RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>75277-312-12</NDCCode>
    <PackageDescription>118 mL in 1 BOTTLE, PLASTIC (75277-312-12) </PackageDescription>
    <NDC11Code>75277-0312-12</NDC11Code>
    <ProductNDC>75277-312</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Dolce &amp; Lay LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>17478-312-12</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (17478-312-12)  &gt; 2.5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>17478-0312-12</NDC11Code>
    <ProductNDC>17478-312</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Olopatadine</ProprietaryName>
    <NonProprietaryName>Olopatadine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20210901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204723</ApplicationNumber>
    <LabelerName>Akorn</LabelerName>
    <SubstanceName>OLOPATADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>33342-312-12</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (33342-312-12)  / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0312-12</NDC11Code>
    <ProductNDC>33342-312</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Memantine And Donepezil</ProprietaryName>
    <NonProprietaryName>Memantine And Donepezil</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208672</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>14; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
    <Description>Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine HydrochlorideThe chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>47682-312-12</NDCCode>
    <PackageDescription>10 PACKET in 1 CARTON (47682-312-12)  / 1 mL in 1 PACKET (47682-312-99) </PackageDescription>
    <NDC11Code>47682-0312-12</NDC11Code>
    <ProductNDC>47682-312</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Medi-first Antiseptic Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>SWAB</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240715</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>UniFirst First Aid Corporation</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. First aid to help prevent infection in minor cuts, scrapes and burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50066-312-24</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (50066-312-24)  &gt; 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>50066-0312-24</NDC11Code>
    <ProductNDC>50066-312</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tukol Day Time Cold And Flu Relief Softgels</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230110</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Genomma Lab USA</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 10; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves common cold and flu symptoms: 1 nasal congestion, 2 cough due to minor throat and bronchial irritation, 3 sore throat, 4 headache, 5 minor aches and pains, 6 fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52685-312-30</NDCCode>
    <PackageDescription>1 TRAY in 1 CARTON (52685-312-30)  &gt; 12 g in 1 TRAY</PackageDescription>
    <NDC11Code>52685-0312-30</NDC11Code>
    <ProductNDC>52685-312</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Advanced Hydro-liquid Compact (refill)</ProprietaryName>
    <ProprietaryNameSuffix>B20</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20090901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>SHISEIDO CO., LTD.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>1.7</StrengthNumber>
    <StrengthUnit>g/12g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>53713-1287-4</NDCCode>
    <PackageDescription>12 TRAY in 1 CARTON (53713-1287-4)  &gt; 312 INJECTION, POWDER, FOR SOLUTION in 1 TRAY</PackageDescription>
    <NDC11Code>53713-1287-04</NDC11Code>
    <ProductNDC>53713-1287</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Peginterferon Alfa-2b</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <StartMarketingDate>20110329</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>SCHERING PLOUGH BRINNY CO</LabelerName>
    <SubstanceName>PEGINTERFERON ALFA-2B</SubstanceName>
    <StrengthNumber>444</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>53713-1312-3</NDCCode>
    <PackageDescription>12 TRAY in 1 CARTON (53713-1312-3)  &gt; 312 INJECTION, POWDER, FOR SOLUTION in 1 TRAY</PackageDescription>
    <NDC11Code>53713-1312-03</NDC11Code>
    <ProductNDC>53713-1312</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Peginterferon Alfa-2b</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <StartMarketingDate>20110329</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>SCHERING PLOUGH BRINNY CO</LabelerName>
    <SubstanceName>PEGINTERFERON ALFA-2B</SubstanceName>
    <StrengthNumber>888</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>53713-1388-3</NDCCode>
    <PackageDescription>12 TRAY in 1 CARTON (53713-1388-3)  &gt; 312 INJECTION, POWDER, FOR SOLUTION in 1 TRAY</PackageDescription>
    <NDC11Code>53713-1388-03</NDC11Code>
    <ProductNDC>53713-1388</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Peginterferon Alfa-2b</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <StartMarketingDate>20110329</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>SCHERING PLOUGH BRINNY CO</LabelerName>
    <SubstanceName>PEGINTERFERON ALFA-2B</SubstanceName>
    <StrengthNumber>296</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>62135-312-12</NDCCode>
    <PackageDescription>120 CAPSULE in 1 BOTTLE (62135-312-12) </PackageDescription>
    <NDC11Code>62135-0312-12</NDC11Code>
    <ProductNDC>62135-312</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Anagrelide</ProprietaryName>
