{
"NDC": [
{
"NDCCode": "87247-418-19",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (87247-418-19) / 40 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "87247-0418-19",
"ProductNDC": "87247-418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Chocolate Chip Pancake Scent",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260219",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Diamond Life Cosmetics Trading FZCO",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260219",
"SamplePackage": "N",
"IndicationAndUsage": " To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use."
},
{
"NDCCode": "87247-139-19",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (87247-139-19) / 40 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "87247-0139-19",
"ProductNDC": "87247-139",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sour Lemon Hand Sanitizer Sugar Macaron Scent",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Diamond Life Cosmetics Trading FZCO",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": " To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use."
},
{
"NDCCode": "87247-418-18",
"PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (87247-418-18) / 35 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "87247-0418-18",
"ProductNDC": "87247-418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Chocolate Chip Pancake Scent",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260219",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Diamond Life Cosmetics Trading FZCO",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260219",
"SamplePackage": "N",
"IndicationAndUsage": " To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use."
},
{
"NDCCode": "0069-2377-10",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (0069-2377-10) / .418 mL in 1 SYRINGE, GLASS (0069-2377-01) ",
"NDC11Code": "00069-2377-10",
"ProductNDC": "0069-2377",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Comirnaty",
"NonProprietaryName": "Covid-19 Vaccine, Mrna",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20231031",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125742",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "RAXTOZINAMERAN",
"StrengthNumber": ".042",
"StrengthUnit": "mg/.418mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20231031",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.",
"Description": "COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile suspension for injection for intramuscular use. Each 0.3 mL dose of COMIRNATY (2024-2025 Formula) is formulated to contain 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage KP.2. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. COMIRNATY does not contain preservatives. The vial stoppers are not made with natural rubber latex. The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex."
},
{
"NDCCode": "0069-2432-10",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (0069-2432-10) / .418 mL in 1 SYRINGE, GLASS (0069-2432-01) ",
"NDC11Code": "00069-2432-10",
"ProductNDC": "0069-2432",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Comirnaty",
"NonProprietaryName": "Covid-19 Vaccine, Mrna",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240822",
"EndMarketingDate": "20260122",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125742",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "BNT162B2 OMICRON (KP.2)",
"StrengthNumber": ".042",
"StrengthUnit": "mg/.418mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240822",
"EndMarketingDatePackage": "20260122",
"SamplePackage": "N",
"IndicationAndUsage": "COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COMIRNATY is approved for use in individuals who are: 1 65 years of age and older, or, 2 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile injectable suspension for intramuscular use. Single-Dose Prefilled Syringe for Individuals 65 Years of Age and Older and Individuals 12 Years Through 64 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2025-2026 Formula) is formulated to contain 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant sublineage LP.8.1. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. Single-Dose Vial for Individuals 5 Years Through 11 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2025-2026 Formula) is formulated to contain 10 mcg of a modRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant sublineage LP.8.1. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.14 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. COMIRNATY does not contain preservatives. The vial stoppers are not made with natural rubber latex. The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex."
},
{
"NDCCode": "0069-2528-10",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (0069-2528-10) / .418 mL in 1 SYRINGE, GLASS (0069-2528-01) ",
"NDC11Code": "00069-2528-10",
"ProductNDC": "0069-2528",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Comirnaty",
"NonProprietaryName": "Covid-19 Vaccine, Mrna",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20250827",
"EndMarketingDate": "20270119",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125742",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "BNT162B2 OMICRON (LP.8.1)",
"StrengthNumber": ".042",
"StrengthUnit": "mg/.418mL",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250827",
"EndMarketingDatePackage": "20270119",
"SamplePackage": "N",
"IndicationAndUsage": "COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COMIRNATY is approved for use in individuals who are: 1 65 years of age and older, or, 2 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile injectable suspension for intramuscular use. Single-Dose Prefilled Syringe for Individuals 65 Years of Age and Older and Individuals 12 Years Through 64 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2026-2027 Formula) is formulated to contain 30 mcg nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 JN.1-descendent variant XFG. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. Single-Dose Vial for Individuals 5 Years Through 11 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2026-2027 Formula) is formulated to contain 10 mcg nucleoside-modified RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 JN.1-descendent variant XFG. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.14 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. COMIRNATY does not contain preservatives. The vial stoppers are not made with natural rubber latex. The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex."
},
{
"NDCCode": "0069-2631-10",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (0069-2631-10) / .418 mL in 1 SYRINGE, GLASS (0069-2631-01) ",
"NDC11Code": "00069-2631-10",
"ProductNDC": "0069-2631",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Comirnaty",
"NonProprietaryName": "Covid-19 Vaccine, Mrna",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20260827",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125742",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "BNT-162B2 OMICRON (XFG) MRNA",
"StrengthNumber": ".042",
"StrengthUnit": "mg/.418mL",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260827",
"SamplePackage": "N",
"IndicationAndUsage": "COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COMIRNATY is approved for use in individuals who are: 1 65 years of age and older, or, 2 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile injectable suspension for intramuscular use. Single-Dose Prefilled Syringe for Individuals 65 Years of Age and Older and Individuals 12 Years Through 64 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2026-2027 Formula) is formulated to contain 30 mcg nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 JN.1-descendent variant XFG. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. Single-Dose Vial for Individuals 5 Years Through 11 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2026-2027 Formula) is formulated to contain 10 mcg nucleoside-modified RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 JN.1-descendent variant XFG. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.14 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. COMIRNATY does not contain preservatives. The vial stoppers are not made with natural rubber latex. The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex."
