RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>68462-312-85</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (68462-312-85)  &gt; 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68462-0312-85</NDC11Code>
    <ProductNDC>68462-312</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teriflunomide</ProprietaryName>
    <NonProprietaryName>Teriflunomide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209663</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>TERIFLUNOMIDE</SubstanceName>
    <StrengthNumber>14</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68462-312-84</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (68462-312-84)  &gt; 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68462-0312-84</NDC11Code>
    <ProductNDC>68462-312</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teriflunomide</ProprietaryName>
    <NonProprietaryName>Teriflunomide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209663</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>TERIFLUNOMIDE</SubstanceName>
    <StrengthNumber>14</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43386-312-85</NDCCode>
    <PackageDescription>850 g in 1 BOTTLE (43386-312-85) </PackageDescription>
    <NDC11Code>43386-0312-85</NDC11Code>
    <ProductNDC>43386-312</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gavilax</ProprietaryName>
    <NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091009</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091077</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/17g</StrengthUnit>
    <Pharm_Classes>Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091009</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>do not take more than directed unless advised by your doctor. the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line. adults and children 17 years of age and older:. use once a day. fill to top of line in cap which is marked to indicate the correct dose (17 g). stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink. do not combine with starch-based thickeners used for difficulty swallowing. ensure that the powder is fully dissolved before drinking. do not drink if there are any clumps. do not use more than 7 days. children 16 years of age or under: ask a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68462-311-85</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (68462-311-85)  &gt; 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68462-0311-85</NDC11Code>
    <ProductNDC>68462-311</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teriflunomide</ProprietaryName>
    <NonProprietaryName>Teriflunomide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209663</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>TERIFLUNOMIDE</SubstanceName>
    <StrengthNumber>7</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68462-423-85</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (68462-423-85)  / 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68462-0423-85</NDC11Code>
    <ProductNDC>68462-423</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teriflunomide</ProprietaryName>
    <NonProprietaryName>Teriflunomide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209663</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>TERIFLUNOMIDE</SubstanceName>
    <StrengthNumber>7</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4‑trifluoromethylphenyl)-amide. Its molecular weight is 270.21 g/mol and the molecular formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in methylene chloride, very slightly soluble in acetonitrile, insoluble in water, ethanol and isopropyl alcohol. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: corn starch, colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The film coating for the 14 mg tablet is made of hypromellose, polyethylene glycol, talc, titanium dioxide. In addition to these, the 7 mg tablet film coating contains iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-424-85</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (68462-424-85)  / 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68462-0424-85</NDC11Code>
    <ProductNDC>68462-424</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teriflunomide</ProprietaryName>
    <NonProprietaryName>Teriflunomide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209663</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>TERIFLUNOMIDE</SubstanceName>
    <StrengthNumber>14</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4‑trifluoromethylphenyl)-amide. Its molecular weight is 270.21 g/mol and the molecular formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in methylene chloride, very slightly soluble in acetonitrile, insoluble in water, ethanol and isopropyl alcohol. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: corn starch, colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The film coating for the 14 mg tablet is made of hypromellose, polyethylene glycol, talc, titanium dioxide. In addition to these, the 7 mg tablet film coating contains iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-583-85</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 CARTON (68462-583-85)  / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68462-0583-85</NDC11Code>
    <ProductNDC>68462-583</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aprepitant</ProprietaryName>
    <NonProprietaryName>Aprepitant</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171012</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207777</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>APREPITANT</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171012</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68462-388-29</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (68462-388-29)  / 1 KIT in 1 BLISTER PACK (68462-388-84) </PackageDescription>
    <NDC11Code>68462-0388-29</NDC11Code>
    <ProductNDC>68462-388</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Marlissa</ProprietaryName>
    <NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20120229</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091452</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>MARLISSA® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
