RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>69313-633-20</NDCCode>
    <PackageDescription>21.5 mg in 1 PACKAGE (69313-633-20)</PackageDescription>
    <NDC11Code>69313-0633-20</NDC11Code>
    <ProductNDC>69313-633</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidoflex</ProprietaryName>
    <ProprietaryNameSuffix>Elbow, Single Pouch</ProprietaryNameSuffix>
    <NonProprietaryName>Lidoflex Elbow</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>NAIMCO, INC. DBA RICHMAR, INC.</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>21.5</StrengthNumber>
    <StrengthUnit>mg/.24mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Use For the temporary relief of pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69313-633-01</NDCCode>
    <PackageDescription>21.5 mg in 1 POUCH (69313-633-01)</PackageDescription>
    <NDC11Code>69313-0633-01</NDC11Code>
    <ProductNDC>69313-633</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidoflex</ProprietaryName>
    <ProprietaryNameSuffix>Elbow, Single Pouch</ProprietaryNameSuffix>
    <NonProprietaryName>Lidoflex Elbow</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>NAIMCO, INC. DBA RICHMAR, INC.</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>21.5</StrengthNumber>
    <StrengthUnit>mg/.24mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Use For the temporary relief of pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69313-633-05</NDCCode>
    <PackageDescription>21.5 mg in 1 BAG (69313-633-05)</PackageDescription>
    <NDC11Code>69313-0633-05</NDC11Code>
    <ProductNDC>69313-633</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidoflex</ProprietaryName>
    <ProprietaryNameSuffix>Elbow, Single Pouch</ProprietaryNameSuffix>
    <NonProprietaryName>Lidoflex Elbow</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>NAIMCO, INC. DBA RICHMAR, INC.</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>21.5</StrengthNumber>
    <StrengthUnit>mg/.24mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Use For the temporary relief of pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69313-632-20</NDCCode>
    <PackageDescription>29 mg in 1 PACKAGE (69313-632-20)</PackageDescription>
    <NDC11Code>69313-0632-20</NDC11Code>
    <ProductNDC>69313-632</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidoflex</ProprietaryName>
    <NonProprietaryName>Lidoflex Single Pouch, Back</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>NAIMCO, INC. DBA RICHMAR, INC.</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>29</StrengthNumber>
    <StrengthUnit>mg/.24mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Use For the temporary relief of pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69313-634-20</NDCCode>
    <PackageDescription>22.7 mg in 1 PACKAGE (69313-634-20)</PackageDescription>
    <NDC11Code>69313-0634-20</NDC11Code>
    <ProductNDC>69313-634</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidoflex</ProprietaryName>
    <NonProprietaryName>Lidoflex Heel</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>NAIMCO, INC. DBA RICHMAR, INC.</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>22.7</StrengthNumber>
    <StrengthUnit>mg/.24mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Use For the temporary relief of pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69313-635-20</NDCCode>
    <PackageDescription>25.8 mg in 1 PACKAGE (69313-635-20)</PackageDescription>
    <NDC11Code>69313-0635-20</NDC11Code>
    <ProductNDC>69313-635</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidoflex</ProprietaryName>
    <NonProprietaryName>Lidoflex Single Pouch, Knee</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>NAIMCO, INC. DBA RICHMAR, INC.</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>25.8</StrengthNumber>
    <StrengthUnit>mg/.24mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Use For the temporary relief of pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69313-636-20</NDCCode>
    <PackageDescription>25.3 mg in 1 PACKAGE (69313-636-20)</PackageDescription>
    <NDC11Code>69313-0636-20</NDC11Code>
    <ProductNDC>69313-636</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidoflex</ProprietaryName>
    <NonProprietaryName>Lidoflex Shoulder</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>NAIMCO, INC. DBA RICHMAR, INC.</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>25.3</StrengthNumber>
    <StrengthUnit>mg/.24mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Use For the temporary relief of pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69313-637-20</NDCCode>
    <PackageDescription>28.1 mg in 1 PACKAGE (69313-637-20)</PackageDescription>
    <NDC11Code>69313-0637-20</NDC11Code>
    <ProductNDC>69313-637</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidoflex</ProprietaryName>
    <NonProprietaryName>Lidoflex Flex Strip Double</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>NAIMCO, INC. DBA RICHMAR, INC.</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>28.1</StrengthNumber>
    <StrengthUnit>mg/.24mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Use For the temporary relief of pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41250-633-20</NDCCode>
    <PackageDescription>20 BLISTER PACK in 1 CARTON (41250-633-20)  / 1 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>41250-0633-20</NDC11Code>
    <ProductNDC>41250-633</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mucus Relief Dm Extended Release Caplets</ProprietaryName>
    <NonProprietaryName>Guaifenesin, Dextromethorphan Hbr</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190101</StartMarketingDate>
    <EndMarketingDate>20250401</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209692</ApplicationNumber>
    <LabelerName>MEIJER, INC.</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
    <StrengthNumber>30; 600</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250401</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relievescough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43744-633-20</NDCCode>
    <PackageDescription>15 g in 1 DRUM (43744-633-20)</PackageDescription>
    <NDC11Code>43744-0633-20</NDC11Code>