},
{
"NDCCode": "42708-148-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-148-30) ",
"NDC11Code": "42708-0148-30",
"ProductNDC": "42708-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078155",
"LabelerName": "QPharma, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210730",
"SamplePackage": "Y",
"IndicationAndUsage": "Simvastatin tablet is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, and triethyl citrate."
},
{
"NDCCode": "43353-858-19",
"PackageDescription": "3060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-858-19) ",
"NDC11Code": "43353-0858-19",
"ProductNDC": "43353-858",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077691",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20131204",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets, USP can be started simultaneously with diet.",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol.Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol.Tablets simvastatin for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin USP and the following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red."
},
{
"NDCCode": "43419-418-18",
"PackageDescription": "1 TUBE in 1 CARTON (43419-418-18) > 60 mL in 1 TUBE",
"NDC11Code": "43419-0418-18",
"ProductNDC": "43419-418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iope Uv Defense Sun Protector Ex",
"NonProprietaryName": "Avobenzone, Homosalate, Octocrylene, Octisalate Lotion",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200427",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Amorepacific Corporation",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200427",
"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": "49502-418-02",
"PackageDescription": "2 TRAY in 1 KIT (49502-418-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-482-06) / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-483-06) / 1 mL in 1 PACKET",
"NDC11Code": "49502-0418-02",
"ProductNDC": "49502-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalimumab",
"NonProprietaryName": "Adalimumab-fkjp",
"DosageFormName": "KIT",
"StartMarketingDate": "20230702",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761154",
"LabelerName": "Viatris Specialty LLC",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230702",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "Adalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.",
"Description": "Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-fkjp is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-fkjp Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of Adalimumab-fkjp is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-fkjp contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-fkjp contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH."
},
{
"NDCCode": "51655-113-26",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-113-26) ",
"NDC11Code": "51655-0113-26",
"ProductNDC": "51655-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078034",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230301",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide."
},
{
"NDCCode": "51655-113-52",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-113-52) ",
"NDC11Code": "51655-0113-52",
"ProductNDC": "51655-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078034",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231226",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide."
},
{
"NDCCode": "68788-4056-2",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (68788-4056-2) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "68788-4056-02",
"ProductNDC": "68788-4056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azelastine Hydrochloride",
"NonProprietaryName": "Azelastine Hydrochloride",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20251117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077954",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "AZELASTINE HYDROCHLORIDE",
"StrengthNumber": "137",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251117",
"SamplePackage": "N",
"IndicationAndUsage": "Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.",
"Description": "Azelastine hydrochloride nasal solution 0.1% (nasal spray), 137 micrograms (mcg) per spray, is an antihistamine formulated as a metered-spray solution for intranasal administration. Azelastine hydrochloride occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37 g/mol. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225ºC and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3OHCl with the following chemical structure. Azelastine hydrochloride nasal solution contains 0.1% azelastine hydrochloride in an aqueous solution at pH 6.8 ± 0.3. It also contains benzalkonium chloride (125 mcg/mL), citric acid, dibasic sodium phosphate, edetate disodium, hypromellose, purified water and sodium chloride. After priming [see Dosage and Administration (2.3)], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The bottle can deliver 200 metered sprays."
},
{
"NDCCode": "70301-1001-1",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-1) ",
"NDC11Code": "70301-1001-01",
"ProductNDC": "70301-1001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rayaldee",
"NonProprietaryName": "Calcifediol",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208010",
"LabelerName": "OPKO Pharmaceuticals LLC",
"SubstanceName": "CALCIFEDIOL",
"StrengthNumber": "30",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161025",
"SamplePackage": "N",
"IndicationAndUsage": "RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use. RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.",
"Description": "Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D3. Calcifediol monohydrate is a white crystalline powder, has a calculated molecular weight of 418.65 and is soluble in alcohol and fatty oils but practically insoluble in water. Chemically, calcifediol monohydrate is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol monohydrate and its structural formula is. RAYALDEE is formulated as extended-release capsules containing 30 mcg of calcifediol. RAYALDEE is available as soft capsules or two-piece banded hard capsules containing 30 mcg of calcifediol for oral administration. Each capsule contains the following excipients: butylated hydroxytoluene, dehydrated alcohol, hypromellose, lauroyl polyoxylglycerides, mineral oil, monoglycerides and diglycerides, and paraffin. The soft capsule shells contain carrageenan, FD&C Blue #1, modified starch, purified water, sodium phosphate dibasic, sorbitol sorbitan solution, and titanium dioxide. Medium chain triglyceride (fractionated coconut) oil is used as a lubricant during manufacture, and trace amounts may be present in the final formulation. The hard capsule shells contain gellan gum, hypromellose, and titanium dioxide."