    <Description>MARLISSA® (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 light orange to orange color MARLISSA® (levonorgestrel and ethinyl estradiol tablets), each containing 0.15 mg of levonorgestrel, USP, a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, USP, an estrogen and 7 light pink to pink inert tablets (without hormones). The structural formulas for the active components are.                                                              Levonorgestrel, USP.                                                            C21H28O2 MW: 312.4. Levonorgestrel, USP is chemically d(-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one.                                                            Ethinyl Estradiol, USP.                                                        C20H24O2 MW: 296.4. Ethinyl Estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each light orange to orange color active tablet contains the following inactive ingredients: FD&amp;C Yellow no. 6, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc. In addition, the film-coating contains hypromellose and macrogol. Each light pink to pink inert tablet contains the following inactive ingredients: D&amp;C Red no. 30, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-646-93</NDCCode>
    <PackageDescription>2 POUCH in 1 CARTON (68462-646-93)  / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK (68462-646-91) </PackageDescription>
    <NDC11Code>68462-0646-93</NDC11Code>
    <ProductNDC>68462-646</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ashlyna</ProprietaryName>
    <NonProprietaryName>Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20150223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203163</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ashlynais indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
    <Description>Ashlyna® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets, USP 0.01 mg) is an extended-cycle oral contraceptive consisting of 84 light blue to blue tablets each containing 0.15 mg of levonorgestrel, USP a synthetic progestogen and 0.03 mg of ethinyl estradiol, USP and 7 light yellow to yellow tablets containing 0.01 mg of ethinyl estradiol, USP. The structural formulas for the active components are. Levonorgestrel, USP. C21H28O2 MW: 312.4. Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-(-)-. Ethinyl Estradiol, USP. C20H24O2 MW: 296.4. Ethinyl Estradiol, USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light blue to blue tablet contains the following inactive ingredients: anhydrous lactose, D&amp;C yellow no. 10 aluminum lake, FD&amp;C blue no. 1 aluminum lake, FD&amp;C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Each light yellow to yellow tablet contains the following inactive ingredients: anhydrous lactose, D&amp;C yellow no. 10 aluminum lake, FD&amp;C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 400, polysorbate 80 and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-672-95</NDCCode>
    <PackageDescription>3 POUCH in 1 CARTON (68462-672-95)  / 1 BLISTER PACK in 1 POUCH (68462-672-91)  / 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68462-0672-95</NDC11Code>
    <ProductNDC>68462-672</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levonorgestrel And Ethinyl Estradiol</ProprietaryName>
    <NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20150612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203164</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
    <Description>Levonorgestrel and Ethinyl Estradiol Tablets, USP are an extended-cycle combination oral contraceptive consisting of 84 light blue to blue active tablets each containing 0.15 mg of levonorgestrel, USP, a synthetic progestin and 0.03 mg of ethinyl estradiol, USP, an estrogen, and 7 white to off-white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel, USP. C21H28O2     MW: 312.45. Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol, USP. C20H24O2     MW: 296.4. Ethinyl Estradiol, USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each light blue to blue active tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hypromellose, anhydrous lactose, talc, magnesium stearate, titanium dioxide, triacetin, FD&amp;C blue no. 1 aluminum lake, FD&amp;C yellow no. 6 aluminum lake, D&amp;C yellow no. 10 aluminum lake. , 2 Each white to off-white inert tablet contains the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, hypromellose, polacrilin potassium, magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-952-10</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (68462-952-10)  / 2 mL in 1 VIAL</PackageDescription>
    <NDC11Code>68462-0952-10</NDC11Code>
    <ProductNDC>68462-952</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20260305</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA220323</ApplicationNumber>
    <LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260305</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine for injection is an atypical antipsychotic indicated: 1 Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) , 2 Efficacy was established in three 1-day trials in adults. (14.3) .</IndicationAndUsage>
    <Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation 10H-Thieno[2,3-b][1,5]benzodiazepine, 2-methyl-4-(4-methyl- 1-piperazinyl)-. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.4. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, freely soluble in methylene dichloride, soluble in acetone, slightly soluble in ethanol, very slightly soluble in methanol and practically insoluble or insoluble in water. Olanzapine for injection is sterile and intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-698-15</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 CARTON (68462-698-15)  / 10 mL in 1 VIAL, SINGLE-DOSE (68462-698-10) </PackageDescription>
    <NDC11Code>68462-0698-15</NDC11Code>
    <ProductNDC>68462-698</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylene Blue</ProprietaryName>
    <NonProprietaryName>Methylene Blue</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20251223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219550</ApplicationNumber>
    <LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
    <SubstanceName>METHYLENE BLUE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylene blue injection is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.</IndicationAndUsage>
