RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>33342-504-79</NDCCode>
    <PackageDescription>30 kg in 1 CONTAINER (33342-504-79) </PackageDescription>
    <NDC11Code>33342-0504-79</NDC11Code>
    <ProductNDC>33342-504</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Vardenafil Hydrochloride Trihydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20160224</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>VARDENAFIL HYDROCHLORIDE TRIHYDRATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>kg/30kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-07-24</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>24-FEB-16</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>33342-504-82</NDCCode>
    <PackageDescription>25 kg in 1 CONTAINER (33342-504-82) </PackageDescription>
    <NDC11Code>33342-0504-82</NDC11Code>
    <ProductNDC>33342-504</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Vardenafil Hydrochloride Trihydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20160224</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>VARDENAFIL HYDROCHLORIDE TRIHYDRATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>kg/25kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-12-28</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>24-FEB-16</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>33342-502-79</NDCCode>
    <PackageDescription>10 kg in 1 CONTAINER (33342-502-79) </PackageDescription>
    <NDC11Code>33342-0502-79</NDC11Code>
    <ProductNDC>33342-502</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Indomethacin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20160116</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>INDOMETHACIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-12-28</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>16-JAN-16</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>33342-607-79</NDCCode>
    <PackageDescription>10 kg in 1 CONTAINER (33342-607-79) </PackageDescription>
    <NDC11Code>33342-0607-79</NDC11Code>
    <ProductNDC>33342-607</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170921</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>21-SEP-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51316-504-79</NDCCode>
    <PackageDescription>400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (51316-504-79) </PackageDescription>
    <NDC11Code>51316-0504-79</NDC11Code>
    <ProductNDC>51316-504</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>8 Hr Arthritis Pain</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250929</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075077</ApplicationNumber>
    <LabelerName>CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>650</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to:minor pain of arthritismuscular achesbackachepremenstrual and menstrual crampsthe common coldheadachetoothache. temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68462-504-81</NDCCode>
    <PackageDescription>3 POUCH in 1 CARTON (68462-504-81)  / 1 BLISTER PACK in 1 POUCH (68462-504-79)  / 21 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68462-0504-81</NDC11Code>
    <ProductNDC>68462-504</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hailey 1.5/30</ProprietaryName>
    <NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180605</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209297</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>NORETHINDRONE ACETATE; ETHINYL ESTRADIOL</SubstanceName>
    <StrengthNumber>1.5; .03</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hailey 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. *The authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason. **This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason. ***N/A-Data not available.</IndicationAndUsage>
    <Description>Hailey® 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP) is a progestogen-estrogen combinations. Hailey 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP) provides a continuous dosage regimen consisting of 21 light green to green oral contraceptive tablets. Each light green to green tablet, for oral administration, contains 1.5 mg norethindrone acetate, USP [(17α)-17-(acetyloxy)-19-norpregn-4-en-20-yn-3-one] and 30 mcg ethinyl estradiol, USP [19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol]. The tablets also contain the following inactive ingredients: acacia, corn starch, D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Yellow #6, lactose monohydrate, magnesium stearate, sucrose, and talc. The structural formulas are as follows. Norethindrone Acetate, USP. Ethinyl Estradiol, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-541-09</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (33342-541-09) </PackageDescription>
    <NDC11Code>33342-0541-09</NDC11Code>
    <ProductNDC>33342-541</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tofacitinib</ProprietaryName>
    <NonProprietaryName>Tofacitinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219530</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>TOFACITINIB CITRATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tofacitinib tablets are Janus kinase (JAK) inhibitors.  Tofacitinib tablets are indicated for the treatment of adult patients with:   Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers.   Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.   Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers.  Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. Tofacitinib tablets are indicated for the treatment of  pediatric patients 2 years of age and older with:  Active PsA, who have had an inadequate response or intolerance to one or more TNF blockers.  Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use:   Use of tofacitinib tablets for RA, AS, PsA, or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.1, 1.2, 1.3, 1.4)   Use of tofacitinib tablets for UC in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.5).</IndicationAndUsage>
