{
"NDC": [
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"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0187-5150-44) / 44 g in 1 BOTTLE, PUMP",
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"ProductNDC": "0187-5150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renova",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021108",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
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"LastUpdate": "2026-02-25",
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"IndicationAndUsage": "(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.). RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. : 1 RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis., 2 RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing., 3 Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time., 4 Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established., 5 Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS).",
"Description": "RENOVA® (tretinoin cream) 0.02% contains the active ingredient tretinoin in a cream base. Tretinoin is a yellow to light-orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-retinoic acid and has a molecular weight of 300.44. The structural formula is represented below. Tretinoin is available as RENOVA at a concentration of 0.02% w/w in an oil-in-water emulsion formulation consisting of benzyl alcohol, butylated hydroxytoluene, caprylic/capric triglyceride, cetyl alcohol, edetate disodium, methylparaben, propylparaben, purified water, stearic acid, stearyl alcohol, steareth 2, steareth 20, and xanthan gum."
},
{
"NDCCode": "0062-0187-15",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0062-0187-15) > 44 g in 1 BOTTLE, PUMP",
"NDC11Code": "00062-0187-15",
"ProductNDC": "0062-0187",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renova",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111018",
"EndMarketingDate": "20151031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021108",
"LabelerName": "Ortho-McNeil Janssen Pharmaceuticals, Inc.",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [Chemical/Ingredient]",
"Status": "Deprecated",
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},
{
"NDCCode": "0187-5150-02",
"PackageDescription": "1 TUBE in 1 CARTON (0187-5150-02) / 2 g in 1 TUBE",
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"ProductNDC": "0187-5150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renova",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20000831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021108",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
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"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20000831",
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"IndicationAndUsage": "(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.). RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. : 1 RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis., 2 RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing., 3 Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time., 4 Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established., 5 Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS).",
"Description": "RENOVA® (tretinoin cream) 0.02% contains the active ingredient tretinoin in a cream base. Tretinoin is a yellow to light-orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-retinoic acid and has a molecular weight of 300.44. The structural formula is represented below. Tretinoin is available as RENOVA at a concentration of 0.02% w/w in an oil-in-water emulsion formulation consisting of benzyl alcohol, butylated hydroxytoluene, caprylic/capric triglyceride, cetyl alcohol, edetate disodium, methylparaben, propylparaben, purified water, stearic acid, stearyl alcohol, steareth 2, steareth 20, and xanthan gum."
},
{
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"PackageDescription": "1 TUBE in 1 CARTON (0187-5150-20) / 20 g in 1 TUBE",
"NDC11Code": "00187-5150-20",
"ProductNDC": "0187-5150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renova",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20000831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021108",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20000831",
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"IndicationAndUsage": "(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.). RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. : 1 RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis., 2 RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing., 3 Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time., 4 Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established., 5 Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS).",
"Description": "RENOVA® (tretinoin cream) 0.02% contains the active ingredient tretinoin in a cream base. Tretinoin is a yellow to light-orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-retinoic acid and has a molecular weight of 300.44. The structural formula is represented below. Tretinoin is available as RENOVA at a concentration of 0.02% w/w in an oil-in-water emulsion formulation consisting of benzyl alcohol, butylated hydroxytoluene, caprylic/capric triglyceride, cetyl alcohol, edetate disodium, methylparaben, propylparaben, purified water, stearic acid, stearyl alcohol, steareth 2, steareth 20, and xanthan gum."
},
{
"NDCCode": "0187-5150-40",
"PackageDescription": "1 TUBE in 1 CARTON (0187-5150-40) / 40 g in 1 TUBE",
"NDC11Code": "00187-5150-40",
"ProductNDC": "0187-5150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renova",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20000831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021108",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20000831",
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"IndicationAndUsage": "(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.). RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. : 1 RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis., 2 RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing., 3 Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time., 4 Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established., 5 Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS).",
"Description": "RENOVA® (tretinoin cream) 0.02% contains the active ingredient tretinoin in a cream base. Tretinoin is a yellow to light-orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-retinoic acid and has a molecular weight of 300.44. The structural formula is represented below. Tretinoin is available as RENOVA at a concentration of 0.02% w/w in an oil-in-water emulsion formulation consisting of benzyl alcohol, butylated hydroxytoluene, caprylic/capric triglyceride, cetyl alcohol, edetate disodium, methylparaben, propylparaben, purified water, stearic acid, stearyl alcohol, steareth 2, steareth 20, and xanthan gum."
