{
"NDC": [
{
"NDCCode": "76151-751-55",
"PackageDescription": "55 mL in 1 BOTTLE, SPRAY (76151-751-55) ",
"NDC11Code": "76151-0751-55",
"ProductNDC": "76151-751",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200527",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Boscia LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200527",
"SamplePackage": "N"
},
{
"NDCCode": "65601-751-55",
"PackageDescription": "208000 mL in 1 DRUM (65601-751-55)",
"NDC11Code": "65601-0751-55",
"ProductNDC": "65601-751",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Winning Hands Foaming Antibacterial",
"NonProprietaryName": "Tricolsan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121112",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Betco Corporation, Ltd.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses. : 1 Antibacterial hand cleaner., 2 Use in a variet of public facilities including daycare centers, hospitals, nursing homes, physicians offices."
},
{
"NDCCode": "76151-221-01",
"PackageDescription": "1 TUBE in 1 CARTON (76151-221-01) / 50 g in 1 TUBE",
"NDC11Code": "76151-0221-01",
"ProductNDC": "76151-221",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boscia Bb Bronze Broad Spectrum Spf 27 Pa Self-adjusting Shade",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Boscia LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "7.55; .98",
"StrengthUnit": "g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "0169-2911-15",
"PackageDescription": "5 SYRINGE, PLASTIC in 1 CARTON (0169-2911-15) / 3 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00169-2911-15",
"ProductNDC": "0169-2911",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xultophy 100/3.6",
"NonProprietaryName": "Insulin Degludec And Liraglutide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20161121",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA208583",
"LabelerName": "Novo Nordisk",
"SubstanceName": "INSULIN DEGLUDEC; LIRAGLUTIDE",
"StrengthNumber": "100; 3.6",
"StrengthUnit": "[iU]/mL; mg/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161121",
"SamplePackage": "N",
"IndicationAndUsage": "XULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: 1 XULTOPHY 100/3.6 contains liraglutide. Coadministration with any other product containing liraglutide or another glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended [see Warnings and Precautions (5.5)]., 2 XULTOPHY 100/3.6 is not recommended for the treatment of diabetic ketoacidosis., 3 XULTOPHY 100/3.6 has not been studied in combination with prandial insulin.",
"Description": "Insulin degludec. Insulin degludec is a long-acting basal human insulin analog. Insulin degludec is produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification. Insulin degludec differs from human insulin in that the amino acid threonine in position B30 has been omitted and a side-chain consisting of glutamic acid and a C16 fatty acid has been attached (chemical name: LysB29(Nε-hexadecandioyl-γ-Glu) des(B30) human insulin). Insulin degludec has a molecular formula of C274H411N65O81S6 and a molecular weight of 6.104 kDa. It has the following structure. Figure 1. Structural Formula of Insulin degludec. Liraglutide. Liraglutide is an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3.751 kDa. It has the following structure. Figure 2. Structural Formula of Liraglutide. XULTOPHY 100/3.6 (insulin degludec and liraglutide) injection, for subcutaneous use, is a combination of a long-acting basal human insulin analog, insulin degludec, and a GLP-1 receptor agonist, liraglutide. XULTOPHY 100/3.6 is a sterile, aqueous, clear, and colorless solution. Each prefilled pen contains 3 mL equivalent to 300 units insulin degludec and 10.8 mg liraglutide. Each mL contains 100 units insulin degludec and 3.6 mg liraglutide. XULTOPHY 100/3.6 contains the following inactive ingredients per mL: glycerol (19.7 mg), phenol (5.7 mg), zinc (55 mcg), and Water for Injection, USP. XULTOPHY 100/3.6 has a pH of approximately 8.15. Hydrochloric acid or sodium hydroxide may be added to adjust pH."