    <Description>Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a 5 mg white to off white, round shaped, film coated tablets. Each tablet of tofacitinib contains 5 mg of tofacitinib (equivalent to 8.08 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 6 mPas, titanium dioxide, macrogol/PEG MW 3350, triacetin. Tofacitinib tablets are supplied for oral administration as a 10 mg light blue to blue colored round shaped, film coated tablets. Each 10 mg tablet of tofacitinib contains 10 mg of tofacitinib (equivalent to 16.16 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 15 mPas, titanium dioxide, Macrogol/PEG MW 4000, Triacetin, FD&amp;C BLUE #2, FD&amp;C BLUE #1.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-541-43</NDCCode>
    <PackageDescription>9 BLISTER PACK in 1 CARTON (33342-541-43)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (33342-541-66) </PackageDescription>
    <NDC11Code>33342-0541-43</NDC11Code>
    <ProductNDC>33342-541</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tofacitinib</ProprietaryName>
    <NonProprietaryName>Tofacitinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219530</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>TOFACITINIB CITRATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tofacitinib tablets are Janus kinase (JAK) inhibitors.  Tofacitinib tablets are indicated for the treatment of adult patients with:   Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers.   Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.   Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers.  Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. Tofacitinib tablets are indicated for the treatment of  pediatric patients 2 years of age and older with:  Active PsA, who have had an inadequate response or intolerance to one or more TNF blockers.  Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use:   Use of tofacitinib tablets for RA, AS, PsA, or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.1, 1.2, 1.3, 1.4)   Use of tofacitinib tablets for UC in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.5).</IndicationAndUsage>
    <Description>Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a 5 mg white to off white, round shaped, film coated tablets. Each tablet of tofacitinib contains 5 mg of tofacitinib (equivalent to 8.08 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 6 mPas, titanium dioxide, macrogol/PEG MW 3350, triacetin. Tofacitinib tablets are supplied for oral administration as a 10 mg light blue to blue colored round shaped, film coated tablets. Each 10 mg tablet of tofacitinib contains 10 mg of tofacitinib (equivalent to 16.16 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 15 mPas, titanium dioxide, Macrogol/PEG MW 4000, Triacetin, FD&amp;C BLUE #2, FD&amp;C BLUE #1.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-541-54</NDCCode>
    <PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (33342-541-54) </PackageDescription>
    <NDC11Code>33342-0541-54</NDC11Code>
    <ProductNDC>33342-541</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tofacitinib</ProprietaryName>
    <NonProprietaryName>Tofacitinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219530</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>TOFACITINIB CITRATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tofacitinib tablets are Janus kinase (JAK) inhibitors.  Tofacitinib tablets are indicated for the treatment of adult patients with:   Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers.   Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.   Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers.  Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. Tofacitinib tablets are indicated for the treatment of  pediatric patients 2 years of age and older with:  Active PsA, who have had an inadequate response or intolerance to one or more TNF blockers.  Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use:   Use of tofacitinib tablets for RA, AS, PsA, or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.1, 1.2, 1.3, 1.4)   Use of tofacitinib tablets for UC in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.5).</IndicationAndUsage>
    <Description>Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a 5 mg white to off white, round shaped, film coated tablets. Each tablet of tofacitinib contains 5 mg of tofacitinib (equivalent to 8.08 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 6 mPas, titanium dioxide, macrogol/PEG MW 3350, triacetin. Tofacitinib tablets are supplied for oral administration as a 10 mg light blue to blue colored round shaped, film coated tablets. Each 10 mg tablet of tofacitinib contains 10 mg of tofacitinib (equivalent to 16.16 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 15 mPas, titanium dioxide, Macrogol/PEG MW 4000, Triacetin, FD&amp;C BLUE #2, FD&amp;C BLUE #1.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-542-09</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (33342-542-09) </PackageDescription>
    <NDC11Code>33342-0542-09</NDC11Code>
    <ProductNDC>33342-542</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tofacitinib</ProprietaryName>
