445-412-20",
"PackageDescription": "60 mL in 1 BOTTLE (70445-412-20) ",
"NDC11Code": "70445-0412-20",
"ProductNDC": "70445-412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200508",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Webb Business Promotion",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200508",
"SamplePackage": "N",
"IndicationAndUsage": "Antibacterial hand sanitizer spray."
},
{
"NDCCode": "70445-412-21",
"PackageDescription": "5 mL in 1 BOTTLE, SPRAY (70445-412-21) ",
"NDC11Code": "70445-0412-21",
"ProductNDC": "70445-412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200508",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Webb Business Promotion",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200508",
"SamplePackage": "N",
"IndicationAndUsage": "Antibacterial hand sanitizer spray."
},
{
"NDCCode": "70445-412-22",
"PackageDescription": "120 mL in 1 BOTTLE (70445-412-22) ",
"NDC11Code": "70445-0412-22",
"ProductNDC": "70445-412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200508",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Webb Business Promotion",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200508",
"SamplePackage": "N",
"IndicationAndUsage": "Antibacterial hand sanitizer spray."
},
{
"NDCCode": "70445-412-26",
"PackageDescription": "20 mL in 1 BOTTLE, SPRAY (70445-412-26) ",
"NDC11Code": "70445-0412-26",
"ProductNDC": "70445-412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200508",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Webb Business Promotion",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200625",
"SamplePackage": "N",
"IndicationAndUsage": "Antibacterial hand sanitizer spray."
},
{
"NDCCode": "70445-412-27",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (70445-412-27) ",
"NDC11Code": "70445-0412-27",
"ProductNDC": "70445-412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200508",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Webb Business Promotion",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200508",
"SamplePackage": "N"
},
{
"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": "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": "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",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191101",
"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": "0299-5906-02",
"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",
"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": "0299-5906-15",
"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",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150701",
"SamplePackage": "N",
"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": "0299-5906-30",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0299-5906-30) / 30 g in 1 BOTTLE, PUMP",
"NDC11Code": "00299-5906-30",
"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": "N",
"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": "0299-5906-45",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0299-5906-45) / 45 g in 1 BOTTLE, PUMP",
"NDC11Code": "00299-5906-45",
"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": "N",
"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": "0299-5906-60",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0299-5906-60) / 60 g in 1 BOTTLE, PUMP",
"NDC11Code": "00299-5906-60",
"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": "N",
"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": "0299-5906-70",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0299-5906-70) / 70 g in 1 BOTTLE, PUMP",
"NDC11Code": "00299-5906-70",
"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": "N",
"IndicationAndUsage": "EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.",
"Description": "EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
},
{
"NDCCode": "0299-5908-00",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (0299-5908-00) / 2 g in 1 TUBE",
"NDC11Code": "00299-5908-00",
"ProductNDC": "0299-5908",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epiduo",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022320",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "1; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081208",
"SamplePackage": "Y",
"IndicationAndUsage": "EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "EPIDUO (adapalene and benzoyl peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Active: Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
},
{
"NDCCode": "0299-5908-02",
"PackageDescription": "2 g in 1 TUBE (0299-5908-02) ",
"NDC11Code": "00299-5908-02",
"ProductNDC": "0299-5908",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epiduo",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022320",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "1; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081208",
"SamplePackage": "Y",
"IndicationAndUsage": "EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "EPIDUO (adapalene and benzoyl peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Active: Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
},
{
"NDCCode": "0299-5908-25",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0299-5908-25) / 45 g in 1 BOTTLE, PUMP",
"NDC11Code": "00299-5908-25",
"ProductNDC": "0299-5908",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epiduo",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022320",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "1; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081208",
"SamplePackage": "N",
"IndicationAndUsage": "EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "EPIDUO (adapalene and benzoyl peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Active: Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
},
{
"NDCCode": "0299-5908-45",
"PackageDescription": "1 TUBE in 1 CARTON (0299-5908-45) / 45 g in 1 TUBE",
"NDC11Code": "00299-5908-45",
"ProductNDC": "0299-5908",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epiduo",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022320",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "1; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081208",
"SamplePackage": "N",
"IndicationAndUsage": "EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "EPIDUO (adapalene and benzoyl peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Active: Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate."