    <Description>Methylene blue is an oxidation-reduction agent. Its chemical name is 3,7-bis(dimethylamino)phenothiazin-5-ium, chloride hydrate. The molecular formula of methylene blue is C16H18ClN3S.xH2O and its molecular weight of 319.85 g/mol for the anhydrous form. The structural formula of methylene blue is. Methylene blue injection, USP is a sterile solution intended for intravenous administration. Each mL of solution contains 5 mg methylene blue and water for injection. Hydrochloric acid added for pH adjustment. Methylene blue injection, USP: is a clear dark blue solution with a pH value between 3.0 and 4.5. The osmolality is between 10 and 15 mOsm/kg. Methylene blue injection, USP strength is expressed in terms of trihydrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-893-56</NDCCode>
    <PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (68462-893-56) </PackageDescription>
    <NDC11Code>68462-0893-56</NDC11Code>
    <ProductNDC>68462-893</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Varenicline Tartrate</ProprietaryName>
    <NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230822</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214255</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>VARENICLINE TARTRATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230822</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
    <Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is white to off white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and very slightly soluble in methanol. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3  C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg white to off-white, modified capsule shaped, film-coated tablets debossed with 'L' on one side and '11' on other side and a 1 mg light pink to pink color, modified capsule shaped, film coated tablets debossed with 'L' on one side and '12' on other side. Each 0.5 mg varenicline tablets contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablets contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: anhydrous dibasic calcium phosphate, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose. The tablet film coating contains hydroxypropyl cellulose, hypromellose, and titanium dioxide. In addition to these, the 1 mg tablet film coating also includes D&amp;C Red #27/phloxine aluminum lake, D&amp;C yellow #10 aluminum lake, and FD&amp;C blue #1/brilliant blue FCF aluminum lake and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-894-04</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (68462-894-04)  / 56 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68462-0894-04</NDC11Code>
    <ProductNDC>68462-894</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Varenicline Tartrate</ProprietaryName>
    <NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230822</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214255</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>VARENICLINE TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230822</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
    <Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is white to off white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and very slightly soluble in methanol. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3  C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg white to off-white, modified capsule shaped, film-coated tablets debossed with 'L' on one side and '11' on other side and a 1 mg light pink to pink color, modified capsule shaped, film coated tablets debossed with 'L' on one side and '12' on other side. Each 0.5 mg varenicline tablets contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablets contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: anhydrous dibasic calcium phosphate, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose. The tablet film coating contains hydroxypropyl cellulose, hypromellose, and titanium dioxide. In addition to these, the 1 mg tablet film coating also includes D&amp;C Red #27/phloxine aluminum lake, D&amp;C yellow #10 aluminum lake, and FD&amp;C blue #1/brilliant blue FCF aluminum lake and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-894-56</NDCCode>
    <PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (68462-894-56) </PackageDescription>
    <NDC11Code>68462-0894-56</NDC11Code>
    <ProductNDC>68462-894</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Varenicline Tartrate</ProprietaryName>
    <NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230822</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214255</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>VARENICLINE TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230822</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
    <Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is white to off white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and very slightly soluble in methanol. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3  C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg white to off-white, modified capsule shaped, film-coated tablets debossed with 'L' on one side and '11' on other side and a 1 mg light pink to pink color, modified capsule shaped, film coated tablets debossed with 'L' on one side and '12' on other side. Each 0.5 mg varenicline tablets contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablets contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: anhydrous dibasic calcium phosphate, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose. The tablet film coating contains hydroxypropyl cellulose, hypromellose, and titanium dioxide. In addition to these, the 1 mg tablet film coating also includes D&amp;C Red #27/phloxine aluminum lake, D&amp;C yellow #10 aluminum lake, and FD&amp;C blue #1/brilliant blue FCF aluminum lake and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-895-04</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (68462-895-04)  *  11 TABLET, FILM COATED in 1 BLISTER PACK *  42 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68462-0895-04</NDC11Code>
    <ProductNDC>68462-895</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Varenicline Tartrate</ProprietaryName>