    <NonProprietaryName>Tofacitinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219530</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>TOFACITINIB CITRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tofacitinib tablets are Janus kinase (JAK) inhibitors.  Tofacitinib tablets are indicated for the treatment of adult patients with:   Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers.   Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.   Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers.  Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. Tofacitinib tablets are indicated for the treatment of  pediatric patients 2 years of age and older with:  Active PsA, who have had an inadequate response or intolerance to one or more TNF blockers.  Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use:   Use of tofacitinib tablets for RA, AS, PsA, or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.1, 1.2, 1.3, 1.4)   Use of tofacitinib tablets for UC in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.5).</IndicationAndUsage>
    <Description>Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a 5 mg white to off white, round shaped, film coated tablets. Each tablet of tofacitinib contains 5 mg of tofacitinib (equivalent to 8.08 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 6 mPas, titanium dioxide, macrogol/PEG MW 3350, triacetin. Tofacitinib tablets are supplied for oral administration as a 10 mg light blue to blue colored round shaped, film coated tablets. Each 10 mg tablet of tofacitinib contains 10 mg of tofacitinib (equivalent to 16.16 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 15 mPas, titanium dioxide, Macrogol/PEG MW 4000, Triacetin, FD&amp;C BLUE #2, FD&amp;C BLUE #1.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-542-43</NDCCode>
    <PackageDescription>9 BLISTER PACK in 1 CARTON (33342-542-43)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (33342-542-66) </PackageDescription>
    <NDC11Code>33342-0542-43</NDC11Code>
    <ProductNDC>33342-542</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tofacitinib</ProprietaryName>
    <NonProprietaryName>Tofacitinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219530</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>TOFACITINIB CITRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tofacitinib tablets are Janus kinase (JAK) inhibitors.  Tofacitinib tablets are indicated for the treatment of adult patients with:   Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers.   Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.   Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers.  Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. Tofacitinib tablets are indicated for the treatment of  pediatric patients 2 years of age and older with:  Active PsA, who have had an inadequate response or intolerance to one or more TNF blockers.  Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use:   Use of tofacitinib tablets for RA, AS, PsA, or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.1, 1.2, 1.3, 1.4)   Use of tofacitinib tablets for UC in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.5).</IndicationAndUsage>
    <Description>Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a 5 mg white to off white, round shaped, film coated tablets. Each tablet of tofacitinib contains 5 mg of tofacitinib (equivalent to 8.08 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 6 mPas, titanium dioxide, macrogol/PEG MW 3350, triacetin. Tofacitinib tablets are supplied for oral administration as a 10 mg light blue to blue colored round shaped, film coated tablets. Each 10 mg tablet of tofacitinib contains 10 mg of tofacitinib (equivalent to 16.16 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 15 mPas, titanium dioxide, Macrogol/PEG MW 4000, Triacetin, FD&amp;C BLUE #2, FD&amp;C BLUE #1.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-542-54</NDCCode>
    <PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (33342-542-54) </PackageDescription>
    <NDC11Code>33342-0542-54</NDC11Code>
    <ProductNDC>33342-542</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tofacitinib</ProprietaryName>
    <NonProprietaryName>Tofacitinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219530</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>TOFACITINIB CITRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tofacitinib tablets are Janus kinase (JAK) inhibitors.  Tofacitinib tablets are indicated for the treatment of adult patients with:   Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers.   Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.   Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers.  Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. Tofacitinib tablets are indicated for the treatment of  pediatric patients 2 years of age and older with:  Active PsA, who have had an inadequate response or intolerance to one or more TNF blockers.  Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use:   Use of tofacitinib tablets for RA, AS, PsA, or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.1, 1.2, 1.3, 1.4)   Use of tofacitinib tablets for UC in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.5).</IndicationAndUsage>
    <Description>Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a 5 mg white to off white, round shaped, film coated tablets. Each tablet of tofacitinib contains 5 mg of tofacitinib (equivalent to 8.08 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 6 mPas, titanium dioxide, macrogol/PEG MW 3350, triacetin. Tofacitinib tablets are supplied for oral administration as a 10 mg light blue to blue colored round shaped, film coated tablets. Each 10 mg tablet of tofacitinib contains 10 mg of tofacitinib (equivalent to 16.16 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 15 mPas, titanium dioxide, Macrogol/PEG MW 4000, Triacetin, FD&amp;C BLUE #2, FD&amp;C BLUE #1.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-216-11</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (33342-216-11) </PackageDescription>
    <NDC11Code>33342-0216-11</NDC11Code>
