{
"NDC": [
{
"NDCCode": "70661-002-39",
"PackageDescription": "30 TABLET in 1 BOTTLE (70661-002-39) ",
"NDC11Code": "70661-0002-39",
"ProductNDC": "70661-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "(rosuvastatin And Ezetimibe)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 10.4",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
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"PackageDescription": "30 TABLET in 1 BOTTLE (70661-003-39) ",
"NDC11Code": "70661-0003-39",
"ProductNDC": "70661-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "(rosuvastatin And Ezetimibe)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 20.8",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210510",
"SamplePackage": "Y",
"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
"NDCCode": "70661-002-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (70661-002-10) ",
"NDC11Code": "70661-0002-10",
"ProductNDC": "70661-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "(rosuvastatin And Ezetimibe)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 10.4",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210615",
"SamplePackage": "Y",
"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
"NDCCode": "70661-002-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (70661-002-30) ",
"NDC11Code": "70661-0002-30",
"ProductNDC": "70661-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "(rosuvastatin And Ezetimibe)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 10.4",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
"NDCCode": "70661-002-35",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (70661-002-35) ",
"NDC11Code": "70661-0002-35",
"ProductNDC": "70661-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "(rosuvastatin And Ezetimibe)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 10.4",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231231",
"SamplePackage": "N",
"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
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"ProductNDC": "59579-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
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"StartMarketingDate": "20071001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205850",
"LabelerName": "Linde Gas & Equipment Inc.",
"SubstanceName": "NITROGEN",
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"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200109",
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},
{
"NDCCode": "70072-002-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (70072-002-02) > 479.39 g in 1 CONTAINER (70072-002-01)",
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"ProductNDC": "70072-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Elf Color",
"NonProprietaryName": "P-phenylenediamine",
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"RouteName": "TOPICAL",
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"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "giod Co.",
"SubstanceName": "P-PHENYLENEDIAMINE",
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"StrengthUnit": "g/479.39g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Shampoo and dry hair before useApply the first solution and keep it on hair for 10 minutes (Adjust the time ±5-10 minutes if needed)Rinse completely and dry hairApply second solution and rinse thoroughly till water runs clear and then shampoo and condition."
},
{
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "75% Alcohol Disnfectant",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD",
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{
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"ProprietaryName": "Luxe And Willow Hand Sanitizing Liquid",
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{
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"NDC11Code": "76314-0002-02",
"ProductNDC": "76314-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fixmyskin Healing Balm Fragrance-free",
"NonProprietaryName": "Hydrocortisone",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20111117",
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"ApplicationNumber": "part348",
"LabelerName": "Lovely Skin, Inc.",
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"LastUpdate": "2021-10-15",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20211231",
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"SamplePackage": "N"
},
{
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"ProductNDC": "77435-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maxenergy Health Care Alcohol Wipes",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20200506",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Haining Baihe Sanitary Products Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200506",
"SamplePackage": "N",
"IndicationAndUsage": "●Help reduce bacteria on the skin."
},
{
"NDCCode": "78160-002-39",
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"NDC11Code": "78160-0002-39",
"ProductNDC": "78160-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Skinact",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Skinact",
"SubstanceName": "ALCOHOL",
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"StrengthUnit": "mL/100mL",
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"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "78505-002-29",
"PackageDescription": "360 POUCH in 1 BOTTLE (78505-002-29) > 3.5 g in 1 POUCH (78505-002-39) ",
"NDC11Code": "78505-0002-29",
"ProductNDC": "78505-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Disinfectant Wipes",
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"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200529",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "JINHUA CHANG GONG CLEANING UTENSILS CO.,LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200610",
"SamplePackage": "N",
"IndicationAndUsage": "For Hand Sanitizing."
},
{
"NDCCode": "83326-002-01",
"PackageDescription": "7.39 mL in 1 TUBE, WITH APPLICATOR (83326-002-01) ",
"NDC11Code": "83326-0002-01",
"ProductNDC": "83326-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zealios Spf Lipguard",
"NonProprietaryName": "Octisalate And Avobenzone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210621",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Personal Best Products Inc. dba Zealios",
"SubstanceName": "OCTISALATE; AVOBENZONE",
"StrengthNumber": "50; 30",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2025-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210621",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn and chapped lips."
