RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>70727-529-99</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (70727-529-99)  / 2.5 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>70727-0529-99</NDC11Code>
    <ProductNDC>70727-529</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rocklatan</ProprietaryName>
    <NonProprietaryName>Netarsudil And Latanoprost Ophthalmic Solution, 0.02%/0.005%</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC; TOPICAL</RouteName>
    <StartMarketingDate>20190312</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208259</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>NETARSUDIL MESYLATE; LATANOPROST</SubstanceName>
    <StrengthNumber>.2; .05</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Rho Kinase Inhibitor [EPC], Rho Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190312</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>ROCKLATAN is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F2α analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.</IndicationAndUsage>
    <Description>ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F2α analogue. The chemical name of netarsudil dimesylate is: (S)-4-(3-amino-1-(isoquinolin-6-yl-amino)-1-oxopropan-2-yl)benzyl 2,4-dimethylbenzoate dimesylate. Its molecular formula is C30H35N3O9S2 and its chemical structure is. Netarsudil mesylate is a light yellow to white powder that is freely soluble in water, soluble in methanol, sparingly soluble in dimethyl formamide, and practically insoluble in dichloromethane and heptane. The chemical name of latanoprost is: isopropyl-(Z)-7[1R,2R,3R,5S) 3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C26H40O5 and its chemical structure is. Latanoprost is a colorless to slightly yellow oil that is very soluble in acetonitrile and freely soluble in acetone, ethanol, ethyl acetate, isopropanol, methanol, and octanol. It is practically insoluble in water. ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is supplied as a sterile, isotonic, buffered aqueous solution of netarsudil mesylate and latanoprost with a pH of approximately 5 and an osmolality of approximately 295 mOsmol/kg. Each mL of ROCKLATAN contains 0.20 mg of netarsudil (equivalent to 0.28 mg of netarsudil dimesylate) and 0.05 mg latanoprost. Benzalkonium chloride, 0.02%, is added as a preservative. The inactive ingredients are: boric acid, mannitol, sodium hydroxide to adjust pH, and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>70727-529-25</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (70727-529-25)  / 2.5 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>70727-0529-25</NDC11Code>
    <ProductNDC>70727-529</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rocklatan</ProprietaryName>
    <NonProprietaryName>Netarsudil And Latanoprost Ophthalmic Solution, 0.02%/0.005%</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC; TOPICAL</RouteName>
    <StartMarketingDate>20190312</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208259</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>NETARSUDIL MESYLATE; LATANOPROST</SubstanceName>
    <StrengthNumber>.2; .05</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Rho Kinase Inhibitor [EPC], Rho Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190312</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ROCKLATAN is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F2α analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.</IndicationAndUsage>
    <Description>ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F2α analogue. The chemical name of netarsudil dimesylate is: (S)-4-(3-amino-1-(isoquinolin-6-yl-amino)-1-oxopropan-2-yl)benzyl 2,4-dimethylbenzoate dimesylate. Its molecular formula is C30H35N3O9S2 and its chemical structure is. Netarsudil mesylate is a light yellow to white powder that is freely soluble in water, soluble in methanol, sparingly soluble in dimethyl formamide, and practically insoluble in dichloromethane and heptane. The chemical name of latanoprost is: isopropyl-(Z)-7[1R,2R,3R,5S) 3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C26H40O5 and its chemical structure is. Latanoprost is a colorless to slightly yellow oil that is very soluble in acetonitrile and freely soluble in acetone, ethanol, ethyl acetate, isopropanol, methanol, and octanol. It is practically insoluble in water. ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is supplied as a sterile, isotonic, buffered aqueous solution of netarsudil mesylate and latanoprost with a pH of approximately 5 and an osmolality of approximately 295 mOsmol/kg. Each mL of ROCKLATAN contains 0.20 mg of netarsudil (equivalent to 0.28 mg of netarsudil dimesylate) and 0.05 mg latanoprost. Benzalkonium chloride, 0.02%, is added as a preservative. The inactive ingredients are: boric acid, mannitol, sodium hydroxide to adjust pH, and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>70727-497-99</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (70727-497-99)  / 2.5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>70727-0497-99</NDC11Code>
    <ProductNDC>70727-497</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rhopressa</ProprietaryName>
    <NonProprietaryName>Netarsudil</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC; TOPICAL</RouteName>