    <ProductNDC>33342-216</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cevimeline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cevimeline Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241020</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206808</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>CEVIMELINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241020</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.</IndicationAndUsage>
    <Description>Cevimeline is cis-2’-methylspiro {1-azabicyclo [2.2.2] octane-3, 5’ -[1,3] oxathiolane} hydrochloride, hydrate (2:1). Its empirical formula is C10H17NOS.HCl.1/2 H2O, and its structural formula is. Cevimeline has a molecular weight of 244.79. It is a white to off white crystalline powder with a melting point range of 201 to 203°C. It is freely soluble in alcohol and chloroform, very soluble in water, and virtually insoluble in ether. The pH of a 1% solution ranges from 4.6 to 5.6. Inactive ingredients include lactose monohydrate, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, and magnesium stearate. Components of the capsule shell include gelatin, sodium lauryl sulfate, titanium dioxide and water. In addition to the ingredients listed above, imprinting black ink contains black iron oxide, butyl alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, shellac, strong ammonia solution, dehydrated alcohol and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-339-07</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (33342-339-07) </PackageDescription>
    <NDC11Code>33342-0339-07</NDC11Code>
    <ProductNDC>33342-339</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210248</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>48</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets is indicated as adjunctive therapy to diet:  to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).   to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.  Limitations of Use  Markedly elevated levels of serum TG (e.g. &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)].  Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82oC. Fenofibrate USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each tablet contains hypromellose 2910, sodium lauryl sulfate, lecithin, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone type-A, colloidal silicon dioxide and sodium stearyl fumarate. In addition, individual tablets contain:. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, iron oxide yellow, lecithin (soya), xanthan gum. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, lecithin (soya),  xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-339-10</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (33342-339-10) </PackageDescription>
    <NDC11Code>33342-0339-10</NDC11Code>
    <ProductNDC>33342-339</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210248</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>48</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets is indicated as adjunctive therapy to diet:  to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).   to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.  Limitations of Use  Markedly elevated levels of serum TG (e.g. &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)].  Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82oC. Fenofibrate USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each tablet contains hypromellose 2910, sodium lauryl sulfate, lecithin, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone type-A, colloidal silicon dioxide and sodium stearyl fumarate. In addition, individual tablets contain:. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, iron oxide yellow, lecithin (soya), xanthan gum. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, lecithin (soya),  xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-339-12</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (33342-339-12)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0339-12</NDC11Code>
    <ProductNDC>33342-339</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210248</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>48</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets is indicated as adjunctive therapy to diet:  to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).   to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.  Limitations of Use  Markedly elevated levels of serum TG (e.g. &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)].  Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82oC. Fenofibrate USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each tablet contains hypromellose 2910, sodium lauryl sulfate, lecithin, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone type-A, colloidal silicon dioxide and sodium stearyl fumarate. In addition, individual tablets contain:. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, iron oxide yellow, lecithin (soya), xanthan gum. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, lecithin (soya),  xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-339-15</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (33342-339-15) </PackageDescription>
    <NDC11Code>33342-0339-15</NDC11Code>
    <ProductNDC>33342-339</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210248</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>48</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets is indicated as adjunctive therapy to diet:  to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).   to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.  Limitations of Use  Markedly elevated levels of serum TG (e.g. &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)].  Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82oC. Fenofibrate USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each tablet contains hypromellose 2910, sodium lauryl sulfate, lecithin, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone type-A, colloidal silicon dioxide and sodium stearyl fumarate. In addition, individual tablets contain:. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, iron oxide yellow, lecithin (soya), xanthan gum. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, lecithin (soya),  xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-340-07</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (33342-340-07) </PackageDescription>