},
{
"NDCCode": "70301-1001-2",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-2) ",
"NDC11Code": "70301-1001-02",
"ProductNDC": "70301-1001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rayaldee",
"NonProprietaryName": "Calcifediol",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208010",
"LabelerName": "OPKO Pharmaceuticals LLC",
"SubstanceName": "CALCIFEDIOL",
"StrengthNumber": "30",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161025",
"SamplePackage": "N",
"IndicationAndUsage": "RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use. RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.",
"Description": "Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D3. Calcifediol monohydrate is a white crystalline powder, has a calculated molecular weight of 418.65 and is soluble in alcohol and fatty oils but practically insoluble in water. Chemically, calcifediol monohydrate is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol monohydrate and its structural formula is. RAYALDEE is formulated as extended-release capsules containing 30 mcg of calcifediol. RAYALDEE is available as soft capsules or two-piece banded hard capsules containing 30 mcg of calcifediol for oral administration. Each capsule contains the following excipients: butylated hydroxytoluene, dehydrated alcohol, hypromellose, lauroyl polyoxylglycerides, mineral oil, monoglycerides and diglycerides, and paraffin. The soft capsule shells contain carrageenan, FD&C Blue #1, modified starch, purified water, sodium phosphate dibasic, sorbitol sorbitan solution, and titanium dioxide. Medium chain triglyceride (fractionated coconut) oil is used as a lubricant during manufacture, and trace amounts may be present in the final formulation. The hard capsule shells contain gellan gum, hypromellose, and titanium dioxide."
},
{
"NDCCode": "70301-1001-3",
"PackageDescription": "7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-3) ",
"NDC11Code": "70301-1001-03",
"ProductNDC": "70301-1001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rayaldee",
"NonProprietaryName": "Calcifediol",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208010",
"LabelerName": "OPKO Pharmaceuticals LLC",
"SubstanceName": "CALCIFEDIOL",
"StrengthNumber": "30",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "Y",
"IndicationAndUsage": "RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use. RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.",
"Description": "Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D3. Calcifediol monohydrate is a white crystalline powder, has a calculated molecular weight of 418.65 and is soluble in alcohol and fatty oils but practically insoluble in water. Chemically, calcifediol monohydrate is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol monohydrate and its structural formula is. RAYALDEE is formulated as extended-release capsules containing 30 mcg of calcifediol. RAYALDEE is available as soft capsules or two-piece banded hard capsules containing 30 mcg of calcifediol for oral administration. Each capsule contains the following excipients: butylated hydroxytoluene, dehydrated alcohol, hypromellose, lauroyl polyoxylglycerides, mineral oil, monoglycerides and diglycerides, and paraffin. The soft capsule shells contain carrageenan, FD&C Blue #1, modified starch, purified water, sodium phosphate dibasic, sorbitol sorbitan solution, and titanium dioxide. Medium chain triglyceride (fractionated coconut) oil is used as a lubricant during manufacture, and trace amounts may be present in the final formulation. The hard capsule shells contain gellan gum, hypromellose, and titanium dioxide."
},
{
"NDCCode": "70301-1002-1",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1002-1) ",
"NDC11Code": "70301-1002-01",
"ProductNDC": "70301-1002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rayaldee",
"NonProprietaryName": "Calcifediol",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240311",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208010",
"LabelerName": "OPKO Pharmaceuticals LLC",
"SubstanceName": "CALCIFEDIOL",
"StrengthNumber": "30",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240311",
"SamplePackage": "N",
"IndicationAndUsage": "RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use. RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.",
"Description": "Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D3. Calcifediol monohydrate is a white crystalline powder, has a calculated molecular weight of 418.65 and is soluble in alcohol and fatty oils but practically insoluble in water. Chemically, calcifediol monohydrate is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol monohydrate and its structural formula is. RAYALDEE is formulated as extended-release capsules containing 30 mcg of calcifediol. RAYALDEE is available as soft capsules or two-piece banded hard capsules containing 30 mcg of calcifediol for oral administration. Each capsule contains the following excipients: butylated hydroxytoluene, dehydrated alcohol, hypromellose, lauroyl polyoxylglycerides, mineral oil, monoglycerides and diglycerides, and paraffin. The soft capsule shells contain carrageenan, FD&C Blue #1, modified starch, purified water, sodium phosphate dibasic, sorbitol sorbitan solution, and titanium dioxide. Medium chain triglyceride (fractionated coconut) oil is used as a lubricant during manufacture, and trace amounts may be present in the final formulation. The hard capsule shells contain gellan gum, hypromellose, and titanium dioxide."
},
{
"NDCCode": "70301-1002-2",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1002-2) ",
"NDC11Code": "70301-1002-02",
"ProductNDC": "70301-1002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rayaldee",
"NonProprietaryName": "Calcifediol",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240311",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208010",
"LabelerName": "OPKO Pharmaceuticals LLC",
"SubstanceName": "CALCIFEDIOL",
"StrengthNumber": "30",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240311",
"SamplePackage": "N",
"IndicationAndUsage": "RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use. RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.",
"Description": "Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D3. Calcifediol monohydrate is a white crystalline powder, has a calculated molecular weight of 418.65 and is soluble in alcohol and fatty oils but practically insoluble in water. Chemically, calcifediol monohydrate is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol monohydrate and its structural formula is. RAYALDEE is formulated as extended-release capsules containing 30 mcg of calcifediol. RAYALDEE is available as soft capsules or two-piece banded hard capsules containing 30 mcg of calcifediol for oral administration. Each capsule contains the following excipients: butylated hydroxytoluene, dehydrated alcohol, hypromellose, lauroyl polyoxylglycerides, mineral oil, monoglycerides and diglycerides, and paraffin. The soft capsule shells contain carrageenan, FD&C Blue #1, modified starch, purified water, sodium phosphate dibasic, sorbitol sorbitan solution, and titanium dioxide. Medium chain triglyceride (fractionated coconut) oil is used as a lubricant during manufacture, and trace amounts may be present in the final formulation. The hard capsule shells contain gellan gum, hypromellose, and titanium dioxide."