},
{
"NDCCode": "76151-105-11",
"PackageDescription": "40 mL in 1 TUBE (76151-105-11) ",
"NDC11Code": "76151-0105-11",
"ProductNDC": "76151-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oil-free Daily Hydration Spf 15",
"NonProprietaryName": "Octinoxate, Avobenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110416",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Boscia LLC",
"SubstanceName": "OCTINOXATE; AVOBENZONE",
"StrengthNumber": "50; 30",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn.",
"Description": "Preservative-free. Dermatologist tested. Non-comedogenic. Alcohol-free, pH balanced, 100% natural fragrance and color, no animals testing and no animal ingredients. An oil-free moisturizer that hydrates the skin, minimizes pores and providers broad spectrum SPF 15. Polysaccharide provides essential moisture, silica powder controls excessive oil while wine Yeast and Marine Complex help protect against external elements. www.boscia.net B105-11 Distributed by boscia LLC. Irvine, CA 92614 Made in Japan U8-2."
},
{
"NDCCode": "76151-105-52",
"PackageDescription": "15 mL in 1 TUBE (76151-105-52) ",
"NDC11Code": "76151-0105-52",
"ProductNDC": "76151-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oil-free Daily Hydration Spf 15",
"NonProprietaryName": "Octinoxate, Avobenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110416",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Boscia LLC",
"SubstanceName": "OCTINOXATE; AVOBENZONE",
"StrengthNumber": "50; 30",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn.",
"Description": "Preservative-free. Dermatologist tested. Non-comedogenic. Alcohol-free, pH balanced, 100% natural fragrance and color, no animals testing and no animal ingredients. An oil-free moisturizer that hydrates the skin, minimizes pores and providers broad spectrum SPF 15. Polysaccharide provides essential moisture, silica powder controls excessive oil while wine Yeast and Marine Complex help protect against external elements. www.boscia.net B105-11 Distributed by boscia LLC. Irvine, CA 92614 Made in Japan U8-2."
},
{
"NDCCode": "76151-106-12",
"PackageDescription": "1 TUBE in 1 CARTON (76151-106-12) / 40 mL in 1 TUBE",
"NDC11Code": "76151-0106-12",
"ProductNDC": "76151-106",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boscia Daily Hydration Spf 15 Broad Spectrum For Normal To Oily Skin",
"NonProprietaryName": "Avobenzone, Octinoxate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121108",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Boscia LLC",
"SubstanceName": "AVOBENZONE; OCTINOXATE",
"StrengthNumber": "30; 60",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions."
},
{
"NDCCode": "76151-207-01",
"PackageDescription": "30 mL in 1 JAR (76151-207-01) ",
"NDC11Code": "76151-0207-01",
"ProductNDC": "76151-207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Restorative Day Moisture Spf 15",
"NonProprietaryName": "Octinoxate, Avobenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110416",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Boscia LLC",
"SubstanceName": "OCTINOXATE; AVOBENZONE",
"StrengthNumber": "50; 30",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn.",
"Description": "Preservative-free. Dermatologist tested. Alcohol-free, pH balanced, 100% natural fragrance and color, no animal testing and no animal ingredients. www.boscia.net B207-01 Distributed by boscia, LLC. Irvine, CA 92614 Made in U.S.A. U8-2."
},
{
"NDCCode": "76151-210-01",
"PackageDescription": "50 g in 1 BOTTLE (76151-210-01) ",
"NDC11Code": "76151-0210-01",
"ProductNDC": "76151-210",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boscia Bb Spf 27 Pa",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110511",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Boscia LLC",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "6.4",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection.",
"Description": "This B.B. Cream creates a lustrous, flawless finish as it hydrates, firms and soothes the skin. Helps diminish the appearance of pores, fine lines and uneven skintone while providing long-wearing, natural coveage that conceals imperfections. Abyssine, a naturally-derived survival molecule, shields and soothes skin while Hydroxyprolisilane promotes skin elasticity and reduces the appearance of fine lines. Beta-Glucon provides essential moisture and protects against environmental damage. Preservative-free. Dermatologist tested. Alcohol-free, pH balanced, 100% artificial fragrance and color free. No animal testing and no animal ingredients. www.boscia.net B210-01 Distributed by boscia, LLC. Irvine, CA 92614 Made in U.S.A. B11-1."