    <NDC11Code>33342-0340-07</NDC11Code>
    <ProductNDC>33342-340</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210248</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets is indicated as adjunctive therapy to diet:  to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).   to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.  Limitations of Use  Markedly elevated levels of serum TG (e.g. &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)].  Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82oC. Fenofibrate USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each tablet contains hypromellose 2910, sodium lauryl sulfate, lecithin, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone type-A, colloidal silicon dioxide and sodium stearyl fumarate. In addition, individual tablets contain:. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, iron oxide yellow, lecithin (soya), xanthan gum. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, lecithin (soya),  xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-340-10</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (33342-340-10) </PackageDescription>
    <NDC11Code>33342-0340-10</NDC11Code>
    <ProductNDC>33342-340</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210248</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
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    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-30</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets is indicated as adjunctive therapy to diet:  to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).   to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.  Limitations of Use  Markedly elevated levels of serum TG (e.g. &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)].  Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82oC. Fenofibrate USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each tablet contains hypromellose 2910, sodium lauryl sulfate, lecithin, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone type-A, colloidal silicon dioxide and sodium stearyl fumarate. In addition, individual tablets contain:. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, iron oxide yellow, lecithin (soya), xanthan gum. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, lecithin (soya),  xanthan gum.</Description>
  </NDC>
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    <NDCCode>33342-340-12</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (33342-340-12)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
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    <ProductNDC>33342-340</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210248</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
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    <Status>Active</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets is indicated as adjunctive therapy to diet:  to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).   to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.  Limitations of Use  Markedly elevated levels of serum TG (e.g. &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)].  Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82oC. Fenofibrate USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each tablet contains hypromellose 2910, sodium lauryl sulfate, lecithin, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone type-A, colloidal silicon dioxide and sodium stearyl fumarate. In addition, individual tablets contain:. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, iron oxide yellow, lecithin (soya), xanthan gum. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, lecithin (soya),  xanthan gum.</Description>
  </NDC>
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    <NDCCode>33342-340-15</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (33342-340-15) </PackageDescription>
    <NDC11Code>33342-0340-15</NDC11Code>
    <ProductNDC>33342-340</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210248</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets is indicated as adjunctive therapy to diet:  to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).   to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.  Limitations of Use  Markedly elevated levels of serum TG (e.g. &gt; 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)].  Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82oC. Fenofibrate USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each tablet contains hypromellose 2910, sodium lauryl sulfate, lecithin, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone type-A, colloidal silicon dioxide and sodium stearyl fumarate. In addition, individual tablets contain:. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, iron oxide yellow, lecithin (soya), xanthan gum. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, lecithin (soya),  xanthan gum.</Description>
  </NDC>
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    <NDCCode>33342-347-10</NDCCode>
    <PackageDescription>90 TABLET in 1 CONTAINER (33342-347-10) </PackageDescription>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210379</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>54</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:  To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).  For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).</IndicationAndUsage>