    <NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230822</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214255</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230822</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
    <Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is white to off white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and very slightly soluble in methanol. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3  C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg white to off-white, modified capsule shaped, film-coated tablets debossed with 'L' on one side and '11' on other side and a 1 mg light pink to pink color, modified capsule shaped, film coated tablets debossed with 'L' on one side and '12' on other side. Each 0.5 mg varenicline tablets contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablets contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: anhydrous dibasic calcium phosphate, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose. The tablet film coating contains hydroxypropyl cellulose, hypromellose, and titanium dioxide. In addition to these, the 1 mg tablet film coating also includes D&amp;C Red #27/phloxine aluminum lake, D&amp;C yellow #10 aluminum lake, and FD&amp;C blue #1/brilliant blue FCF aluminum lake and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-4453-85</NDCCode>
    <PackageDescription>30 DOSE PACK in 1 CARTON (0002-4453-85)  / 1 BLISTER PACK in 1 DOSE PACK (0002-4453-01)  / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00002-4453-85</NDC11Code>
    <ProductNDC>0002-4453</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zyprexa</ProprietaryName>
    <ProprietaryNameSuffix>Zydis</ProprietaryNameSuffix>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20000601</StartMarketingDate>
    <EndMarketingDate>20260630</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021086</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20000601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
    <Description>ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&amp;C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&amp;C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-4454-85</NDCCode>
    <PackageDescription>30 DOSE PACK in 1 CARTON (0002-4454-85)  / 1 BLISTER PACK in 1 DOSE PACK (0002-4454-01)  / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00002-4454-85</NDC11Code>
    <ProductNDC>0002-4454</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zyprexa</ProprietaryName>
    <ProprietaryNameSuffix>Zydis</ProprietaryNameSuffix>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20000601</StartMarketingDate>
    <EndMarketingDate>20260331</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021086</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20000601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
    <Description>ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&amp;C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&amp;C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-4455-85</NDCCode>
    <PackageDescription>30 DOSE PACK in 1 CARTON (0002-4455-85)  / 1 BLISTER PACK in 1 DOSE PACK (0002-4455-01)  / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
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    <ProductNDC>0002-4455</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zyprexa</ProprietaryName>
    <ProprietaryNameSuffix>Zydis</ProprietaryNameSuffix>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010901</StartMarketingDate>
    <EndMarketingDate>20260331</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021086</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20010901</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
    <Description>ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&amp;C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&amp;C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.</Description>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zyprexa</ProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010901</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021086</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
    <Description>ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&amp;C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&amp;C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.</Description>
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    <NDCCode>0378-6550-53</NDCCode>
    <PackageDescription>3 POUCH in 1 CARTON (0378-6550-53)  / 1 BLISTER PACK in 1 POUCH (0378-6550-85)  / 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00378-6550-53</NDC11Code>
    <ProductNDC>0378-6550</ProductNDC>
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    <ProprietaryName>Levonorgestrel And Ethinyl Estradiol</ProprietaryName>
    <NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20130816</StartMarketingDate>
    <EndMarketingDate>20260630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091663</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20130816</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levonorgestrel and ethinyl estradiol tablets, 0.15 mg/30 mcg are indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
    <Description>Levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/30 mcg are a combination oral contraceptives (COC) consisting of 21 white to off-white active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 green inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel. C21H28O2MW: 312.45. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,(17α)-(-)-. Ethinyl Estradiol. C20H24O2 MW: 296.40. Ethinyl Estradiol is 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each white to off-white active tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and polacrilin potassium. Each green inert tablet contains the following inactive ingredients: FD&amp;C Blue No. 1 aluminum lake, lactose monohydrate, magnesium stearate, polacrilin potassium, and yellow oxide of iron.</Description>
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    <NDC11Code>57237-0312-51</NDC11Code>
    <ProductNDC>57237-312</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dextromethorphan Hbr. And Guaifenesin</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hbr. And Guaifenesin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230612</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012.85</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