},
{
"NDCCode": "76151-210-95",
"PackageDescription": "10 g in 1 BOTTLE (76151-210-95) ",
"NDC11Code": "76151-0210-95",
"ProductNDC": "76151-210",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boscia Bb Spf 27 Pa",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110511",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Boscia LLC",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "6.4",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection.",
"Description": "This B.B. Cream creates a lustrous, flawless finish as it hydrates, firms and soothes the skin. Helps diminish the appearance of pores, fine lines and uneven skintone while providing long-wearing, natural coveage that conceals imperfections. Abyssine, a naturally-derived survival molecule, shields and soothes skin while Hydroxyprolisilane promotes skin elasticity and reduces the appearance of fine lines. Beta-Glucon provides essential moisture and protects against environmental damage. Preservative-free. Dermatologist tested. Alcohol-free, pH balanced, 100% artificial fragrance and color free. No animal testing and no animal ingredients. www.boscia.net B210-01 Distributed by boscia, LLC. Irvine, CA 92614 Made in U.S.A. B11-1."
},
{
"NDCCode": "76151-211-02",
"PackageDescription": "50 g in 1 TUBE (76151-211-02) ",
"NDC11Code": "76151-0211-02",
"ProductNDC": "76151-211",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boscia Bb Broad Spectrum Spf 27 Pa Self Adjusting Shade",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Boscia LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "10.02; .97",
"StrengthUnit": "g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "76151-211-96",
"PackageDescription": "25 g in 1 JAR (76151-211-96) ",
"NDC11Code": "76151-0211-96",
"ProductNDC": "76151-211",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boscia Bb Broad Spectrum Spf 27 Pa Self Adjusting Shade",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Boscia LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "10.02; .97",
"StrengthUnit": "g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "76151-217-01",
"PackageDescription": "1 JAR in 1 CARTON (76151-217-01) / 30 mL in 1 JAR",
"NDC11Code": "76151-0217-01",
"ProductNDC": "76151-217",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boscia Restorative Day Moisture Broad Spectrum Spf 15 For Dry Skin",
"NonProprietaryName": "Avobenzone, Octinoxate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121116",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Boscia LLC",
"SubstanceName": "AVOBENZONE; OCTINOXATE",
"StrengthNumber": "30; 65",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions."
},
{
"NDCCode": "76151-231-01",
"PackageDescription": "50 g in 1 TUBE (76151-231-01) ",
"NDC11Code": "76151-0231-01",
"ProductNDC": "76151-231",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boscia B.b. Light Broad Spectrum Spf 27 Pa Self-adjusting Shade",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121106",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Boscia LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "11.25; .98",
"StrengthUnit": "g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "76151-241-01",
"PackageDescription": "50 g in 1 TUBE (76151-241-01) ",
"NDC11Code": "76151-0241-01",
"ProductNDC": "76151-241",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boscia Daily Defense Sunscreen Broad Spectrum Spf 50 Pa",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Boscia LLC",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "7.25; 5.742; 4.75",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "76151-251-01",
"PackageDescription": "1 TUBE in 1 CARTON (76151-251-01) / 40 mL in 1 TUBE",
"NDC11Code": "76151-0251-01",
"ProductNDC": "76151-251",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boscia Self-defense Vital Antioxidant Moisture Broad Spectrum Spf 30",
"NonProprietaryName": "Avobenzone, Octinoxate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121103",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Boscia LLC",
"SubstanceName": "AVOBENZONE; OCTINOXATE",
"StrengthNumber": "30; 75",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions."
},
{
"NDCCode": "76151-261-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (76151-261-01) / 16 g in 1 BOTTLE",
"NDC11Code": "76151-0261-01",
"ProductNDC": "76151-261",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boscia All In One B.b. Eye Brightener Broad Spectrum Spf 20",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140410",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Boscia LLC",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "6.45",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see decreases the risk of skin cancer and early skin aging caused by the sun. Directions),."