    <StartMarketingDate>20171218</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208254</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>NETARSUDIL MESYLATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Rho Kinase Inhibitor [EPC], Rho Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171218</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>RHOPRESSA is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.</IndicationAndUsage>
    <Description>Netarsudil is a Rho kinase inhibitor. Its chemical name is (S)-4-(3-amino-1-(isoquinolin-6-yl-amino)-1-oxopropan-2-yl) benzyl 2,4-dimethylbenzoate dimesylate. The molecular formula of the free base is C28H27N3O3 and the molecular formula of the dimesylate is C30H35N3O9S2. The molecular weight of the free base is 453.54 and the molecular weight of the dimesylate is 645.74. The chemical structure is. Netarsudil dimesylate is a light yellow-to-white powder that is freely soluble in water, soluble in methanol, sparingly soluble in dimethyl formamide, and practically insoluble in dichloromethane and heptane. RHOPRESSA (netarsudil ophthalmic solution) 0.02% is supplied as a sterile, isotonic, buffered aqueous solution of netarsudil dimesylate with a pH of approximately 5 and an osmolality of approximately 295 mOsmol/kg. It is intended for topical application in the eye. Each mL of RHOPRESSA contains 0.2 mg of netarsudil (equivalent to 0.28 mg of netarsudil dimesylate). Benzalkonium chloride, 0.015%, is added as a preservative. The inactive ingredients are: boric acid, mannitol, sodium hydroxide to adjust pH, and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>70727-324-01</NDCCode>
    <PackageDescription>150 g in 1 BOTTLE (70727-324-01) </PackageDescription>
    <NDC11Code>70727-0324-01</NDC11Code>
    <ProductNDC>70727-324</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Netarsudil Mesylate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20171218</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>NETARSUDIL MESYLATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-12-07</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>18-DEC-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>70727-497-25</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (70727-497-25)  / 2.5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>70727-0497-25</NDC11Code>
    <ProductNDC>70727-497</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rhopressa</ProprietaryName>
    <NonProprietaryName>Netarsudil</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC; TOPICAL</RouteName>
    <StartMarketingDate>20171218</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208254</ApplicationNumber>
    <LabelerName>Alcon Laboratories, Inc.</LabelerName>
    <SubstanceName>NETARSUDIL MESYLATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Rho Kinase Inhibitor [EPC], Rho Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RHOPRESSA is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.</IndicationAndUsage>
    <Description>Netarsudil is a Rho kinase inhibitor. Its chemical name is (S)-4-(3-amino-1-(isoquinolin-6-yl-amino)-1-oxopropan-2-yl) benzyl 2,4-dimethylbenzoate dimesylate. The molecular formula of the free base is C28H27N3O3 and the molecular formula of the dimesylate is C30H35N3O9S2. The molecular weight of the free base is 453.54 and the molecular weight of the dimesylate is 645.74. The chemical structure is. Netarsudil dimesylate is a light yellow-to-white powder that is freely soluble in water, soluble in methanol, sparingly soluble in dimethyl formamide, and practically insoluble in dichloromethane and heptane. RHOPRESSA (netarsudil ophthalmic solution) 0.02% is supplied as a sterile, isotonic, buffered aqueous solution of netarsudil dimesylate with a pH of approximately 5 and an osmolality of approximately 295 mOsmol/kg. It is intended for topical application in the eye. Each mL of RHOPRESSA contains 0.2 mg of netarsudil (equivalent to 0.28 mg of netarsudil dimesylate). Benzalkonium chloride, 0.015%, is added as a preservative. The inactive ingredients are: boric acid, mannitol, sodium hydroxide to adjust pH, and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0526-51</NDCCode>
    <PackageDescription>28 CAPSULE in 1 BLISTER PACK (0078-0526-51) </PackageDescription>
    <NDC11Code>00078-0526-51</NDC11Code>
    <ProductNDC>0078-0526</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tasigna</ProprietaryName>
    <NonProprietaryName>Nilotinib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071029</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022068</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>NILOTINIB HYDROCHLORIDE MONOHYDRATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071029</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tasigna is a kinase inhibitor indicated for the treatment of: 1 Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2) , 3 Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. (1.3) .</IndicationAndUsage>