},
{
"NDCCode": "70301-1002-3",
"PackageDescription": "7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1002-3) ",
"NDC11Code": "70301-1002-03",
"ProductNDC": "70301-1002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rayaldee",
"NonProprietaryName": "Calcifediol",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240311",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208010",
"LabelerName": "OPKO Pharmaceuticals LLC",
"SubstanceName": "CALCIFEDIOL",
"StrengthNumber": "30",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240311",
"SamplePackage": "Y",
"IndicationAndUsage": "RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use. RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.",
"Description": "Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D3. Calcifediol monohydrate is a white crystalline powder, has a calculated molecular weight of 418.65 and is soluble in alcohol and fatty oils but practically insoluble in water. Chemically, calcifediol monohydrate is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol monohydrate and its structural formula is. RAYALDEE is formulated as extended-release capsules containing 30 mcg of calcifediol. RAYALDEE is available as soft capsules or two-piece banded hard capsules containing 30 mcg of calcifediol for oral administration. Each capsule contains the following excipients: butylated hydroxytoluene, dehydrated alcohol, hypromellose, lauroyl polyoxylglycerides, mineral oil, monoglycerides and diglycerides, and paraffin. The soft capsule shells contain carrageenan, FD&C Blue #1, modified starch, purified water, sodium phosphate dibasic, sorbitol sorbitan solution, and titanium dioxide. Medium chain triglyceride (fractionated coconut) oil is used as a lubricant during manufacture, and trace amounts may be present in the final formulation. The hard capsule shells contain gellan gum, hypromellose, and titanium dioxide."
},
{
"NDCCode": "70518-1860-1",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1860-1) ",
"NDC11Code": "70518-1860-01",
"ProductNDC": "70518-1860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078155",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190709",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablet is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, and triethyl citrate."
},
{
"NDCCode": "70518-3630-2",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3630-2) ",
"NDC11Code": "70518-3630-02",
"ProductNDC": "70518-3630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078034",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241015",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide."
},
{
"NDCCode": "81746-418-01",
"PackageDescription": "3.32 g in 1 BOX (81746-418-01) ",
"NDC11Code": "81746-0418-01",
"ProductNDC": "81746-418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Killa Extra Strength",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M006",
"LabelerName": "Zitsticka, Inc.",
"SubstanceName": "MAGNESIUM SALICYLATE",
"StrengthNumber": ".0664",
"StrengthUnit": "g/3.32g",
"Status": "Deprecated",
"LastUpdate": "2023-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230101",
"SamplePackage": "N"
},
{
"NDCCode": "84515-418-01",
"PackageDescription": "15 g in 1 BOX (84515-418-01) ",
"NDC11Code": "84515-0418-01",
"ProductNDC": "84515-418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Avocado Moisturizer",
"NonProprietaryName": "Avocado Moisturizer",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241016",
"EndMarketingDate": "20311231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241016",
"EndMarketingDatePackage": "20311231",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "87247-014-03",
"PackageDescription": "1 KIT in 1 BOX (87247-014-03) * 40 mL in 1 BOTTLE, SPRAY * 40 mL in 1 BOTTLE, SPRAY * 40 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "87247-0014-03",
"ProductNDC": "87247-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sour Lemon Hand Sanitizer Trio - Sweet Cherry, Toasted Marshmallow And Sugar Macaron Scent",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Diamond Life Cosmetics Trading FZCO",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": " To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use."
},
{
"NDCCode": "87247-015-05",
"PackageDescription": "1 KIT in 1 BOX (87247-015-05) * 40 mL in 1 BOTTLE, SPRAY * 40 mL in 1 BOTTLE, SPRAY * 40 mL in 1 BOTTLE, SPRAY * 40 mL in 1 BOTTLE, SPRAY * 40 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "87247-0015-05",
"ProductNDC": "87247-015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sour Lemon Hand Sanitizer Set - Sweet Cherry, Salted Caramel, Sugar Macaron, Toasted Marshmallow And Souffle Vanilla Scent",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Diamond Life Cosmetics Trading FZCO",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": " To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use."
},
{
"NDCCode": "87247-017-02",
"PackageDescription": "1 KIT in 1 BOX (87247-017-02) * 40 mL in 1 BOTTLE, SPRAY * 40 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "87247-0017-02",
"ProductNDC": "87247-017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sour Lemon 2 Pc Hand Sanitizer With Stickers - Salted Caramel And Souffle Vanilla Scent",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Diamond Life Cosmetics Trading FZCO",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": " To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use."
},
{
"NDCCode": "87247-128-08",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (87247-128-08) / 40 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "87247-0128-08",
"ProductNDC": "87247-128",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soft Touch Hand Sanitizer Peony Blush Scent",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Diamond Life Cosmetics Trading FZCO",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": " To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use."
},
{
"NDCCode": "87247-129-09",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (87247-129-09) / 40 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "87247-0129-09",
"ProductNDC": "87247-129",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tropical Touch Hand Sanitizer Hibiscus Scent",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Diamond Life Cosmetics Trading FZCO",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": " To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use."