},
{
"NDCCode": "76151-301-50",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (76151-301-50) > 50 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "76151-0301-50",
"ProductNDC": "76151-301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boscia Skin Perfecting Bb Broad Spectrum Spf 30 Venice",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190412",
"EndMarketingDate": "20220114",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Boscia, LLC.",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "126; 46",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"Description": "Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium."
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"Description": "Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium."
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"Description": "Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium."
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"Description": "Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium."
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"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140521",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces 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 amlodipine. 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 one 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. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.",
"Description": "Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium."
},
{
"NDCCode": "10135-751-12",
"PackageDescription": "12 SUPPOSITORY in 1 CARTON (10135-751-12) ",
"NDC11Code": "10135-0751-12",
"ProductNDC": "10135-751",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Acetate",
"NonProprietaryName": "Hydrocortisone Acetate",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone Acetate Suppositories are indicated for use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani.",
"Description": "Each Hydrocortisone Acetate Suppository for rectal administration contains hydrocortisone acetate USP in a hydrogenated palm kernel oil base. Hydrocortisone acetate is a corticosteroid. The molecular weight of hydrocortisone acetate is 404.50. Chemically, hydrocortisone acetate is pregn-4-ene-3, 20 dione, 21- (acetyloxy)-11, 17-dihydroxy-, (11β)- with an empirical formula of C23 H32O6 and the following structural formula."
}
]
}
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<NDC>
<NDCCode>76151-751-55</NDCCode>
<PackageDescription>55 mL in 1 BOTTLE, SPRAY (76151-751-55) </PackageDescription>
<NDC11Code>76151-0751-55</NDC11Code>
<ProductNDC>76151-751</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>65601-751-55</NDCCode>
<PackageDescription>208000 mL in 1 DRUM (65601-751-55)</PackageDescription>
<NDC11Code>65601-0751-55</NDC11Code>
<ProductNDC>65601-751</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Winning Hands Foaming Antibacterial</ProprietaryName>
<NonProprietaryName>Tricolsan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Betco Corporation, Ltd.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses. : 1 Antibacterial hand cleaner., 2 Use in a variet of public facilities including daycare centers, hospitals, nursing homes, physicians offices.</IndicationAndUsage>
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<NDC>
<NDCCode>76151-221-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (76151-221-01) / 50 g in 1 TUBE</PackageDescription>
<NDC11Code>76151-0221-01</NDC11Code>
<ProductNDC>76151-221</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia Bb Bronze Broad Spectrum Spf 27 Pa Self-adjusting Shade</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>7.55; .98</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0169-2911-15</NDCCode>
<PackageDescription>5 SYRINGE, PLASTIC in 1 CARTON (0169-2911-15) / 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00169-2911-15</NDC11Code>
<ProductNDC>0169-2911</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xultophy 100/3.6</ProprietaryName>
<NonProprietaryName>Insulin Degludec And Liraglutide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20161121</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA208583</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<SubstanceName>INSULIN DEGLUDEC; LIRAGLUTIDE</SubstanceName>
<StrengthNumber>100; 3.6</StrengthNumber>
<StrengthUnit>[iU]/mL; mg/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: 1 XULTOPHY 100/3.6 contains liraglutide. Coadministration with any other product containing liraglutide or another glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended [see Warnings and Precautions (5.5)]., 2 XULTOPHY 100/3.6 is not recommended for the treatment of diabetic ketoacidosis., 3 XULTOPHY 100/3.6 has not been studied in combination with prandial insulin.</IndicationAndUsage>