    <StrengthNumber>10; 100</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</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>
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    <LastUpdate>2026-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>67877-172-85</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (67877-172-85)  / 10 TABLET in 1 BLISTER PACK (67877-172-33) </PackageDescription>
    <NDC11Code>67877-0172-85</NDC11Code>
    <ProductNDC>67877-172</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202295</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1), 2 Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1), 3 Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 4 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2), 5 Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3-to 4-week trials and one maintenance trial. (14.2), 6 Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 7 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 8 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2), 9 Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine and Fluoxetine in Combination for the:, 10 Treatment of depressive episodes associated with bipolar I disorder. (1.5), 11 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax., 12 Treatment of treatment resistant depression. (1.6), 13 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water.       Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine, USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are lactose monohydrate, hydroxypropyl cellulose, mannitol, and magnesium stearate. The color coating contains pectin, triacetin, titanium dioxide, talc, and FD&amp;C Blue No. 2 Aluminum Lake (15 mg strength) or Iron Oxide Red (20 mg strength). Olanzapine tablets, USP of all strengths are imprinted with edible ink which contains shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide.  FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-173-85</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (67877-173-85)  / 10 TABLET in 1 BLISTER PACK (67877-173-33) </PackageDescription>
    <NDC11Code>67877-0173-85</NDC11Code>
    <ProductNDC>67877-173</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202295</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1), 2 Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1), 3 Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 4 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2), 5 Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3-to 4-week trials and one maintenance trial. (14.2), 6 Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 7 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 8 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2), 9 Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine and Fluoxetine in Combination for the:, 10 Treatment of depressive episodes associated with bipolar I disorder. (1.5), 11 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax., 12 Treatment of treatment resistant depression. (1.6), 13 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water.       Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine, USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are lactose monohydrate, hydroxypropyl cellulose, mannitol, and magnesium stearate. The color coating contains pectin, triacetin, titanium dioxide, talc, and FD&amp;C Blue No. 2 Aluminum Lake (15 mg strength) or Iron Oxide Red (20 mg strength). Olanzapine tablets, USP of all strengths are imprinted with edible ink which contains shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide.  FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
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    <PackageDescription>3 BLISTER PACK in 1 CARTON (67877-174-85)  / 10 TABLET in 1 BLISTER PACK (67877-174-33) </PackageDescription>
    <NDC11Code>67877-0174-85</NDC11Code>
    <ProductNDC>67877-174</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202295</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1), 2 Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1), 3 Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 4 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2), 5 Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3-to 4-week trials and one maintenance trial. (14.2), 6 Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 7 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 8 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2), 9 Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine and Fluoxetine in Combination for the:, 10 Treatment of depressive episodes associated with bipolar I disorder. (1.5), 11 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax., 12 Treatment of treatment resistant depression. (1.6), 13 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water.       Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine, USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are lactose monohydrate, hydroxypropyl cellulose, mannitol, and magnesium stearate. The color coating contains pectin, triacetin, titanium dioxide, talc, and FD&amp;C Blue No. 2 Aluminum Lake (15 mg strength) or Iron Oxide Red (20 mg strength). Olanzapine tablets, USP of all strengths are imprinted with edible ink which contains shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide.  FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
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    <NDCCode>67877-175-85</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (67877-175-85)  / 10 TABLET in 1 BLISTER PACK (67877-175-33) </PackageDescription>
    <NDC11Code>67877-0175-85</NDC11Code>