},
{
"NDCCode": "84165-002-39",
"PackageDescription": "39 BAG in 1 BOX (84165-002-39) / 21 g in 1 BAG (84165-002-01) ",
"NDC11Code": "84165-0002-39",
"ProductNDC": "84165-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine Pain Relief Gel-patch",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250328",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Guangzhou Zhupuyou E-commerce Co., Ltd",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": ".04",
"StrengthUnit": "g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250328",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,elbows."
},
{
"NDCCode": "84165-006-39",
"PackageDescription": "39 BAG in 1 BOX (84165-006-39) / 1 KIT in 1 BAG * 21 g in 1 BAG (84165-002-01) * 12 g in 1 BAG (84165-005-01) * 9 g in 1 BAG (84165-107-01) ",
"NDC11Code": "84165-0006-39",
"ProductNDC": "84165-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine Pain Relief Gel-patch",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250414",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Guangzhou Zhupuyou E-commerce Co., Ltd",
"Status": "Active",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250414",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shouldcrs,elbows."
},
{
"NDCCode": "90091-002-39",
"PackageDescription": "59 mL in 1 BOTTLE (90091-002-39) ",
"NDC11Code": "90091-0002-39",
"ProductNDC": "90091-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clearsolv Liquid Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ClearSolv Solvents USA Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "0270-1316-52",
"PackageDescription": "10 BOTTLE in 1 BOX (0270-1316-52) / 75 mL in 1 BOTTLE",
"NDC11Code": "00270-1316-52",
"ProductNDC": "0270-1316",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isovue",
"ProprietaryNameSuffix": "370",
"NonProprietaryName": "Iopamidol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "19851231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018735",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "IOPAMIDOL",
"StrengthNumber": "755",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19851231",
"SamplePackage": "N",
"IndicationAndUsage": "ISOVUE is a radiographic contrast agent indicated for. Intra-arterial Procedures † (1.1): 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.",
"Description": "ISOVUE (iopamidol) injection is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5- lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C17H22I3N3O8, and the following structural formula. ISOVUE is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 ISOVUE 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 ISOVUE 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 ISOVUE 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 ISOVUE 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine."
},
{
"NDCCode": "0270-1411-25",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1411-25) > 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00270-1411-25",
"ProductNDC": "0270-1411",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isovue-m",
"NonProprietaryName": "Iopamidol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRATHECAL",
"StartMarketingDate": "19851231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018735",
"LabelerName": "Bracco Diagnostics Inc",
"SubstanceName": "IOPAMIDOL",
"StrengthNumber": "408",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19851231",
"EndMarketingDatePackage": "20231031",
"SamplePackage": "N",
"IndicationAndUsage": "ISOVUE-M (lopamidol Injection) is indicated for intrathecal administration in adult neuroradiology including myelography (lumbar, thoracic, cervical, total columnar), and for contrast enhancement of computed tomographic (CECT) cisternography and ventriculography. ISOVUE-M 200 (lopamidol Injection) is indicated for thoraco-lumbar myelography in children over the age of two years.",
"Description": "ISOVUE-M (lopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intrathecal administration. Each mL of ISOVUE-M 200 (lopamidol Injection 41%) provides 408 mg iopamidol with 1 mg tromethamine and 0.26 mg edetate calcium disodium. The solution contains approximately 0.029 mg (0.001 mEq) sodium and 200 mg organically bound iodine per mL. Each mL of ISOVUE-M 300 (lopamidol Injection 61%) provides 612 mg iopamidol with 1 mg tromethamine and 0.39 mg edetate calcium disodium. The solution contains approximately 0.043 mg (0.002 mEq) sodium and 300 mg organically bound iodine per mL. The pH of ISOVUE-M contrast media has bean adjusted to 6.5-7.5 with hydrochloric acid and/or sodium hydroxide. Pertinent physicochemical data are noted below. ISOVUE-M (lopamidol Injection) is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively). lopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]- 2,4,6-triiodo-5-lactamidoisophthalamide. Structural formula."