},
{
"NDCCode": "0187-5150-60",
"PackageDescription": "1 TUBE in 1 CARTON (0187-5150-60) / 60 g in 1 TUBE",
"NDC11Code": "00187-5150-60",
"ProductNDC": "0187-5150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renova",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20000831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021108",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20000831",
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"IndicationAndUsage": "(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.). RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. : 1 RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis., 2 RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing., 3 Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time., 4 Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established., 5 Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS).",
"Description": "RENOVA® (tretinoin cream) 0.02% contains the active ingredient tretinoin in a cream base. Tretinoin is a yellow to light-orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-retinoic acid and has a molecular weight of 300.44. The structural formula is represented below. Tretinoin is available as RENOVA at a concentration of 0.02% w/w in an oil-in-water emulsion formulation consisting of benzyl alcohol, butylated hydroxytoluene, caprylic/capric triglyceride, cetyl alcohol, edetate disodium, methylparaben, propylparaben, purified water, stearic acid, stearyl alcohol, steareth 2, steareth 20, and xanthan gum."
},
{
"NDCCode": "0187-0005-03",
"PackageDescription": "6 TUBE in 1 CARTON (0187-0005-03) > 3 g in 1 TUBE",
"NDC11Code": "00187-0005-03",
"ProductNDC": "0187-0005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Altreno",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209353",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2020-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180824",
"SamplePackage": "Y",
"IndicationAndUsage": "ALTRENO® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "ALTRENO (tretinoin) lotion is an opaque, pale yellow lotion containing 0.05% tretinoin by weight for topical administration. Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds and a metabolite of vitamin A. Tretinoin has the following chemical structure:. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Each gram of ALTRENO contains 0.5 mg (0.05%) of tretinoin in an opaque, pale yellow lotion base consisting of benzyl alcohol, butylated hydroxytoluene, carbomer copolymer type B (Pemulen TR-1), carbomer homopolymer type A (Carbopol 981), glycerin, methylparaben, mineral oil, octoxynol-9, purified water, sodium hyaluronate, soluble collagen and trolamine."
},
{
"NDCCode": "0187-0005-10",
"PackageDescription": "10 TUBE in 1 CARTON (0187-0005-10) > 3 g in 1 TUBE (0187-0005-04) ",
"NDC11Code": "00187-0005-10",
"ProductNDC": "0187-0005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Altreno",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209353",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2020-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190522",
"SamplePackage": "Y",
"IndicationAndUsage": "ALTRENO® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "ALTRENO (tretinoin) lotion is an opaque, pale yellow lotion containing 0.05% tretinoin by weight for topical administration. Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds and a metabolite of vitamin A. Tretinoin has the following chemical structure:. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Each gram of ALTRENO contains 0.5 mg (0.05%) of tretinoin in an opaque, pale yellow lotion base consisting of benzyl alcohol, butylated hydroxytoluene, carbomer copolymer type B (Pemulen TR-1), carbomer homopolymer type A (Carbopol 981), glycerin, methylparaben, mineral oil, octoxynol-9, purified water, sodium hyaluronate, soluble collagen and trolamine."
},
{
"NDCCode": "0187-0005-20",
"PackageDescription": "1 TUBE in 1 CARTON (0187-0005-20) > 20 g in 1 TUBE",
"NDC11Code": "00187-0005-20",
"ProductNDC": "0187-0005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Altreno",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209353",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2020-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191108",
"SamplePackage": "N",
"IndicationAndUsage": "ALTRENO® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "ALTRENO (tretinoin) lotion is an opaque, pale yellow lotion containing 0.05% tretinoin by weight for topical administration. Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds and a metabolite of vitamin A. Tretinoin has the following chemical structure:. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Each gram of ALTRENO contains 0.5 mg (0.05%) of tretinoin in an opaque, pale yellow lotion base consisting of benzyl alcohol, butylated hydroxytoluene, carbomer copolymer type B (Pemulen TR-1), carbomer homopolymer type A (Carbopol 981), glycerin, methylparaben, mineral oil, octoxynol-9, purified water, sodium hyaluronate, soluble collagen and trolamine."
