RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>0781-5219-32</NDCCode>
    <PackageDescription>270 TABLET, FILM COATED in 1 BOTTLE (0781-5219-32) </PackageDescription>
    <NDC11Code>00781-5219-32</NDC11Code>
    <ProductNDC>0781-5219</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sevelamer Carbonate</ProprietaryName>
    <NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180416</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200959</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>SEVELAMER CARBONATE</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-02-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180416</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0781-2158-32</NDCCode>
    <PackageDescription>270 CAPSULE in 1 BOTTLE, PLASTIC (0781-2158-32) </PackageDescription>
    <NDC11Code>00781-2158-32</NDC11Code>
    <ProductNDC>0781-2158</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212600</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone capsules are available as white hard gelatin capsules containing 267 mg of pirfenidone for oral administration. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow crystalline, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 108°C. Pirfenidone capsule contains pirfenidone and the following inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate, and pregelatinized starch. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule black printing ink includes iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-3474-32</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0781-3474-32)  *  30 mL in 1 VIAL, SINGLE-DOSE (0781-3470-90)  *  3 mL in 1 VIAL (0781-3473-93) </PackageDescription>
    <NDC11Code>00781-3474-32</NDC11Code>
    <ProductNDC>0781-3474</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carmustine</ProprietaryName>
    <NonProprietaryName>Carmustine</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20210526</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211202</ApplicationNumber>
    <LabelerName>Sandoz Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-02-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210526</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carmustine for injection is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: 1 Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors ( 1) , 2 Multiple myeloma-in combination with prednisone ( 1) , 3 Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs ( 1) , 4 Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs (  1)  .</IndicationAndUsage>
    <Description>The active ingredient in carmustine for injection, USP is a nitrosourea with the chemical name 1,3-bis(2-chloroethyl)-1-nitrosourea and a molecular weight of 214.05. The drug product is supplied as sterile lyophilized pale yellow granules or a congealed mass, and it is highly soluble in alcohol and lipids, and poorly soluble in water. Carmustine for injection, USP is administered by intravenous infusion after reconstitution, as recommended. The structural formula of carmustine is. Carmustine for injection, USP is available in 100-mg single-dose vials of lyophilized material. Sterile diluent for constitution of carmustine for injection, USP is co-packaged with the active drug product for use in constitution of the lyophile. The diluent is supplied in a vial containing 3 mL of Dehydrated Alcohol Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-4003-32</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0781-4003-32)  *  1 VIAL, MULTI-DOSE in 1 CARTON (0781-3006-42)  / 2.8 mL in 1 VIAL, MULTI-DOSE *  1 mL in 1 PACKET</PackageDescription>
    <NDC11Code>00781-4003-32</NDC11Code>
    <ProductNDC>0781-4003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leuprolide Acetate</ProprietaryName>
    <NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19980804</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074728</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980804</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.</IndicationAndUsage>
    <Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula. Leuprolide acetate injection is a sterile, aqueous solution intended for subcutaneous injection. It is available in a 2.8 mL multiple-dose vial containing leuprolide acetate (5 mg/mL), sodium chloride, USP (6.3 mg/mL) for tonicity adjustment, benzyl alcohol, NF as a preservative (9 mg/mL), and water for injection, USP. The pH may have been adjusted with sodium hydroxide, NF and/or acetic acid, NF. The pH range is 4.0 to 6.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-4054-42</NDCCode>
    <PackageDescription>14 BLISTER PACK in 1 CARTON (0781-4054-42)  &gt; 1 KIT in 1 BLISTER PACK (0781-4054-32) </PackageDescription>
    <NDC11Code>00781-4054-42</NDC11Code>
    <ProductNDC>0781-4054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lansoprazole, Amoxicillin And Clarithromycin</ProprietaryName>
    <NonProprietaryName>Lansoprazole, Amoxicillin And Clarithromycin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20140304</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202588</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140304</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0781-8085-32</NDCCode>
    <PackageDescription>270 TABLET, FILM COATED in 1 CARTON (0781-8085-32) </PackageDescription>
    <NDC11Code>00781-8085-32</NDC11Code>