},
{
"NDCCode": "87247-130-00",
"PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (87247-130-00) / 40 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "87247-0130-00",
"ProductNDC": "87247-130",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bcbgeneration Hand Sanitizer Peony Blush Scent",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Diamond Life Cosmetics Trading FZCO",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": " To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>87247-418-19</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (87247-418-19) / 40 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>87247-0418-19</NDC11Code>
<ProductNDC>87247-418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Chocolate Chip Pancake Scent</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260219</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Diamond Life Cosmetics Trading FZCO</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>87247-139-19</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (87247-139-19) / 40 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>87247-0139-19</NDC11Code>
<ProductNDC>87247-139</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sour Lemon Hand Sanitizer Sugar Macaron Scent</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Diamond Life Cosmetics Trading FZCO</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>87247-418-18</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 POUCH (87247-418-18) / 35 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>87247-0418-18</NDC11Code>
<ProductNDC>87247-418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Chocolate Chip Pancake Scent</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260219</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Diamond Life Cosmetics Trading FZCO</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0069-2377-10</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (0069-2377-10) / .418 mL in 1 SYRINGE, GLASS (0069-2377-01) </PackageDescription>
<NDC11Code>00069-2377-10</NDC11Code>
<ProductNDC>0069-2377</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Comirnaty</ProprietaryName>
<NonProprietaryName>Covid-19 Vaccine, Mrna</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20231031</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125742</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>RAXTOZINAMERAN</SubstanceName>
<StrengthNumber>.042</StrengthNumber>
<StrengthUnit>mg/.418mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20231031</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.</IndicationAndUsage>
<Description>COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile suspension for injection for intramuscular use. Each 0.3 mL dose of COMIRNATY (2024-2025 Formula) is formulated to contain 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage KP.2. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. COMIRNATY does not contain preservatives. The vial stoppers are not made with natural rubber latex. The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>0069-2432-10</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (0069-2432-10) / .418 mL in 1 SYRINGE, GLASS (0069-2432-01) </PackageDescription>
<NDC11Code>00069-2432-10</NDC11Code>
<ProductNDC>0069-2432</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Comirnaty</ProprietaryName>
<NonProprietaryName>Covid-19 Vaccine, Mrna</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240822</StartMarketingDate>
<EndMarketingDate>20260122</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125742</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>BNT162B2 OMICRON (KP.2)</SubstanceName>
<StrengthNumber>.042</StrengthNumber>
<StrengthUnit>mg/.418mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240822</StartMarketingDatePackage>
<EndMarketingDatePackage>20260122</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COMIRNATY is approved for use in individuals who are: 1 65 years of age and older, or, 2 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile injectable suspension for intramuscular use. Single-Dose Prefilled Syringe for Individuals 65 Years of Age and Older and Individuals 12 Years Through 64 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2025-2026 Formula) is formulated to contain 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant sublineage LP.8.1. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. Single-Dose Vial for Individuals 5 Years Through 11 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2025-2026 Formula) is formulated to contain 10 mcg of a modRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant sublineage LP.8.1. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.14 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. COMIRNATY does not contain preservatives. The vial stoppers are not made with natural rubber latex. The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex.</Description>
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<NDC>
<NDCCode>0069-2528-10</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (0069-2528-10) / .418 mL in 1 SYRINGE, GLASS (0069-2528-01) </PackageDescription>
<NDC11Code>00069-2528-10</NDC11Code>
<ProductNDC>0069-2528</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Comirnaty</ProprietaryName>
<NonProprietaryName>Covid-19 Vaccine, Mrna</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20250827</StartMarketingDate>
<EndMarketingDate>20270119</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125742</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>BNT162B2 OMICRON (LP.8.1)</SubstanceName>
<StrengthNumber>.042</StrengthNumber>
<StrengthUnit>mg/.418mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COMIRNATY is approved for use in individuals who are: 1 65 years of age and older, or, 2 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile injectable suspension for intramuscular use. Single-Dose Prefilled Syringe for Individuals 65 Years of Age and Older and Individuals 12 Years Through 64 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2026-2027 Formula) is formulated to contain 30 mcg nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 JN.1-descendent variant XFG. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. Single-Dose Vial for Individuals 5 Years Through 11 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2026-2027 Formula) is formulated to contain 10 mcg nucleoside-modified RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 JN.1-descendent variant XFG. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.14 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. COMIRNATY does not contain preservatives. The vial stoppers are not made with natural rubber latex. The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex.</Description>
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<NDC>
<NDCCode>0069-2631-10</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (0069-2631-10) / .418 mL in 1 SYRINGE, GLASS (0069-2631-01) </PackageDescription>
<NDC11Code>00069-2631-10</NDC11Code>
<ProductNDC>0069-2631</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Comirnaty</ProprietaryName>