<Description>Insulin degludec. Insulin degludec is a long-acting basal human insulin analog. Insulin degludec is produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification. Insulin degludec differs from human insulin in that the amino acid threonine in position B30 has been omitted and a side-chain consisting of glutamic acid and a C16 fatty acid has been attached (chemical name: LysB29(Nε-hexadecandioyl-γ-Glu) des(B30) human insulin). Insulin degludec has a molecular formula of C274H411N65O81S6 and a molecular weight of 6.104 kDa. It has the following structure. Figure 1. Structural Formula of Insulin degludec. Liraglutide. Liraglutide is an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3.751 kDa. It has the following structure. Figure 2. Structural Formula of Liraglutide. XULTOPHY 100/3.6 (insulin degludec and liraglutide) injection, for subcutaneous use, is a combination of a long-acting basal human insulin analog, insulin degludec, and a GLP-1 receptor agonist, liraglutide. XULTOPHY 100/3.6 is a sterile, aqueous, clear, and colorless solution. Each prefilled pen contains 3 mL equivalent to 300 units insulin degludec and 10.8 mg liraglutide. Each mL contains 100 units insulin degludec and 3.6 mg liraglutide. XULTOPHY 100/3.6 contains the following inactive ingredients per mL: glycerol (19.7 mg), phenol (5.7 mg), zinc (55 mcg), and Water for Injection, USP. XULTOPHY 100/3.6 has a pH of approximately 8.15. Hydrochloric acid or sodium hydroxide may be added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>76151-105-11</NDCCode>
<PackageDescription>40 mL in 1 TUBE (76151-105-11) </PackageDescription>
<NDC11Code>76151-0105-11</NDC11Code>
<ProductNDC>76151-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oil-free Daily Hydration Spf 15</ProprietaryName>
<NonProprietaryName>Octinoxate, Avobenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110416</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE</SubstanceName>
<StrengthNumber>50; 30</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
<Description>Preservative-free. Dermatologist tested. Non-comedogenic. Alcohol-free, pH balanced, 100% natural fragrance and color, no animals testing and no animal ingredients. An oil-free moisturizer that hydrates the skin, minimizes pores and providers broad spectrum SPF 15. Polysaccharide provides essential moisture, silica powder controls excessive oil while wine Yeast and Marine Complex help protect against external elements. www.boscia.net B105-11 Distributed by boscia LLC. Irvine, CA 92614 Made in Japan U8-2.</Description>
</NDC>
<NDC>
<NDCCode>76151-105-52</NDCCode>
<PackageDescription>15 mL in 1 TUBE (76151-105-52) </PackageDescription>
<NDC11Code>76151-0105-52</NDC11Code>
<ProductNDC>76151-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oil-free Daily Hydration Spf 15</ProprietaryName>
<NonProprietaryName>Octinoxate, Avobenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110416</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE</SubstanceName>
<StrengthNumber>50; 30</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
<Description>Preservative-free. Dermatologist tested. Non-comedogenic. Alcohol-free, pH balanced, 100% natural fragrance and color, no animals testing and no animal ingredients. An oil-free moisturizer that hydrates the skin, minimizes pores and providers broad spectrum SPF 15. Polysaccharide provides essential moisture, silica powder controls excessive oil while wine Yeast and Marine Complex help protect against external elements. www.boscia.net B105-11 Distributed by boscia LLC. Irvine, CA 92614 Made in Japan U8-2.</Description>
</NDC>
<NDC>
<NDCCode>76151-106-12</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (76151-106-12) / 40 mL in 1 TUBE</PackageDescription>
<NDC11Code>76151-0106-12</NDC11Code>
<ProductNDC>76151-106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia Daily Hydration Spf 15 Broad Spectrum For Normal To Oily Skin</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121108</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE</SubstanceName>
<StrengthNumber>30; 60</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76151-207-01</NDCCode>
<PackageDescription>30 mL in 1 JAR (76151-207-01) </PackageDescription>
<NDC11Code>76151-0207-01</NDC11Code>
<ProductNDC>76151-207</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Restorative Day Moisture Spf 15</ProprietaryName>
<NonProprietaryName>Octinoxate, Avobenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110416</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE</SubstanceName>
<StrengthNumber>50; 30</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
<Description>Preservative-free. Dermatologist tested. Alcohol-free, pH balanced, 100% natural fragrance and color, no animal testing and no animal ingredients. www.boscia.net B207-01 Distributed by boscia, LLC. Irvine, CA 92614 Made in U.S.A. U8-2.</Description>
</NDC>
<NDC>
<NDCCode>76151-210-01</NDCCode>
<PackageDescription>50 g in 1 BOTTLE (76151-210-01) </PackageDescription>
<NDC11Code>76151-0210-01</NDC11Code>
<ProductNDC>76151-210</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia Bb Spf 27 Pa</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110511</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>6.4</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection.</IndicationAndUsage>