    <ProductNDC>0781-8085</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220502</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212560</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220502</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (dark pink) pirfenidone for oral administration. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow crystalline, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 108°C. Pirfenidone tablet contains pirfenidone and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, pregelatinized starch, and silicon dioxide. 267 mg tablets contains opadry II yellow which consist of: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. 801 mg tablets contains opadry II pink which consist of: iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>69968-0781-1</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (69968-0781-1)  / 32 mL in 1 TUBE</PackageDescription>
    <NDC11Code>69968-0781-01</NDC11Code>
    <ProductNDC>69968-0781</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neutrogena Mineral Uv Tint Face Light Spf 30</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20221205</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Kenvue Brands LLC</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>32; 216</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0781-2299-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2299-01) </PackageDescription>
    <NDC11Code>00781-2299-01</NDC11Code>
    <ProductNDC>0781-2299</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250916</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202836</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&amp;C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD &amp; C yellow No. 5, FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD&amp;C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD&amp;C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&amp;C red No. 40, FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&amp;C blue No. 2/Indigo carmine aluminum lake, FD&amp;C red No. 40/Allura red AC aluminum lake, FD&amp;C blue No. 1/Brilliant blue FCF aluminum lake, and D&amp;C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&amp;C blue No. 2/Indigo carmine aluminum lake, FD&amp;C red No. 40/Allura red AC aluminum lake, FD&amp;C blue No. 1/Brilliant blue FCF aluminum lake, and D&amp;C yellow No. 10 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-2476-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2476-01) </PackageDescription>
    <NDC11Code>00781-2476-01</NDC11Code>
    <ProductNDC>0781-2476</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250916</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202836</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&amp;C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD &amp; C yellow No. 5, FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD&amp;C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD&amp;C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&amp;C red No. 40, FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&amp;C blue No. 2/Indigo carmine aluminum lake, FD&amp;C red No. 40/Allura red AC aluminum lake, FD&amp;C blue No. 1/Brilliant blue FCF aluminum lake, and D&amp;C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&amp;C blue No. 2/Indigo carmine aluminum lake, FD&amp;C red No. 40/Allura red AC aluminum lake, FD&amp;C blue No. 1/Brilliant blue FCF aluminum lake, and D&amp;C yellow No. 10 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-2477-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2477-01) </PackageDescription>
    <NDC11Code>00781-2477-01</NDC11Code>
    <ProductNDC>0781-2477</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250916</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202836</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&amp;C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD &amp; C yellow No. 5, FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD&amp;C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD&amp;C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&amp;C red No. 40, FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&amp;C blue No. 2/Indigo carmine aluminum lake, FD&amp;C red No. 40/Allura red AC aluminum lake, FD&amp;C blue No. 1/Brilliant blue FCF aluminum lake, and D&amp;C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&amp;C blue No. 2/Indigo carmine aluminum lake, FD&amp;C red No. 40/Allura red AC aluminum lake, FD&amp;C blue No. 1/Brilliant blue FCF aluminum lake, and D&amp;C yellow No. 10 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-2478-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2478-01) </PackageDescription>
    <NDC11Code>00781-2478-01</NDC11Code>
    <ProductNDC>0781-2478</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250916</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202836</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&amp;C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD &amp; C yellow No. 5, FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD&amp;C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD&amp;C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&amp;C red No. 40, FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&amp;C blue No. 2/Indigo carmine aluminum lake, FD&amp;C red No. 40/Allura red AC aluminum lake, FD&amp;C blue No. 1/Brilliant blue FCF aluminum lake, and D&amp;C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&amp;C blue No. 2/Indigo carmine aluminum lake, FD&amp;C red No. 40/Allura red AC aluminum lake, FD&amp;C blue No. 1/Brilliant blue FCF aluminum lake, and D&amp;C yellow No. 10 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-2479-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2479-01) </PackageDescription>
    <NDC11Code>00781-2479-01</NDC11Code>