    <Description>Fenofibrate tablets USP, is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate . The chemical name for fenofibrate  is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate  is insoluble in water. The melting point is 79-82°C. Fenofibrate  is a white solid which is stable under ordinary conditions.Inactive Ingredients Each tablet contains Croscarmellose sodium, Crospovidone, Docusate sodium, Lecithin, Mannitol, Microcrystalline cellulose, Polyvinyl alcohol-part hydrolyzed, Povidone,Sodium lauryl Sulphate, Sodium stearyl fumarate, Talc, Titanium dioxide, Xanthan gum. In addition, 54 mg individual tablets contain: Iron oxide yellow FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
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    <PackageDescription>10 BLISTER PACK in 1 CARTON (33342-347-12)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0347-12</NDC11Code>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210379</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:  To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).  For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).</IndicationAndUsage>
    <Description>Fenofibrate tablets USP, is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate . The chemical name for fenofibrate  is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate  is insoluble in water. The melting point is 79-82°C. Fenofibrate  is a white solid which is stable under ordinary conditions.Inactive Ingredients Each tablet contains Croscarmellose sodium, Crospovidone, Docusate sodium, Lecithin, Mannitol, Microcrystalline cellulose, Polyvinyl alcohol-part hydrolyzed, Povidone,Sodium lauryl Sulphate, Sodium stearyl fumarate, Talc, Titanium dioxide, Xanthan gum. In addition, 54 mg individual tablets contain: Iron oxide yellow FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-347-47</NDCCode>
    <PackageDescription>9 BLISTER PACK in 1 CARTON (33342-347-47)  / 14 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0347-47</NDC11Code>
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    <ApplicationNumber>ANDA210379</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
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    <LastUpdate>2026-03-18</LastUpdate>
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    <StartMarketingDatePackage>20260121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:  To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).  For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).</IndicationAndUsage>
    <Description>Fenofibrate tablets USP, is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate . The chemical name for fenofibrate  is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate  is insoluble in water. The melting point is 79-82°C. Fenofibrate  is a white solid which is stable under ordinary conditions.Inactive Ingredients Each tablet contains Croscarmellose sodium, Crospovidone, Docusate sodium, Lecithin, Mannitol, Microcrystalline cellulose, Polyvinyl alcohol-part hydrolyzed, Povidone,Sodium lauryl Sulphate, Sodium stearyl fumarate, Talc, Titanium dioxide, Xanthan gum. In addition, 54 mg individual tablets contain: Iron oxide yellow FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
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    <PackageDescription>90 TABLET in 1 CONTAINER (33342-348-10) </PackageDescription>
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    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
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    <LastUpdate>2026-03-18</LastUpdate>
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    <StartMarketingDatePackage>20260121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:  To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).  For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).</IndicationAndUsage>
    <Description>Fenofibrate tablets USP, is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate . The chemical name for fenofibrate  is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate  is insoluble in water. The melting point is 79-82°C. Fenofibrate  is a white solid which is stable under ordinary conditions.Inactive Ingredients Each tablet contains Croscarmellose sodium, Crospovidone, Docusate sodium, Lecithin, Mannitol, Microcrystalline cellulose, Polyvinyl alcohol-part hydrolyzed, Povidone,Sodium lauryl Sulphate, Sodium stearyl fumarate, Talc, Titanium dioxide, Xanthan gum. In addition, 54 mg individual tablets contain: Iron oxide yellow FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
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    <PackageDescription>10 BLISTER PACK in 1 CARTON (33342-348-12)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
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    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
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    <StrengthUnit>mg/1</StrengthUnit>
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    <StartMarketingDatePackage>20260121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:  To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).  For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).</IndicationAndUsage>
    <Description>Fenofibrate tablets USP, is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate . The chemical name for fenofibrate  is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate  is insoluble in water. The melting point is 79-82°C. Fenofibrate  is a white solid which is stable under ordinary conditions.Inactive Ingredients Each tablet contains Croscarmellose sodium, Crospovidone, Docusate sodium, Lecithin, Mannitol, Microcrystalline cellulose, Polyvinyl alcohol-part hydrolyzed, Povidone,Sodium lauryl Sulphate, Sodium stearyl fumarate, Talc, Titanium dioxide, Xanthan gum. In addition, 54 mg individual tablets contain: Iron oxide yellow FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