},
{
"NDCCode": "0187-0005-45",
"PackageDescription": "1 TUBE in 1 CARTON (0187-0005-45) > 45 g in 1 TUBE",
"NDC11Code": "00187-0005-45",
"ProductNDC": "0187-0005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Altreno",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
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"LabelerName": "Bausch Health US, LLC",
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"IndicationAndUsage": "ALTRENO® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "ALTRENO (tretinoin) lotion is an opaque, pale yellow lotion containing 0.05% tretinoin by weight for topical administration. Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds and a metabolite of vitamin A. Tretinoin has the following chemical structure:. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Each gram of ALTRENO contains 0.5 mg (0.05%) of tretinoin in an opaque, pale yellow lotion base consisting of benzyl alcohol, butylated hydroxytoluene, carbomer copolymer type B (Pemulen TR-1), carbomer homopolymer type A (Carbopol 981), glycerin, methylparaben, mineral oil, octoxynol-9, purified water, sodium hyaluronate, soluble collagen and trolamine."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "ALTRENO® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
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{
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"ProductNDC": "0187-1824",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr. Lewinn By Kinerase",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
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"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
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},
{
"NDCCode": "0187-2097-15",
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"ProductTypeName": "HUMAN OTC DRUG",
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"SubstanceName": "OCTINOXATE; ZINC OXIDE",
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"Status": "Deprecated",
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},
{
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"PackageDescription": "1 TUBE in 1 CARTON (0187-5140-20) / 20 g in 1 TUBE",
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"ProductNDC": "0187-5140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Retin-a Micro",
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"MarketingCategoryName": "NDA",
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"LabelerName": "Bausch Health US LLC",
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"Description": "Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C20H28O2 and the following chemical structure. RETIN-A MICRO (tretinoin) gel is for topical use. Each gram of RETIN-A MICRO gel: : 1 0.04%, contains 0.4 mg of tretinoin , 2 0.06%, contains 0.6 mg of tretinoin , 3 0.08%, contains 0.8 mg of tretinoin , 4 0.1%, contains 1 mg of tretinoin ."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Bausch Health US LLC",
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Bausch Health US LLC",
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"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Retin-a Micro",
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"DosageFormName": "GEL",
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{
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{
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{
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},
{
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"SamplePackage": "N",
"IndicationAndUsage": "CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).",
"Description": "Alemtuzumab, a CD52-directed cytolytic antibody, is a recombinant DNA-derived humanized monoclonal antibody (CAMPATH-1H). CAMPATH-1H is an IgG1 kappa antibody with human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (CAMPATH-1G). The CAMPATH-1H antibody has an approximate molecular weight of 150 kD. CAMPATH is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product. CAMPATH (alemtuzumab) injection is a sterile, clear, colorless, isotonic solution (pH 6.8–7.4) in a single-dose vial for intravenous use. Each single-dose vial of CAMPATH contains 30 mg alemtuzumab, 8.0 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate. No preservatives are added."
},
{
"NDCCode": "58468-0357-3",
"PackageDescription": "3 VIAL, SINGLE-USE in 1 CARTON (58468-0357-3) / 1 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "58468-0357-03",
"ProductNDC": "58468-0357",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Campath",
"NonProprietaryName": "Alemtuzumab",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091130",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103948",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "ALEMTUZUMAB",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "CD52-directed Antibody Interactions [MoA], CD52-directed Cytolytic Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091130",
"SamplePackage": "N",
"IndicationAndUsage": "CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).",
"Description": "Alemtuzumab, a CD52-directed cytolytic antibody, is a recombinant DNA-derived humanized monoclonal antibody (CAMPATH-1H). CAMPATH-1H is an IgG1 kappa antibody with human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (CAMPATH-1G). The CAMPATH-1H antibody has an approximate molecular weight of 150 kD. CAMPATH is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product. CAMPATH (alemtuzumab) injection is a sterile, clear, colorless, isotonic solution (pH 6.8–7.4) in a single-dose vial for intravenous use. Each single-dose vial of CAMPATH contains 30 mg alemtuzumab, 8.0 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate. No preservatives are added."