    <ProductNDC>0781-2479</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250916</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202836</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&amp;C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD &amp; C yellow No. 5, FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD&amp;C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD&amp;C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&amp;C red No. 40, FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&amp;C blue No. 2/Indigo carmine aluminum lake, FD&amp;C red No. 40/Allura red AC aluminum lake, FD&amp;C blue No. 1/Brilliant blue FCF aluminum lake, and D&amp;C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&amp;C blue No. 2/Indigo carmine aluminum lake, FD&amp;C red No. 40/Allura red AC aluminum lake, FD&amp;C blue No. 1/Brilliant blue FCF aluminum lake, and D&amp;C yellow No. 10 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-2480-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2480-01) </PackageDescription>
    <NDC11Code>00781-2480-01</NDC11Code>
    <ProductNDC>0781-2480</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250916</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202836</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&amp;C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD &amp; C yellow No. 5, FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD&amp;C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD&amp;C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&amp;C red No. 40, FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&amp;C blue No. 2/Indigo carmine aluminum lake, FD&amp;C red No. 40/Allura red AC aluminum lake, FD&amp;C blue No. 1/Brilliant blue FCF aluminum lake, and D&amp;C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&amp;C blue No. 2/Indigo carmine aluminum lake, FD&amp;C red No. 40/Allura red AC aluminum lake, FD&amp;C blue No. 1/Brilliant blue FCF aluminum lake, and D&amp;C yellow No. 10 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-2481-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2481-01) </PackageDescription>
    <NDC11Code>00781-2481-01</NDC11Code>
    <ProductNDC>0781-2481</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250916</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202836</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&amp;C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD &amp; C yellow No. 5, FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD&amp;C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&amp;C blue No. 1, FD&amp;C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&amp;C red No. 40, FD&amp;C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&amp;C blue No. 2/Indigo carmine aluminum lake, FD&amp;C red No. 40/Allura red AC aluminum lake, FD&amp;C blue No. 1/Brilliant blue FCF aluminum lake, and D&amp;C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&amp;C blue No. 2/Indigo carmine aluminum lake, FD&amp;C red No. 40/Allura red AC aluminum lake, FD&amp;C blue No. 1/Brilliant blue FCF aluminum lake, and D&amp;C yellow No. 10 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-3159-72</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (0781-3159-72)  / 2 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00781-3159-72</NDC11Code>
    <ProductNDC>0781-3159</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20111024</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201588</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111024</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine for injection is an atypical antipsychotic indicated: 1 Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) , 2 Efficacy was established in three 1-day trials in adults. (14.3) .</IndicationAndUsage>
    <Description>Olanzapine 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. 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>0781-5766-31</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0781-5766-31) </PackageDescription>
    <NDC11Code>00781-5766-31</NDC11Code>
    <ProductNDC>0781-5766</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sitagliptin Phosphate</ProprietaryName>
    <NonProprietaryName>Sitagliptin Phosphate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202387</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin tablets. [See Warnings and Precautions (5.1).].</IndicationAndUsage>
    <Description>Sitagliptin tablets, USP contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The molecular formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, and ether; and insoluble in 2-propanol. Each film-coated tablet of sitagliptin contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. The film coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropyl cellulose, polyethylene glycol, talc, and titanium dioxide. In addition, the 100 mg tablets contains ferric oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-5766-92</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0781-5766-92) </PackageDescription>
    <NDC11Code>00781-5766-92</NDC11Code>
    <ProductNDC>0781-5766</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sitagliptin Phosphate</ProprietaryName>
    <NonProprietaryName>Sitagliptin Phosphate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202387</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin tablets. [See Warnings and Precautions (5.1).].</IndicationAndUsage>
    <Description>Sitagliptin tablets, USP contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The molecular formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, and ether; and insoluble in 2-propanol. Each film-coated tablet of sitagliptin contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. The film coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropyl cellulose, polyethylene glycol, talc, and titanium dioxide. In addition, the 100 mg tablets contains ferric oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-5768-31</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0781-5768-31) </PackageDescription>
    <NDC11Code>00781-5768-31</NDC11Code>
    <ProductNDC>0781-5768</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sitagliptin Phosphate</ProprietaryName>