    <Description>Tasigna contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to slightly yellowish to slightly greenish yellow powder with the molecular formula and weight, respectively, of C28H22F3N7OHCl  H2O and 584 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pKa1 was determined to be 2.1; pKa2 was estimated to be 5.4. The chemical name of nilotinib monohydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below. Tasigna (nilotinib) capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55 mg, 166 mg, and 221 mg nilotinib monohydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and poloxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow), iron oxide (black), and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0526-87</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (0078-0526-87)  / 28 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00078-0526-87</NDC11Code>
    <ProductNDC>0078-0526</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tasigna</ProprietaryName>
    <NonProprietaryName>Nilotinib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071029</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022068</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>NILOTINIB HYDROCHLORIDE MONOHYDRATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071029</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tasigna is a kinase inhibitor indicated for the treatment of: 1 Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2) , 3 Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. (1.3) .</IndicationAndUsage>
    <Description>Tasigna contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to slightly yellowish to slightly greenish yellow powder with the molecular formula and weight, respectively, of C28H22F3N7OHCl  H2O and 584 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pKa1 was determined to be 2.1; pKa2 was estimated to be 5.4. The chemical name of nilotinib monohydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below. Tasigna (nilotinib) capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55 mg, 166 mg, and 221 mg nilotinib monohydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and poloxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow), iron oxide (black), and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0592-51</NDCCode>
    <PackageDescription>28 CAPSULE in 1 BLISTER PACK (0078-0592-51) </PackageDescription>
    <NDC11Code>00078-0592-51</NDC11Code>
    <ProductNDC>0078-0592</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tasigna</ProprietaryName>
    <NonProprietaryName>Nilotinib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071029</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022068</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>NILOTINIB HYDROCHLORIDE MONOHYDRATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071029</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tasigna is a kinase inhibitor indicated for the treatment of: 1 Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2) , 3 Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. (1.3) .</IndicationAndUsage>
    <Description>Tasigna contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to slightly yellowish to slightly greenish yellow powder with the molecular formula and weight, respectively, of C28H22F3N7OHCl  H2O and 584 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pKa1 was determined to be 2.1; pKa2 was estimated to be 5.4. The chemical name of nilotinib monohydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below. Tasigna (nilotinib) capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55 mg, 166 mg, and 221 mg nilotinib monohydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and poloxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow), iron oxide (black), and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0592-87</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (0078-0592-87)  / 28 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00078-0592-87</NDC11Code>
    <ProductNDC>0078-0592</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tasigna</ProprietaryName>
    <NonProprietaryName>Nilotinib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071029</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022068</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>NILOTINIB HYDROCHLORIDE MONOHYDRATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071029</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tasigna is a kinase inhibitor indicated for the treatment of: 1 Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2) , 3 Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. (1.3) .</IndicationAndUsage>
    <Description>Tasigna contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to slightly yellowish to slightly greenish yellow powder with the molecular formula and weight, respectively, of C28H22F3N7OHCl  H2O and 584 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pKa1 was determined to be 2.1; pKa2 was estimated to be 5.4. The chemical name of nilotinib monohydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below. Tasigna (nilotinib) capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55 mg, 166 mg, and 221 mg nilotinib monohydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and poloxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow), iron oxide (black), and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0951-66</NDCCode>