},
{
"NDCCode": "63323-187-30",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-187-30) / 30 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "63323-0187-30",
"ProductNDC": "63323-187",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20000905",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "234",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20000905",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Chloride Injection, USP, 23.4%, is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirements of the patient with unusual fluid and electrolyte needs. After available clinical and laboratory information is considered and correlated, the appropriate number of milliequivalents of sodium chloride required can be withdrawn from Sodium Chloride Injection, USP, 23.4% and diluted for use. Sodium Chloride Injection is indicated for the treatment of sodium, chloride and water deficiencies that commonly occur in many diseases. Isotonic Sodium Chloride Injection should be limited to cases in which the chloride loss is greater than the sodium loss, as in vomiting from pyloric obstruction, or in which the loss is about equal, as in vomiting from duodenal, jejunal or ileal obstruction and in the replacement of aspirated gastrointestinal fluids. The toxic symptoms that follow various forms of intestinal obstruction are accompanied by a marked reduction of blood chloride and often sodium chloride has a lifesaving effect. Symptoms of sodium chloride deficiency are very similar to those of Addison’s disease and large doses of sodium chloride will produce temporary alleviation of the symptoms. Other disorders in which sodium chloride is therapeutically useful include extensive burns, failure of gastric secretion and postoperative intestinal paralysis.",
"Description": "Sodium Chloride Injection, USP, 23.4%, is a concentrated, nonisotonic, sterile, nonpyrogenic solution of sodium chloride 234 mg in Water for Injection. pH adjusted with sodium hydroxide or hydrochloric acid if necessary. pH 4.5-7.0 when diluted to a concentration of 0.9%. 8008 mOsmol/L. Sodium chloride is an electrolyte replenisher. It occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water; it is soluble in glycerin and slightly soluble in alcohol. The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44."
},
{
"NDCCode": "0003-5150-14",
"PackageDescription": "1 KIT in 1 CARTON (0003-5150-14) * 1 BLISTER PACK in 1 PACKAGE (0003-0050-00) / 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK * 1 BLISTER PACK in 1 PACKAGE (0003-1100-10) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK",
"NDC11Code": "00003-5150-14",
"ProductNDC": "0003-5150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cobenfy",
"NonProprietaryName": "Xanomeline And Trospium Chloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20240927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216158",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240927",
"SamplePackage": "Y",
"IndicationAndUsage": "COBENFY is indicated for the treatment of schizophrenia in adults.",
"Description": "COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium)."
},
{
"NDCCode": "0024-5150-10",
"PackageDescription": "3 KIT in 1 CARTON (0024-5150-10) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, SINGLE-USE (0024-5154-11) * 1 mL in 1 AMPULE (0024-5152-11) ",
"NDC11Code": "00024-5150-10",
"ProductNDC": "0024-5150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elitek",
"NonProprietaryName": "Rasburicase",
"DosageFormName": "KIT",
"StartMarketingDate": "20020712",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103946",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020712",
"SamplePackage": "N",
"IndicationAndUsage": "Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.",
"Description": "Elitek (rasburicase) is a recombinant urate-oxidase produced by a genetically modified Saccharomyces cerevisiae strain. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus. Rasburicase is a tetrameric protein with identical subunits. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kDa. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. Elitek is supplied in 2 mL or 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1.5 mg/mL after reconstitution. Elitek 1.5 mg presentation contains 1.5 mg rasburicase, 10.6 mg mannitol, 15.9 mg L-alanine, between 12.6 and 14.3 mg of dibasic sodium phosphate (lyophilized powder), and a diluent (1 mL Water for Injection, USP, and 1 mg Poloxamer 188). Elitek 7.5 mg presentation contains 7.5 mg of rasburicase, 53 mg mannitol, 79.5 mg L-alanine, and between 63 and 71.5 mg dibasic sodium phosphate (lyophilized powder) and a diluent (5 mL Water for Injection, USP, and 5 mg Poloxamer 188)."