    <NonProprietaryName>Sitagliptin Phosphate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202387</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin tablets. [See Warnings and Precautions (5.1).].</IndicationAndUsage>
    <Description>Sitagliptin tablets, USP contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The molecular formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, and ether; and insoluble in 2-propanol. Each film-coated tablet of sitagliptin contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. The film coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropyl cellulose, polyethylene glycol, talc, and titanium dioxide. In addition, the 100 mg tablets contains ferric oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-5768-92</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0781-5768-92) </PackageDescription>
    <NDC11Code>00781-5768-92</NDC11Code>
    <ProductNDC>0781-5768</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sitagliptin Phosphate</ProprietaryName>
    <NonProprietaryName>Sitagliptin Phosphate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202387</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin tablets. [See Warnings and Precautions (5.1).].</IndicationAndUsage>
    <Description>Sitagliptin tablets, USP contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The molecular formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, and ether; and insoluble in 2-propanol. Each film-coated tablet of sitagliptin contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. The film coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropyl cellulose, polyethylene glycol, talc, and titanium dioxide. In addition, the 100 mg tablets contains ferric oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-5770-10</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (0781-5770-10) </PackageDescription>
    <NDC11Code>00781-5770-10</NDC11Code>
    <ProductNDC>0781-5770</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sitagliptin Phosphate</ProprietaryName>
    <NonProprietaryName>Sitagliptin Phosphate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202387</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin tablets. [See Warnings and Precautions (5.1).].</IndicationAndUsage>
    <Description>Sitagliptin tablets, USP contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The molecular formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, and ether; and insoluble in 2-propanol. Each film-coated tablet of sitagliptin contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. The film coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropyl cellulose, polyethylene glycol, talc, and titanium dioxide. In addition, the 100 mg tablets contains ferric oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-5770-31</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0781-5770-31) </PackageDescription>
    <NDC11Code>00781-5770-31</NDC11Code>
    <ProductNDC>0781-5770</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sitagliptin Phosphate</ProprietaryName>
    <NonProprietaryName>Sitagliptin Phosphate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202387</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin tablets. [See Warnings and Precautions (5.1).].</IndicationAndUsage>
    <Description>Sitagliptin tablets, USP contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The molecular formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, and ether; and insoluble in 2-propanol. Each film-coated tablet of sitagliptin contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. The film coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropyl cellulose, polyethylene glycol, talc, and titanium dioxide. In addition, the 100 mg tablets contains ferric oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-5770-92</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0781-5770-92) </PackageDescription>
    <NDC11Code>00781-5770-92</NDC11Code>
    <ProductNDC>0781-5770</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sitagliptin Phosphate</ProprietaryName>
    <NonProprietaryName>Sitagliptin Phosphate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202387</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin tablets. [See Warnings and Precautions (5.1).].</IndicationAndUsage>
    <Description>Sitagliptin tablets, USP contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The molecular formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, and ether; and insoluble in 2-propanol. Each film-coated tablet of sitagliptin contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. The film coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropyl cellulose, polyethylene glycol, talc, and titanium dioxide. In addition, the 100 mg tablets contains ferric oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-5801-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0781-5801-05) </PackageDescription>
    <NDC11Code>00781-5801-05</NDC11Code>