},
{
"NDCCode": "0480-3154-45",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0480-3154-45) / 45 g in 1 BOTTLE, PUMP",
"NDC11Code": "00480-3154-45",
"ProductNDC": "0480-3154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene And Benzoyl Peroxide",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221128",
"EndMarketingDate": "20270228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209641",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "3; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221128",
"EndMarketingDatePackage": "20270228",
"SamplePackage": "N",
"IndicationAndUsage": "Adapalene and benzoyl peroxide topical gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.",
"Description": "Adapalene and benzoyl peroxide topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene USP, 0.3% and benzoyl peroxide USP, 2.5%. Adapalene USP, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene, USP is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene, USP. Molecular formula: C28H28O3 Molecular weight: 412.5. Benzoyl peroxide, USP is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide, USP is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide, USP. Molecular formula: C14H10O4 Molecular weight: 242.23. Adapalene and benzoyl peroxide topical gel 0.3%/2.5% contains the following inactive ingredients: carbomer 980, docusate sodium, edetate disodium, glycerin, poloxamer 124, propylene glycol, purified water, sodium hydroxide, and sorbitan monooleate."
},
{
"NDCCode": "0781-7182-19",
"PackageDescription": "1 TUBE in 1 CARTON (0781-7182-19) > 45 g in 1 TUBE",
"NDC11Code": "00781-7182-19",
"ProductNDC": "0781-7182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene And Benzoyl Peroxide",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206164",
"LabelerName": "Sandoz Inc.",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "1; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180523",
"SamplePackage": "N",
"IndicationAndUsage": "Adapalene and benzoyl peroxide gel 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "Adapalene and benzoyl peroxide gel 0.1% / 2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. 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 0.1% / 2.5% contains the following inactive ingredients: carbopol 980, d-limonene, docusate sodium solution, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sodium hydroxide and sorbitan monooleate."
},
{
"NDCCode": "0781-7182-70",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0781-7182-70) > 45 g in 1 BOTTLE, PUMP",
"NDC11Code": "00781-7182-70",
"ProductNDC": "0781-7182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene And Benzoyl Peroxide",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206164",
"LabelerName": "Sandoz Inc.",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "1; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180523",
"SamplePackage": "N",
"IndicationAndUsage": "Adapalene and benzoyl peroxide gel 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "Adapalene and benzoyl peroxide gel 0.1% / 2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. 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 0.1% / 2.5% contains the following inactive ingredients: carbopol 980, d-limonene, docusate sodium solution, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sodium hydroxide and sorbitan monooleate."
},
{
"NDCCode": "21922-052-50",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (21922-052-50) / 45 g in 1 BOTTLE, PUMP",
"NDC11Code": "21922-0052-50",
"ProductNDC": "21922-052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206164",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "1; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230814",
"SamplePackage": "N",
"IndicationAndUsage": "Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. 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 USP, 0.1% / 2.5% contains the following inactive ingredients: carbopol 980, d-limonene, docusate sodium solution, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sodium hydroxide and sorbitan monooleate."
},
{
"NDCCode": "29300-412-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (29300-412-01) ",
"NDC11Code": "29300-0412-01",
"ProductNDC": "29300-412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213136",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200106",
"SamplePackage": "N",
"IndicationAndUsage": "Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.",
"Description": "Atenolol, USP a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as 4-[2-hydroxy-3-[(1-methylethyl) amino] propoxy]-benzeneacetamide. The molecular and structural formulas are. C14H22N2O3. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate."