    <PackageDescription>120 CAPSULE in 1 BOTTLE, PLASTIC (0078-0951-66) </PackageDescription>
    <NDC11Code>00078-0951-66</NDC11Code>
    <ProductNDC>0078-0951</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tasigna</ProprietaryName>
    <NonProprietaryName>Nilotinib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071029</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022068</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>NILOTINIB HYDROCHLORIDE MONOHYDRATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tasigna is a kinase inhibitor indicated for the treatment of: 1 Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2) , 3 Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. (1.3) .</IndicationAndUsage>
    <Description>Tasigna contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to slightly yellowish to slightly greenish yellow powder with the molecular formula and weight, respectively, of C28H22F3N7OHCl  H2O and 584 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pKa1 was determined to be 2.1; pKa2 was estimated to be 5.4. The chemical name of nilotinib monohydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below. Tasigna (nilotinib) capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55 mg, 166 mg, and 221 mg nilotinib monohydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and poloxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow), iron oxide (black), and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0270-5164-12</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-12)  / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00270-5164-12</NDC11Code>
    <ProductNDC>0270-5164</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multihance</ProprietaryName>
    <NonProprietaryName>Gadobenate Dimeglumine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20041123</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021357</ApplicationNumber>
    <LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
    <SubstanceName>GADOBENATE DIMEGLUMINE</SubstanceName>
    <StrengthNumber>529</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20041123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>magnetic resonance imaging (MRI) of the central nervoussystem (CNS) in adults and pediatric patients (including term neonates),to visualize lesions with abnormal blood-brain barrier or abnormalvascularity of the brain, spine, and associated tissues. (1.1). magnetic resonance angiography (MRA) to evaluate adultswith known or suspected renal or aorto-ilio-femoral occlusive vasculardisease. (1.2).</IndicationAndUsage>
    <Description>MultiHance injection is supplied as a sterile, nonpyrogenic, clear, colorless to slightly yellow aqueous solution intended for intravenous use only. Each mL of MultiHance contains 529 mg gadobenate dimeglumine and water for injection. MultiHance contains no preservatives. Gadobenate dimeglumine is chemically designated as (4RS)-[4-carboxy-5,8,11-tris(carboxymethyl)- 1-phenyl-2-oxa-5,8,11-triazatridecan-13-oato(5-)] gadolinate(2-) dihydrogen compound with 1-deoxy-1-(methylamino)-D-glucitol (1:2) with a molecular weight of 1058.2 and an empirical formula of C22H28GdN3O11  2C7H17NO5. The structural formula is as follows. MultiHance has a pH of 6.5-7.5. Pertinent physicochemical parameters are provided below. MultiHance has an osmolality 6.9 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use.</Description>
  </NDC>
  <NDC>
    <NDCCode>0270-5164-13</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-13)  / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00270-5164-13</NDC11Code>
    <ProductNDC>0270-5164</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multihance</ProprietaryName>
    <NonProprietaryName>Gadobenate Dimeglumine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20041123</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021357</ApplicationNumber>
    <LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
    <SubstanceName>GADOBENATE DIMEGLUMINE</SubstanceName>
    <StrengthNumber>529</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20041123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>magnetic resonance imaging (MRI) of the central nervoussystem (CNS) in adults and pediatric patients (including term neonates),to visualize lesions with abnormal blood-brain barrier or abnormalvascularity of the brain, spine, and associated tissues. (1.1). magnetic resonance angiography (MRA) to evaluate adultswith known or suspected renal or aorto-ilio-femoral occlusive vasculardisease. (1.2).</IndicationAndUsage>
    <Description>MultiHance injection is supplied as a sterile, nonpyrogenic, clear, colorless to slightly yellow aqueous solution intended for intravenous use only. Each mL of MultiHance contains 529 mg gadobenate dimeglumine and water for injection. MultiHance contains no preservatives. Gadobenate dimeglumine is chemically designated as (4RS)-[4-carboxy-5,8,11-tris(carboxymethyl)- 1-phenyl-2-oxa-5,8,11-triazatridecan-13-oato(5-)] gadolinate(2-) dihydrogen compound with 1-deoxy-1-(methylamino)-D-glucitol (1:2) with a molecular weight of 1058.2 and an empirical formula of C22H28GdN3O11  2C7H17NO5. The structural formula is as follows. MultiHance has a pH of 6.5-7.5. Pertinent physicochemical parameters are provided below. MultiHance has an osmolality 6.9 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use.</Description>