},
{
"NDCCode": "0093-5150-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0093-5150-01) ",
"NDC11Code": "00093-5150-01",
"ProductNDC": "0093-5150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moexipril Hydrochloride",
"NonProprietaryName": "Moexipril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076204",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "MOEXIPRIL HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030508",
"SamplePackage": "N",
"IndicationAndUsage": "Moexipril hydrochloride tablets USP are indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using moexipril hydrochloride tablets USP, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that moexipril hydrochloride tablets USP do not have a similar risk (see WARNINGS). In considering use of moexipril hydrochloride tablets USP, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS,Angioedema).",
"Description": "Moexipril hydrochloride, USP, the hydrochloride salt of moexipril, is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is. C27H34N2O7HCl M.W. 535.04. Moexipril hydrochloride, USP is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. Moexipril hydrochloride tablets USP are supplied as bisected, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride, USP for oral administration. In addition to the active ingredient, moexipril hydrochloride, USP, the tablet core contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The film coating of the 7.5 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. The film coating of the 15 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Moexipril hydrochloride tablets USP meet USP Dissolution Test 2."
},
{
"NDCCode": "0363-5150-26",
"PackageDescription": "74 g in 1 PACKAGE (0363-5150-26) ",
"NDC11Code": "00363-5150-26",
"ProductNDC": "0363-5150",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica Montana",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190620",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "WALGREENS CO.",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/g",
"Status": "Active",
"LastUpdate": "2022-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190620",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves muscle pain and stiffness due to minor injuries, overexertion and falls, reduces pain, swelling and discoloration from bruises."
}
]
}
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<NDC>
<NDCCode>0187-5150-44</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0187-5150-44) / 44 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00187-5150-44</NDC11Code>
<ProductNDC>0187-5150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renova</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20000831</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021108</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.). RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. : 1 RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis., 2 RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing., 3 Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time., 4 Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established., 5 Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS).</IndicationAndUsage>
<Description>RENOVA® (tretinoin cream) 0.02% contains the active ingredient tretinoin in a cream base. Tretinoin is a yellow to light-orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-retinoic acid and has a molecular weight of 300.44. The structural formula is represented below. Tretinoin is available as RENOVA at a concentration of 0.02% w/w in an oil-in-water emulsion formulation consisting of benzyl alcohol, butylated hydroxytoluene, caprylic/capric triglyceride, cetyl alcohol, edetate disodium, methylparaben, propylparaben, purified water, stearic acid, stearyl alcohol, steareth 2, steareth 20, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0062-0187-15</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0062-0187-15) > 44 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00062-0187-15</NDC11Code>
<ProductNDC>0062-0187</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renova</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111018</StartMarketingDate>
<EndMarketingDate>20151031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021108</ApplicationNumber>
<LabelerName>Ortho-McNeil Janssen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>0187-5150-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0187-5150-02) / 2 g in 1 TUBE</PackageDescription>
<NDC11Code>00187-5150-02</NDC11Code>
<ProductNDC>0187-5150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renova</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20000831</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021108</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.). RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. : 1 RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis., 2 RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing., 3 Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time., 4 Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established., 5 Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS).</IndicationAndUsage>
<Description>RENOVA® (tretinoin cream) 0.02% contains the active ingredient tretinoin in a cream base. Tretinoin is a yellow to light-orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-retinoic acid and has a molecular weight of 300.44. The structural formula is represented below. Tretinoin is available as RENOVA at a concentration of 0.02% w/w in an oil-in-water emulsion formulation consisting of benzyl alcohol, butylated hydroxytoluene, caprylic/capric triglyceride, cetyl alcohol, edetate disodium, methylparaben, propylparaben, purified water, stearic acid, stearyl alcohol, steareth 2, steareth 20, and xanthan gum.</Description>