},
{
"NDCCode": "16480-002-02",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (16480-002-02) > 38 mL in 1 BOTTLE, GLASS (16480-002-01)",
"NDC11Code": "16480-0002-02",
"ProductNDC": "16480-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chan Yat Hing She Kun Wool Lok Medicated Oil",
"NonProprietaryName": "Camphor, Menthol, Turpentine Oil",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Chan Yat Hing Medicine Factory",
"SubstanceName": "CAMPHOR (SYNTHETIC); METHYL SALICYLATE; MENTHOL; TURPENTINE OIL",
"StrengthNumber": "9; 5; 39; 18",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Temporarily relieves minor aches and pains of muscles and joints due to: simple backaches, arthritis, strains, bruises, sprains."
},
{
"NDCCode": "41433-002-01",
"PackageDescription": "25 mL in 1 BOTTLE (41433-002-01) ",
"NDC11Code": "41433-0002-01",
"ProductNDC": "41433-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Siang Pureoil Formula Ii 25 Cc",
"NonProprietaryName": "Menthol, Peppermint, Camphor, Clove, Cinnamon",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "BERTRAM (1958) COMPANY LIMITED",
"SubstanceName": "MENTHOL; PEPPERMINT; CAMPHOR (NATURAL); CLOVE; CINNAMON OIL",
"StrengthNumber": "39.5; 34.5; 8; .3; .2",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieve body aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 bruises, 5 sprains."
},
{
"NDCCode": "66993-002-10",
"PackageDescription": "1 TUBE in 1 CARTON (66993-002-10) / 42.5 g in 1 TUBE",
"NDC11Code": "66993-0002-10",
"ProductNDC": "66993-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol Vaginal Cream",
"NonProprietaryName": "Estradiol",
"DosageFormName": "CREAM",
"RouteName": "VAGINAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212313",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol Vaginal Cream, USP, 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.",
"Description": "Each gram of Estradiol Vaginal Cream, USP, 0.01% contains 0.1 mg of estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate disodium, and tertiary-butylhydroquinone. Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is:."
},
{
"NDCCode": "70436-125-82",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70436-125-82) / 50 mL in 1 VIAL, SINGLE-DOSE (70436-125-37) ",
"NDC11Code": "70436-0125-82",
"ProductNDC": "70436-125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iopamidol",
"NonProprietaryName": "Iopamidol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20240415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217134",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "IOPAMIDOL",
"StrengthNumber": "510",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240415",
"SamplePackage": "N",
"IndicationAndUsage": "Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.",
"Description": "Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine."
},
{
"NDCCode": "70436-127-52",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70436-127-52) / 50 mL in 1 VIAL, SINGLE-DOSE (70436-127-37) ",
"NDC11Code": "70436-0127-52",
"ProductNDC": "70436-127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iopamidol",
"NonProprietaryName": "Iopamidol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20240415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217134",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "IOPAMIDOL",
"StrengthNumber": "755",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240415",
"SamplePackage": "N",
"IndicationAndUsage": "Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.",
"Description": "Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine."
},
{
"NDCCode": "70436-127-62",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70436-127-62) / 75 mL in 1 VIAL, SINGLE-DOSE (70436-127-39) ",
"NDC11Code": "70436-0127-62",
"ProductNDC": "70436-127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iopamidol",
"NonProprietaryName": "Iopamidol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20240415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217134",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "IOPAMIDOL",
"StrengthNumber": "755",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240415",
"SamplePackage": "N",
"IndicationAndUsage": "Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.",
"Description": "Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine."
},
{
"NDCCode": "70436-127-82",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70436-127-82) / 100 mL in 1 VIAL, SINGLE-DOSE (70436-127-40) ",
"NDC11Code": "70436-0127-82",
"ProductNDC": "70436-127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iopamidol",
"NonProprietaryName": "Iopamidol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20240415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217134",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "IOPAMIDOL",
"StrengthNumber": "755",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240415",
"SamplePackage": "N",
"IndicationAndUsage": "Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.",
"Description": "Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine."
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"Description": "Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine."
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"Description": "Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine."
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"Description": "Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine."
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"Description": "Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine."