    <ProductNDC>43744-633</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Mupirocin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20120808</StartMarketingDate>
    <EndMarketingDate>20130624</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>MUPIROCIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>43744-633-22</NDCCode>
    <PackageDescription>20 g in 1 DRUM (43744-633-22)</PackageDescription>
    <NDC11Code>43744-0633-22</NDC11Code>
    <ProductNDC>43744-633</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Mupirocin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20120808</StartMarketingDate>
    <EndMarketingDate>20130624</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>MUPIROCIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>52125-633-20</NDCCode>
    <PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (52125-633-20)</PackageDescription>
    <NDC11Code>52125-0633-20</NDC11Code>
    <ProductNDC>52125-633</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150330</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022032</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55289-633-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (55289-633-20) </PackageDescription>
    <NDC11Code>55289-0633-20</NDC11Code>
    <ProductNDC>55289-633</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Chlorzoxazone</ProprietaryName>
    <NonProprietaryName>Chlorzoxazone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110822</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089859</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CHLORZOXAZONE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110831</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
    <Description>Chlorzoxazone, USP is a centrally-acting skeletal muscle relaxant, available as tablets of 500 mg for oral administration. Its chemical name is 5-Chloro-2-benzoxazolinone, and its structural formula is. Chlorzoxazone, USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone, USP is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia. Chlorzoxazone Tablets, USP contain the inactive ingredients docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellullose, pregelatinized starch, sodium benzoate, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>75622-633-20</NDCCode>
    <PackageDescription>40 CLOTH in 1 POUCH (75622-633-20) </PackageDescription>
    <NDC11Code>75622-0633-20</NDC11Code>
    <ProductNDC>75622-633</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Deyo</ProprietaryName>
    <NonProprietaryName>Disinfecting Wet Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Henan Yeesain Health Technology Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.75</StrengthNumber>
    <StrengthUnit>mL/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201009</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For sanitizing to help in reducing bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>76420-633-20</NDCCode>
    <PackageDescription>20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-633-20) </PackageDescription>
    <NDC11Code>76420-0633-20</NDC11Code>
    <ProductNDC>76420-633</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Duloxetine</ProprietaryName>
    <NonProprietaryName>Duloxetine</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208706</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250403</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
    <Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C 18H 19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, 40 mg or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4 mg, 33.7 mg, 44.9 mg or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&amp;C Red No. 3 (40 mg), FD&amp;C Blue No. 1 (40 mg), FD&amp;C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body &amp; cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay &amp; Organic Impurities test pending.</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>
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    <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>
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    <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>
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    <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>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <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>
  <NDC>
    <NDCCode>0074-7034-02</NDCCode>
    <PackageDescription>2 CARTON in 1 CARTON (0074-7034-02)  / 1 KIT in 1 CARTON *  2 SYRINGE, GLASS in 1 CARTON (0074-7032-90)  / 1 mL in 1 SYRINGE, GLASS (0074-7032-01) </PackageDescription>
    <NDC11Code>00074-7034-02</NDC11Code>
    <ProductNDC>0074-7034</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230322</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761105</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3).</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 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/1.2mL (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>0074-7036-04</NDCCode>
    <PackageDescription>4 CARTON in 1 CARTON (0074-7036-04)  / 1 KIT in 1 CARTON *  1 mL in 1 SYRINGE, GLASS (0074-7032-01) </PackageDescription>
    <NDC11Code>00074-7036-04</NDC11Code>
    <ProductNDC>0074-7036</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230322</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761105</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3).</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 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/1.2mL (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>0074-7040-02</NDCCode>
    <PackageDescription>2 CARTON in 1 CARTON (0074-7040-02)  / 1 KIT in 1 CARTON *  1 mL in 1 SYRINGE, GLASS (0074-7032-01) </PackageDescription>
    <NDC11Code>00074-7040-02</NDC11Code>
    <ProductNDC>0074-7040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Skyrizi</ProprietaryName>
    <NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20240304</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>20240304</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>
</NDCList>