RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>67877-610-33</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (67877-610-33)  / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>67877-0610-33</NDC11Code>
    <ProductNDC>67877-610</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tizanidne Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tizanidne Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212196</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tizanidine capsules are indicated for the treatment of spasticity in adults.</IndicationAndUsage>
    <Description>Tizanidine capsules contains tizanidine hydrochloride the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride is almost white to slightly yellow, crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Tizanidine capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride USP, respectively), and the inactive ingredients sugar spheres, hypromellose and silicon dioxide. Each capsule shell contains FD and C Blue1, FD and C Red 3 (4 mg and 6 mg), gelatin and titanium dioxide. The 2 mg and 6 mg capsule is printed with white pharmaceutical ink which contains shellac, propylene glycol, potassium hydroxide and titanium dioxide; 4 mg capsule is printed with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-610-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (67877-610-05) </PackageDescription>
    <NDC11Code>67877-0610-05</NDC11Code>
    <ProductNDC>67877-610</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tizanidne Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tizanidne Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212196</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tizanidine capsules are indicated for the treatment of spasticity in adults.</IndicationAndUsage>
    <Description>Tizanidine capsules contains tizanidine hydrochloride the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride is almost white to slightly yellow, crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Tizanidine capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride USP, respectively), and the inactive ingredients sugar spheres, hypromellose and silicon dioxide. Each capsule shell contains FD and C Blue1, FD and C Red 3 (4 mg and 6 mg), gelatin and titanium dioxide. The 2 mg and 6 mg capsule is printed with white pharmaceutical ink which contains shellac, propylene glycol, potassium hydroxide and titanium dioxide; 4 mg capsule is printed with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-610-15</NDCCode>
    <PackageDescription>150 CAPSULE in 1 BOTTLE (67877-610-15) </PackageDescription>
    <NDC11Code>67877-0610-15</NDC11Code>
    <ProductNDC>67877-610</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tizanidne Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tizanidne Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212196</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tizanidine capsules are indicated for the treatment of spasticity in adults.</IndicationAndUsage>
    <Description>Tizanidine capsules contains tizanidine hydrochloride the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride is almost white to slightly yellow, crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Tizanidine capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride USP, respectively), and the inactive ingredients sugar spheres, hypromellose and silicon dioxide. Each capsule shell contains FD and C Blue1, FD and C Red 3 (4 mg and 6 mg), gelatin and titanium dioxide. The 2 mg and 6 mg capsule is printed with white pharmaceutical ink which contains shellac, propylene glycol, potassium hydroxide and titanium dioxide; 4 mg capsule is printed with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>47682-610-33</NDCCode>
    <PackageDescription>50 PACKET in 1 BOX (47682-610-33)  / 2 TABLET, COATED in 1 PACKET (47682-610-99) </PackageDescription>
    <NDC11Code>47682-0610-33</NDC11Code>
    <ProductNDC>47682-610</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Green Guard Ibupro Relief</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075010</ApplicationNumber>
    <LabelerName>Unifirst First Aid Corporation</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. Temporarily relieves minor aches and pains associated with. ■ headache ■ toothache ■ backache ■ menstrual cramps. ■ common cold ■ muscular aches ■ minor arthritis pain. Temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54766-730-33</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (54766-730-33)  *  3 TABLET in 1 BLISTER PACK (68040-610-25)  *  1  in 1 PACKET *  1 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-33)  &gt; 4 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>54766-0730-33</NDC11Code>
    <ProductNDC>54766-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Analpram Advanced</ProprietaryName>
    <NonProprietaryName>Hydrocortisone Acetate And Pramoxine Hydrochloride</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150807</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2017-02-24</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>59310-610-33</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (59310-610-33)  / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>59310-0610-33</NDC11Code>
    <ProductNDC>59310-610</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cinqair</ProprietaryName>
    <NonProprietaryName>Reslizumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160418</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761033</ApplicationNumber>
    <LabelerName>Teva Respiratory, LLC</LabelerName>
    <SubstanceName>RESLIZUMAB</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-5 Antagonist [EPC], Interleukin-5 Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170604</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>CINQAIR® is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see Clinical Studies (14)]. Limitation of Use: 1 CINQAIR is not indicated for treatment of other eosinophilic conditions., 2 CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>CINQAIR (reslizumab) is a humanized interleukin-5 antagonist monoclonal antibody (IgG4κ). Reslizumab is produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells. Reslizumab has a molecular weight of approximately 147 kDa. CINQAIR is a sterile, preservative-free, clear to slightly hazy/opalescent, colorless to slightly yellow solution (injection) for intravenous infusion. Since CINQAIR is a protein, proteinaceous particles may be present in the solution that appear as translucent to white, amorphous particulates. Each single-use vial contains 100 mg reslizumab in 10 mL. Each mL contains 10 mg of reslizumab, glacial acetic acid (0.12 mg), sodium acetate trihydrate (2.45 mg), and sucrose (70 mg), with a pH of 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>73870-610-33</NDCCode>
    <PackageDescription>1249 L in 1 CONTAINER (73870-610-33) </PackageDescription>
    <NDC11Code>73870-0610-33</NDC11Code>
    <ProductNDC>73870-610</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shsnh6-3610</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200716</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Shotwell Hydrogenics, LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200716</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>85110-610-33</NDCCode>
    <PackageDescription>9 g in 1 PACKET (85110-610-33) </PackageDescription>
    <NDC11Code>85110-0610-33</NDC11Code>
    <ProductNDC>85110-610</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Paingel</ProprietaryName>