    <NonProprietaryName>Anagrelide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050418</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076683</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC</LabelerName>
    <SubstanceName>ANAGRELIDE HYDROCHLORIDE ANHYDROUS</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Platelet Production [PE], Phosphodiesterase 3 Inhibitors [MoA], Platelet-reducing Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events.</IndicationAndUsage>
    <Description>Anagrelide Hydrochloride, USP is a platelet-reducing agent. Its chemical name is 6,7-dichloro-1,5-dihydroimidazo[2,1-b]quinazolin-2(3H)-one monohydrochloride monohydrate. The molecular formula is C 10H 7Cl 2N 3OHClH 2O which corresponds to a molecular weight of 310.55. The structural formula is:. Anagrelide Hydrochloride, USP is an off-white powder. It is very slightly soluble in water and sparingly soluble in dimethyl sulfoxide and dimethylformamide. Anagrelide Capsules, USP is supplied as capsules for oral administration, containing 0.5 mg and 1 mg of anagrelide base (as anagrelide hydrochloride, USP). The capsules also contain lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and crospovidone. Capsule shell contains gelatin, titanium dioxide and black iron oxide (1mg). Additionally, capsule shells are imprinted with black imprint ink, it contains ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-312-12</NDCCode>
    <PackageDescription>12 SUPPOSITORY in 1 BOX (67877-312-12)</PackageDescription>
    <NDC11Code>67877-0312-12</NDC11Code>
    <ProductNDC>67877-312</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone Acetate</ProprietaryName>
    <NonProprietaryName>Hydrocortisone Acetate</NonProprietaryName>
    <DosageFormName>SUPPOSITORY</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20131001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>HYDROCORTISONE ACETATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-03-04</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>68428-312-12</NDCCode>
    <PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-312-12) </PackageDescription>
    <NDC11Code>68428-0312-12</NDC11Code>
    <ProductNDC>68428-312</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Chlorinum</ProprietaryName>
    <NonProprietaryName>Chlorine</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100203</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>CHLORINE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>84126-312-12</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (84126-312-12)  *  177 mL in 1 BOTTLE, PLASTIC (84126-310-06)  *  177 mL in 1 BOTTLE, PLASTIC (84126-311-06) </PackageDescription>
    <NDC11Code>84126-0312-12</NDC11Code>
    <ProductNDC>84126-312</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Vicks Dayquil Kids And Vicks Nyquil Kids</ProprietaryName>
    <ProprietaryNameSuffix>Free Of Artificial Dyes And Sugar Cold And Cough Plus</ProprietaryNameSuffix>
    <NonProprietaryName>Dextromethorphan Hbr, Guaifenesin, Diphenhydramine Hcl</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240625</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0002-3230-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3230-30) </PackageDescription>
    <NDC11Code>00002-3230-30</NDC11Code>
    <ProductNDC>0002-3230</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Symbyax</ProprietaryName>
    <NonProprietaryName>Olanzapine And Fluoxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070409</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021520</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE; OLANZAPINE</SubstanceName>
    <StrengthNumber>25; 3</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SYMBYAX® is indicated for the treatment of: : 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]. , 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)]. .</IndicationAndUsage>
    <Description>SYMBYAX (olanzapine and fluoxetine HCl capsules) combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac and Sarafem). Olanzapine 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. Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NOHCl, which corresponds to a molecular weight of 345.79. The chemical structures are. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. SYMBYAX capsules are available for oral administration in the following strength combinations. Each capsule also contains pregelatinized starch, gelatin, dimethicone, titanium dioxide, sodium lauryl sulfate, edible black ink, red iron oxide, yellow iron oxide, and/or black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-3231-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3231-30) </PackageDescription>
    <NDC11Code>00002-3231-30</NDC11Code>
    <ProductNDC>0002-3231</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Symbyax</ProprietaryName>
    <NonProprietaryName>Olanzapine And Fluoxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20031224</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021520</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE; OLANZAPINE</SubstanceName>
    <StrengthNumber>25; 6</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SYMBYAX® is indicated for the treatment of: : 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]. , 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)]. .</IndicationAndUsage>