<NonProprietaryName>Covid-19 Vaccine, Mrna</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20260827</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125742</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>BNT-162B2 OMICRON (XFG) MRNA</SubstanceName>
<StrengthNumber>.042</StrengthNumber>
<StrengthUnit>mg/.418mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COMIRNATY is approved for use in individuals who are: 1 65 years of age and older, or, 2 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile injectable suspension for intramuscular use. Single-Dose Prefilled Syringe for Individuals 65 Years of Age and Older and Individuals 12 Years Through 64 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2026-2027 Formula) is formulated to contain 30 mcg nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 JN.1-descendent variant XFG. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. Single-Dose Vial for Individuals 5 Years Through 11 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19. Each 0.3 mL dose of COMIRNATY (2026-2027 Formula) is formulated to contain 10 mcg nucleoside-modified RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 JN.1-descendent variant XFG. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.14 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. COMIRNATY does not contain preservatives. The vial stoppers are not made with natural rubber latex. The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>42708-148-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-148-30) </PackageDescription>
<NDC11Code>42708-0148-30</NDC11Code>
<ProductNDC>42708-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078155</ApplicationNumber>
<LabelerName>QPharma, Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210730</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Simvastatin tablet is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>43353-858-19</NDCCode>
<PackageDescription>3060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-858-19) </PackageDescription>
<NDC11Code>43353-0858-19</NDC11Code>
<ProductNDC>43353-858</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077691</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets, USP can be started simultaneously with diet.</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol.Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol.Tablets simvastatin for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin USP and the following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red.</Description>
</NDC>
<NDC>
<NDCCode>43419-418-18</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (43419-418-18) > 60 mL in 1 TUBE</PackageDescription>
<NDC11Code>43419-0418-18</NDC11Code>
<ProductNDC>43419-418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iope Uv Defense Sun Protector Ex</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octocrylene, Octisalate Lotion</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200427</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Amorepacific Corporation</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200427</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>49502-418-02</NDCCode>
<PackageDescription>2 TRAY in 1 KIT (49502-418-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-482-06) / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-483-06) / 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>49502-0418-02</NDC11Code>
<ProductNDC>49502-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adalimumab</ProprietaryName>
<NonProprietaryName>Adalimumab-fkjp</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230702</StartMarketingDate>
<EndMarketingDate>20250930</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761154</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230702</StartMarketingDatePackage>
<EndMarketingDatePackage>20250930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.</IndicationAndUsage>
<Description>Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-fkjp is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-fkjp Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of Adalimumab-fkjp is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-fkjp contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-fkjp contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>51655-113-26</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-113-26) </PackageDescription>
<NDC11Code>51655-0113-26</NDC11Code>
<ProductNDC>51655-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078034</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>51655-113-52</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-113-52) </PackageDescription>
<NDC11Code>51655-0113-52</NDC11Code>
<ProductNDC>51655-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078034</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>68788-4056-2</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (68788-4056-2) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>68788-4056-02</NDC11Code>
<ProductNDC>68788-4056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azelastine Hydrochloride</ProprietaryName>
<NonProprietaryName>Azelastine Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20251117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077954</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AZELASTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>137</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.</IndicationAndUsage>
<Description>Azelastine hydrochloride nasal solution 0.1% (nasal spray), 137 micrograms (mcg) per spray, is an antihistamine formulated as a metered-spray solution for intranasal administration. Azelastine hydrochloride occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37 g/mol. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225ºC and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3OHCl with the following chemical structure. Azelastine hydrochloride nasal solution contains 0.1% azelastine hydrochloride in an aqueous solution at pH 6.8 ± 0.3. It also contains benzalkonium chloride (125 mcg/mL), citric acid, dibasic sodium phosphate, edetate disodium, hypromellose, purified water and sodium chloride. After priming [see Dosage and Administration (2.3)], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The bottle can deliver 200 metered sprays.</Description>
</NDC>
<NDC>
<NDCCode>70301-1001-1</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-1) </PackageDescription>
<NDC11Code>70301-1001-01</NDC11Code>
<ProductNDC>70301-1001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rayaldee</ProprietaryName>
<NonProprietaryName>Calcifediol</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208010</ApplicationNumber>
<LabelerName>OPKO Pharmaceuticals LLC</LabelerName>
<SubstanceName>CALCIFEDIOL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use. RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.</IndicationAndUsage>