    <NonProprietaryName>Camphor, Menthol</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251128</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>NACOR BUSINESS GROUP LLC</LabelerName>
    <SubstanceName>MENTHOL; CAMPHOR (SYNTHETIC)</SubstanceName>
    <StrengthNumber>10; 6</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67877-172-35</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (67877-172-35)  / 10 TABLET in 1 BLISTER PACK (67877-172-33) </PackageDescription>
    <NDC11Code>67877-0172-35</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>20271231</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>67877-172-85</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>20271231</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>67877-173-35</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (67877-173-35)  / 10 TABLET in 1 BLISTER PACK (67877-173-33) </PackageDescription>
    <NDC11Code>67877-0173-35</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>20271231</ListingRecordCertifiedThrough>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>67877-176-85</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (67877-176-85)  / 10 TABLET in 1 BLISTER PACK (67877-176-33) </PackageDescription>
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    <ProductNDC>67877-176</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
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    <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>20271231</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>67877-177-35</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (67877-177-35)  / 10 TABLET in 1 BLISTER PACK (67877-177-33) </PackageDescription>
    <NDC11Code>67877-0177-35</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>20271231</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>20271231</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>67877-217-38</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (67877-217-38)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-217-33) </PackageDescription>
    <NDC11Code>67877-0217-38</NDC11Code>
    <ProductNDC>67877-217</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091184</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate and copovidone. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-218-38</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (67877-218-38)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-218-33) </PackageDescription>
    <NDC11Code>67877-0218-38</NDC11Code>
    <ProductNDC>67877-218</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091184</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>850</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate and copovidone. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-221-38</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (67877-221-38)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-221-33) </PackageDescription>
    <NDC11Code>67877-0221-38</NDC11Code>
    <ProductNDC>67877-221</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091184</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate and copovidone. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-240-33</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (67877-240-33)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>67877-0240-33</NDC11Code>
    <ProductNDC>67877-240</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alendronate Sodium</ProprietaryName>
    <NonProprietaryName>Alendronate Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090258</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>ALENDRONATE SODIUM</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-11-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>67877-241-33</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (67877-241-33)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>67877-0241-33</NDC11Code>
    <ProductNDC>67877-241</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alendronate Sodium</ProprietaryName>
    <NonProprietaryName>Alendronate Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090258</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>ALENDRONATE SODIUM</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-11-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>67877-242-33</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (67877-242-33)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>67877-0242-33</NDC11Code>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
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    <LastUpdate>2026-08-08</LastUpdate>
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    <IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of: 1  Schizophrenia (1.1), 2  Bipolar I disorder manic episodes (1.2), 3  Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
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    <PackageDescription>1 BLISTER PACK in 1 CARTON (67877-245-33)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>67877-0245-33</NDC11Code>
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    <ProprietaryName>Quetiapine</ProprietaryName>
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    <LabelerName>Ascend Laboratories, LLC</LabelerName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of: 1  Schizophrenia (1.1), 2  Bipolar I disorder manic episodes (1.2), 3  Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
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    <NDCCode>67877-246-33</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (67877-246-33)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>67877-0246-33</NDC11Code>
    <ProductNDC>67877-246</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine</ProprietaryName>
    <NonProprietaryName>Quetiapine</NonProprietaryName>
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    <LabelerName>Ascend Laboratories, LLC</LabelerName>
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    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of: 1  Schizophrenia (1.1), 2  Bipolar I disorder manic episodes (1.2), 3  Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
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    <NDC11Code>67877-0247-33</NDC11Code>
    <ProductNDC>67877-247</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine</ProprietaryName>
    <NonProprietaryName>Quetiapine</NonProprietaryName>
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    <LabelerName>Ascend Laboratories, LLC</LabelerName>
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    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of: 1  Schizophrenia (1.1), 2  Bipolar I disorder manic episodes (1.2), 3  Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
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    <NDC11Code>67877-0248-33</NDC11Code>
    <ProductNDC>67877-248</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine</ProprietaryName>
    <NonProprietaryName>Quetiapine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
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    <StartMarketingDate>20130301</StartMarketingDate>
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    <ApplicationNumber>ANDA201504</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
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    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of: 1  Schizophrenia (1.1), 2  Bipolar I disorder manic episodes (1.2), 3  Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
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