    <Description>SYMBYAX (olanzapine and fluoxetine HCl capsules) combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac and Sarafem). Olanzapine 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. Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NOHCl, which corresponds to a molecular weight of 345.79. The chemical structures are. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. SYMBYAX capsules are available for oral administration in the following strength combinations. Each capsule also contains pregelatinized starch, gelatin, dimethicone, titanium dioxide, sodium lauryl sulfate, edible black ink, red iron oxide, yellow iron oxide, and/or black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-4112-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (0002-4112-30) </PackageDescription>
    <NDC11Code>00002-4112-30</NDC11Code>
    <ProductNDC>0002-4112</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zyprexa</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970623</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020592</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>2.5</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>19970623</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>
  </NDC>
  <NDC>
    <NDCCode>0002-4115-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (0002-4115-30) </PackageDescription>
    <NDC11Code>00002-4115-30</NDC11Code>
    <ProductNDC>0002-4115</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zyprexa</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19961001</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020592</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>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19961001</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>
  </NDC>
  <NDC>
    <NDCCode>0002-4420-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (0002-4420-30) </PackageDescription>
    <NDC11Code>00002-4420-30</NDC11Code>
    <ProductNDC>0002-4420</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zyprexa</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010301</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020592</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>20010301</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>
  </NDC>
  <NDC>
    <NDCCode>0002-4456-85</NDCCode>
    <PackageDescription>30 DOSE PACK in 1 CARTON (0002-4456-85)  / 1 BLISTER PACK in 1 DOSE PACK (0002-4456-01)  / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00002-4456-85</NDC11Code>
    <ProductNDC>0002-4456</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>
    <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>
  </NDC>
  <NDC>
    <NDCCode>0093-5503-56</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (0093-5503-56) </PackageDescription>
    <NDC11Code>00093-5503-56</NDC11Code>
    <ProductNDC>0093-5503</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
    <NonProprietaryName>Olanzapine And Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130410</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202074</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>3; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]., 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa®, and Zyprexa® Zydis®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac® and Sarafem®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The chemical structures are. C17H20N4S                    M.W. 312.44. C17H18F3NOHCl          M.W. 345.79. Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule also contains D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&amp;C Yellow No. 10 and FD&amp;C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&amp;C Red No. 28, FD&amp;C Blue No. 1, and FD&amp;C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>0093-5504-56</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (0093-5504-56) </PackageDescription>
    <NDC11Code>00093-5504-56</NDC11Code>
    <ProductNDC>0093-5504</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
    <NonProprietaryName>Olanzapine And Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120619</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077528</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>6; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120619</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]., 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa®, and Zyprexa® Zydis®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac® and Sarafem®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The chemical structures are. C17H20N4S                    M.W. 312.44. C17H18F3NOHCl          M.W. 345.79. Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule also contains D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&amp;C Yellow No. 10 and FD&amp;C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&amp;C Red No. 28, FD&amp;C Blue No. 1, and FD&amp;C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>0093-5505-56</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (0093-5505-56) </PackageDescription>
    <NDC11Code>00093-5505-56</NDC11Code>
    <ProductNDC>0093-5505</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
    <NonProprietaryName>Olanzapine And Fluoxetine</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120619</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077528</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>6; 50</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120619</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]., 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa®, and Zyprexa® Zydis®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac® and Sarafem®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The chemical structures are. C17H20N4S                    M.W. 312.44. C17H18F3NOHCl          M.W. 345.79. Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule also contains D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&amp;C Yellow No. 10 and FD&amp;C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&amp;C Red No. 28, FD&amp;C Blue No. 1, and FD&amp;C Red No. 40.</Description>