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<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
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<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roszet</ProprietaryName>
<NonProprietaryName>(rosuvastatin And Ezetimibe)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Althera Pharmaceuticals LLC</LabelerName>
<SubstanceName>EZETIMIBE; ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10; 10.4</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.</IndicationAndUsage>
<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>70661-002-35</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (70661-002-35) </PackageDescription>
<NDC11Code>70661-0002-35</NDC11Code>
<ProductNDC>70661-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roszet</ProprietaryName>
<NonProprietaryName>(rosuvastatin And Ezetimibe)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213072</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals LLC</LabelerName>
<SubstanceName>EZETIMIBE; ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10; 10.4</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.</IndicationAndUsage>
<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>59579-002-39</NDCCode>
<PackageDescription>72915 L in 1 DEWAR (59579-002-39) </PackageDescription>
<NDC11Code>59579-0002-39</NDC11Code>
<ProductNDC>59579-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205850</ApplicationNumber>
<LabelerName>Linde Gas & Equipment Inc.</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70072-002-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (70072-002-02) > 479.39 g in 1 CONTAINER (70072-002-01)</PackageDescription>
<NDC11Code>70072-0002-02</NDC11Code>
<ProductNDC>70072-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Elf Color</ProprietaryName>
<NonProprietaryName>P-phenylenediamine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150905</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>giod Co.</LabelerName>
<SubstanceName>P-PHENYLENEDIAMINE</SubstanceName>
<StrengthNumber>9.58</StrengthNumber>
<StrengthUnit>g/479.39g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Shampoo and dry hair before useApply the first solution and keep it on hair for 10 minutes (Adjust the time ±5-10 minutes if needed)Rinse completely and dry hairApply second solution and rinse thoroughly till water runs clear and then shampoo and condition.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73905-002-39</NDCCode>
<PackageDescription>10000 mL in 1 BOTTLE (73905-002-39) </PackageDescription>
<NDC11Code>73905-0002-39</NDC11Code>
<ProductNDC>73905-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>75% Alcohol Disnfectant</ProprietaryName>
<NonProprietaryName>75% Alcohol Disnfectant</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<EndMarketingDate>20240423</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<EndMarketingDatePackage>20240423</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>74168-002-39</NDCCode>
<PackageDescription>6000 mL in 1 BOTTLE (74168-002-39) </PackageDescription>
<NDC11Code>74168-0002-39</NDC11Code>
<ProductNDC>74168-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Luxe And Willow Hand Sanitizing Liquid</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200508</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Zhejiang Yasili Cosmetics Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76314-002-02</NDCCode>
<PackageDescription>7.39 mL in 1 PACKAGE (76314-002-02) </PackageDescription>
<NDC11Code>76314-0002-02</NDC11Code>
<ProductNDC>76314-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fixmyskin Healing Balm Fragrance-free</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Lovely Skin, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>77435-002-01</NDCCode>
<PackageDescription>40 POUCH in 1 BAG (77435-002-01) > 3.39 g in 1 POUCH</PackageDescription>
<NDC11Code>77435-0002-01</NDC11Code>
<ProductNDC>77435-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Maxenergy Health Care Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200506</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Haining Baihe Sanitary Products Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>●Help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78160-002-39</NDCCode>
<PackageDescription>15000 mL in 1 BOTTLE (78160-002-39) </PackageDescription>
<NDC11Code>78160-0002-39</NDC11Code>
<ProductNDC>78160-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Skinact</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Skinact</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78505-002-29</NDCCode>
<PackageDescription>360 POUCH in 1 BOTTLE (78505-002-29) > 3.5 g in 1 POUCH (78505-002-39) </PackageDescription>
<NDC11Code>78505-0002-29</NDC11Code>
<ProductNDC>78505-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Disinfectant Wipes</ProprietaryName>
<NonProprietaryName>Disinfectant Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200529</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>JINHUA CHANG GONG CLEANING UTENSILS CO.,LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For Hand Sanitizing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83326-002-01</NDCCode>
<PackageDescription>7.39 mL in 1 TUBE, WITH APPLICATOR (83326-002-01) </PackageDescription>
<NDC11Code>83326-0002-01</NDC11Code>
<ProductNDC>83326-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zealios Spf Lipguard</ProprietaryName>
<NonProprietaryName>Octisalate And Avobenzone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210621</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Personal Best Products Inc. dba Zealios</LabelerName>