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<NDC>
<NDCCode>0187-5150-20</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0187-5150-20) / 20 g in 1 TUBE</PackageDescription>
<NDC11Code>00187-5150-20</NDC11Code>
<ProductNDC>0187-5150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renova</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20000831</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021108</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.). RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. : 1 RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis., 2 RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing., 3 Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time., 4 Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established., 5 Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS).</IndicationAndUsage>
<Description>RENOVA® (tretinoin cream) 0.02% contains the active ingredient tretinoin in a cream base. Tretinoin is a yellow to light-orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-retinoic acid and has a molecular weight of 300.44. The structural formula is represented below. Tretinoin is available as RENOVA at a concentration of 0.02% w/w in an oil-in-water emulsion formulation consisting of benzyl alcohol, butylated hydroxytoluene, caprylic/capric triglyceride, cetyl alcohol, edetate disodium, methylparaben, propylparaben, purified water, stearic acid, stearyl alcohol, steareth 2, steareth 20, and xanthan gum.</Description>
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<IndicationAndUsage>(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.). RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. : 1 RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis., 2 RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing., 3 Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time., 4 Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established., 5 Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS).</IndicationAndUsage>
<Description>RENOVA® (tretinoin cream) 0.02% contains the active ingredient tretinoin in a cream base. Tretinoin is a yellow to light-orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-retinoic acid and has a molecular weight of 300.44. The structural formula is represented below. Tretinoin is available as RENOVA at a concentration of 0.02% w/w in an oil-in-water emulsion formulation consisting of benzyl alcohol, butylated hydroxytoluene, caprylic/capric triglyceride, cetyl alcohol, edetate disodium, methylparaben, propylparaben, purified water, stearic acid, stearyl alcohol, steareth 2, steareth 20, and xanthan gum.</Description>
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<LabelerName>Bausch Health US LLC</LabelerName>
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<StrengthUnit>mg/g</StrengthUnit>
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<IndicationAndUsage>(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.). RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. : 1 RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis., 2 RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing., 3 Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time., 4 Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established., 5 Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS).</IndicationAndUsage>
<Description>RENOVA® (tretinoin cream) 0.02% contains the active ingredient tretinoin in a cream base. Tretinoin is a yellow to light-orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-retinoic acid and has a molecular weight of 300.44. The structural formula is represented below. Tretinoin is available as RENOVA at a concentration of 0.02% w/w in an oil-in-water emulsion formulation consisting of benzyl alcohol, butylated hydroxytoluene, caprylic/capric triglyceride, cetyl alcohol, edetate disodium, methylparaben, propylparaben, purified water, stearic acid, stearyl alcohol, steareth 2, steareth 20, and xanthan gum.</Description>
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<StrengthUnit>mg/g</StrengthUnit>
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<IndicationAndUsage>ALTRENO® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>ALTRENO (tretinoin) lotion is an opaque, pale yellow lotion containing 0.05% tretinoin by weight for topical administration. Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds and a metabolite of vitamin A. Tretinoin has the following chemical structure:. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Each gram of ALTRENO contains 0.5 mg (0.05%) of tretinoin in an opaque, pale yellow lotion base consisting of benzyl alcohol, butylated hydroxytoluene, carbomer copolymer type B (Pemulen TR-1), carbomer homopolymer type A (Carbopol 981), glycerin, methylparaben, mineral oil, octoxynol-9, purified water, sodium hyaluronate, soluble collagen and trolamine.</Description>
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<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ALTRENO® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>ALTRENO (tretinoin) lotion is an opaque, pale yellow lotion containing 0.05% tretinoin by weight for topical administration. Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds and a metabolite of vitamin A. Tretinoin has the following chemical structure:. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Each gram of ALTRENO contains 0.5 mg (0.05%) of tretinoin in an opaque, pale yellow lotion base consisting of benzyl alcohol, butylated hydroxytoluene, carbomer copolymer type B (Pemulen TR-1), carbomer homopolymer type A (Carbopol 981), glycerin, methylparaben, mineral oil, octoxynol-9, purified water, sodium hyaluronate, soluble collagen and trolamine.</Description>