    <ProductNDC>0781-5801</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sitagliptin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Sitagliptin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202388</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50; 500</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sitagliptin and metformin hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin and metformin hydrochloride should not be used in patients with type 1 diabetes mellitus. Sitagliptin and metformin hydrochloride have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin and metformin hydrochloride. [see Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>Sitagliptin and metformin hydrochloride tablets for oral use contain two oral antihyperglycemic drugs: sitagliptin and metformin hydrochloride. Sitagliptin. Sitagliptin is an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin is present in Sitagliptin and metformin hydrochloride tablets in the form of sitagliptin phosphate monohydrate. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate with a molecular formula of C16H15F6N5OH3PO4H2O and a molecular weight of 523.32. The structural formula is. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Metformin hydrochloride. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin hydrochloride is a white crystalline powder with a molecular formula of C4H11N5HCl 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. The structural formula is as shown. Sitagliptin and metformin hydrochloride. Sitagliptin and metformin hydrochloride are available for oral administration as tablets containing 64.25 mg sitagliptin phosphate monohydrate and metformin hydrochloride equivalent to: 50 mg sitagliptin as free base and 500 mg metformin hydrochloride (Sitagliptin and metformin hydrochloride 50 mg/500 mg) or 1,000 mg metformin hydrochloride (Sitagliptin and metformin hydrochloride 50 mg/1,000 mg). Each film-coated tablet of sitagliptin and metformin hydrochloride contains the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, povidone K30, sodium lauryl sulfate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropyl cellulose, talc, titanium dioxide, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-5801-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0781-5801-60) </PackageDescription>
    <NDC11Code>00781-5801-60</NDC11Code>
    <ProductNDC>0781-5801</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sitagliptin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Sitagliptin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202388</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50; 500</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sitagliptin and metformin hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin and metformin hydrochloride should not be used in patients with type 1 diabetes mellitus. Sitagliptin and metformin hydrochloride have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin and metformin hydrochloride. [see Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>Sitagliptin and metformin hydrochloride tablets for oral use contain two oral antihyperglycemic drugs: sitagliptin and metformin hydrochloride. Sitagliptin. Sitagliptin is an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin is present in Sitagliptin and metformin hydrochloride tablets in the form of sitagliptin phosphate monohydrate. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate with a molecular formula of C16H15F6N5OH3PO4H2O and a molecular weight of 523.32. The structural formula is. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Metformin hydrochloride. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin hydrochloride is a white crystalline powder with a molecular formula of C4H11N5HCl 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. The structural formula is as shown. Sitagliptin and metformin hydrochloride. Sitagliptin and metformin hydrochloride are available for oral administration as tablets containing 64.25 mg sitagliptin phosphate monohydrate and metformin hydrochloride equivalent to: 50 mg sitagliptin as free base and 500 mg metformin hydrochloride (Sitagliptin and metformin hydrochloride 50 mg/500 mg) or 1,000 mg metformin hydrochloride (Sitagliptin and metformin hydrochloride 50 mg/1,000 mg). Each film-coated tablet of sitagliptin and metformin hydrochloride contains the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, povidone K30, sodium lauryl sulfate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropyl cellulose, talc, titanium dioxide, and triethyl citrate.</Description>
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    <IndicationAndUsage>Sitagliptin and metformin hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin and metformin hydrochloride should not be used in patients with type 1 diabetes mellitus. Sitagliptin and metformin hydrochloride have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin and metformin hydrochloride. [see Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>Sitagliptin and metformin hydrochloride tablets for oral use contain two oral antihyperglycemic drugs: sitagliptin and metformin hydrochloride. Sitagliptin. Sitagliptin is an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin is present in Sitagliptin and metformin hydrochloride tablets in the form of sitagliptin phosphate monohydrate. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate with a molecular formula of C16H15F6N5OH3PO4H2O and a molecular weight of 523.32. The structural formula is. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Metformin hydrochloride. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin hydrochloride is a white crystalline powder with a molecular formula of C4H11N5HCl 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. The structural formula is as shown. Sitagliptin and metformin hydrochloride. Sitagliptin and metformin hydrochloride are available for oral administration as tablets containing 64.25 mg sitagliptin phosphate monohydrate and metformin hydrochloride equivalent to: 50 mg sitagliptin as free base and 500 mg metformin hydrochloride (Sitagliptin and metformin hydrochloride 50 mg/500 mg) or 1,000 mg metformin hydrochloride (Sitagliptin and metformin hydrochloride 50 mg/1,000 mg). Each film-coated tablet of sitagliptin and metformin hydrochloride contains the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, povidone K30, sodium lauryl sulfate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropyl cellulose, talc, titanium dioxide, and triethyl citrate.</Description>