    <ProductNDC>67877-175</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202295</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1), 2 Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1), 3 Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 4 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2), 5 Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3-to 4-week trials and one maintenance trial. (14.2), 6 Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 7 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 8 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2), 9 Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine and Fluoxetine in Combination for the:, 10 Treatment of depressive episodes associated with bipolar I disorder. (1.5), 11 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax., 12 Treatment of treatment resistant depression. (1.6), 13 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water.       Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine, USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are lactose monohydrate, hydroxypropyl cellulose, mannitol, and magnesium stearate. The color coating contains pectin, triacetin, titanium dioxide, talc, and FD&amp;C Blue No. 2 Aluminum Lake (15 mg strength) or Iron Oxide Red (20 mg strength). Olanzapine tablets, USP of all strengths are imprinted with edible ink which contains shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide.  FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-176-85</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (67877-176-85)  / 10 TABLET in 1 BLISTER PACK (67877-176-33) </PackageDescription>
    <NDC11Code>67877-0176-85</NDC11Code>
    <ProductNDC>67877-176</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202295</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1), 2 Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1), 3 Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 4 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2), 5 Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3-to 4-week trials and one maintenance trial. (14.2), 6 Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 7 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 8 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2), 9 Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine and Fluoxetine in Combination for the:, 10 Treatment of depressive episodes associated with bipolar I disorder. (1.5), 11 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax., 12 Treatment of treatment resistant depression. (1.6), 13 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water.       Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine, USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are lactose monohydrate, hydroxypropyl cellulose, mannitol, and magnesium stearate. The color coating contains pectin, triacetin, titanium dioxide, talc, and FD&amp;C Blue No. 2 Aluminum Lake (15 mg strength) or Iron Oxide Red (20 mg strength). Olanzapine tablets, USP of all strengths are imprinted with edible ink which contains shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide.  FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-177-85</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (67877-177-85)  / 10 TABLET in 1 BLISTER PACK (67877-177-33) </PackageDescription>
    <NDC11Code>67877-0177-85</NDC11Code>
    <ProductNDC>67877-177</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202295</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1), 2 Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1), 3 Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 4 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2), 5 Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3-to 4-week trials and one maintenance trial. (14.2), 6 Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 7 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 8 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2), 9 Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine and Fluoxetine in Combination for the:, 10 Treatment of depressive episodes associated with bipolar I disorder. (1.5), 11 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax., 12 Treatment of treatment resistant depression. (1.6), 13 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water.       Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine, USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are lactose monohydrate, hydroxypropyl cellulose, mannitol, and magnesium stearate. The color coating contains pectin, triacetin, titanium dioxide, talc, and FD&amp;C Blue No. 2 Aluminum Lake (15 mg strength) or Iron Oxide Red (20 mg strength). Olanzapine tablets, USP of all strengths are imprinted with edible ink which contains shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide.  FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>70700-116-85</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (70700-116-85)  / 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>70700-0116-85</NDC11Code>
    <ProductNDC>70700-116</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Altavera</ProprietaryName>
    <NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20220901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079102</ApplicationNumber>
    <LabelerName>Xiromed, LLC.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2023-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230302</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Altavera is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
    <Description>Altavera (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 peach active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are. LevonorgestrelC21H28O2 MW: 312.4. Ethinyl EstradiolC20H24O2 MW: 296.4. Ethinyl Estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each peach active tablet contains the following inactive ingredients: lactose anhydrous, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide. Each white inert tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-101-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (68462-101-10) </PackageDescription>
    <NDC11Code>68462-0101-10</NDC11Code>
    <ProductNDC>68462-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluconazole</ProprietaryName>
    <NonProprietaryName>Fluconazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077253</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>FLUCONAZOLE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: : 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
    <Description>Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1’,1’-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.27. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&amp;C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30.</Description>
  </NDC>
</NDCList>