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    <PackageDescription>500 TABLET in 1 CONTAINER (33342-348-15) </PackageDescription>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <StrengthUnit>mg/1</StrengthUnit>
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    <StartMarketingDatePackage>20260121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:  To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).  For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).</IndicationAndUsage>
    <Description>Fenofibrate tablets USP, is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate . The chemical name for fenofibrate  is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate  is insoluble in water. The melting point is 79-82°C. Fenofibrate  is a white solid which is stable under ordinary conditions.Inactive Ingredients Each tablet contains Croscarmellose sodium, Crospovidone, Docusate sodium, Lecithin, Mannitol, Microcrystalline cellulose, Polyvinyl alcohol-part hydrolyzed, Povidone,Sodium lauryl Sulphate, Sodium stearyl fumarate, Talc, Titanium dioxide, Xanthan gum. In addition, 54 mg individual tablets contain: Iron oxide yellow FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
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    <NDCCode>33342-001-09</NDCCode>
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    <NonProprietaryName>Lamivudine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190502</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090198</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>LAMIVUDINE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190502</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamivudine is nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use:  The dosage of this product is for HIV-1 and not for HBV.</IndicationAndUsage>
    <Description>Lamivudine USP is a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine USP is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine USP is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine USP has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine USP is a white to off-white crystalline solid with a solubility of approximately 70 mg per mL in water at 20°C. Lamivudine tablets, USP are for oral administration. Each scored 150-mg film-coated tablet contains 150 mg of lamivudine USP and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. Each 300-mg film-coated tablet contains 300 mg of lamivudine USP and the inactive ingredients black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-002-07</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-002-07) </PackageDescription>
    <NDC11Code>33342-0002-07</NDC11Code>
    <ProductNDC>33342-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamivudine</ProprietaryName>
    <NonProprietaryName>Lamivudine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190502</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090198</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>LAMIVUDINE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190502</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamivudine is nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use:  The dosage of this product is for HIV-1 and not for HBV.</IndicationAndUsage>
    <Description>Lamivudine USP is a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine USP is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine USP is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine USP has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine USP is a white to off-white crystalline solid with a solubility of approximately 70 mg per mL in water at 20°C. Lamivudine tablets, USP are for oral administration. Each scored 150-mg film-coated tablet contains 150 mg of lamivudine USP and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. Each 300-mg film-coated tablet contains 300 mg of lamivudine USP and the inactive ingredients black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-003-09</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (33342-003-09) </PackageDescription>
    <NDC11Code>33342-0003-09</NDC11Code>
    <ProductNDC>33342-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamivudine And Zidovudine</ProprietaryName>
    <NonProprietaryName>Lamivudine And Zidovudine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180830</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090679</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>LAMIVUDINE; ZIDOVUDINE</SubstanceName>
    <StrengthNumber>150; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-07-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180830</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.</IndicationAndUsage>
    <Description>Lamivudine and zidovudine tablets, USP are combination tablets containing lamivudine and zidovudine. Lamivudine and zidovudine (azidothymidine, AZT, or ZDV) are synthetic nucleoside analogues with activity against HIV-1. Lamivudine and zidovudine tablets, USP are for oral administration. Each film-coated tablet contains 150 mg of lamivudine, 300 mg of zidovudine, and the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.Lamivudine The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2´,3´-dideoxy,3´-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off-white crystalline solid and is soluble in water.Zidovudine The chemical name of zidovudine is 3′-azido-3′-deoxythymidine. It has a molecular formula of C10H13N5O4 and a molecular weight of 267.24 g per mol. It has the following structural formula. Zidovudine is a white to beige, odorless, crystalline solid with a solubility of 20.1 mg per mL in water at 25°C. Meets USP Dissolution Test 2.</Description>
  </NDC>
</NDCList>