<Description>This B.B. Cream creates a lustrous, flawless finish as it hydrates, firms and soothes the skin. Helps diminish the appearance of pores, fine lines and uneven skintone while providing long-wearing, natural coveage that conceals imperfections. Abyssine, a naturally-derived survival molecule, shields and soothes skin while Hydroxyprolisilane promotes skin elasticity and reduces the appearance of fine lines. Beta-Glucon provides essential moisture and protects against environmental damage. Preservative-free. Dermatologist tested. Alcohol-free, pH balanced, 100% artificial fragrance and color free. No animal testing and no animal ingredients. www.boscia.net B210-01 Distributed by boscia, LLC. Irvine, CA 92614 Made in U.S.A. B11-1.</Description>
</NDC>
<NDC>
<NDCCode>76151-210-95</NDCCode>
<PackageDescription>10 g in 1 BOTTLE (76151-210-95) </PackageDescription>
<NDC11Code>76151-0210-95</NDC11Code>
<ProductNDC>76151-210</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia Bb Spf 27 Pa</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110511</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>6.4</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection.</IndicationAndUsage>
<Description>This B.B. Cream creates a lustrous, flawless finish as it hydrates, firms and soothes the skin. Helps diminish the appearance of pores, fine lines and uneven skintone while providing long-wearing, natural coveage that conceals imperfections. Abyssine, a naturally-derived survival molecule, shields and soothes skin while Hydroxyprolisilane promotes skin elasticity and reduces the appearance of fine lines. Beta-Glucon provides essential moisture and protects against environmental damage. Preservative-free. Dermatologist tested. Alcohol-free, pH balanced, 100% artificial fragrance and color free. No animal testing and no animal ingredients. www.boscia.net B210-01 Distributed by boscia, LLC. Irvine, CA 92614 Made in U.S.A. B11-1.</Description>
</NDC>
<NDC>
<NDCCode>76151-211-02</NDCCode>
<PackageDescription>50 g in 1 TUBE (76151-211-02) </PackageDescription>
<NDC11Code>76151-0211-02</NDC11Code>
<ProductNDC>76151-211</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia Bb Broad Spectrum Spf 27 Pa Self Adjusting Shade</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>10.02; .97</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76151-211-96</NDCCode>
<PackageDescription>25 g in 1 JAR (76151-211-96) </PackageDescription>
<NDC11Code>76151-0211-96</NDC11Code>
<ProductNDC>76151-211</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia Bb Broad Spectrum Spf 27 Pa Self Adjusting Shade</ProprietaryName>
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<DosageFormName>CREAM</DosageFormName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>10.02; .97</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76151-217-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (76151-217-01) / 30 mL in 1 JAR</PackageDescription>
<NDC11Code>76151-0217-01</NDC11Code>
<ProductNDC>76151-217</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia Restorative Day Moisture Broad Spectrum Spf 15 For Dry Skin</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121116</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE</SubstanceName>
<StrengthNumber>30; 65</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76151-231-01</NDCCode>
<PackageDescription>50 g in 1 TUBE (76151-231-01) </PackageDescription>
<NDC11Code>76151-0231-01</NDC11Code>
<ProductNDC>76151-231</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia B.b. Light Broad Spectrum Spf 27 Pa Self-adjusting Shade</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>11.25; .98</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76151-241-01</NDCCode>
<PackageDescription>50 g in 1 TUBE (76151-241-01) </PackageDescription>
<NDC11Code>76151-0241-01</NDC11Code>
<ProductNDC>76151-241</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia Daily Defense Sunscreen Broad Spectrum Spf 50 Pa</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>7.25; 5.742; 4.75</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76151-251-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (76151-251-01) / 40 mL in 1 TUBE</PackageDescription>
<NDC11Code>76151-0251-01</NDC11Code>
<ProductNDC>76151-251</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia Self-defense Vital Antioxidant Moisture Broad Spectrum Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121103</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE</SubstanceName>
<StrengthNumber>30; 75</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76151-261-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (76151-261-01) / 16 g in 1 BOTTLE</PackageDescription>
<NDC11Code>76151-0261-01</NDC11Code>
<ProductNDC>76151-261</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia All In One B.b. Eye Brightener Broad Spectrum Spf 20</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140410</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Boscia LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>6.45</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see decreases the risk of skin cancer and early skin aging caused by the sun. Directions),.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76151-301-50</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (76151-301-50) > 50 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>76151-0301-50</NDC11Code>