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  <NDC>
    <NDCCode>0093-5506-56</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (0093-5506-56) </PackageDescription>
    <NDC11Code>00093-5506-56</NDC11Code>
    <ProductNDC>0093-5506</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
    <NonProprietaryName>Olanzapine And Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120619</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077528</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>12; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120619</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]., 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa®, and Zyprexa® Zydis®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac® and Sarafem®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The chemical structures are. C17H20N4S                    M.W. 312.44. C17H18F3NOHCl          M.W. 345.79. Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule also contains D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&amp;C Yellow No. 10 and FD&amp;C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&amp;C Red No. 28, FD&amp;C Blue No. 1, and FD&amp;C Red No. 40.</Description>
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  <NDC>
    <NDCCode>0093-5507-56</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (0093-5507-56) </PackageDescription>
    <NDC11Code>00093-5507-56</NDC11Code>
    <ProductNDC>0093-5507</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
    <NonProprietaryName>Olanzapine And Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120619</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077528</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>12; 50</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120619</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]., 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa®, and Zyprexa® Zydis®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac® and Sarafem®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The chemical structures are. C17H20N4S                    M.W. 312.44. C17H18F3NOHCl          M.W. 345.79. Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule also contains D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&amp;C Yellow No. 10 and FD&amp;C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&amp;C Red No. 28, FD&amp;C Blue No. 1, and FD&amp;C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9744-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-USE in 1 PACKAGE (0143-9744-10)  / 1 mL in 1 VIAL, SINGLE-USE (0143-9744-01) </PackageDescription>
    <NDC11Code>00143-9744-10</NDC11Code>
    <ProductNDC>0143-9744</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Granisetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Granisetron Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20091223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078629</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>GRANISETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3) receptor antagonist indicated for: 1 The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.</IndicationAndUsage>
    <Description>Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3) receptor antagonist. Chemically it is endo-N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride with a molecular weight of 348.9 (312.4 free base). Its empirical formula is C18H24N4OHCl, while its chemical structure is. Granisetron hydrochloride is a white to off-white solid that is readily soluble in water and normal saline at 20°C. Granisetron Hydrochloride Injection, USP is a clear, colorless, sterile, nonpyrogenic, aqueous solution for intravenous administration. Granisetron Hydrochloride Injection, USP 1 mg/mL is available in 1 mL single dose and 4 mL multiple dose vials. 1 mg/mL: Each mL contains 1.12 mg granisetron hydrochloride equivalent to granisetron, 1 mg; sodium chloride, 9 mg; citric acid anhydrous, 2 mg; and benzyl alcohol, 10 mg, as a preservative. The solution’s pH ranges from 4.0 to 6.0; pH adjusted with sodium hydroxide/hydrochloric acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9745-05</NDCCode>
    <PackageDescription>5 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-05)  / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01) </PackageDescription>
    <NDC11Code>00143-9745-05</NDC11Code>
    <ProductNDC>0143-9745</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Granisetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Granisetron Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20091223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078629</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>GRANISETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3) receptor antagonist indicated for: 1 The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.</IndicationAndUsage>
    <Description>Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3) receptor antagonist. Chemically it is endo-N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride with a molecular weight of 348.9 (312.4 free base). Its empirical formula is C18H24N4OHCl, while its chemical structure is. Granisetron hydrochloride is a white to off-white solid that is readily soluble in water and normal saline at 20°C. Granisetron Hydrochloride Injection, USP is a clear, colorless, sterile, nonpyrogenic, aqueous solution for intravenous administration. Granisetron Hydrochloride Injection, USP 1 mg/mL is available in 1 mL single dose and 4 mL multiple dose vials. 1 mg/mL: Each mL contains 1.12 mg granisetron hydrochloride equivalent to granisetron, 1 mg; sodium chloride, 9 mg; citric acid anhydrous, 2 mg; and benzyl alcohol, 10 mg, as a preservative. The solution’s pH ranges from 4.0 to 6.0; pH adjusted with sodium hydroxide/hydrochloric acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9745-10</NDCCode>