<Description>Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D3. Calcifediol monohydrate is a white crystalline powder, has a calculated molecular weight of 418.65 and is soluble in alcohol and fatty oils but practically insoluble in water. Chemically, calcifediol monohydrate is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol monohydrate and its structural formula is. RAYALDEE is formulated as extended-release capsules containing 30 mcg of calcifediol. RAYALDEE is available as soft capsules or two-piece banded hard capsules containing 30 mcg of calcifediol for oral administration. Each capsule contains the following excipients: butylated hydroxytoluene, dehydrated alcohol, hypromellose, lauroyl polyoxylglycerides, mineral oil, monoglycerides and diglycerides, and paraffin. The soft capsule shells contain carrageenan, FD&C Blue #1, modified starch, purified water, sodium phosphate dibasic, sorbitol sorbitan solution, and titanium dioxide. Medium chain triglyceride (fractionated coconut) oil is used as a lubricant during manufacture, and trace amounts may be present in the final formulation. The hard capsule shells contain gellan gum, hypromellose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70301-1001-2</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-2) </PackageDescription>
<NDC11Code>70301-1001-02</NDC11Code>
<ProductNDC>70301-1001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rayaldee</ProprietaryName>
<NonProprietaryName>Calcifediol</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208010</ApplicationNumber>
<LabelerName>OPKO Pharmaceuticals LLC</LabelerName>
<SubstanceName>CALCIFEDIOL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use. RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.</IndicationAndUsage>
<Description>Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D3. Calcifediol monohydrate is a white crystalline powder, has a calculated molecular weight of 418.65 and is soluble in alcohol and fatty oils but practically insoluble in water. Chemically, calcifediol monohydrate is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol monohydrate and its structural formula is. RAYALDEE is formulated as extended-release capsules containing 30 mcg of calcifediol. RAYALDEE is available as soft capsules or two-piece banded hard capsules containing 30 mcg of calcifediol for oral administration. Each capsule contains the following excipients: butylated hydroxytoluene, dehydrated alcohol, hypromellose, lauroyl polyoxylglycerides, mineral oil, monoglycerides and diglycerides, and paraffin. The soft capsule shells contain carrageenan, FD&C Blue #1, modified starch, purified water, sodium phosphate dibasic, sorbitol sorbitan solution, and titanium dioxide. Medium chain triglyceride (fractionated coconut) oil is used as a lubricant during manufacture, and trace amounts may be present in the final formulation. The hard capsule shells contain gellan gum, hypromellose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70301-1001-3</NDCCode>
<PackageDescription>7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-3) </PackageDescription>
<NDC11Code>70301-1001-03</NDC11Code>
<ProductNDC>70301-1001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rayaldee</ProprietaryName>
<NonProprietaryName>Calcifediol</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208010</ApplicationNumber>
<LabelerName>OPKO Pharmaceuticals LLC</LabelerName>
<SubstanceName>CALCIFEDIOL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use. RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.</IndicationAndUsage>
<Description>Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D3. Calcifediol monohydrate is a white crystalline powder, has a calculated molecular weight of 418.65 and is soluble in alcohol and fatty oils but practically insoluble in water. Chemically, calcifediol monohydrate is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol monohydrate and its structural formula is. RAYALDEE is formulated as extended-release capsules containing 30 mcg of calcifediol. RAYALDEE is available as soft capsules or two-piece banded hard capsules containing 30 mcg of calcifediol for oral administration. Each capsule contains the following excipients: butylated hydroxytoluene, dehydrated alcohol, hypromellose, lauroyl polyoxylglycerides, mineral oil, monoglycerides and diglycerides, and paraffin. The soft capsule shells contain carrageenan, FD&C Blue #1, modified starch, purified water, sodium phosphate dibasic, sorbitol sorbitan solution, and titanium dioxide. Medium chain triglyceride (fractionated coconut) oil is used as a lubricant during manufacture, and trace amounts may be present in the final formulation. The hard capsule shells contain gellan gum, hypromellose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70301-1002-1</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1002-1) </PackageDescription>
<NDC11Code>70301-1002-01</NDC11Code>
<ProductNDC>70301-1002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rayaldee</ProprietaryName>
<NonProprietaryName>Calcifediol</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240311</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208010</ApplicationNumber>
<LabelerName>OPKO Pharmaceuticals LLC</LabelerName>
<SubstanceName>CALCIFEDIOL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use. RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.</IndicationAndUsage>
<Description>Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D3. Calcifediol monohydrate is a white crystalline powder, has a calculated molecular weight of 418.65 and is soluble in alcohol and fatty oils but practically insoluble in water. Chemically, calcifediol monohydrate is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol monohydrate and its structural formula is. RAYALDEE is formulated as extended-release capsules containing 30 mcg of calcifediol. RAYALDEE is available as soft capsules or two-piece banded hard capsules containing 30 mcg of calcifediol for oral administration. Each capsule contains the following excipients: butylated hydroxytoluene, dehydrated alcohol, hypromellose, lauroyl polyoxylglycerides, mineral oil, monoglycerides and diglycerides, and paraffin. The soft capsule shells contain carrageenan, FD&C Blue #1, modified starch, purified water, sodium phosphate dibasic, sorbitol sorbitan solution, and titanium dioxide. Medium chain triglyceride (fractionated coconut) oil is used as a lubricant during manufacture, and trace amounts may be present in the final formulation. The hard capsule shells contain gellan gum, hypromellose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70301-1002-2</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1002-2) </PackageDescription>
<NDC11Code>70301-1002-02</NDC11Code>
<ProductNDC>70301-1002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rayaldee</ProprietaryName>
<NonProprietaryName>Calcifediol</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240311</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208010</ApplicationNumber>
<LabelerName>OPKO Pharmaceuticals LLC</LabelerName>
<SubstanceName>CALCIFEDIOL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use. RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.</IndicationAndUsage>