<ProductNDC>76151-301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia Skin Perfecting Bb Broad Spectrum Spf 30 Venice</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190412</StartMarketingDate>
<EndMarketingDate>20220114</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Boscia, LLC.</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>126; 46</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190412</StartMarketingDatePackage>
<EndMarketingDatePackage>20220114</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76151-302-50</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (76151-302-50) > 50 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>76151-0302-50</NDC11Code>
<ProductNDC>76151-302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia Skin Perfecting Bb Broad Spectrum Spf 30 Manhattan Beach</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190412</StartMarketingDate>
<EndMarketingDate>20220113</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Boscia, LLC.</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>126; 46</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190412</StartMarketingDatePackage>
<EndMarketingDatePackage>20220113</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76151-303-50</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (76151-303-50) > 50 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>76151-0303-50</NDC11Code>
<ProductNDC>76151-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia Skin Perfecting Bb Broad Spectrum Spf 30 Newport</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190412</StartMarketingDate>
<EndMarketingDate>20210206</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Boscia, LLC.</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>126; 46</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-02-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190412</StartMarketingDatePackage>
<EndMarketingDatePackage>20210206</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76151-304-50</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (76151-304-50) > 50 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>76151-0304-50</NDC11Code>
<ProductNDC>76151-304</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boscia Skin Perfecting Bb Broad Spectrum Spf 30 La Jolla</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190412</StartMarketingDate>
<EndMarketingDate>20210207</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Boscia, LLC.</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>126; 46</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-02-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190412</StartMarketingDatePackage>
<EndMarketingDatePackage>20210207</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-4513-93</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4513-93) </PackageDescription>
<NDC11Code>00378-4513-93</NDC11Code>
<ProductNDC>0378-4513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Atorvastatin</ProprietaryName>
<NonProprietaryName>Amlodipine And Atorvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200465</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces 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 amlodipine. 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 one 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. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
</NDC>
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<NDCCode>0378-4514-93</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4514-93) </PackageDescription>
<NDC11Code>00378-4514-93</NDC11Code>
<ProductNDC>0378-4514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Atorvastatin</ProprietaryName>
<NonProprietaryName>Amlodipine And Atorvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200465</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
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<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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<IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces 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 amlodipine. 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 one 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. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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<NDC>
<NDCCode>10135-751-12</NDCCode>
<PackageDescription>12 SUPPOSITORY in 1 CARTON (10135-751-12) </PackageDescription>
<NDC11Code>10135-0751-12</NDC11Code>
<ProductNDC>10135-751</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Acetate</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20220801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone Acetate Suppositories are indicated for use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani.</IndicationAndUsage>
<Description>Each Hydrocortisone Acetate Suppository for rectal administration contains hydrocortisone acetate USP in a hydrogenated palm kernel oil base. Hydrocortisone acetate is a corticosteroid. The molecular weight of hydrocortisone acetate is 404.50. Chemically, hydrocortisone acetate is pregn-4-ene-3, 20 dione, 21- (acetyloxy)-11, 17-dihydroxy-, (11β)- with an empirical formula of C23 H32O6 and the following structural formula.</Description>
</NDC>
</NDCList>