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    <IndicationAndUsage>Sitagliptin and metformin hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin and metformin hydrochloride should not be used in patients with type 1 diabetes mellitus. Sitagliptin and metformin hydrochloride have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin and metformin hydrochloride. [see Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>Sitagliptin and metformin hydrochloride tablets for oral use contain two oral antihyperglycemic drugs: sitagliptin and metformin hydrochloride. Sitagliptin. Sitagliptin is an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin is present in Sitagliptin and metformin hydrochloride tablets in the form of sitagliptin phosphate monohydrate. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate with a molecular formula of C16H15F6N5OH3PO4H2O and a molecular weight of 523.32. The structural formula is. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Metformin hydrochloride. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin hydrochloride is a white crystalline powder with a molecular formula of C4H11N5HCl 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. The structural formula is as shown. Sitagliptin and metformin hydrochloride. Sitagliptin and metformin hydrochloride are available for oral administration as tablets containing 64.25 mg sitagliptin phosphate monohydrate and metformin hydrochloride equivalent to: 50 mg sitagliptin as free base and 500 mg metformin hydrochloride (Sitagliptin and metformin hydrochloride 50 mg/500 mg) or 1,000 mg metformin hydrochloride (Sitagliptin and metformin hydrochloride 50 mg/1,000 mg). Each film-coated tablet of sitagliptin and metformin hydrochloride contains the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, povidone K30, sodium lauryl sulfate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropyl cellulose, talc, titanium dioxide, and triethyl citrate.</Description>
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    <IndicationAndUsage>Sitagliptin and metformin hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin and metformin hydrochloride should not be used in patients with type 1 diabetes mellitus. Sitagliptin and metformin hydrochloride have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin and metformin hydrochloride. [see Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>Sitagliptin and metformin hydrochloride tablets for oral use contain two oral antihyperglycemic drugs: sitagliptin and metformin hydrochloride. Sitagliptin. Sitagliptin is an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin is present in Sitagliptin and metformin hydrochloride tablets in the form of sitagliptin phosphate monohydrate. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate with a molecular formula of C16H15F6N5OH3PO4H2O and a molecular weight of 523.32. The structural formula is. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Metformin hydrochloride. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin hydrochloride is a white crystalline powder with a molecular formula of C4H11N5HCl 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. The structural formula is as shown. Sitagliptin and metformin hydrochloride. Sitagliptin and metformin hydrochloride are available for oral administration as tablets containing 64.25 mg sitagliptin phosphate monohydrate and metformin hydrochloride equivalent to: 50 mg sitagliptin as free base and 500 mg metformin hydrochloride (Sitagliptin and metformin hydrochloride 50 mg/500 mg) or 1,000 mg metformin hydrochloride (Sitagliptin and metformin hydrochloride 50 mg/1,000 mg). Each film-coated tablet of sitagliptin and metformin hydrochloride contains the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, povidone K30, sodium lauryl sulfate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropyl cellulose, talc, titanium dioxide, and triethyl citrate.</Description>
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    <IndicationAndUsage>Sitagliptin and metformin hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin and metformin hydrochloride should not be used in patients with type 1 diabetes mellitus. Sitagliptin and metformin hydrochloride have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin and metformin hydrochloride. [see Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>Sitagliptin and metformin hydrochloride tablets for oral use contain two oral antihyperglycemic drugs: sitagliptin and metformin hydrochloride. Sitagliptin. Sitagliptin is an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin is present in Sitagliptin and metformin hydrochloride tablets in the form of sitagliptin phosphate monohydrate. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate with a molecular formula of C16H15F6N5OH3PO4H2O and a molecular weight of 523.32. The structural formula is. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Metformin hydrochloride. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin hydrochloride is a white crystalline powder with a molecular formula of C4H11N5HCl 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. The structural formula is as shown. Sitagliptin and metformin hydrochloride. Sitagliptin and metformin hydrochloride are available for oral administration as tablets containing 64.25 mg sitagliptin phosphate monohydrate and metformin hydrochloride equivalent to: 50 mg sitagliptin as free base and 500 mg metformin hydrochloride (Sitagliptin and metformin hydrochloride 50 mg/500 mg) or 1,000 mg metformin hydrochloride (Sitagliptin and metformin hydrochloride 50 mg/1,000 mg). Each film-coated tablet of sitagliptin and metformin hydrochloride contains the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, povidone K30, sodium lauryl sulfate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropyl cellulose, talc, titanium dioxide, and triethyl citrate.</Description>
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