  </NDC>
  <NDC>
    <NDCCode>0270-5164-14</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-14)  / 15 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00270-5164-14</NDC11Code>
    <ProductNDC>0270-5164</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multihance</ProprietaryName>
    <NonProprietaryName>Gadobenate Dimeglumine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20041123</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021357</ApplicationNumber>
    <LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
    <SubstanceName>GADOBENATE DIMEGLUMINE</SubstanceName>
    <StrengthNumber>529</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20041123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>magnetic resonance imaging (MRI) of the central nervoussystem (CNS) in adults and pediatric patients (including term neonates),to visualize lesions with abnormal blood-brain barrier or abnormalvascularity of the brain, spine, and associated tissues. (1.1). magnetic resonance angiography (MRA) to evaluate adultswith known or suspected renal or aorto-ilio-femoral occlusive vasculardisease. (1.2).</IndicationAndUsage>
    <Description>MultiHance injection is supplied as a sterile, nonpyrogenic, clear, colorless to slightly yellow aqueous solution intended for intravenous use only. Each mL of MultiHance contains 529 mg gadobenate dimeglumine and water for injection. MultiHance contains no preservatives. Gadobenate dimeglumine is chemically designated as (4RS)-[4-carboxy-5,8,11-tris(carboxymethyl)- 1-phenyl-2-oxa-5,8,11-triazatridecan-13-oato(5-)] gadolinate(2-) dihydrogen compound with 1-deoxy-1-(methylamino)-D-glucitol (1:2) with a molecular weight of 1058.2 and an empirical formula of C22H28GdN3O11  2C7H17NO5. The structural formula is as follows. MultiHance has a pH of 6.5-7.5. Pertinent physicochemical parameters are provided below. MultiHance has an osmolality 6.9 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use.</Description>
  </NDC>
  <NDC>
    <NDCCode>0270-5164-15</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-15)  / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00270-5164-15</NDC11Code>
    <ProductNDC>0270-5164</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multihance</ProprietaryName>
    <NonProprietaryName>Gadobenate Dimeglumine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20041123</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021357</ApplicationNumber>
    <LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
    <SubstanceName>GADOBENATE DIMEGLUMINE</SubstanceName>
    <StrengthNumber>529</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20041123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>magnetic resonance imaging (MRI) of the central nervoussystem (CNS) in adults and pediatric patients (including term neonates),to visualize lesions with abnormal blood-brain barrier or abnormalvascularity of the brain, spine, and associated tissues. (1.1). magnetic resonance angiography (MRA) to evaluate adultswith known or suspected renal or aorto-ilio-femoral occlusive vasculardisease. (1.2).</IndicationAndUsage>
    <Description>MultiHance injection is supplied as a sterile, nonpyrogenic, clear, colorless to slightly yellow aqueous solution intended for intravenous use only. Each mL of MultiHance contains 529 mg gadobenate dimeglumine and water for injection. MultiHance contains no preservatives. Gadobenate dimeglumine is chemically designated as (4RS)-[4-carboxy-5,8,11-tris(carboxymethyl)- 1-phenyl-2-oxa-5,8,11-triazatridecan-13-oato(5-)] gadolinate(2-) dihydrogen compound with 1-deoxy-1-(methylamino)-D-glucitol (1:2) with a molecular weight of 1058.2 and an empirical formula of C22H28GdN3O11  2C7H17NO5. The structural formula is as follows. MultiHance has a pH of 6.5-7.5. Pertinent physicochemical parameters are provided below. MultiHance has an osmolality 6.9 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use.</Description>
  </NDC>
  <NDC>
    <NDCCode>0270-5264-16</NDCCode>
    <PackageDescription>5 BOTTLE, GLASS in 1 BOX (0270-5264-16)  / 50 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>00270-5264-16</NDC11Code>
    <ProductNDC>0270-5264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multihance</ProprietaryName>
    <NonProprietaryName>Gadobenate Dimeglumine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20041123</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021358</ApplicationNumber>
    <LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
    <SubstanceName>GADOBENATE DIMEGLUMINE</SubstanceName>
    <StrengthNumber>529</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20041123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>magnetic resonance imaging (MRI) of the central nervoussystem (CNS) in adults and pediatric patients (including term neonates),to visualize lesions with abnormal blood-brain barrier or abnormalvascularity of the brain, spine, and associated tissues (1.1). magnetic resonance angiography (MRA) to evaluate adultswith known or suspected renal or aorto-ilio-femoral occlusive vasculardisease. (1.2).</IndicationAndUsage>