    <PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-10)  / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01) </PackageDescription>
    <NDC11Code>00143-9745-10</NDC11Code>
    <ProductNDC>0143-9745</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Granisetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Granisetron Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20091223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078629</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>GRANISETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3) receptor antagonist indicated for: 1 The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.</IndicationAndUsage>
    <Description>Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3) receptor antagonist. Chemically it is endo-N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride with a molecular weight of 348.9 (312.4 free base). Its empirical formula is C18H24N4OHCl, while its chemical structure is. Granisetron hydrochloride is a white to off-white solid that is readily soluble in water and normal saline at 20°C. Granisetron Hydrochloride Injection, USP is a clear, colorless, sterile, nonpyrogenic, aqueous solution for intravenous administration. Granisetron Hydrochloride Injection, USP 1 mg/mL is available in 1 mL single dose and 4 mL multiple dose vials. 1 mg/mL: Each mL contains 1.12 mg granisetron hydrochloride equivalent to granisetron, 1 mg; sodium chloride, 9 mg; citric acid anhydrous, 2 mg; and benzyl alcohol, 10 mg, as a preservative. The solution’s pH ranges from 4.0 to 6.0; pH adjusted with sodium hydroxide/hydrochloric acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-5510-93</NDCCode>
    <PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5510-93) </PackageDescription>
    <NDC11Code>00378-5510-93</NDC11Code>
    <ProductNDC>0378-5510</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140512</StartMarketingDate>
    <EndMarketingDate>20251130</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202285</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140512</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine orally disintegrating tablets are 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>Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belong 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 orally disintegrating tablets are 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. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, guar gum, magnesium stearate, mannitol, microcrystalline cellulose and sodium lauryl sulfate. Meets USP Disintegration Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-5511-93</NDCCode>
    <PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5511-93) </PackageDescription>
    <NDC11Code>00378-5511-93</NDC11Code>
    <ProductNDC>0378-5511</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140512</StartMarketingDate>
    <EndMarketingDate>20251130</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202285</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140512</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine orally disintegrating tablets are 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>Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belong 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 orally disintegrating tablets are 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. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, guar gum, magnesium stearate, mannitol, microcrystalline cellulose and sodium lauryl sulfate. Meets USP Disintegration Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>0480-3472-24</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (0480-3472-24)  / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00480-3472-24</NDC11Code>
    <ProductNDC>0480-3472</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amethyst</ProprietaryName>
    <NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079218</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LEVONORGESTREL; ETHINYL ESTRADIOL</SubstanceName>
    <StrengthNumber>90; 20</StrengthNumber>
    <StrengthUnit>ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amethyst (levonorgestrel and ethinyl estradiol tablets) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10. Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. : 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. , 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. , 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. , 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. , 5 Foams, creams, gels, vaginal suppositories, and vaginal film. , 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. , 7 With spermicidal cream or jelly. , 8 Without spermicides. , 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. , 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. .</IndicationAndUsage>
    <Description>Twenty-eight (28) white tablets each containing 90 mcg of levonorgestrel, USP (17α)-(–)13-ethyl-17-hydroxy-18, 19-dinorpregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 20 mcg of ethinyl estradiol, USP (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Levonorgestrel, USPC21H28O2             M.W. 312.45. Ethinyl Estradiol, USPC20H24O2             M.W. 296.40.</Description>
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