<SubstanceName>OCTISALATE; AVOBENZONE</SubstanceName>
<StrengthNumber>50; 30</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn and chapped lips.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84165-002-39</NDCCode>
<PackageDescription>39 BAG in 1 BOX (84165-002-39) / 21 g in 1 BAG (84165-002-01) </PackageDescription>
<NDC11Code>84165-0002-39</NDC11Code>
<ProductNDC>84165-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Pain Relief Gel-patch</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250328</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Guangzhou Zhupuyou E-commerce Co., Ltd</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>.04</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,elbows.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84165-006-39</NDCCode>
<PackageDescription>39 BAG in 1 BOX (84165-006-39) / 1 KIT in 1 BAG * 21 g in 1 BAG (84165-002-01) * 12 g in 1 BAG (84165-005-01) * 9 g in 1 BAG (84165-107-01) </PackageDescription>
<NDC11Code>84165-0006-39</NDC11Code>
<ProductNDC>84165-006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Pain Relief Gel-patch</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250414</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Guangzhou Zhupuyou E-commerce Co., Ltd</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shouldcrs,elbows.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>90091-002-39</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (90091-002-39) </PackageDescription>
<NDC11Code>90091-0002-39</NDC11Code>
<ProductNDC>90091-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clearsolv Liquid Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ClearSolv Solvents USA Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0270-1316-52</NDCCode>
<PackageDescription>10 BOTTLE in 1 BOX (0270-1316-52) / 75 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00270-1316-52</NDC11Code>
<ProductNDC>0270-1316</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isovue</ProprietaryName>
<ProprietaryNameSuffix>370</ProprietaryNameSuffix>
<NonProprietaryName>Iopamidol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>19851231</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018735</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>IOPAMIDOL</SubstanceName>
<StrengthNumber>755</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19851231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ISOVUE is a radiographic contrast agent indicated for. Intra-arterial Procedures † (1.1): 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.</IndicationAndUsage>
<Description>ISOVUE (iopamidol) injection is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5- lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C17H22I3N3O8, and the following structural formula. ISOVUE is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 ISOVUE 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 ISOVUE 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 ISOVUE 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 ISOVUE 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>0270-1411-25</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1411-25) > 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00270-1411-25</NDC11Code>
<ProductNDC>0270-1411</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isovue-m</ProprietaryName>
<NonProprietaryName>Iopamidol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRATHECAL</RouteName>
<StartMarketingDate>19851231</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018735</ApplicationNumber>
<LabelerName>Bracco Diagnostics Inc</LabelerName>
<SubstanceName>IOPAMIDOL</SubstanceName>
<StrengthNumber>408</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19851231</StartMarketingDatePackage>
<EndMarketingDatePackage>20231031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ISOVUE-M (lopamidol Injection) is indicated for intrathecal administration in adult neuroradiology including myelography (lumbar, thoracic, cervical, total columnar), and for contrast enhancement of computed tomographic (CECT) cisternography and ventriculography. ISOVUE-M 200 (lopamidol Injection) is indicated for thoraco-lumbar myelography in children over the age of two years.</IndicationAndUsage>
<Description>ISOVUE-M (lopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intrathecal administration. Each mL of ISOVUE-M 200 (lopamidol Injection 41%) provides 408 mg iopamidol with 1 mg tromethamine and 0.26 mg edetate calcium disodium. The solution contains approximately 0.029 mg (0.001 mEq) sodium and 200 mg organically bound iodine per mL. Each mL of ISOVUE-M 300 (lopamidol Injection 61%) provides 612 mg iopamidol with 1 mg tromethamine and 0.39 mg edetate calcium disodium. The solution contains approximately 0.043 mg (0.002 mEq) sodium and 300 mg organically bound iodine per mL. The pH of ISOVUE-M contrast media has bean adjusted to 6.5-7.5 with hydrochloric acid and/or sodium hydroxide. Pertinent physicochemical data are noted below. ISOVUE-M (lopamidol Injection) is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively). lopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]- 2,4,6-triiodo-5-lactamidoisophthalamide. Structural formula.</Description>
</NDC>
<NDC>
<NDCCode>16480-002-02</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (16480-002-02) > 38 mL in 1 BOTTLE, GLASS (16480-002-01)</PackageDescription>
<NDC11Code>16480-0002-02</NDC11Code>
<ProductNDC>16480-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chan Yat Hing She Kun Wool Lok Medicated Oil</ProprietaryName>
