RESTful Lookup — Test-Drive (2007 – 2026)

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  <NDC>
    <NDCCode>65862-054-23</NDCCode>
    <PackageDescription>2100 TABLET, FILM COATED in 1 BAG (65862-054-23) </PackageDescription>
    <NDC11Code>65862-0054-23</NDC11Code>
    <ProductNDC>65862-054</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20061220</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-01-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20-DEC-06</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>64330-054-45</NDCCode>
    <PackageDescription>23 kg in 1 DRUM (64330-054-45) </PackageDescription>
    <NDC11Code>64330-0054-45</NDC11Code>
    <ProductNDC>64330-054</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Zaleplon</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20180105</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Centaur Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>ZALEPLON</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <DEASchedule>CIV</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2026-08-27</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>29-AUG-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>65862-054-00</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (65862-054-00) </PackageDescription>
    <NDC11Code>65862-0054-00</NDC11Code>
    <ProductNDC>65862-054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077691</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia. .</IndicationAndUsage>
    <Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-054-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (65862-054-30) </PackageDescription>
    <NDC11Code>65862-0054-30</NDC11Code>
    <ProductNDC>65862-054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077691</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia. .</IndicationAndUsage>
    <Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-054-39</NDCCode>
    <PackageDescription>3000 TABLET, FILM COATED in 1 BOTTLE (65862-054-39) </PackageDescription>
    <NDC11Code>65862-0054-39</NDC11Code>
    <ProductNDC>65862-054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077691</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia. .</IndicationAndUsage>
    <Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-054-45</NDCCode>
    <PackageDescription>45 TABLET, FILM COATED in 1 BOTTLE (65862-054-45) </PackageDescription>
    <NDC11Code>65862-0054-45</NDC11Code>
    <ProductNDC>65862-054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077691</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia. .</IndicationAndUsage>
    <Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-054-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (65862-054-90) </PackageDescription>
    <NDC11Code>65862-0054-90</NDC11Code>
    <ProductNDC>65862-054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077691</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia. .</IndicationAndUsage>
    <Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-054-99</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (65862-054-99) </PackageDescription>
    <NDC11Code>65862-0054-99</NDC11Code>
    <ProductNDC>65862-054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077691</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia. .</IndicationAndUsage>
    <Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-201-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65862-201-05) </PackageDescription>
    <NDC11Code>65862-0201-05</NDC11Code>
    <ProductNDC>65862-201</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Losartan Potassium</ProprietaryName>
    <NonProprietaryName>Losartan Potassium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101006</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090083</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101006</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
    <Description>Losartan potassium tablets are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP, titanium dioxide, FD&amp;C blue #2/indigo carmine aluminum lake, D&amp;C yellow #10 aluminum lake, and purified water. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-201-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (65862-201-30) </PackageDescription>
    <NDC11Code>65862-0201-30</NDC11Code>
    <ProductNDC>65862-201</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
    <Description>Losartan potassium tablets are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP, titanium dioxide, FD&amp;C blue #2/indigo carmine aluminum lake, D&amp;C yellow #10 aluminum lake, and purified water. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
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    <IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
    <Description>Losartan potassium tablets are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP, titanium dioxide, FD&amp;C blue #2/indigo carmine aluminum lake, D&amp;C yellow #10 aluminum lake, and purified water. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
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    <IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
    <Description>Losartan potassium tablets are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP, titanium dioxide, FD&amp;C blue #2/indigo carmine aluminum lake, D&amp;C yellow #10 aluminum lake, and purified water. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
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    <IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
    <Description>Losartan potassium tablets are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP, titanium dioxide, FD&amp;C blue #2/indigo carmine aluminum lake, D&amp;C yellow #10 aluminum lake, and purified water. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
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    <IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
    <Description>Losartan potassium tablets are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP, titanium dioxide, FD&amp;C blue #2/indigo carmine aluminum lake, D&amp;C yellow #10 aluminum lake, and purified water. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
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    <IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
    <Description>Losartan potassium tablets are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP, titanium dioxide, FD&amp;C blue #2/indigo carmine aluminum lake, D&amp;C yellow #10 aluminum lake, and purified water. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
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    <IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
    <Description>Losartan potassium tablets are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP, titanium dioxide, FD&amp;C blue #2/indigo carmine aluminum lake, D&amp;C yellow #10 aluminum lake, and purified water. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
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    <IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
    <Description>Losartan potassium tablets are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP, titanium dioxide, FD&amp;C blue #2/indigo carmine aluminum lake, D&amp;C yellow #10 aluminum lake, and purified water. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