},
{
"NDCCode": "29300-412-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (29300-412-05) ",
"NDC11Code": "29300-0412-05",
"ProductNDC": "29300-412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213136",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200106",
"SamplePackage": "N",
"IndicationAndUsage": "Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.",
"Description": "Atenolol, USP a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as 4-[2-hydroxy-3-[(1-methylethyl) amino] propoxy]-benzeneacetamide. The molecular and structural formulas are. C14H22N2O3. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate."
},
{
"NDCCode": "29300-412-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (29300-412-10) ",
"NDC11Code": "29300-0412-10",
"ProductNDC": "29300-412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213136",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220826",
"SamplePackage": "N",
"IndicationAndUsage": "Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.",
"Description": "Atenolol, USP a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as 4-[2-hydroxy-3-[(1-methylethyl) amino] propoxy]-benzeneacetamide. The molecular and structural formulas are. C14H22N2O3. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>70445-412-23</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE, SPRAY (70445-412-23) </PackageDescription>
<NDC11Code>70445-0412-23</NDC11Code>
<ProductNDC>70445-412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200508</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Webb Business Promotion</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Antibacterial hand sanitizer spray.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52125-412-23</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (52125-412-23)</PackageDescription>
<NDC11Code>52125-0412-23</NDC11Code>
<ProductNDC>52125-412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150317</StartMarketingDate>
<EndMarketingDate>20171212</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078332</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>70445-412-20</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (70445-412-20) </PackageDescription>
<NDC11Code>70445-0412-20</NDC11Code>
<ProductNDC>70445-412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200508</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Webb Business Promotion</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Antibacterial hand sanitizer spray.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70445-412-21</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, SPRAY (70445-412-21) </PackageDescription>
<NDC11Code>70445-0412-21</NDC11Code>
<ProductNDC>70445-412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200508</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Webb Business Promotion</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Antibacterial hand sanitizer spray.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70445-412-22</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (70445-412-22) </PackageDescription>
<NDC11Code>70445-0412-22</NDC11Code>
<ProductNDC>70445-412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200508</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Webb Business Promotion</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Antibacterial hand sanitizer spray.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70445-412-26</NDCCode>
<PackageDescription>20 mL in 1 BOTTLE, SPRAY (70445-412-26) </PackageDescription>
<NDC11Code>70445-0412-26</NDC11Code>
<ProductNDC>70445-412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200508</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Webb Business Promotion</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Antibacterial hand sanitizer spray.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70445-412-27</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (70445-412-27) </PackageDescription>
<NDC11Code>70445-0412-27</NDC11Code>
<ProductNDC>70445-412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200508</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Webb Business Promotion</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</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>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>0299-5906-00</NDCCode>
<PackageDescription>2 g in 1 TUBE (0299-5906-00) </PackageDescription>
<NDC11Code>00299-5906-00</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-02</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (0299-5906-02) / 2 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-5906-02</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-05</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (0299-5906-05) / 5 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-5906-05</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-15</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-5906-15) / 15 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5906-15</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-30</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-5906-30) / 30 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5906-30</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-45</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-5906-45) / 45 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5906-45</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-60</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-5906-60) / 60 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5906-60</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5906-70</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-5906-70) / 70 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5906-70</NDC11Code>
<ProductNDC>0299-5906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo Forte</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207917</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5908-00</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (0299-5908-00) / 2 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-5908-00</NDC11Code>
<ProductNDC>0299-5908</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081208</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022320</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081208</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>EPIDUO (adapalene and benzoyl peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Active: Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5908-02</NDCCode>
<PackageDescription>2 g in 1 TUBE (0299-5908-02) </PackageDescription>
<NDC11Code>00299-5908-02</NDC11Code>