<NonProprietaryName>Camphor, Menthol, Turpentine Oil</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Chan Yat Hing Medicine Factory</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); METHYL SALICYLATE; MENTHOL; TURPENTINE OIL</SubstanceName>
<StrengthNumber>9; 5; 39; 18</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporarily relieves minor aches and pains of muscles and joints due to: simple backaches, arthritis, strains, bruises, sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41433-002-01</NDCCode>
<PackageDescription>25 mL in 1 BOTTLE (41433-002-01) </PackageDescription>
<NDC11Code>41433-0002-01</NDC11Code>
<ProductNDC>41433-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Siang Pureoil Formula Ii 25 Cc</ProprietaryName>
<NonProprietaryName>Menthol, Peppermint, Camphor, Clove, Cinnamon</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>BERTRAM (1958) COMPANY LIMITED</LabelerName>
<SubstanceName>MENTHOL; PEPPERMINT; CAMPHOR (NATURAL); CLOVE; CINNAMON OIL</SubstanceName>
<StrengthNumber>39.5; 34.5; 8; .3; .2</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieve body aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 bruises, 5 sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66993-002-10</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (66993-002-10) / 42.5 g in 1 TUBE</PackageDescription>
<NDC11Code>66993-0002-10</NDC11Code>
<ProductNDC>66993-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol Vaginal Cream</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212313</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol Vaginal Cream, USP, 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.</IndicationAndUsage>
<Description>Each gram of Estradiol Vaginal Cream, USP, 0.01% contains 0.1 mg of estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate disodium, and tertiary-butylhydroquinone. Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>70436-125-82</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70436-125-82) / 50 mL in 1 VIAL, SINGLE-DOSE (70436-125-37) </PackageDescription>
<NDC11Code>70436-0125-82</NDC11Code>
<ProductNDC>70436-125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iopamidol</ProprietaryName>
<NonProprietaryName>Iopamidol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217134</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>IOPAMIDOL</SubstanceName>
<StrengthNumber>510</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.</IndicationAndUsage>
<Description>Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>70436-127-52</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70436-127-52) / 50 mL in 1 VIAL, SINGLE-DOSE (70436-127-37) </PackageDescription>
<NDC11Code>70436-0127-52</NDC11Code>
<ProductNDC>70436-127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iopamidol</ProprietaryName>
<NonProprietaryName>Iopamidol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217134</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>IOPAMIDOL</SubstanceName>
<StrengthNumber>755</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.</IndicationAndUsage>
<Description>Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>70436-127-62</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70436-127-62) / 75 mL in 1 VIAL, SINGLE-DOSE (70436-127-39) </PackageDescription>
<NDC11Code>70436-0127-62</NDC11Code>
<ProductNDC>70436-127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iopamidol</ProprietaryName>
<NonProprietaryName>Iopamidol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217134</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>IOPAMIDOL</SubstanceName>
<StrengthNumber>755</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.</IndicationAndUsage>
<Description>Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>70436-127-82</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70436-127-82) / 100 mL in 1 VIAL, SINGLE-DOSE (70436-127-40) </PackageDescription>
<NDC11Code>70436-0127-82</NDC11Code>
<ProductNDC>70436-127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iopamidol</ProprietaryName>
<NonProprietaryName>Iopamidol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217134</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>IOPAMIDOL</SubstanceName>
<StrengthNumber>755</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.</IndicationAndUsage>
<Description>Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>70436-211-80</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (70436-211-80) / 50 mL in 1 VIAL, SINGLE-DOSE (70436-211-37) </PackageDescription>
<NDC11Code>70436-0211-80</NDC11Code>
<ProductNDC>70436-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iopamidol</ProprietaryName>
<NonProprietaryName>Iopamidol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217134</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>IOPAMIDOL</SubstanceName>
<StrengthNumber>408</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.</IndicationAndUsage>
<Description>Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine.</Description>
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<IndicationAndUsage>Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.</IndicationAndUsage>
<Description>Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine.</Description>
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<IndicationAndUsage>Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.</IndicationAndUsage>
<Description>Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine.</Description>
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<IndicationAndUsage>Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.</IndicationAndUsage>
<Description>Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine.</Description>
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