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<IndicationAndUsage>ALTRENO® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>ALTRENO (tretinoin) lotion is an opaque, pale yellow lotion containing 0.05% tretinoin by weight for topical administration. Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds and a metabolite of vitamin A. Tretinoin has the following chemical structure:. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Each gram of ALTRENO contains 0.5 mg (0.05%) of tretinoin in an opaque, pale yellow lotion base consisting of benzyl alcohol, butylated hydroxytoluene, carbomer copolymer type B (Pemulen TR-1), carbomer homopolymer type A (Carbopol 981), glycerin, methylparaben, mineral oil, octoxynol-9, purified water, sodium hyaluronate, soluble collagen and trolamine.</Description>
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<StrengthUnit>mg/g</StrengthUnit>
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<IndicationAndUsage>ALTRENO® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>ALTRENO (tretinoin) lotion is an opaque, pale yellow lotion containing 0.05% tretinoin by weight for topical administration. Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds and a metabolite of vitamin A. Tretinoin has the following chemical structure:. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Each gram of ALTRENO contains 0.5 mg (0.05%) of tretinoin in an opaque, pale yellow lotion base consisting of benzyl alcohol, butylated hydroxytoluene, carbomer copolymer type B (Pemulen TR-1), carbomer homopolymer type A (Carbopol 981), glycerin, methylparaben, mineral oil, octoxynol-9, purified water, sodium hyaluronate, soluble collagen and trolamine.</Description>
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<StrengthUnit>mg/g</StrengthUnit>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALTRENO® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>ALTRENO (tretinoin) lotion is an opaque, pale yellow lotion containing 0.05% tretinoin by weight for topical administration. Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds and a metabolite of vitamin A. Tretinoin has the following chemical structure:. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Each gram of ALTRENO contains 0.5 mg (0.05%) of tretinoin in an opaque, pale yellow lotion base consisting of benzyl alcohol, butylated hydroxytoluene, carbomer copolymer type B (Pemulen TR-1), carbomer homopolymer type A (Carbopol 981), glycerin, methylparaben, mineral oil, octoxynol-9, purified water, sodium hyaluronate, soluble collagen and trolamine.</Description>
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<PackageDescription>48 g in 1 TUBE (0187-1824-01)</PackageDescription>
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<ProductNDC>0187-1824</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr. Lewinn By Kinerase</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121205</StartMarketingDate>
<EndMarketingDate>20160331</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>2.88; 1.44</StrengthNumber>
<StrengthUnit>g/48g; g/48g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0187-2097-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0187-2097-15) > 48 g in 1 TUBE</PackageDescription>
<NDC11Code>00187-2097-15</NDC11Code>
<ProductNDC>0187-2097</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kinerase</ProprietaryName>
<ProprietaryNameSuffix>Bb Cream With Kinetin</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130902</StartMarketingDate>
<EndMarketingDate>20160831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>2.88; 1.44</StrengthNumber>
<StrengthUnit>g/48g; g/48g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
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<PackageDescription>1 TUBE in 1 CARTON (0187-5140-20) / 20 g in 1 TUBE</PackageDescription>
<NDC11Code>00187-5140-20</NDC11Code>
<ProductNDC>0187-5140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Retin-a Micro</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19970207</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020475</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).</IndicationAndUsage>
<Description>Alemtuzumab, a CD52-directed cytolytic antibody, is a recombinant DNA-derived humanized monoclonal antibody (CAMPATH-1H). CAMPATH-1H is an IgG1 kappa antibody with human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (CAMPATH-1G). The CAMPATH-1H antibody has an approximate molecular weight of 150 kD. CAMPATH is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product. CAMPATH (alemtuzumab) injection is a sterile, clear, colorless, isotonic solution (pH 6.8–7.4) in a single-dose vial for intravenous use. Each single-dose vial of CAMPATH contains 30 mg alemtuzumab, 8.0 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate. No preservatives are added.</Description>
</NDC>
<NDC>
<NDCCode>63323-187-30</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-187-30) / 30 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>63323-0187-30</NDC11Code>
<ProductNDC>63323-187</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20000905</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>234</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Chloride Injection, USP, 23.4%, is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirements of the patient with unusual fluid and electrolyte needs. After available clinical and laboratory information is considered and correlated, the appropriate number of milliequivalents of sodium chloride required can be withdrawn from Sodium Chloride Injection, USP, 23.4% and diluted for use. Sodium Chloride Injection is indicated for the treatment of sodium, chloride and water deficiencies that commonly occur in many diseases. Isotonic Sodium Chloride Injection should be limited to cases in which the chloride loss is greater than the sodium loss, as in vomiting from pyloric obstruction, or in which the loss is about equal, as in vomiting from duodenal, jejunal or ileal obstruction and in the replacement of aspirated gastrointestinal fluids. The toxic symptoms that follow various forms of intestinal obstruction are accompanied by a marked reduction of blood chloride and often sodium chloride has a lifesaving effect. Symptoms of sodium chloride deficiency are very similar to those of Addison’s disease and large doses of sodium chloride will produce temporary alleviation of the symptoms. Other disorders in which sodium chloride is therapeutically useful include extensive burns, failure of gastric secretion and postoperative intestinal paralysis.</IndicationAndUsage>