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    <StartMarketingDatePackage>20101006</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
    <Description>Losartan potassium tablets are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP, titanium dioxide, FD&amp;C blue #2/indigo carmine aluminum lake, D&amp;C yellow #10 aluminum lake, and purified water. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-1050-01</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (0074-1050-01)  / 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00074-1050-01</NDC11Code>
    <ProductNDC>0074-1050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20210426</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761105</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <SubstanceName>RISANKIZUMAB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210426</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
    <Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-1050-70</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (0074-1050-70)  / 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00074-1050-70</NDC11Code>
    <ProductNDC>0074-1050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20210426</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761105</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <SubstanceName>RISANKIZUMAB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210426</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
    <Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-1065-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0074-1065-01)  *  1.2 mL in 1 CARTRIDGE (0074-1066-02)  *  1.2 mL in 1 CARTRIDGE (0074-1066-01) </PackageDescription>
    <NDC11Code>00074-1065-01</NDC11Code>
    <ProductNDC>0074-1065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220923</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761105</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220923</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
    <Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-1065-02</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0074-1065-02)  *  1.2 mL in 1 CARTRIDGE (0074-1066-02)  *  1.2 mL in 1 CARTRIDGE (0074-1066-01) </PackageDescription>
    <NDC11Code>00074-1065-02</NDC11Code>
    <ProductNDC>0074-1065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220923</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761105</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220923</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
    <Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-1070-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0074-1070-01)  *  2.4 mL in 1 CARTRIDGE (0074-1069-02)  *  2.4 mL in 1 CARTRIDGE (0074-1069-01) </PackageDescription>
    <NDC11Code>00074-1070-01</NDC11Code>
    <ProductNDC>0074-1070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220616</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761105</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220616</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
    <Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-1070-02</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0074-1070-02)  *  2.4 mL in 1 CARTRIDGE (0074-1069-02)  *  2.4 mL in 1 CARTRIDGE (0074-1069-01) </PackageDescription>
    <NDC11Code>00074-1070-02</NDC11Code>
    <ProductNDC>0074-1070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220616</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761105</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220616</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
    <Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-2100-01</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (0074-2100-01)  / 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00074-2100-01</NDC11Code>
    <ProductNDC>0074-2100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20210426</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761105</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <SubstanceName>RISANKIZUMAB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210426</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
    <Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-2100-70</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (0074-2100-70)  / 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00074-2100-70</NDC11Code>
    <ProductNDC>0074-2100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20210426</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761105</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <SubstanceName>RISANKIZUMAB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210426</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
    <Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-4059-01</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0074-4059-01)  / .37 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>00074-4059-01</NDC11Code>
    <ProductNDC>0074-4059</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20260612</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761105</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <SubstanceName>RISANKIZUMAB</SubstanceName>
    <StrengthNumber>55</StrengthNumber>
    <StrengthUnit>mg/.37mL</StrengthUnit>
    <Pharm_Classes>Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
    <Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-4059-71</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0074-4059-71)  / .37 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>00074-4059-71</NDC11Code>
    <ProductNDC>0074-4059</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20260612</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761105</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <SubstanceName>RISANKIZUMAB</SubstanceName>
    <StrengthNumber>55</StrengthNumber>
    <StrengthUnit>mg/.37mL</StrengthUnit>
    <Pharm_Classes>Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260612</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
    <Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-5015-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0074-5015-01)  / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00074-5015-01</NDC11Code>
    <ProductNDC>0074-5015</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220616</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761262</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <SubstanceName>RISANKIZUMAB</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220616</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
    <Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-5015-02</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0074-5015-02)  / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00074-5015-02</NDC11Code>
    <ProductNDC>0074-5015</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220616</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761262</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <SubstanceName>RISANKIZUMAB</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220616</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
    <Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
  </NDC>
</NDCList>