<ProductNDC>0299-5908</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081208</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022320</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081208</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>EPIDUO (adapalene and benzoyl peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Active: Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5908-25</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-5908-25) / 45 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5908-25</NDC11Code>
<ProductNDC>0299-5908</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081208</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022320</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>EPIDUO (adapalene and benzoyl peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Active: Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0299-5908-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0299-5908-45) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-5908-45</NDC11Code>
<ProductNDC>0299-5908</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epiduo</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081208</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022320</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>EPIDUO (adapalene and benzoyl peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Active: Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C 28H 28O 3Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C 14H 10O 4Molecular weight: 242.23. EPIDUO gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>0480-3154-45</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0480-3154-45) / 45 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00480-3154-45</NDC11Code>
<ProductNDC>0480-3154</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>20221128</StartMarketingDate>
<EndMarketingDate>20270228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209641</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221128</StartMarketingDatePackage>
<EndMarketingDatePackage>20270228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adapalene and benzoyl peroxide topical gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>Adapalene and benzoyl peroxide topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene USP, 0.3% and benzoyl peroxide USP, 2.5%. Adapalene USP, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene, USP is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene, USP. Molecular formula: C28H28O3 Molecular weight: 412.5. Benzoyl peroxide, USP is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide, USP is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide, USP. Molecular formula: C14H10O4 Molecular weight: 242.23. Adapalene and benzoyl peroxide topical gel 0.3%/2.5% contains the following inactive ingredients: carbomer 980, docusate sodium, edetate disodium, glycerin, poloxamer 124, propylene glycol, purified water, sodium hydroxide, and sorbitan monooleate.</Description>
</NDC>
<NDC>
<NDCCode>0781-7182-19</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0781-7182-19) > 45 g in 1 TUBE</PackageDescription>
<NDC11Code>00781-7182-19</NDC11Code>
<ProductNDC>0781-7182</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>20180523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206164</ApplicationNumber>
<LabelerName>Sandoz Inc.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adapalene and benzoyl peroxide gel 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>Adapalene and benzoyl peroxide gel 0.1% / 2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. 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 0.1% / 2.5% contains the following inactive ingredients: carbopol 980, d-limonene, docusate sodium solution, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sodium hydroxide and sorbitan monooleate.</Description>
</NDC>
<NDC>
<NDCCode>0781-7182-70</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0781-7182-70) > 45 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00781-7182-70</NDC11Code>
<ProductNDC>0781-7182</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>20180523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206164</ApplicationNumber>
<LabelerName>Sandoz Inc.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adapalene and benzoyl peroxide gel 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>Adapalene and benzoyl peroxide gel 0.1% / 2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. 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 0.1% / 2.5% contains the following inactive ingredients: carbopol 980, d-limonene, docusate sodium solution, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sodium hydroxide and sorbitan monooleate.</Description>
</NDC>
<NDC>
<NDCCode>21922-052-50</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (21922-052-50) / 45 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>21922-0052-50</NDC11Code>
<ProductNDC>21922-052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206164</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. 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 USP, 0.1% / 2.5% contains the following inactive ingredients: carbopol 980, d-limonene, docusate sodium solution, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sodium hydroxide and sorbitan monooleate.</Description>
</NDC>
<NDC>
<NDCCode>29300-412-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (29300-412-01) </PackageDescription>
<NDC11Code>29300-0412-01</NDC11Code>
<ProductNDC>29300-412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213136</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as 4-[2-hydroxy-3-[(1-methylethyl) amino] propoxy]-benzeneacetamide. The molecular and structural formulas are. C14H22N2O3. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>29300-412-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (29300-412-05) </PackageDescription>
<NDC11Code>29300-0412-05</NDC11Code>
<ProductNDC>29300-412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213136</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as 4-[2-hydroxy-3-[(1-methylethyl) amino] propoxy]-benzeneacetamide. The molecular and structural formulas are. C14H22N2O3. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>29300-412-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (29300-412-10) </PackageDescription>
<NDC11Code>29300-0412-10</NDC11Code>
<ProductNDC>29300-412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213136</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as 4-[2-hydroxy-3-[(1-methylethyl) amino] propoxy]-benzeneacetamide. The molecular and structural formulas are. C14H22N2O3. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.</Description>
</NDC>
</NDCList>