<Description>Sodium Chloride Injection, USP, 23.4%, is a concentrated, nonisotonic, sterile, nonpyrogenic solution of sodium chloride 234 mg in Water for Injection. pH adjusted with sodium hydroxide or hydrochloric acid if necessary. pH 4.5-7.0 when diluted to a concentration of 0.9%. 8008 mOsmol/L. Sodium chloride is an electrolyte replenisher. It occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water; it is soluble in glycerin and slightly soluble in alcohol. The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44.</Description>
</NDC>
<NDC>
<NDCCode>0003-5150-14</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0003-5150-14) * 1 BLISTER PACK in 1 PACKAGE (0003-0050-00) / 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK * 1 BLISTER PACK in 1 PACKAGE (0003-1100-10) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00003-5150-14</NDC11Code>
<ProductNDC>0003-5150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cobenfy</ProprietaryName>
<NonProprietaryName>Xanomeline And Trospium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216158</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240927</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>COBENFY is indicated for the treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium).</Description>
</NDC>
<NDC>
<NDCCode>0024-5150-10</NDCCode>
<PackageDescription>3 KIT in 1 CARTON (0024-5150-10) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, SINGLE-USE (0024-5154-11) * 1 mL in 1 AMPULE (0024-5152-11) </PackageDescription>
<NDC11Code>00024-5150-10</NDC11Code>
<ProductNDC>0024-5150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elitek</ProprietaryName>
<NonProprietaryName>Rasburicase</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20020712</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103946</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.</IndicationAndUsage>
<Description>Elitek (rasburicase) is a recombinant urate-oxidase produced by a genetically modified Saccharomyces cerevisiae strain. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus. Rasburicase is a tetrameric protein with identical subunits. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kDa. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. Elitek is supplied in 2 mL or 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1.5 mg/mL after reconstitution. Elitek 1.5 mg presentation contains 1.5 mg rasburicase, 10.6 mg mannitol, 15.9 mg L-alanine, between 12.6 and 14.3 mg of dibasic sodium phosphate (lyophilized powder), and a diluent (1 mL Water for Injection, USP, and 1 mg Poloxamer 188). Elitek 7.5 mg presentation contains 7.5 mg of rasburicase, 53 mg mannitol, 79.5 mg L-alanine, and between 63 and 71.5 mg dibasic sodium phosphate (lyophilized powder) and a diluent (5 mL Water for Injection, USP, and 5 mg Poloxamer 188).</Description>
</NDC>
<NDC>
<NDCCode>0093-5150-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0093-5150-01) </PackageDescription>
<NDC11Code>00093-5150-01</NDC11Code>
<ProductNDC>0093-5150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moexipril Hydrochloride</ProprietaryName>
<NonProprietaryName>Moexipril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076204</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>MOEXIPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Moexipril hydrochloride tablets USP are indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using moexipril hydrochloride tablets USP, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that moexipril hydrochloride tablets USP do not have a similar risk (see WARNINGS). In considering use of moexipril hydrochloride tablets USP, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS,Angioedema).</IndicationAndUsage>
<Description>Moexipril hydrochloride, USP, the hydrochloride salt of moexipril, is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is. C27H34N2O7HCl M.W. 535.04. Moexipril hydrochloride, USP is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. Moexipril hydrochloride tablets USP are supplied as bisected, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride, USP for oral administration. In addition to the active ingredient, moexipril hydrochloride, USP, the tablet core contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The film coating of the 7.5 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. The film coating of the 15 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Moexipril hydrochloride tablets USP meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0363-5150-26</NDCCode>
<PackageDescription>74 g in 1 PACKAGE (0363-5150-26) </PackageDescription>
<NDC11Code>00363-5150-26</NDC11Code>
<ProductNDC>0363-5150</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnica Montana</ProprietaryName>
<NonProprietaryName>Arnica Montana</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190620</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>WALGREENS CO.</LabelerName>
<SubstanceName>ARNICA MONTANA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves muscle pain and stiffness due to minor injuries, overexertion and falls, reduces pain, swelling and discoloration from bruises.</IndicationAndUsage>
</NDC>
</NDCList>