    <Description>MultiHance injection is supplied as a sterile, nonpyrogenic, clear, colorless to slightly yellow aqueous solution intended for intravenous use only. Each mL of MultiHance contains 529 mg gadobenate dimeglumine and water for injection. MultiHance contains no preservatives. Gadobenate dimeglumine is chemically designated as (4RS)-[4-carboxy-5,8,11-tris(carboxymethyl)- 1-phenyl-2-oxa-5,8,11-triazatridecan-13-oato(5-)] gadolinate(2-) dihydrogen compound with 1-deoxy-1-(methylamino)-D-glucitol (1:2) with a molecular weight of 1058.2 and an empirical formula of C22H28GdN3O11  2C7H17NO5. The structural formula is as follows. MultiHance has a pH of 6.5-7.5. Pertinent physicochemical parameters are provided below. MultiHance has an osmolality 6.9 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use.</Description>
  </NDC>
  <NDC>
    <NDCCode>0270-5264-17</NDCCode>
    <PackageDescription>5 BOTTLE, GLASS in 1 BOX (0270-5264-17)  / 100 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>00270-5264-17</NDC11Code>
    <ProductNDC>0270-5264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multihance</ProprietaryName>
    <NonProprietaryName>Gadobenate Dimeglumine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20041123</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021358</ApplicationNumber>
    <LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
    <SubstanceName>GADOBENATE DIMEGLUMINE</SubstanceName>
    <StrengthNumber>529</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20041123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>magnetic resonance imaging (MRI) of the central nervoussystem (CNS) in adults and pediatric patients (including term neonates),to visualize lesions with abnormal blood-brain barrier or abnormalvascularity of the brain, spine, and associated tissues (1.1). magnetic resonance angiography (MRA) to evaluate adultswith known or suspected renal or aorto-ilio-femoral occlusive vasculardisease. (1.2).</IndicationAndUsage>
    <Description>MultiHance injection is supplied as a sterile, nonpyrogenic, clear, colorless to slightly yellow aqueous solution intended for intravenous use only. Each mL of MultiHance contains 529 mg gadobenate dimeglumine and water for injection. MultiHance contains no preservatives. Gadobenate dimeglumine is chemically designated as (4RS)-[4-carboxy-5,8,11-tris(carboxymethyl)- 1-phenyl-2-oxa-5,8,11-triazatridecan-13-oato(5-)] gadolinate(2-) dihydrogen compound with 1-deoxy-1-(methylamino)-D-glucitol (1:2) with a molecular weight of 1058.2 and an empirical formula of C22H28GdN3O11  2C7H17NO5. The structural formula is as follows. MultiHance has a pH of 6.5-7.5. Pertinent physicochemical parameters are provided below. MultiHance has an osmolality 6.9 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7355-04</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (0904-7355-04)  / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-7355-04</NDC11Code>
    <ProductNDC>0904-7355</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212244</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for:  Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].  Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lurasidone hydrochloride tablets are atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S, 7R, 7aS)-2-{ (1R,2R)-2-[ 4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl] methyl] cyclohexyl methyl}hexahydro-4, 7-methano-1H-isoindole-1, 3 (2H)-dione hydrochloride. Its molecular formula is C28H36N4O2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, lactose monohydrate, pregelatinized starch, croscarmellose sodium, povidone, anhydrous citric acid, magnesium stearate, hypromellose, titanium dioxide and Polyethylene glycol. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&amp;C Blue No. 1 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7356-61</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7356-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-7356-61</NDC11Code>
    <ProductNDC>0904-7356</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212244</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for:  Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].  Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lurasidone hydrochloride tablets are atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S, 7R, 7aS)-2-{ (1R,2R)-2-[ 4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl] methyl] cyclohexyl methyl}hexahydro-4, 7-methano-1H-isoindole-1, 3 (2H)-dione hydrochloride. Its molecular formula is C28H36N4O2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, lactose monohydrate, pregelatinized starch, croscarmellose sodium, povidone, anhydrous citric acid, magnesium stearate, hypromellose, titanium dioxide and Polyethylene glycol. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&amp;C Blue No. 1 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7357-61</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7357-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-7357-61</NDC11Code>