<Description>Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D3. Calcifediol monohydrate is a white crystalline powder, has a calculated molecular weight of 418.65 and is soluble in alcohol and fatty oils but practically insoluble in water. Chemically, calcifediol monohydrate is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol monohydrate and its structural formula is. RAYALDEE is formulated as extended-release capsules containing 30 mcg of calcifediol. RAYALDEE is available as soft capsules or two-piece banded hard capsules containing 30 mcg of calcifediol for oral administration. Each capsule contains the following excipients: butylated hydroxytoluene, dehydrated alcohol, hypromellose, lauroyl polyoxylglycerides, mineral oil, monoglycerides and diglycerides, and paraffin. The soft capsule shells contain carrageenan, FD&C Blue #1, modified starch, purified water, sodium phosphate dibasic, sorbitol sorbitan solution, and titanium dioxide. Medium chain triglyceride (fractionated coconut) oil is used as a lubricant during manufacture, and trace amounts may be present in the final formulation. The hard capsule shells contain gellan gum, hypromellose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70301-1002-3</NDCCode>
<PackageDescription>7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1002-3) </PackageDescription>
<NDC11Code>70301-1002-03</NDC11Code>
<ProductNDC>70301-1002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rayaldee</ProprietaryName>
<NonProprietaryName>Calcifediol</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240311</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208010</ApplicationNumber>
<LabelerName>OPKO Pharmaceuticals LLC</LabelerName>
<SubstanceName>CALCIFEDIOL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240311</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use. RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.</IndicationAndUsage>
<Description>Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D3. Calcifediol monohydrate is a white crystalline powder, has a calculated molecular weight of 418.65 and is soluble in alcohol and fatty oils but practically insoluble in water. Chemically, calcifediol monohydrate is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol monohydrate and its structural formula is. RAYALDEE is formulated as extended-release capsules containing 30 mcg of calcifediol. RAYALDEE is available as soft capsules or two-piece banded hard capsules containing 30 mcg of calcifediol for oral administration. Each capsule contains the following excipients: butylated hydroxytoluene, dehydrated alcohol, hypromellose, lauroyl polyoxylglycerides, mineral oil, monoglycerides and diglycerides, and paraffin. The soft capsule shells contain carrageenan, FD&C Blue #1, modified starch, purified water, sodium phosphate dibasic, sorbitol sorbitan solution, and titanium dioxide. Medium chain triglyceride (fractionated coconut) oil is used as a lubricant during manufacture, and trace amounts may be present in the final formulation. The hard capsule shells contain gellan gum, hypromellose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70518-1860-1</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1860-1) </PackageDescription>
<NDC11Code>70518-1860-01</NDC11Code>
<ProductNDC>70518-1860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078155</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablet is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>70518-3630-2</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3630-2) </PackageDescription>
<NDC11Code>70518-3630-02</NDC11Code>
<ProductNDC>70518-3630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078034</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>81746-418-01</NDCCode>
<PackageDescription>3.32 g in 1 BOX (81746-418-01) </PackageDescription>
<NDC11Code>81746-0418-01</NDC11Code>
<ProductNDC>81746-418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Killa Extra Strength</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Zitsticka, Inc.</LabelerName>
<SubstanceName>MAGNESIUM SALICYLATE</SubstanceName>
<StrengthNumber>.0664</StrengthNumber>
<StrengthUnit>g/3.32g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84515-418-01</NDCCode>
<PackageDescription>15 g in 1 BOX (84515-418-01) </PackageDescription>
<NDC11Code>84515-0418-01</NDC11Code>
<ProductNDC>84515-418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Avocado Moisturizer</ProprietaryName>
<NonProprietaryName>Avocado Moisturizer</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241016</StartMarketingDate>
<EndMarketingDate>20311231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241016</StartMarketingDatePackage>
<EndMarketingDatePackage>20311231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>87247-014-03</NDCCode>
<PackageDescription>1 KIT in 1 BOX (87247-014-03) * 40 mL in 1 BOTTLE, SPRAY * 40 mL in 1 BOTTLE, SPRAY * 40 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>87247-0014-03</NDC11Code>
<ProductNDC>87247-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sour Lemon Hand Sanitizer Trio - Sweet Cherry, Toasted Marshmallow And Sugar Macaron Scent</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Diamond Life Cosmetics Trading FZCO</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>87247-015-05</NDCCode>
<PackageDescription>1 KIT in 1 BOX (87247-015-05) * 40 mL in 1 BOTTLE, SPRAY * 40 mL in 1 BOTTLE, SPRAY * 40 mL in 1 BOTTLE, SPRAY * 40 mL in 1 BOTTLE, SPRAY * 40 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>87247-0015-05</NDC11Code>
<ProductNDC>87247-015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sour Lemon Hand Sanitizer Set - Sweet Cherry, Salted Caramel, Sugar Macaron, Toasted Marshmallow And Souffle Vanilla Scent</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Diamond Life Cosmetics Trading FZCO</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>87247-017-02</NDCCode>
<PackageDescription>1 KIT in 1 BOX (87247-017-02) * 40 mL in 1 BOTTLE, SPRAY * 40 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>87247-0017-02</NDC11Code>
<ProductNDC>87247-017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sour Lemon 2 Pc Hand Sanitizer With Stickers - Salted Caramel And Souffle Vanilla Scent</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Diamond Life Cosmetics Trading FZCO</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>87247-128-08</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (87247-128-08) / 40 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>87247-0128-08</NDC11Code>
<ProductNDC>87247-128</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soft Touch Hand Sanitizer Peony Blush Scent</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Diamond Life Cosmetics Trading FZCO</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>87247-129-09</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (87247-129-09) / 40 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>87247-0129-09</NDC11Code>
<ProductNDC>87247-129</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tropical Touch Hand Sanitizer Hibiscus Scent</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Diamond Life Cosmetics Trading FZCO</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>87247-130-00</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 POUCH (87247-130-00) / 40 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>87247-0130-00</NDC11Code>
<ProductNDC>87247-130</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bcbgeneration Hand Sanitizer Peony Blush Scent</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Diamond Life Cosmetics Trading FZCO</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use.</IndicationAndUsage>
</NDC>
</NDCList>