    <ProductNDC>0904-7357</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212244</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for:  Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].  Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lurasidone hydrochloride tablets are atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S, 7R, 7aS)-2-{ (1R,2R)-2-[ 4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl] methyl] cyclohexyl methyl}hexahydro-4, 7-methano-1H-isoindole-1, 3 (2H)-dione hydrochloride. Its molecular formula is C28H36N4O2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, lactose monohydrate, pregelatinized starch, croscarmellose sodium, povidone, anhydrous citric acid, magnesium stearate, hypromellose, titanium dioxide and Polyethylene glycol. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&amp;C Blue No. 1 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7358-61</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7358-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-7358-61</NDC11Code>
    <ProductNDC>0904-7358</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212244</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for:  Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].  Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lurasidone hydrochloride tablets are atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S, 7R, 7aS)-2-{ (1R,2R)-2-[ 4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl] methyl] cyclohexyl methyl}hexahydro-4, 7-methano-1H-isoindole-1, 3 (2H)-dione hydrochloride. Its molecular formula is C28H36N4O2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, lactose monohydrate, pregelatinized starch, croscarmellose sodium, povidone, anhydrous citric acid, magnesium stearate, hypromellose, titanium dioxide and Polyethylene glycol. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&amp;C Blue No. 1 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7359-04</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (0904-7359-04)  / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-7359-04</NDC11Code>
    <ProductNDC>0904-7359</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212244</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for:  Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].  Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lurasidone hydrochloride tablets are atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S, 7R, 7aS)-2-{ (1R,2R)-2-[ 4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl] methyl] cyclohexyl methyl}hexahydro-4, 7-methano-1H-isoindole-1, 3 (2H)-dione hydrochloride. Its molecular formula is C28H36N4O2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, lactose monohydrate, pregelatinized starch, croscarmellose sodium, povidone, anhydrous citric acid, magnesium stearate, hypromellose, titanium dioxide and Polyethylene glycol. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&amp;C Blue No. 1 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7421-46</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0904-7421-46) </PackageDescription>
    <NDC11Code>00904-7421-46</NDC11Code>
    <ProductNDC>0904-7421</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208037</ApplicationNumber>
    <LabelerName>MAJOR PHARMACEUTICALS</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)].  Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].  Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. The 20 mg, 40 mg, 60 mg, 80 mg and 120 mg tablets contain the following inactive ingredients: carnauba wax, citric acid anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, mannitol, polyethylene glycol, povidone, pregelatinized starch, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7422-46</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0904-7422-46) </PackageDescription>
    <NDC11Code>00904-7422-46</NDC11Code>
    <ProductNDC>0904-7422</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208037</ApplicationNumber>
    <LabelerName>MAJOR PHARMACEUTICALS</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)].  Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].  Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. The 20 mg, 40 mg, 60 mg, 80 mg and 120 mg tablets contain the following inactive ingredients: carnauba wax, citric acid anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, mannitol, polyethylene glycol, povidone, pregelatinized starch, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7423-46</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0904-7423-46) </PackageDescription>
    <NDC11Code>00904-7423-46</NDC11Code>
    <ProductNDC>0904-7423</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208037</ApplicationNumber>
    <LabelerName>MAJOR PHARMACEUTICALS</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)].  Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].  Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. The 20 mg, 40 mg, 60 mg, 80 mg and 120 mg tablets contain the following inactive ingredients: carnauba wax, citric acid anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, mannitol, polyethylene glycol, povidone, pregelatinized starch, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7424-46</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0904-7424-46) </PackageDescription>
    <NDC11Code>00904-7424-46</NDC11Code>
    <ProductNDC>0904-7424</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208037</ApplicationNumber>
    <LabelerName>MAJOR PHARMACEUTICALS</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)].  Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].  Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. The 20 mg, 40 mg, 60 mg, 80 mg and 120 mg tablets contain the following inactive ingredients: carnauba wax, citric acid anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, mannitol, polyethylene glycol, povidone, pregelatinized starch, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7425-46</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0904-7425-46) </PackageDescription>
    <NDC11Code>00904-7425-46</NDC11Code>
    <ProductNDC>0904-7425</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208037</ApplicationNumber>
    <LabelerName>MAJOR PHARMACEUTICALS</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)].  Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].  Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. The 20 mg, 40 mg, 60 mg, 80 mg and 120 mg tablets contain the following inactive ingredients: carnauba wax, citric acid anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, mannitol, polyethylene glycol, povidone, pregelatinized starch, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-529-12</NDCCode>
    <PackageDescription>12 CAPSULE in 1 BOTTLE (10544-529-12)</PackageDescription>
    <NDC11Code>10544-0529-12</NDC11Code>
    <ProductNDC>10544-529</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131003</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090836</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Cephalexin capsules, USP is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin capsules, USP is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note-Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Cephalexin capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of cephalexin. The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD &amp; C Blue No. 1, D &amp; C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD &amp; C Red No. 40; 333 mg and 750 mg Capsules contains FD &amp; C Yellow No. 6. The imprinting ink contains; shellac, strong ammonia solution, and potassium hydroxide.Also black Iron oxide is used in 250mg,333mg and 500mg and titanium dioxide is used in 750mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-529-21</NDCCode>
    <PackageDescription>21 CAPSULE in 1 BOTTLE (10544-529-21)</PackageDescription>
    <NDC11Code>10544-0529-21</NDC11Code>
    <ProductNDC>10544-529</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131003</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090836</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Cephalexin capsules, USP is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin capsules, USP is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note-Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Cephalexin capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of cephalexin. The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD &amp; C Blue No. 1, D &amp; C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD &amp; C Red No. 40; 333 mg and 750 mg Capsules contains FD &amp; C Yellow No. 6. The imprinting ink contains; shellac, strong ammonia solution, and potassium hydroxide.Also black Iron oxide is used in 250mg,333mg and 500mg and titanium dioxide is used in 750mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-529-40</NDCCode>
    <PackageDescription>40 CAPSULE in 1 BOTTLE (10544-529-40)</PackageDescription>
    <NDC11Code>10544-0529-40</NDC11Code>
    <ProductNDC>10544-529</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131003</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090836</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Cephalexin capsules, USP is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin capsules, USP is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note-Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Cephalexin capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of cephalexin. The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD &amp; C Blue No. 1, D &amp; C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD &amp; C Red No. 40; 333 mg and 750 mg Capsules contains FD &amp; C Yellow No. 6. The imprinting ink contains; shellac, strong ammonia solution, and potassium hydroxide.Also black Iron oxide is used in 250mg,333mg and 500mg and titanium dioxide is used in 750mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>10685-529-17</NDCCode>
    <PackageDescription>800 mL in 1 BAG (10685-529-17) </PackageDescription>
    <NDC11Code>10685-0529-17</NDC11Code>
    <ProductNDC>10685-529</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pc529 Ultrex</ProprietaryName>
    <NonProprietaryName>Chloroxylenol</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140121</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>CARROLL COMPANY</LabelerName>
    <SubstanceName>CHLOROXYLENOL</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>g/1000mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand washing in public washrooms, work areas, healthcare facilities. ofice buildings, food service facilities, and wherever cleanliness and. antimicrobial properties are desired.</IndicationAndUsage>
  </NDC>
</NDCList>